Asian Hospital & Healthcare Management - Issue 12

Vibration Response Imaging

Fibre Optic Plethysmography

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Quality Assurance in Surgery

Socially responsible behaviour across the value chain of private hospitals ensures that their role as legitimate healthcare providers is accepted.

John Zinkin Deputy Chairman CSR Malaysia

Visiting Fellow International Centre for Corporate Social Responsibility Nottingham University Business School UK

Corporate Social Responsibility in Private Hospitals

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Contents HEALTHCARE MANAGEMENT Cover Story

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New Drugs in

14

Corporate Social Responsibility

Anaesthesia A review

Swati Daftary, Consultant Anaesthesiologist, Jaslok Hospital & Research Centre, India

Stem Cell Therapy

27

The good, the bad and the confusing Michael Marber, Professor, Cardiology, Divisional Lead Mrinal Saha, Specialist Registrar, Cardiology, St. Thomas Hospital, UK

in Private Hospitals

SURGICAL SPECIALITY

Socially responsible behaviour across the value chain of private hospitals ensures that their role as legitimate healthcare providers is accepted.

Integrated Operating Rooms

29

Enabled by Richard Wolf’s ‘CORE’ system: A case study Henning Baldauf Project Manager - Core, Richard Wolf GmbH, Germany

Quality Assurance Programmes for Surgery 30 How and why in Asia?

John Zinkin,

Deputy Chairman CSR Malaysia Visiting Fellow International Centre for Corporate Social Responsibility Nottingham University Business School UK

Safe and Reliable Healthcare

Supporting strategy and structure

Learning from complaints

09

11

17

Delon Wu, President, Taiwan Hospital Association, Taiwan

Emerging opportunities

Matthew Dennis, Cancer Market Specialist, Espicom Business Intelligence, UK

35

Oral diseases and beyond

Innovations

37 Vibration Response Imaging A new methodology for measurement of lung vibrations Igal Kushnir, President and CEO, Deep Breeze Ltd, Israel

MEDICAL SCIENCES Cancer Nanomedicine

Oral-based Diagnostics

Antoon J M Ligtenberg, Assistant Professor, Department of Oral Biochemistry, Academic Centre for Dentistry Amsterdam (ACTA), The Netherlands

Ron Paterson, Health and Disability Commissioner, New Zealand

Leadership and Strategy in Healthcare

Yoshihiro Suematsu, Assistant Professor, Division of Cardiothoracic Surgery, University of Tokyo, Japan

DIAGNOSTICS

Peter A Gross, Chairman, Internal Medicine, Hackensack University Medical Center, USA

Healthcare in New Zealand

32 Advances in Cardiac Surgery

07

Michael Leonard, Physician Leader, Patient Safety, Kaiser Permanente Allan Frankel, Director, Patient Safety, Partners Healthcare, USA

In the Passionate Pursuit of Healthcare Excellence

Malcolm J Underwood, Professor, Department of Surgery CA van Hasselt, Professor, Department of Surgery Hong Fung, Cluster Chief Executive, New Territories, East, Chinese University of Hong Kong, Hong Kong SAR

19

Point-of-care Diagnostics

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Tapping the potential

Neil Butt, Consultant, Richard Owen, Consultant, Product and Process Engineering, PA Consulting Group, UK

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Asian Hospital & Healthcare Management

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2007

Circle 02

CONTENTS

TECHNOLOGY, EQUIPMENT & DEVICES Fiber Optic Plethysmography for Non-invasive Cardiac Monitoring

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Andy T Augousti, Professor, Applied Physics and Instrumentation, Faculty of Science, Kingston University, UK

George D Jelatis, Security Architect, Parkway Associates, USA

An emerging surgical revolution

Expansion time

48

Grace Jones Akhil Tandulwadikar Prasanthi Potluri Feroz Zaheer

Copy Editors Kiran BV Jagadeesh N Art Director M A Hannan Visualiser Narsingoji Raju

Project Associates

51

FACILITIES & Operations

Circulation Executives

Kevin Smith Kranti Kalidindi Abhishek Jain Chigarapati Diwakar

Advertising Support Team

Manoranjan Luke Rajkiran Boda L Vandana Chowdary P Venkata Nagendra Reddy

Marketing Manager Ahmed Tariq

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Stella Powell N Sweta Madhubabu Pasulla Santosh Kumar Dasari Anthony M

Circulation Manager Gagan Kumar Vallabhaneni

Andrew Wee, Research Analyst, APAC Healthcare, Frost & Sullivan, Singapore

Hospital of Tomorrow

Healthcare Editorial Team

Project Coordinators Sunny Roger Yuvraj Sahni

John R Adler, Jr., Professor, Neurosurgery and Director, Radiosurgery and Stereotactic Surgery, Stanford University School of Medicine, USA

China’s Medical Device Industry

2007

Chief Editor Rajeshwer Chigullapalli

Networking Implanted Medical Devices Ensuring effectiveness 45 and security

CyberKnife Radiosurgery

Issue 12

Asian Hospital & Healthcare Management is published by SPG Media Limited in association with Frost & Sullivan

The design perspective Henning Lensch, Managing Partner, RRP architects+engineers, Germany

INFORMATION TECHNOLOGY Building a e-Hospital Lessons from Taiwan

57

Min-Huei Hsu, Chief Information Officer, Wan Fang Hospital, Taipei Medical University, Taiwan

Spotlight

Information Technology in Healthcare Creating a stronger healthcare system

Madhav R Ragam, Director, Healthcare & Life Sciences, IBM Asia Pacific, Singapore

CEO, SPG Media Group Keith Sadler

Head, SPG Media, India Sanjay Manglik

SPG Media Group Plc Brunel House 55-57 North Wharf Road London, W2 1LA Tel : +44 (0) 20 7915 9660 Fax : +44 (0) 20 7724 2089

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SPG Media Private Limited 2nd Floor, Challa Chambers 6-3-907 –912, Rajbhavan Road Somajiguda, Hyderabad - 500082 India Tel : + 91 40 66837361/62/63 Fax : +91 40 23318066

Email: ahhm@spgmedia.com www.asianhhm.com | www.frost.com | www.spgmedia.com ISBN No. 1 85938 681 4 © SPG Media Limited. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying or otherwise, without prior permission of the publisher and copyright owner. Whilst every effort has been made to ensure the accuracy of the information in this publication, the publisher accepts no responsibility for errors or omissions.

The products and services advertised are not endorsed by or connected with the publisher or its associates. The editorial opinions expressed in this publication are those of individual authors and not necessarily those of the publisher or of its associates.

Copies of Asian Hospital & Healthcare Management can be purchased at the indicated cover prices. For bulk order reprints minimum order required is 500 copies, POA.

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Asian Hospital & Healthcare Management

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2007

Foreword Socially responsible, efficient healthcare Healthcare organisations, whether owned by the state or privately, either for-profit or not, shall provide incentives for efficiency, emphasise on safety, and have measures to practice and communicate socially responsible behaviour.

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t has been the fundamental premise that business organisations exist to create wealth for their shareholders ever since Adam Smith’s Wealth of Nations laid the foundations of classical free market economic theory in the 18th century. Several countries began building their economies on the free market model under which, business organisations regard their customers as important stakeholders. At the economy level, this model ensures that the most efficient users of shareholders’ money receive their capital investments.

The concept of corporate social responsibility in the context of businesses, in general, adds another dimension to this scenario. It postulates that business organisations should consider the society as a stakeholder in addition to their shareholders and customers. In doing so, corporations ensure their long-term survival. This is supported by the views of Peter Drucker, who argued that every organisation must be able to state that its business exists to serve public good (Practice of Management), in order to survive and thrive.

Unlike other businesses, however, a hospital’s raison d’etre is healthcare, which directly fits with notions of public good. Therefore, the dimensions of corporate social responsibility acquire a slightly different colour in the context of hospitals. More so, if the hospitals are privately owned, for-profit organisations. It is this aspect that is analysed in depth, in the cover story “Corporate Social Responsibility in Private Hospitals”,

by John Zinkin, Deputy Chairman, CSR Malaysia and Managing Director, Zinkin Ettinger Ltd., Malaysia.

The role of privately owned healthcare organisations is likely to increase in the future as state-owned healthcare systems are under severe strain in several regions. Asia’s two emerging economies, India and China, which have experienced stupendous economic growth as a result of reforms, too, still lag in the area of healthcare for all. The economic success achieved on the strength of countries’ human resources will be sustainable on the strength of improved healthcare systems.

Therefore, the message is loud and clear for the leaders of healthcare, whether the organisations are owned by the state or privately, either for-profit or not; they shall provide incentives for efficiency, emphasise on safety, and have measures to practice and communicate socially responsible behaviour. As an IBM study predicts, the future customers of healthcare will increasingly pay out of their pocket for healthcare, be more informed on account of proliferation of information enabled by information technology, and are likely to comparison-shop for the best healthcare providers just as they do when they buy a consumer durable.

Organisations that strive to be socially responsible will build brands that would be strong enough to sustain their performance over the long term.

Rajeshwer Chigullapalli Chief Editor

Essential reading for the healthcare professional

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Asian Hospital & Healthcare Management

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H E A L T H C A R E M anagement

Safe and Reliable Healthcare Supporting strategy and structure

Effective leaders translate their strategic goals into a few simple statements that everyone working in the organisation can understand and to which they can align their behaviour.

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o consistently deliver superior clinical quality and value, healthcare organisations must ensure that their strategy and structure are well coordinated. Organisations that succeed will be able to deliver superior clinical care and outcomes, and will have market advantage in brand reputation and operational efficiency. Success requires work in four areas: 1. Leadership—senior, administrative and clinical 2. human factors 3. reliable care systems and 4. patient–centric care.

Leadership Leaders must model and live organisational values everyday. If there is notable difference between the values inscribed on the hospital wall and what staff and patients experience every day, then habitual excellence is not possible. Cultural surveys have been useful in American hospitals to assess the real perceptions of staff as to their perception of management, the quality of their work experience, and how safe they feel to advocate for safe care.

Effective leaders translate their strategic goals into a few simple statements that

everyone working in the organisation can understand and to which they can align their behaviour.

If too many, or, made too complex, front line workers can neither remember the goals nor, while providing care, consistently align their behaviour to them. By contrast, Ascension Healthcare, the largest faith-based American health system with 67 hospitals, espouses 3 goals for everybody everyday: care that is safe, care that works (reliable delivery of evidence based medicine), and care that leaves no one behind (fulfilling their social mission of providing care to disenfranchised patients without health insurance or other care options). The mantra at Ascension is that “by the year 2008, we will have no preventable patient harm or deaths.” If achieved, this mission will be a competitive advantage as clear measures of quality and patient safety become more readily available for patients and purchasers.

At Brigham & Women’s Hospital in Boston a management tool called Leadership Patient Safety WalkRounds engages senior leadership on a weekly basis with front line staff. Through careful planning, the WalkRounds appear as relaxed conversations where staff can feel safe discussing any topic including errors. On these

Michael Leonard Physician Leader Patient Safety Kaiser Permanente Allan Frankel Director Patient Safety Partners Healthcare USA

rounds, a scribe’s sole job is to record every issue brought forth and by whom, so it can be evaluated, and feedback given to every staff member who contributes. The topics discussed during WalkRounds are evaluated for risk, assigned to appropriate individuals, and tracked to ensure resolution. After six years and hundreds of rounds, employees and physicians know that they can be forthright in their comments without a punitive response, and that their concerns will be acted upon. Visible physician leadership is critically important in the adoption of collaborative clinical practice necessary to achieve superior clinical outcomes. The traditional educational approach of physicians as individual experts and vigilance as the mechanism to ensure safety is not an effective strategy given the complexity of modern medical care. Yes, we need skilled experts,

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but as we have learned from other high-risk industries – such as aviation, nuclear power and military operations – the ability to work collaboratively within reliable systems is a critical success factor. This perspective is best understood when viewing the behaviour of stellar physician leaders in the first couple of minutes when a team comes together. They establish effective team behaviour and an environment of supportive respect by actively engaging all participants in a discussion of plans, disavowing personal perfection (“We’re all experts, but because we’re human we’ll all make mistakes. That includes me.”), and clarifying the goals and pitfalls of the job ahead.

Human factors Applied human factors science provides tools to support effective teamwork and communication. Communication failures are the central theme in the overwhelming majority of avoidable adverse patient outcomes. Often, healthcare providers hesitate to speak up about their concerns because they don’t know the plan of care (and worry they will appear ineffective) or they were previously treated with disrespect when they did voice concerns. The other common pitfall is “the assumption we’re all in the same movie”, rather than using structured communication such as a read-back to ensure all have the same understanding of the plan of care.

The authors have taught human factors and team work training in multiple American health systems. The four elements necessary for effective teamwork and communication are: 1. Structured language – using an SBAR (Situation–Background–Assessment– Recommendation) briefing model that offers predictability, and closed loop communication techniques like read-back 2. Critical language – “I need a little clarity” that allows anyone to “stop the line” if they are concerned about the well-being of the patient 3. Psychological safety – an environment of respect where anyone feels safe to speak up and voice a concern—a significant issue in cultures that place emphasis on politeness and respect 4. Effective leadership – described previously as the ability to rapidly engage healthcare employees in team behaviour. These four

Asian Hospital & Healthcare Management

elements are the distillation of decades of work in high risk industries and our experience working with medical teams in high risk clinical areas over the past several years.

This basic communication package can be embedded within a few clinical elements that clinicians use every day to care for patients. High risk clinical areas like obstetrics, surgical services, emergency medicine, critical care and others are natural areas for intervention, though virtually any clinical area can benefit from the systematic adoption of these tools and behaviours.

Reliability and reliable design The concept of reliability—defined as defect free care over time for a patient—has evolved from high risk industries and is gaining traction in healthcare. Reliable systems support the delivery of consistent, superior care. For example, in surgical care, infection rates are affected by administration of prophylactic antibiotics within 60 minutes prior to incision. The tracking of antibiotic administration and surgical infection rates are currently required metrics in American healthcare. In many ICUs ventilator associated pneumonias, previously considered an irreducible cost of long term ventilation, has virtually been eliminated by the combination of peptic ulcer disease and deep venous thrombosis prophylaxis, elevating the head-of-the–bed 30 degrees and sedation vacations.

Many healthcare systems have adopted improvement methods like Toyota Lean or Six Sigma, which allow frontline experts to contribute to process improvement and elimination of waste. The organisations that are making quantum leaps in quality and safety—and are realising substantial operational efficiencies—have embedded these techniques within their culture. Similar to Toyota, they relentlessly focus on how to improve the way they improve, rather than applying a solution and declaring victory.

Patient-centric care Patient-centric care, ultimately the singular goal of all healthcare efforts, is to deliver safe and reliable care for all. Leading health systems continuously learn about the patient experience and how medical care is perceived by patients and families. In America, a common failing is that physicians and hospitals ascertain success by assessing the

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technical delivery of care, i.e. how long did it take to successfully intervene in patients with acute myocardial ischemia? Interestingly, we have learned that these technical markers are often invisible to patients, who process their medical care as a profound social experience. Understanding this, we must redefine what constitutes successful care. It is not adequate to intervene technically, we must engage patients so that they understand the care they receive and feel supported throughout. This then highlights health literacy as a major problem because in America, the average citizen reads at an 8th grade level, while frequently we provide them with information formulated at a college reading level. Patients with health literacy issues consume four times the average resources annually, and consistently have poorer clinical outcomes.

Two simple techniques from the American Medical Association have shown great benefit: Ask Me Three—that every patient and their family must understand three aspects of every component of care—“ what is my basic medical problem, why is it important that I understand this, and what needs to happen for me to get better?” The second technique is the “Teach Back”, in which instead of asking them if they understand and having the patient politely nod in agreement, we ask “you have heard us talk about your care, now please take a minute and tell me how you will explain it to your family.”

Often we have assumed patients and families understand, but on closer inspection their lack of understanding can seriously impact their care process and health status.

In summary In regards the endeavour to achieve safe and reliable healthcare, we are at best at the end of the beginning, but over the past decade the pattern, form and shape of success have become clear. The tapestry of safe and reliable healthcare is woven with the threads of leadership engagement, human factors theory application, reliable design implementation, and understanding of patients’ holistic needs. “Safety and Reliability” is not a series of projects, it is an overarching strategy formulated into understandable and simple goals and supported by extraordinarily elegant organisational structure, all of which can be envisioned only by enlightened leadership.

H E A L T H C A R E M anagement

In the Passionate Pursuit of Healthcare Excellence It’s time for healthcare organisations to adopt drastic changes in their existing systems in order to reduce medical errors and deliver quality healthcare.

Peter A Gross Chairman Internal Medicine Hackensack University Medical Center USA

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he healthcare system in the United States is in disarray. Communication among providers is poor.

Providers continue to function without adequate data, thus, preventing mid-course corrections when the service they provide is off the mark. A shared organisational vision is lacking among healthcare providers.

The suffusion of information technology is slow compared to other industries. A strong performance improvement structure to facilitate improvement is minimal in most healthcare institutions. The use of evidencebased medicine versus anecdotal experience to guide the practice of medicine is not often distinguished. The coup de gras is that care is not centered on the patient but on the disease. As a result, awareness of the physical and emotional needs of the patient with a disease is not considered and a prevention focus is missing.

Is it hopeless or can these issues be dealt with more effectively and care coordinated around the patient’s needs? To begin to address the dysfunction in “modern” medical care, the Institute of Medicine (IOM) issued its now famous report—To Err is Human—in 2000. They pointed out that the frequency and severity of accidental injury in the healthcare system is a serious problem. While the number of deaths attrib-

uted to this dysfunctional system has been debated, whatever is the number, it is too large. The report concluded that the problem is caused by faulty systems of care, not faulty providers. To address the issue, they emphasised that new systems of care must be developed.

In their follow-up document—Crossing the Quality Chasm, the IOM urged that each process of care should be safe, effective, efficient, equitable, timely and patient centered. They developed 10 new rules for 21st century healthcare (see Table 1).

in the healthcare institution—this would be a structural measure. The group should be knowledgeable and experienced in measuring processes and outcomes. Then, we can start with measures that have been vetted for a number of years and are evidence-based such as the measures for acute myocardial infarction (AMI). The AMI process measures include the use of aspirin and a betablocker on admission and discharge, use of an ACE inhibitor or an ARB if heart failure is present, and door to balloon inflation time of less than 90 minutes. These are process measures based on studies in the medical 10 New Rules for 21st Century Health Care* literature that show a 1. Develop healing relationships 6. Safety is a system property decrease in mortality 2. Customize care to patient 7. Embrace transparency when these processes 3. Patient is source of control 8. Anticipate patient’s needs are followed. In fact, they are more accu4. Share knowledge 9. Reduce waste rately called process5. Use evidence-based medicine 10. Cooperation is a professional priority oriented outcome *Crossing the Quality Chasm, Institute of Medicine, 2001 Table: 1 indicators. A more standard outcome While most of the New Rules in indicator would be mortality in the hospiTable 1 are actionable now, two will require tal or within 30 days. Mortality assessment special attention. The patient as the source depends on risk-adjustment and is a more of control will depend on developing the difficult measure to assess accurately. tools for creating a more informed patient If you adopt the Institute for Health—the responsibility being shared by the care Improvement’s 100,000 lives campaign provider team and the patient. The other you will have access to bundles of perforknotty issue is embracing transparency. To mance measures for managing AMI, predeal with transparency, the legal system will venting ventilator-associated pneumonia, have to make some adjustments so this New central venous line infections and surgical Rule doesn’t result in a malpractice quagsite infections, and reducing adverse drug mire. events with medication reconciliation. All Where do we begin? We begin by meaof these are evidence-based. Finally, ongosuring. Using the Donabedian construct— ing studies are attempting to determine if structure, process and outcome measures— rapid response teams can detect failing pawe can begin. First, we need to have a tients early and prevent their transfer to an performance improvement group available intensive care unit or death.

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H E A L T H C A R E M anagement

Implementation Strategies for Changing Provider Behavior* Generally ineffective

Variably effective

Generally effective

Research publications

Audit and feedback

Provider reminders

Dissemination of guidelines

Local opinion leaders

Computer provider order entry systems

Didactic lectures

Local consensus conferences

Clinical decision support systems

Consumer education

Academic detailing Barrier-oriented interventions Collaborate with mid-level providers

*Gross et al. Medical Care 2001;39:8(Suppl II):85-92

Table: 2

occasionally given before the diagnosis of 1. Identify patients correctly CAP is made, in order 2. Improve effective communication among providers to comply with the 3. Improve the safety of high-alert medications four-hour window al4. Eliminate wrong-site, wrong-patient, wrong-procedure surgery lowed for antibiotic administration from 5. Time out to verify checklist before starting a procedure the time of entry to 6. Mark the precise site for surgery the emergency room 7. Reduce the risk of health care-acquired infections with hand hygiene to the time of antibi8. Reduce the risk of patient harm from falls otic administration.

Table: 3 Because the diagnosis of CAP is not always Stages of acceptance of impending change clear, making the 1. Denial: “The data are wrong” four-hour window can 2. Anger: “Who are you to judge my practice?” be difficult. Therefore, 3. Bargaining: “My patients are sicker, so those measures just don’t apply to me.” it is best to lower the 4. Depression: “The situation is hopeless” and “I’m leaving medicine.” compliance goal from 5. Acceptance: “like it or not, we must be at the table and learn to play by the new rules.”

100% to 95%, for ex6. Leadership: “We will actually help make the new rules and lead the field.” ample, to account for those unusual cases Table: 4 where the diagnosis It is of interest that compliance with is not clear on initial presentation to the process measures translates into better outhealthcare system. comes. They showed that for every 10% We have a lot of work to do to correct increase in compliance with the measures a the poor performance demonstrated by Mc10% reduction occurred in inpatient morGlynn et al. What are some of the impletality. The CMS-Premier Hospital Quality mentation tools that we can use to improve?

Initiative Demonstration project showed Additional factors are support from senior that in one year for community-acquired leadership to help shape the organisational pneumonia (CAP) and coronary artery culture. Involvement of the Board of Trustbypass graft surgery among approximately ees of the institution is important. Atten3,000 hospital deaths were avoided and tion to financial aspects of quality improveUS$1 billion was saved. ment will make an impact on these leaders.

How well are we doing with reachEfforts to reduce waste, bring down length ing compliance with these well-described, of stay, use resources more wisely and effievidence-based measures? McGlynn and ciently, and go lean by cutting 1%-3% from colleagues studied compliance with many the budget annually will enhance support to measures in 12 communities and found any investments that have to be made in the that compliance reached only 55%. improvement effort.

There is a downside or potential unMost critical is the development of intended consequences to performance new systems of care delivery. The new sysmeasurement. Human nature may lead tems will vary from one institution to the to gaming the system to achieve complinext. For example, in our medical centre, ance. For example, for CAP, antibiotics are we found that inserting mid-level providers International Patient Safety Goals from Joint Commission International

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such as nurse practitioners, experts in a given medical condition such as heart failure, heart attack or stroke, was critical to monitoring the care patients received and vital to intervening with the physicians when performance measures were not being met.

The nurse practitioner was always backed up by the specialty and department chiefs.

This approach inserted a redundancy into the system of care and assured compliance.

Another method for achieving compliance is to use the tools of reliability science.

To achieve 80%-90% compliance—i.e., 1-2 failures out of 10, use checklists and other standard order sheets, reminders, audit and feedback, avoid reliance on memory, and train in quality improvement. To move to the 95% level—i.e., 5 or less failures out of 100, institute computerised physician order entry with clinical decision support that provide decision aids and reminders to the provider, make the desired action the default action, simplify and standardise, and use redundancy as described above. Attention to human factors engineering is also helpful. Finally, to reach the 99% compliance level which is rare today—i.e., 5 or less failures out of 1,000, analyse each critical failure with the techniques of root cause analysis in retrospect and failure mode and effect analysis in prospect.

First, enlist the support of the innovators at your institution, then, the early adopters and early majority will follow.

Gradual adoption is critical and easier than attempting to accomplish all at once. Don’t worry about the traditionalists. They typically make up about 15% of the providers.

They may not be worth the effort as you may never convince them to change.

Similar approaches can be applied to improving patient safety—the other side of the quality coin. These international patient safety goals also require instituting new systems mentioned in Table 3.

As you go about improving the quality and patient safety at your institution, keep in mind Kuebler-Ross’s stages of acceptance of impending change (actually, Kuebler-Ross described it in relation to acceptance of death) (Table 4).

Life is short; art is long. Good work takes a long time to accomplish.

Full references are available on www.asianhhm.com/magazine/

H E A L T H C A R E M anagement

Healthcare in New Zealand Learning from complaints

Quality improvement measures made across the health sector as a result of complaints made to the Health and Disability Commissioner are evidence that investigating systemic failures in care, and recommending improvements, is making a positive difference in New Zealand.

Ron Paterson Health and Disability Commissioner New Zealand

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here is a growing international interest in using patient complaints to address problems with quality in healthcare. In New Zealand, the complaint mechanisms under the Health and Disability Commissioner Act 1994 have become the primary vehicle for dealing with complaints about the quality of healthcare and disability services.

The complaints system New Zealand has had a health and disability service complaint system in place for over a decade. This complaints system is headed by the Health and Disability Commissioner, who has the role of promoting and protecting the rights of health and disability consumers, and facilitating the resolution of complaints. The Commissioner’s specific complaints investigation role relates to alleged breaches of the statutory Code of Health and Disability Services Consumers’ Rights (the Code).

Consumers of health and disability services have ten rights under the Code, which cover basic principles such as the right to respect, the right to an appropriate standard of care and the right to full information and to give informed consent, and places duties on providers regarding complaint procedures.

Consumers in both the private and public sector are covered, and the duties apply to health professionals, unregistered healthcare

providers and institutional providers such as hospitals and rest homes.

The Health and Disability Commissioner complaints process ensures that the rights set out in the Code are enforced. One of the primary objectives of the Health and Disability Commissioner is to “secure the fair, simple, speedy and efficient resolution of complaints”. The complaints system ensures a degree of accountability for healthcare providers, but also allows consumers to express their concerns, facilitates the resolution of complaints, triggers an investigation in appropriate cases, and ensures action is taken to reduce the risk of harm to other patients.

Anyone can make a complaint to the Commissioner alleging that any action of a healthcare or disability services provider appears to be in breach of the Code. Essentially, this means complaints may be made about anything related to the quality of services (including the way in which they were provided, and the handling of a complaint about them). The Commissioner may also undertake investigations on his or her own initiative, without waiting for a complaint to be made, allowing the Commissioner to fulfil a “consumer watchdog” role and to ensure public safety.

The Commissioner’s investigation is an impartial and independent process to which the rules of natural justice apply.

Investigations often involve liaison with the other bodies with an interest in the subject matter of the complaint. Where the quality of care is in issue, the Commissioner will obtain independent expert advice from a peer of the provider with knowledge of, and experience in the matters under investigation. After an investigation, the

Commissioner forms an opinion as to whether the provider has breached the Code.

Improvements in quality of care There is growing evidence that investigating systemic failures in care, and recommending improvements, is making a positive difference in the health and disability sectors. Landmark research has recently been published on the relationship between complaints and quality of care in New Zealand. Dr Marie Bismark compared 398 complaints to the Commissioner relating to public hospital admission in 1998 with a nationally representative sample of noncomplainants who suffered adverse events in the same year. Bismark concluded that “complaints offer a valuable portal for observing serious threats to patient safety and may facilitate efforts to improve quality”.

The following Commissioner’s reports are illustrative of the way in which complaints can be influential in bringing about quality improvements in healthcare: Medication mix-up A report released in November 2005 highlighted the systemic issues regarding medication safety in public hospitals. The Commissioner received a complaint from Mrs Anderson’s daughter about the care her mother received at a hospital. 91 year old Mrs Anderson presented to the hospital’s Emergency Department with a suspected lower respiratory tract infection. At some time during the course of her clinical assessment or admission, a computergenerated patient identification label was affixed to the top of a completed drug chart intended for another patient. Due to this error, Mrs Anderson received incorrect

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medications (and did not receive her own regular medications) for a period of four days.

While the error was perpetuated by a number of individuals in the medical and nursing teams, the critical issue identified in the investigation was that various organisational and system factors outside of the individual providers’ control ultimately conspired to create a dangerous situation for Mrs Anderson. Accordingly, the hospital was held to have breached Right 4 of the Code.

A copy of the report was sent to the Minister of Health, the Director-General of Health, the Medical Council, the Nursing Council, the Royal Australasian College of Physicians, the Accident Compensation Corporation, the Coroner, and the national Quality Use of Medicines Group. The report was also posted on the Commissioner’s website, www.hdc.org.nz. Following the report, the Commissioner visited the hospital to follow up on his recommendations that the report be circulated for orientation and training purposes, and that a number of changes be made to the policies and practices in place.

This report has been widely used for teaching purposes in the health sector, and prompted one metropolitan DHB to write: “This DHB has taken the key messages from your review very seriously indeed. The measures we have put in place since receiving your report include: redesigning the drug chart so that the patient’s name is handwritten; assigning a common area for patient records and drug charts in all wards; keeping the patient labels with the drug charts; and deploying a ‘10 rules of safe prescribing’ document to all medical officers and senior nurses.” The report has prompted medication safety audits and improvements in hospitals throughout New Zealand.

Graseby pump In another case, the Commissioner’s recommended changes regarding the use and manufacture of a medical device are being adopted nationally. A complaint was received from the Police on behalf of the family of a woman who died while receiving palliative care at home for end-stage lung cancer. The woman’s death followed the administration of an overdose of morphine by a palliative care nurse. The morphine was administered subcutaneously, using a Graseby pump. The Commissioner

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found that the nurse had inadvertently set the pump to deliver 20mm of diluted medication per hour instead of 2mm per hour.

Accordingly, the nurse was found in breach of the Code. A factor contributing to the error was confusion about the operation of two different types of Graseby pump—a “green” one, which delivered medication at millimetres per 24 hours and a “blue” pump set at millimetres per hour.

The Commissioner’s report recommended that to reduce the risk of error, where practicable, palliative care services move towards using one type of pump for the administration of subcutaneous medication. The recommendation was sent to all DHBs, Hospice New Zealand, and the Society of Palliative Medicine. They were subsequently contacted to see what followup action they had taken. Only six of the 21 DHBs reported that they were still using two types of pump (and they were either phasing out one model, or had responded to the recommendation by instituting tighter protocols, new labels, or training to reduce the potential for error). All DHBs indicated that they had carefully considered the concerns raised by the Commissioner, and had drawn them to the attention of appropriate staff. The Society of Palliative Medicine supported the Commissioner’s recommendation and Hospice New Zealand advised its members of the risks involved in holding and using different types of the pump. It asked the manufacturer to consider developing a standard pump with a single scale setting. The company, Graseby International, replied that this would be considered as part of its product development process.

Pharmacy error Another recent complaint has resulted in widespread changes in the systems in place at pharmacies to reduce the risk of errors. In March 2005 the Commissioner received a complaint from the mother of a 10 year old girl who had been dispensed the incorrect strength of medication on two separate occasions at her local pharmacy. An investigation revealed that there had been a failure to check the medications before they were dispensed. Staff also failed to accurately record who was responsible for those checks, so it was not possible to establish the identity of the responsible pharmacist. The Commissioner’s report found the pharmacists and

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the pharmacy in breach of the Code for failing to have adequate systems in place to prevent such mistakes. The report was sent to the Pharmacy Council, the Pharmaceutical Society, the Pharmacy Guild, and Medsafe (New Zealand Medicines and Medical Devices Safety Authority). The Commissioner also made a recommendation that Roche and Jansen-Cilag Pty Ltd review labelling of medication to assist pharmacists to clearly identify different strengths of medication.

The report was also published on the Commissioner’s website.

In addition to systems changes implemented at the individual pharmacy, the Pharmacy Council of NZ reported that it is “actively addressing” the issues raised, including standardisation of dispensing procedures and mechanisms for sharing procedural changes made as a result of errors. In a recent survey, 83% of pharmacists said that the media attention to this case had prompted action in their pharmacy (Pharmacy Today, Sept 2006).

Conclusion These cases are part of a body of evidence on the use of complaints to improve the quality of healthcare. The Health and Disability Commissioner complaints system plays a key role in linking dispute resolution with improvements in patient safety and quality of healthcare. The Commissioner’s reports are widely reported in the media and are used for educational purposes throughout the health sector. The complaints system is linked to other strategies for improving the quality of care, such as continuing professional development, audit, risk management, and critical incident reporting, which promotes learning from complaints and the implementation of quality improvement measures. Leading safety experts Alan Merry and Mary Seddon recently commended the New Zealand Health and Disability Commissioner on “a world-leading focus on addressing aspects of the system which contribute to patient harm, rather than only seeking to identify individual scapegoats when things go wrong”. This focus on investigating systemic failures in care, learning from complaints, and recommending quality improvements, is making a positive difference to the quality of health care in New Zealand.

References are available on request from: rpaterson@hdc.org.nz

H E A L T H C A R E M anagement

Healthcare Recruitment: The B. E. Smith way “Improving Lives through Healthcare Recruitment.”

How does B. E. Smith live up to its tag line?

As quoted by Doug Smith, B. E. Smith’s CEO and President, “when we say Improving Lives through Healthcare Recruitment, we are talking of improving the lives of patients through better leadership of hospitals and their departments, the lives of healthcare leadership candidates [and their colleagues and families] through better career opportunities, and the lives of community members when we bring good families in. In summary, we positively impact the whole ecology of lives by what we do, recruiting quality healthcare leadership”.

What is the biggest challenge in recruitment for the healthcare industry?

There is only one [worldwide] overall challenge: the demand-supply imbalance of quality leadership talent due to the increasing aging population in the developed economies and booming population of developing economies.

The development of hospital facilities without proper leadership affects quality of care negatively.

What are Best Practices that B. E. Smith follows?

B. E. Smith’s Best Practices involve not only the process outlined below but also our team approach. These teams work intimately to find the best talent for our clients and are comprised of our business development executives along with our executive consultants (all with healthcare leadership experience and expertise) and their research colleagues.

• Comprehensive understanding of the client’s needs during initial discussions with key stakeholders • Preparation of the position profile based on client’s need and presentation for approval by client • Development of a marketing plan and attractive campaign to our target potential candidates • Identification, screening, evaluation and narrowing of the pool of candidates based on client’s specifications • Agreement with client on the final list of best candidates and development of comprehensive profiles • Comprehensive background and reference checks on selected candidates • Travel arrangements and interview scheduling for presentation of candidates to client • Negotiation of terms of employment with client and candidate to ensure all expectations are communicated before an offer is made

• Ongoing communication with client and placed candidate following the search to ease potential transition issues for candidate such as family relocation etc • Closing procedures involving communication with non selected candidates as well as a client satisfaction survey How does the Interim Management recruitment service of B. E. Smith help hospitals?

Not only is B. E. Smith able, in a timely and affordable fashion, to provide its clients with qualified, highly experienced individuals who will perform the every day function of the open positions, they also benefit from the following added value: • The interim executive is an employee of B. E. Smith thus alleviating our clients from all people management activities typically associated with their own employees • This interim “on loan” works in tandem with a B. E. Smith executive project manager giving the client the benefit of two professionals’ expertise and experience • Once the client organization has defined its requirements, our interims follow the predictable B. E. Smith process: assessment, action plan development and plan implementation • The interim executive arrives therefore with a client specific objective which may involve, among other duties, being a change agent, management transitioning, mentoring, activities involving regulatory compliance and any other project management. These services, as performed by our executives, are typically not performed by our client’s permanent employee often because of lack of time and resources How can Asian hospitals benefit from B. E. Smith's services?

They can benefit from the full array of services we have developed but mainly from the expertise we have acquired over the years by focusing only on hospital leadership talent, unlike our competition. Deployed through the high caliber talent employed at B. E. Smith, our consultants are experienced healthcare executives who have walked in their clients’ shoes. Finally, the most beneficial service we can tangibly provide Asian hospitals is the access to American healthcare educated leadership from C-level executives to directors of all departments in a hospital. No one delivers healthcare leadership talent like we do.

Advertorial

For more details about B. E. Smith’s services, visit www.besmith.com or contact Doug Smith, President or Caroline Krause, Vice President at 001-913-752-4528 w w w . a s i a n h h m . c o m 13

Cover story

H E A L T H C A R E M anagement

Corporate Social Responsibility in Private Hospitals

Being responsible means finding the right balance between what patients want and what governments can afford, and that staff are willing to provide the care needed. Doing this affects the entire hospital value chain. Doing this well, ensures the long term success that shareholders demand.

John Zinkin Deputy Chairman CSR Malaysia Visiting Fellow International Centre for Corporate Social Responsibility Nottingham University Business School UK and Managing Director Zinkin Ettinger sdn bhd Malaysia

“A business that does not show a profit at least equal to its cost of capital is irresponsible; it wastes society’s resources. Economic profit performance is the base without which business cannot discharge any other responsibilities, cannot be a good employer, a good citizen, a good neighbour. But economic performance is not the only responsibility of a business…

Every organization must assume responsibility for its impact on employees, the environment, customers, and whomever and whatever it touches. That is social responsibility.”

The Daily Drucker, Peter Drucker

14 Asian Hospital & Healthcare Management

A

t the heart of delivering good private healthcare lies an apparent contradiction. Hospitals for profit are expected to make money, arguably capitalising on patients’ misfortune and suffering. Some may feel that being socially responsible means providing unlimited healthcare without paying attention to profit. Yet as Peter Drucker’s quotation above shows, they would be wrong because being socially responsible is first and foremost about using scarce resources well and this applies to not-for-profit hospitals just as much as it does to profit-making hos-

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pitals. The advantage profit-making hospitals have, is that normally profits are a good signal that what is being provided is valued and being done efficiently. Yet in this area too, there is a problem because some treatments cannot be justified on grounds of profits.

Who are the stakeholders?

So what do we really mean by corporate social responsibility (CSR) in the private hospital context? Perhaps the easiest way to answer the question is to consider who the stakeholders of private healthcare are.

H E A L T H C A R E M anagement

First and foremost they are customers (patients and families) served by hospitals, employees working in hospitals and governments who have a vital interest in public health of electorates that can vote them out of office if they are dissatisfied with the health service they receive. Shareholders are also primary stakeholders, but in many countries are regarded as less important because much of society still has to come to terms with the idea of making money from peoples’ suffering.

Customers

In business, as opposed to healthcare the focus is on creating and retaining loyal customers. Again in the words of Peter Drucker: “It is the customer who determines what a business is. For it is the customer, and he alone, who through being willing to pay for a good or a service, converts economic resources into wealth, things into goods. What the business thinks it produces is not of the first importance—especially not to the future of the business and to its success. What the customer thinks he is buying, what he considers ‘value’ is decisive—it determines what a business is, what it produces and whether it will prosper.

The customer is the foundation of a business and keeps it in existence. He alone gives employment. And it is to supply the consumer that society entrusts wealth-producing resources to the business enterprise.”

Drucker, The Practice of Management There are, however, problems when we apply this thinking to healthcare: 1. Patients demand the best care regardless of economic justification and are often unable to pay for it, looking to government to meet the bill 2. Governments are finding they can no longer afford to do this 3. Successful healthcare reduces the number of patient visits; it does not try to maximise loyalty or retention, unlike business. We cannot, therefore, adopt a customer focused approach designed to maximise repeat purchase!

Employees

Without good, caring doctors and nurses, hospitals cannot deliver the care patients expect. If they provide the best terms and working conditions, recognising in a world short of medical talent, they compete globally to keep their best people; and if they ensure administrative procedures fa-

CSR and the Hospital Value Chain R&D Natural Capital > Biopiracy > Patenting traditional remedies Social Capital > Compution > Intellectual property > Abuse of indigenous people's knowledge Human Capital > Discrimination > Human Rights > Union Rights > Health & Safety > Working hours

Purchasing

Outpatient Care

Production

Marketing & Sales

Management Policies

Pollution/Spills Emissions/GHGs Use of water > Use of energy > Bandage/parts disposal

Environmental damage Waste > Pollution > GHGs

>

>

3 'R's

>

-- Reduce

>

-- Reuse

-- Recycle

>

Corruption Social inequity > Abuse of indigenous people > Intellectual property

>

>

>

>

Discrimination Human Rights > Unicon Rights > Health & Safety > Working hours

>

>

>

> >

Corruption Social inequity

Discrimination Human Rights > Unicon Rights > Health & Safety > Working hours

No comption Obey the law > Avoid politics > Support education

>

Corruption Social inequity > Ethical marketing > Generics v. brands

>

Corruption Social inequity > Ethical marketing > Generics v. brands

>

>

>

>

>

Discrimination Unicon Rights > Health & Safety > Working hours

>

Discrimination Unicon Rights > Health & Safety > Working hours

>

>

>

Diversity & Inclusion Meritocracy > Respect Union Rights > Good Health & Safety > Good working hours > Pay for performance >

Figure: 1

cilitate patient care then, in the words of Hippocrates, staff will be motivated to: "Declare the past, diagnose the present, foretell the future; practice these acts. As to diseases, make a habit of two things—to help, or at least to do no harm."

Governments

Governments need to be re-elected and so their interest is quite simply making sure that healthcare does not a become political ‘hot potato’. Governments welcome private healthcare as long as it is politically acceptable and so private hospitals that forget this in their search to be profitable put themselves at risk of losing their “Licence to Operate”.

Shareholders

A fair return on capital employed is all that shareholders can ask for, and they need to remember that unlike many other businesses, the provision of healthcare is an emotional and moral issue that may mean they have to live with a lower rate of return than they might otherwise like. If they are perceived to be “scalping” their patients, they will lose their “Licence to Operate”.

CSR equals capital stock renewal Another way of looking at CSR is to regard it as a form of Capital Stock Renewal reflecting the need to preserve natural capital (by minimising the hospital’s environmental footprint), to improve social capital (by supporting the institutional framework of

laws and acceptable business practices) and to invest in human capital (by empowering and training staff). If we look at CSR in this way, we can see how it affects the hospital value chain in figure 1: As can be seen, there are a number of issues hospitals must address if they are to behave responsibly across the value chain.

Natural capital

The issues appear in R&D where private medicine needs to be careful to avoid charges of abetting biopiracy and encouraging the patenting of traditional medicines.

They also appear in "purchasing" and “production” (the processes, by which patients are admitted, diagnosed and treated) and relate primarily to the environmental impact hospitals can have through waste, pollution, emissions and the use of water and energy. From a policy perspective, hospitals need to think about adopting the ‘3Rs' designed to reduce, re-use (if possible) and recycle (again if possible) necessary inputs.

Social capital

The key issues here are to ensure that all the way through the value chain, business is undertaken so as to avoid, or at least minimise the opportunities for corruption. The issues involving intellectual property are more complicated because they require careful cost-benefit analysis of the value of generics versus patented brands. From a marketing perspective, hospitals should adopt a policy

w w w . a s i a n h h m . c o m 15

H E A L T H C A R E M anagement

The Business Case of truthful selling and ethical marketing, lest they become associated with capitalising on the suffering of others.

Human capital

Here the issues that run right across the value chain all are associated with how best to recruit, retain, upgrade and motivate scarce qualified staff who are in demand everywhere in the world.

This approach recognises the fact that for organisations to be truly socially responsible, they must focus on: 1. What they exist to do 2. How they go about doing it and 3. Only lastly, what they do with the money once they have made it The business case for CSR Properly embedded, socially responsible behaviour across the hospital’s value chain ensures that the role of private hospitals as legitimate healthcare providers will be accepted by both government and electorates alike. It will: 1. Preserve access to patients and their demand for services provided because pa-

16 Asian Hospital & Healthcare Management

tients will not feel ‘scalped’ 2. Guarantee the supply of willing and motivated staff because employees will feel the hospital is doing what is ‘right’ to patients and staff 3. Keep governments ‘on side’ as they will not have political repercussions to fear 4. As a result, provide access to quality partners and investors from around the world, happy to be associated with organisations that respect the environment, the laws and conventions of the countries in which they operate and provide good care for both patients and staff, thus ensuring a benign political environment.

Figure 2 summarises the business case for being socially responsible for business, and it applies equally to private hospitals.

Conclusion The first responsibility is to use scarce resources well and private hospitals have the benefit of the profit mechanism to signal they are doing this. Being responsible means finding the right balance between

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CSR Pathways to Shareholder Value Product and process innovation Reduced waste and emission Efficient use of resources Occupational health and safety Stakeholder engagement

Tangible outcomes

Intangible assets

Value to society Employees satisfaction Environmental protection Community quality of life

Increased profitability Improved capital utilisation

Customer satisfaction

Shareholder value

Intellectual capital Licence to operate Reputation and brand image Reduced risk

Source: GEMI Figure: 2

what patients want and governments can afford, ensuring that society as a whole has good standards of public health, and that staff are willing and able to provide the care needed. Doing this affects the entire hospital value chain. Doing this well guarantees access to patient demand and employee supply and ensures public acceptability and acceptance of private medicine, thus ensuring the long term success that shareholders demand if they are to get an adequate return on their investment.

H E A L T H C A R E M anagement

Leadership and Strategy in Healthcare Hospital leaders should formulate and communicate vision for the institution.

They should also continuously keep evolving the vision and motivate the followers to accomplish the mission.

Delon Wu President Taiwan Hospital Association Taiwan

I

t appears that everyone knows what leadership is. However, it is not easy to define the word leadership. Webster’s New World English Dictionary explains “leadership” as “the capacity to be a leader” or “ability to lead”. Indeed, there are many legendary leaders in business history, such as George Eastman of the Eastman Kodak Co., Henry Ford of the Ford Motor Co., Andrew Carnegie of the Carnegie Steel Co., Samuel Moore Walton of the WalMart, Robert Noyce of Intel, Konosuke Matsushita of the Matsushita Electric Industrial Co., and YC Wang of the Formosa Plastics Group. These giants are characterised by their ability to tell the difference between the seemingly impossible and the genuinely impossible, by their courage to bet on the vision of market potential, by their ability to shape the market vision into the company mission and to be the message for customers, employees, and investors, by their ability to deliver more than what they have promised, and by their will of not to look back.

These giants are born with these characteristics. A competent leader, nonetheless, is a person who is striving for excellence, able to make an enjoyable atmosphere for his people, able to hug and kick, able to make a quick decision, able to handle a

crisis, able to stay clean about a sour mission, and having passion, persistence and partnerships, and able to work with a team and build a consensus. There is no difference for a hospital manager as compared to a business leader. Hospital leaders should formulate and communicate vision for the institution. They should also continuously keep evolving the vision and motivate the followers to accomplish the mission. The leader should be aware of his own emotion, able to manage his own emotion, able to read the emotion of his people, and able to manage the relationship with his people. There appear to be two basic styles of leading people. Julius Caesar was a field general of the late Roman republic, who greatly extended the Roman Empire before seizing power and making himself the Roman emperor. As a field general, he required the respect and support of his soldiers and needed personal charisma to win popularity. Erwin Johannes Eugen Rommel was the German Field Marshal, served in France, Italy and Romania. He commanded the 7th Panzer Division assisting Italians in North Africa, which became the Africa Korps. He accomplished a series of brilliant battles driving the British back hundreds of miles and gained his nickname of “Desert Fox”.

However, he faced shortage in supplies and tanks, under constant and close surveillance of the Gestapo and Hitler and, thus, required the respect and support of his soldiers as well as the German people back home to accomplish his work. In contrast, The Duke of Wellington who defeated Napoleon at Waterloo in 1815 and Bernard Law Montgomery, Field Marshal of the

Eighth Army, who defeated Erwin Rommel in Egypt were leaders with different executive style. They were fully supported by their boss with a clear-cut mission to win the war.

The leader should shape a strategy for the institution. In early 1970s, Mr. YC Wang, Board Chairman of the Formosa Plastics Group, decided to build a non-profit hospital to serve the middle and lower income family in Taiwan, to provide equal service to all peoples with low cost, and to become a major center for medical education and research. He wished to recruit the best physicians and to install the best equipment for the hospital. During that period, Taiwan was developing from an agriculture-dependent to an industrialised society. There were only few tertiary referral hospitals with a total of less than 3,000 beds capable of performing open-heart surgery or brain surgery to serve a population of 14.84 million people.

Although there were 11,518 beds countrywide, more than 70% of the hospitals were operated by the government with a size of less than 200 beds; less than 30% of the hospitals were operated by the private sector and the size was very small, usually less than 50 beds. Good medical service was a luxury.

The university hospital or the few medical centers were like the white ivory tower not accessible to the ordinary people. Visiting a hospital was like visiting a bureaucratic government office; patients had to pay a guarantee-deposit before hospital admission, frequently requiring a special “red-envelope” tip for service by physicians.

Meanwhile, there were 6 medical schools with approximately 800 graduates annually.

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H E A L T H C A R E M anagement

The few university hospitals and medical centers were not sufficient for post-graduate training of these 800 medical graduates.

There appeared not much future for the new physicians. As a consequence, the new medical graduates went abroad for opportunity.

It was under these circumstances that Mr. YC Wang shaped his mission.

The first Chang Gung Memorial Hospital was opened in December 1976. It was a “patient-centered” and “service-oriented” hospital with service encompassing primary clinic care to tertiary inpatient care.

The hospital applied the 4Cs of business management to the operation: Capital, Corporation, Consumer and Communication. It radically revolutionised the medical practice in Taiwan and quickly dominated the market of medical service.

During 1980s, other intenders duplicated the strategy and eventually changed the medical system in Taiwan, providing the background for the implementation of National Health Insurance Program by the government in 1995. Presently, 70% of the health providers are privately owned and

18 Asian Hospital & Healthcare Management

30% publicly owned. The Economist listed Taiwan as the second healthiest country in the “World Healthy Nations List” in 2000. Chang Gung Medical Group consists of 6 hospitals with 8,500 beds, 2 universities, 1 health village for senior citizens and one nursing home; the hospitals serve 10% of the population in Taiwan and share 8% of total expense of the National Health Insurance Program annually.

The success story of Chang Gung Medical Group may serve as an example of leadership and strategy in hospital management.

It fits the model of “Blue Ocean Strategy” recently proposed by Kim and Mauborgne.

It eliminated the guarantee-deposit, the red-envelope tip, and patient discrimination; it reduced the price of hospital service, the patient waiting time, and the complexity of paper work; it raised the accessibility, efficacy and quality of care, and salaries of personnel; it created ease of hospital visit, incentive of physicians, nurses and technicians as well as a new form of healthcare.

Full references are available on www.asianhhm.com/magazine/

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BOOK Shelf

Blue Ocean Strategy Authors : W. Chan Kim Renée Mauborgne Year of Publication: 2005 Pages: 256 Description: Based on a study of 150 strategic moves spanning more than a hundred years and thirty industries, Kim and Mauborgne argue that tomorrow's leading companies will succeed not by battling competitors, but by creating "blue oceans" of uncontested market space ripe for growth. Such strategic moves—termed “value innovation”—create powerful leaps in value for both the firm and its buyers, rendering rivals obsolete and unleashing new demand.

For more books, visit Knowledge Bank section of www.asianhhm.com

M edical S ciences

Cancer Nanomedicine Emerging opportunities

Nanotechnology has many advantages when applied to medicine. However, continued research into disease processes at the molecular level is essential for its development.

Matthew Dennis Cancer Market Specialist Espicom Business Intelligence UK

D

iagnosing, treating and tracking the progress of therapies for each type of cancer that exists has long been a dream of oncologists, and one that has grown recently alongside developments in genomics, proteomics and cell biology. Now, a revolution in nanotechnology is pushing personalised cancer treatment closer than ever before.

Future techniques in medical diagnosis and treatment have often been the subject of science fiction and fantasy. What was once the stuff of fiction is now closer to becoming reality. Nature already operates at the nanoscale and we are acquiring an increasingly profound understanding of natural processes at this scale, enabled by a new generation of scientific instruments.

Armed with this knowledge, we are able to design devices that can either directly interact with, or influence, the behaviour of living cells. As with any nascent and rapidly developing field, there are research, technological and ethical challenges to be considered, and the approaches to these constitute an integral part of this field.

Nanotechnology has many advantages when applied to medicine. At the nanometre scale, materials often exhibit surprisingly different physical, chemical and biological properties, compared to the very same material in bulk form. The properties of nanoparticles, such as increased chemical activity and the ability to cross tissue barriers, are leading to new drug targeting

and delivery techniques. In the future, a nanoparticle or a set of nanoparticles may be designed to search for, find and destroy a single diseased cell, driving us ever closer to realising the ultimate goal of disease prevention. In the foreseeable future, nanotechnology as applied to medicine, will lead to advancement in remote monitoring and care, where a patient may be treated at home, a less expensive option, and one that is more conducive to a successful medical outcome than treatment at a hospital.

Continued research into disease processes at the molecular level is essential for the development of nanomedicine, and involves teams of scientists from across conventional disciplines, such as physics, chemistry, surgery and mathematics, as well as those from the relatively new fields of genomics, proteomics, metabolomics, pharmacokinetic modelling and microscope design.

Highlighted below are the six main areas under which progress in nanomedicine is expected to advance over the next five to ten years. These areas were identified by the National Cancer Institute (NCI) in its 2004 Cancer Nanotechnology Plan , which set out to describe how to accelerate the application of nanotechnology to cancer research and clinical care, emphasising the need for cross-disciplinary and cross-sector collaboration to develop and deliver the public health benefits. After each potential area for development, there is an analysis of the specific section, with three predicted development scenarios over the five to ten year time course: optimistic, realistic and pessimistic.

These six sections are: • Molecular imaging and early detection • In vivo imaging www.nano.cancer.gov/about_alliance/cancer_nanotechnology_plan.asp

• Reporters of efficacy • Multi-functional therapeutics • Prevention and control and • Research enablers As the field of nanotechnology continues to grow, an increasing number of countries are developing research agendas with particular focus on specific areas of nanomedicine. This has led to some identifiable research trends and initiatives. There are however, many research programmes with broad initiatives that are not specific to cancer. Some trends are highlighted below that have been identified from national and international reports.

At the CancerNano 2006 Symposium, held from 7th to 11th May, in Boston, MA, researchers from around the world gathered to discuss the next steps for taking promising cancer-fighting nanoresearch from the laboratory to clinical trials. The Symposium was co-produced by the Nano Science and Technology Institute, the National Cancer Institute (NCI) and the National Institutes of Health. “We have a lot of exciting nanotechnology research going on throughout the country, and our main goal now is to expand the connections between the nanotech and cancer communities, and help get today’s cancer-focused nano research out of the labs and into clinical trials,” stated Dr Mansoor Amiji, co-chair of the Symposium from the Department of Pharmaceutical Sciences at Northeastern University in Boston.

The Symposium highlighted many promising nano-driven research projects: • An in-body detection system based on quantum dots that can safely be inserted into the human body to find, detect and make images of cancer cells as early as possible (even before symptoms appear) • In-body gene and drug-delivery systems

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M edical S ciences

that can be safely inserted into the human body to target cancer cells directly (with time-release delivery of treatment drugs or gene therapy) • In-body monitoring and surveillance systems that detect cancer mutations (via triggers or genetic markers) • New nanoscale tools, protocols and methodologies for designing drugs for more efficient, targeted release into the system and • New nano-driven diagnostics that will enable cancer investigators to more quickly identify submolecular targets for research, clinical development and/or predict drug resistance At the present stage, it is not possible to determine the amount of funding that has been allocated to nanomedicine with respect to oncology. This is partly due to the emerging nature of the technology, but primarily because much nanotechnology R&D at this stage is not disease-specific, being at a much more basic and therefore general level. There is however, information relating to nanotechnology funding as a whole. Nanotechnology R&D spending is distributed among governments (including national, regional, State and local), universities, corporations and venture capital investors. The availability and consistency of accurate figures varies for the different categories. When comparing the available data for various countries, difficulties can arise due to differences in the definition of nanotechnology, the inclusion of private contributions or other variations in the calculation of government funding, difficulty in getting some private, especially venture capital, investment data, mismatch in investment periods, and the various exchange rates employed.

The majority of products in development for the treatment of cancer are still in preclinical development, though a few are nearing approval and possible market launch. Of the products identified by Espicom Business Intelligence: • 3 (6%) are either in Phase III or have filed for approval • 9 (17%) are currently in Phase II development

Examples of public funding for R&D in nanoscience and nanotechnology

Anaesthetic Facility Expenditure on nanoscience and nanotechnologies US

The US’ 21st Century Nanotechnology Research and Development Act (passed in 2003) allocated nearly US$3.7 billion to nanotechnology from 2005 to 2008 (which excludes a substantial defence-related expenditure). This compares with US$750 million in 2003.

Europe

Current funding for nanotechnology R&D is approximately EUR 1 billion, two-thirds of which comes from national and regional programmes.

UK

With the launch of its nanotechnology strategy in 2003, the UK Government pledged £45 million per year from 2003 to 2009.

Japan

Funding rose from US$400 million in 2001 to US$800 million in 2003, and was expected to rise by a further 20% in 2004.

India

India’s Department of Science and Technology will invest US$20 million from 2004 to 2009 in their Nanomaterials Science and Technology Initiative.

Brazil

The projected budget for nanoscience during the 2004 to 2007 period is approximately US$25 million.

Products currently on the market with oncology applications

Product

Type of nanomaterial

Indication

Company

Abraxane

Nanoparticle albumin

Non-small cell lung cancer, breast cancer, others

Abraxis BioScience

DaunoXome

Liposomal formulation of daunorubicin

Kaposi’s sarcoma

Gilead Sciences

CellSearch Circulating tumour Cell Kit

Magnetic nanoparticles (ferrofluids)

Metastatic breast cancer

Immunicon

Verigene platform and Bio-barcode Technology

DNA-functionalised gold nanoparticles

Diagnostics

Nanosphere

Caelyx/Doxil

Doxorubicin liposome injection

Ovarian cancer, AIDSrelated Kaposi’s sarcoma and recurrent breast cancer

Ortho Biotech (Johnson & Johnson)

Myocet

Liposome encapsulated doxorubicin citrate complex

Recurrent breast cancer

Zeneus Pharma

• 11 (20%) are currently in Phase I development and • 31 (57%) are currently in preclinical development

the market. Four drugs that have already been launched are all reformulations of currently approved anticancer drugs that aim to reduce the side effects associated with the original forms. This seems to be a common trend for many of the companies that are developing nanomedicines: trying to improve the safety profiles of drugs that are already approved. This offers many advantages over developing novel therapeutics and is showing that nanotechnology can be used safely.

Once these drugs have been on the market for a period of time then it may give other companies the confidence to develop therapies incorporating nanotechnology from the drug discovery stage. However, it will be some time before these start to make their way through into companies’ development pipelines.

Further analysis can reveal that, of the products identified: • 32 (59%) are nanotechnology reformulations of currently approved anticancer drugs • 15 (28%) use nanotechnology to deliver new or unapproved drugs or are treating cancer in another way • 4 (7%) are nanotechnology imaging agents • 1 (2%) is using nanotechnology to detect cancer; and • 2 (4%) are using nanotechnology for other cancer applications In its report “Emerging Opportunities in Cancer Nanomedicine” (published August 2006), Espicom identified six products that are employing nanotechnology in relation to cancer treatments which are currently on

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M edical S ciences

New Drugs in

Anaesthesia A review

New drugs are being developed in anaesthesia, so as to reduce the number of side-effects and to improve patient outcome.

T

he history of anaesthesia mentions use of non-pharmacological (Cold, Concussion, Carotid compression, Nerve compression, Blood letting and Hypnosis) and pharmacological techniques (use of alcohol, opium, hyoscine, cannabis, cocaine) in ancient and mediaeval times for anaesthesia.

1850 onwards, as anaesthesia became popular, more and more surgeries were carried out under general anaesthesia. At that time, any surgery under general anaesthesia practically mandated a stay in the hospital, often to recover not from the surgery but from the effects of the anaesthesia used during the operation. Patients were woozy for hours, unable to get out of bed, nauseated and vomiting, and even if they wanted to eat, they couldn’t because their digestive systems were paralysed. People receiving anaesthesia were also at risk—a significant number died not from their disease but from the anaesthetic drugs themselves.

Present scenario With better understanding of surgery, instrumentation and devices like endoscopic equipments, there was an acute need for anaesthesiologists to keep up with this pace. By the mid twentieth century, we had learnt to control mortality figures to a great extent. Obviously the need then was to take care of disturbing morbidities like severe postoperative nausea vomiting, pain, delayed recovery and prolonged hospitalisation. Most of these problems are greatly reduced today thanks to some wonderful drug molecules and better understanding of pharmacokinetics and pharmacodynamics. Day care surgeries today form a

Swati Daftary Consultant Anaesthesiologist Jaslok Hospital & Research Centre India

single largest group of surgeries all over the world. Most of the new anaesthesia drugs cater to the demands of these surgeries and primarily aim at an early and uneventful recovery. Some of these newer drugs which are available since last decade are reviewed below.

New drugs Premedication – Dexmedetomidine

Specific, selective alpha2 agonist gives excellent anxiolysis and sedation pre-operatively. Its features include: • Haemodynamic stability, low heart rate and anaesthesia intra-operatively.

• The benefits also extend into the postoperative period with prophylaxis against ischaemic events, analgesia and reduced shivering.

• Available in parentral formulation. A dosage of 1-2.5 µg/kg is given over 2 minutes. Short half life of 2 hours.

• Ideal for perioperative use. Antagonising the sedative/hypnotic effects of dexmedetomidine with atipamezole will permit rapid recovery from anaesthesia, regardless of the duration—a technique already widely and successfully practised in veterinary anaesthesia!

Induction and maintenance — Xenon

Xenon is Greek for stranger. It was discovered in 1898. Manufactured by frac-

tional distillation of air and costs 2000 times more than N2O. Owing to environmental concerns, there may be no alternative but to use xenon in distant future even if it incurs an increase in cost.

• Colourless and odourless gas with no irritation to the respiratory tract. Well tolerated with gas induction • Low blood/gas and oil/water partition co-efficients allowing rapid induction and eduction • Produces unconsciousness with analgesia and a degree of muscle relaxation • MAC of 60-70% allows a reasonable inspired oxygen concentration

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• It does cause respiratory depression, to the point of apnoea • It is cardiac stable • Not metabolised in the body and is eliminated rapidly and completely via the lungs • It is non-toxic and is not associated with allergic reactions • Stable in storage, no interaction with anaesthesia circuits or soda lime. Should not be used with rubber anaesthesia circuits as there is a high loss through the rubber • Non-flammable • Expensive Muscle relaxation – Cisatracurium

Cisatracurium besilate is a non-depolarising neuromuscular blocking agent with an intermediate duration of action, cardiostability, and faster recovery than vecuronium. Hoffman degradation as for atracurium. Compared with atracurium, less laudanosine is produced (this is then cleared renally). Well tolerated; no significant histamine release. Recovery seems NOT to be prolonged with liver or renal dysfunction.

Rocuronium bromide:

• ED90: 0.3 mg/kg – intubating dose: 0.6-1.0 mg/kg – onset: 1-1.5 minutes, clinical duration: 30-60 min • Maintenance dose: 0.1-0.15 mg/kg, duration: 15-30 min • Metabolised by liver, 75-80% • Excreted by kidney, 20-25% • ½ life β: ~ 60 minutes • Mild CV effects- vagolysis, no/minimal histamine release, • Prolonged duration in the elderly + liver disease • Only non-depolariser approved for RSI Neuromuscular block Reversal– ORG 25969 / Sugammadex The results of four ongoing Phase II trials indicate that a new selective relaxant binding agent, a ϒ-cyclodextrin (GC) compound, has the potential to radically change the way neuromuscular blockade is administered and reversed. Depending on the dose of the GC compound, moderate and deep neuromuscular blockade in patients receiving either rocuronium or vecuronium was reversed rapidly and safely, often in less than two minutes. This

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compound encapsulates muscle relaxant and promotes dissociation from Ach receptor. This is revolutionary, especially when you look at its implications in a difficult airway.

Local anaesthetics – Levobupivacaine, opivacaine Ropivacaine: A long-acting local anaesthetic with less cardiac and central nervous system toxicity than bupivacaine, and a smaller tendency to cause motor block. It is less lipid soluble than bupivacaine and more selective for A delta and C fibres than motor nerve fibres, giving a greater degree of separation between motor and sensory blockade when used in concentrations below 0.25%. Minimum effective concentration is 0.2%. It is highly protein-bound (94%) with terminal t1/2 111 min. and maximum allowable dose is 2 mg/kg.

Levobupivacaine: The S(-)enantiomer of bupivacaine, with less cardiovascular and central nervous toxicity, a slightly longer duration of sensory block, but otherwise similar to its parent. Compared to bupivacaine it is as potent, with a trend towards longer sensory block; with epidural usage it produces less prolonged motor block; Differentiation not seen with peripheral placement; lethal dose 1.3 to 1.6 times higher; less cardiac effect including less depression of contractility and fewer arrhythmias; higher convulsive doses. It has elimination t1/2 ‘1.3 hours’, and protein binding > 97%. Recommended maximum dosage same as bupivacaine. Observe precautions as for all local anaesthetics.

Analgesics – Remifentanil A typical μ opiate receptor agonist with ultra-rapid clearance and offset of action, that is independent of excretory organ function. It is 20 to 30 times more potent than alfentanil. Undergoes rapid hydrolysis by nonspecific esterases to almost inactive remifentanil acid. This metabolism is not altered by end-organ function or genetic variablility of specific esteraes (like plasma cholinesterease); redistribution is of little consequence. Context-sensitive half time is 3-5min regardless of infusion duration.

Full recovery of respiratory function occurs in ‘10 to 15 min’. Given by continuous infusion, it reduces induction dose of thiopentone by 30%; Lowers the MAC of

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volatile agents. Supplement with N2O, propofol or isoflurane.

Adverse effects:

1. Anticipate and prevent postoperative pain 2. Bradycardia may occur 3. Dose-dependent respiratory depression, Muscle rigidity occurs 4. NOT for epidural use as the lyophilised powder contains 15mg of glycine 5. If given alone, may cause awareness New formulations New formulations of known drugs are being developed to either cut down their drawbacks or to improve their efficacy.

Some of the drugs which are being worked on are Propofol, Midazolam and local anaesthetics.

Drugs for hypnosis and sedation may have problems in the form of extended duration of action, unwanted cardiovascular and respiratory effects and issues with their vehicle including pain on injection, hyperlipidaemia and vulnerability to bacterial growth. Three main strategies are being employed to improve these drugs.

Reformulation: to overcome issues of formulation vehicle as in Propofol. As not a single formulation is problem free, we have multiple formulations claiming advantages. Standard- Propofol 1% and 2% in 10% soya oil as long chain triglycerides - Addition of EDTA or sodium sulphite does not support bacterial growth but can cause allergic reaction or yellowish discolouration (more with sulphite).

- An emulsion containing long and medium chain triglycerides reduces incidence of pain on injection - Propofol 6% in 10% soya oil reduces hyperlipidaemia - Propofol 1% in 5% soya oil with or without EDTA – pain on injection ↑4 times - Propofol in cyclodextrin based formulation Pro-drug approaches: Focused mainly on propofol to achieve good water solubility. The inherent problem is of slow onset and offset of action as they need to be rapidly metabolised to liberate the active compound. e.g. Methyl phosphate pro-drug of propofol, Aquavan→ The phase III trial have been halted due to high level of adverse events.

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The soft drug approach: This has been previously used in remifentanil, propanidid and mivacurium. The aim is to produce metabolically-labile agent which is hydrolysed rapidly by blood and tissue esterases so as to have rapid recovery profile.

TD-4756, esters of barbiturates(Aryx) and benzodiazepine ligands(CeNeS) are some examples of such compounds.

• Effect of intraoperative magnesium infusion on perioperative analgesia Anaesthesiology. 1996 Feb; 84(2): 340-7, Eur J Anaesthesiol. 2002 Jan; 19(1):52-6. J Clin Anesth. 2004 Jun; 16(4):262-5.

Novel clinical uses of known drugs: • Intranasal Nicotine for postop. Pain treatment. Anaesthesiology 101: 141721, 2004 • Analgesic effects of Gabapentin on acute postop. Pain Anaesthesiology 100: 935938,2004, Acta Anaesthesiol Scand 48: 322-327.2004 • Oral Amantadine (antiparkinson and antiviral) for postop. Pain Anaesthesiology 100: 134-141,2004 • Introp use of Adenosine is associated with reduced opioid requirement in postop period Anaesthesiology 1999; 90: 956-963.

Rapacuronium bromide: FDA approval for clinical use of this non-depolarising muscle relaxant came on August 8, 1999. The drug was developed as a substitute for succinylcholine in the setting of a rapid sequence induction. Clinical experience with this drug showed increased incidence of severe, life-threatening bronchospasm in children with rapid injection. Nineteen months later, on March 27, 2001, the manufacturer withdrew the drug from the market voluntarily.

Rofecoxib: This selective COX-2 inhibitor was withdrawn worldwide in October 2004 after the reports of cardiovascular risks were published.

The rapid rise and fall of a few new drugs: Rapacuronium, Cleofol and Rofecoxib

Cleofol®: Clear propofol promoted as ‘vegetarian’ formulation of propofol fell in disrepute after reporting of very painful injection and increased incidence of severe thrombophlebitis.

The above list is obviously not comprehensive. We are still looking for an ideal local, intravenous, inhalational anaesthetic, a safe and a very effective pain killer.

Conclusion This disproves the concern that use of old / less expensive drugs may compromise patient outcome and satisfaction and that newer and costlier drugs are always safer.

Some suggest that national societies should create guidelines for cost-beneficial practice. Others favour physician autonomy in drug selection. There will be great reluctance to deny patients pharmacologically superior drugs based on cost alone, especially since drugs are such a small portion of the total surgical costs. The aim should be to manage and modify drug practice in anaesthesia depending on changing needs to provide value-based care.

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Stem Cell Therapy

The good, the bad and the confusing Stem cell therapies offer great potential for treating diseases. However, a lot of questions remain to be answered before this potential can be realised.

Michael Marber Professor Cardiology, Divisional Lead Mrinal Saha Specialist Registrar, Cardiology St. Thomas Hospital UK

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he number of people affected by coronary artery disease is staggering.

The American Heart Association’s reports that in 2003 alone there were almost 480,000 deaths attributable to coronary disease in the United States, representing 1 in 5 of all deaths. In addition, over 13 million Americans suffer from the consequences of heart attack, which include angina and heart failure. Furthermore, cardiovascular disease is no longer regarded as being particular to developed economies: almost 80% of deaths due to heart and blood vessel dysfunction worldwide occur in emerging economies.

Therefore, it will come as no surprise that a great deal of effort has been made in developing new technologies for the injured heart. Possibly the most high profile scientific endeavour in medical science over the past 10 years has been the attempt to harness the potential of embryonic stem cells and adult progenitor cells. These cells are defined by their ability to self-renew and mature into one or more cell types. Instead of replacing the entire damaged organ therefore, this approach provides precursor cells that may replace damaged components. In theory, there are several different sources from which these cells can be harvested: foetal tissue (from terminated pregnancies), embryos, umbilical cord, bone marrow and possibly other sites such as fat tissue.

Unfortunately, progress in stem cell science has sometimes been in the spotlight for the wrong reasons. We believe this has two principal explanations.

Firstly, some countries lack clear legislative measures to bolster the ethical boundaries created by research committees. In India several reports have emerged in recent years of clinics offering miraculous cures, albeit with an eye-watering fee attached, but whose results have not fallen under the scrutiny of peer-review. Hence, accusations have arisen of the exploitation of potentially desperate people. Perhaps it is this relative paucity of regulation that has attracted foreign businesses, which are known to use Indian patients as a test bed for their stem cell research, both in private and government-funded institutions. Another widely publicised case in point is that of the eminent Korean stem cell scientist, Hwang Woo-Suk, whose reputation was called into question over the issue of whether he was aware of the donation of eggs for experimentation by one of his own researchers.

The use of embryonic or fetal stem cells is the most strictly regulated. Although these are the most powerful weapons in the regenerative therapy armamentarium, they are also the most complex from an ethical perspective. Unregulated embryo research is possibly the reason for much of the negative attention that this field has drawn, underlining the need for more exacting controls.

Secondly, despite the presence of a strict legislative and ethical framework, much of the work that has emerged from the study of stem cells in heart disease has been notable for a lack of cohesion. Although it has been less than a decade since the possibility of a cell-based repair method for the heart working with animal models arose, there have since been literally dozens of experi-

ments conducted in humans reported in the scientific press. The rapidity of translation from the laboratory bench to the bedside is perhaps a reflection of the potential rewards to pioneers in this new era of biotechnology.

Maybe because of this haste, scientific rigor has been pushed aside in favour of perceived progress. As a result, there is a confusing— some might say chaotic—variety of different approaches to the same problem. How can we separate the signal from the noise?

To date, the main categories of cells that have been investigated for their potential to repair damaged heart tissue include skeletal myoblasts (resident satellite stem cells of skeletal muscle), and multipotent stem cells, derived from bone marrow.

Skeletal myoblasts were the first cells to be used in a clinical trial. Cells were injected in the scarred portions of heart muscle damaged by heart attack. Importantly, there was a small but significant improvement in the pumping function after almost a year. However, there was a significant downside. The pilot trial failed to demonstrate that these cells from skeletal muscle could transform into heart muscle cells. Moreover, 4 of the 10 patients developed potentially life-threatening heart rhythm abnormalities. This was possibly due to a lack of integration at the electrical level between the host cells and the implanted cells. Patients in the latest phase of this trial now require prophylactic insertion of an internal defibrillator, a specialised pacemaker capable of delivering an electric “shock” to revert the rhythm to normal.

In 2001 came the first report of bone marrow cells being used in the context of a heart attack (myocardial infarction), and these are now the most commonly used type of cells. A 46 year old man received his own bone marrow derived stem cells delivered by an injection into his coronary artery.

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Not only was the procedure safe, but at 10 weeks the patient had significantly improved the pumping capacity of his heart. These investigators subsequently published the first trial of cell therapy in acute myocardial infarction, in which patients derived a similar degree of benefit. The profusion of trials that followed all seemed to show promise.

On closer inspection, however, the benefits observed in stem cell recipients should be tempered by considering some important methodological criticisms.

Some trials, such as TOPCARE-AMI (Transplantation Of Progenitor Cells and Regeneration Enhancement in Acute Myocardial Infarction), were not randomised, thus opening the door to unwanted bias, and leaving the possibility that observed effects may have occurred despite the presence of stem cell infusion. Others did not include a group in whom a “sham” bone marrow harvest or infusion occurred such as BOOST-(BOne marrOw transfer to enhance ST-elevation infarct regeneration), thereby allowing for a potential confounding effect of the bonemarrow harvest procedure itself.

Furthermore, in BOOST, the relative improvement in heart function seen at 6 months was no longer evident at 18 months, suggesting that in this case, at least, the effect of cell therapy was simply to accelerate recovery.

There are numerous other areas of contention. It is not clear, for example, which subset of bone marrow stem cell is the most effective, or if a generalised “soup” of cells

is preferable to a highly selected population. Other investigators have used cells harvested after prior “enrichment” with growth factors designed to expand the desired cell sub-population. However, in some experiments, patients treated in this way had an acceleration of re-narrowing of the coronary arteries which were originally opened to treat the myocardial infarction.

The timing of delivery of stem cells has varied from hours to days after the heart attack. The mode of delivery of cells also differs between experiments. Some have been given intravenously, some down the coronary arteries, and some injected directly into the heart muscle itself. Similarly, there is no consensus as to the number of cells which should be delivered, which varies by up to 3 orders of magnitude.

Another crucial factor determining the success of a study is the method by which it is measured. Most studies have determined the change in the function of the left ventricle (LV), the main pumping chamber of the heart, as the principal outcome measure.

This is because LV function appears to be one of the best indicators of prognosis after myocardial infarction. The method of assessment of LV function, however, encompasses the spectrum of modalities available, including, angiography, echo, magnetic resonance imaging (MRI), and single positron emission tomography (SPECT), all of which have been used at variable time-points after infarction, and each having different sensitivities for detecting change.

Even after these differences are taken into account, the magnitude of improvement is typically not large. REPAIR-AMI (Reinfusion of Enriched Progenitor Cells And Infarct Remodelling in Acute Myocardial Infarction) is the largest double blind, placebo-controlled trial to date. This rigorously designed and well-executed study investigated 101 patients, in whom there was an improvement of LV function in the celltreated group of 5.5% vs. 3.0% (measured

by LV angiography) at 4 months, with fewer adverse clinical events in the treated group after 1 year. This result should be put into context, however. In a recent study, patients were treated for their heart attack with standard therapy, i.e. they did not receive stem cells. At 5 months, with just usual care, ejection fraction as measured by contrastenhanced MRI (ce-MRI) had improved by 7%, with a 31% reduction in infarct size.

This is a result comparable to the best of those from cell therapy studies.

Given the current state of affairs, perhaps it is time to resolve the many unanswered questions such as: Which cell to use? How many cells to deliver? Which delivery route is best? When should cells be delivered? Which endpoint is of most relevance? Offering cell therapy to patients is tempting, particularly if no other option seems to be available. But proceeding into largely uncharted territory with contradictory scientific studies as the only means of guidance, may result in a step back from, rather than in to, the future.

Product Showcase

ZOLL AutoPulse Non-invasive Cardiac Support Pump

T

he AutoPulse®—the only device of its kind—delivers the consistent, uninterrupted chest compressions that new AHA/ERC Guidelines are calling for. It is an automated, portable device with an easy-to-use, load-distributing LifeBand® that squeezes the entire chest, improving blood flow to the heart and brain during cardiac arrest.1-3 Additionally, it offers the benefit of freeing up rescuers to focus on other life-saving interventions.

A recent independent study4 conducted in the United States, using the AutoPulse, showed that survival rates of cardiac arrest patients dramatically improved when treated with an automated CPR device, versus manual CPR, prior to reaching the hospital. Data showed a survival-to-hospital-discharge rate of 9.7 percent using automated CPR, versus 2.9 percent using manual chest compressions. There was also a 71 percent higher rate of return of spontaneous circulation with the use of the AutoPulse than with conventional CPR

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References: 1. Timerman S et al. Improved hemodynamic performance with a novel chest compression device during treatment of in-hospital cardiac arrest. Resuscitation.

2004;61:273-280.

2. Halperin HR et al. Cardiopulmonary resuscitation with a novel chest compression device during a porcine model of cardiac arrest. Journal of the American College of Cardiology. 2004;44(11):2214-2220.

3. Ikeno F et al. Augmentation of tissue perfusion by a novel compression device increases neurologically intact survival in a porcine model of prolonged cardiac arrest.

Resuscitation. 2006;68:109-118.

4. Ong MEH, Ornato JP, Edwards D, et al. Use of an automated, load-distributing band chest compression device for out-of-hospital cardiac arrest resuscitation.

JAMA. 2006;295:2629-2637.

Further information: www.zoll.com

S u rgical S peciality

Integrated Operating Rooms Enabled by Richard Wolf's 'CORE' system: A case study With all the complicated systems that make up today's operating room, controlling can become a complex process.

The Wolf CORE system allows all the different devices to be controlled with one easy-to-use system.

Henning Baldauf Project Manager - Core, Richard Wolf GmbH, Germany Hospital Chemnitz

Helios Hospital Group

The unrivalled advantage of this solution is shown in the voice-controlled version. The simple and legible device functions displayed are used in this case as the voicecontrolled commands to operate the system. The speaker independent voice control currently used represents the highest technological standard and guarantees efficient and direct control of devices such as ENDO camera, light and OR table from the sterile field of the operating room.

Muljibhai Patel Urological Hospital

Clinique Generale-Beaulieu, Geneva

In the modern operating room there are a large number of highly developed, specialised devices for widely different applications, such as endoscopic camera systems, HF devices, insufflators, OR tables and lamps. Sometimes the complicated operation of different devices leads to an increasing load for surgeons and clinical personnel.

The outcome can mean unsatisfactory results. Richard Wolf has therefore paid attention to keeping its products simple and focussed on providing devices that are self-explanatory to operate.

With the introduction of the CORE integrated OR solution, Richard Wolf GmbH provides a complete system solution for minimally invasive (MI) surgery that meets the challenges that face the surgical community.

A simple central system CORE focuses on the highest functionality of the individual devices coupled with the simplest operating method for the entire system. This is achieved by simple, intuitive interactive guidance. All devices networked in the system are imaged on the monitor by a uniformly designed user menu. In this case the symbols normally used on the device to show its functions are displayed on the touchscreen by simple, readable terms which can be set to different national languages.

Image management CORE also combines with MEDIMAGEÂŽ to provide clinical partners with a complete, digital patient image and document management system. Proceeding from stations for image acquisition, processing and archive, it offers every form of image management, including server, network and telecommunication possibilities, as well as customised solutions designed specifically for the customer. MEDIMAGE unites in this case all types of images, films and reports from surgery, radiology, cardiology or any other discipline. Furthermore, it offers the possibility of intraoperative display of pre-operative x-ray image data (x-ray, CT) on suitable monitors in the operation field of the physician.

Training and consultation Telemedicine has been developed with the introduction of the videoconference and telecommunication solutions The videoconference equipment enables sharing of experience among specialist colleagues and consultations with specialists, and can provide efficient support in the education and further training of medical practitioners and students. It is possible for transmissions from inside the operating room to be displayed in a conference or plenary hall, as well as allowing live communication from hospital to hospital. It also allows a central control of such elements as video routing and videoconferencing, as well as peripheral components such as the operating room lighting.

Individual tailoring Richard Wolf GmbH, as system integrator of the CORE integrated operating room, offers you this service from a single source. The company is available with its expertise in all phases of project design and management.

Richard Wolf can help determine a requirements profile and design professional solution proposals which configure your system in accordance with the tasks required of it. Furthermore, it can organise reliable installation, commissioning and training for your system solution and provide service and maintenance programmes tailored individually to your needs.

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Quality Assurance Programmes for Surgery How and why in Asia?

It is inevitable that the concept of quality assurance in surgery will expand worldwide and encompass other surgical disciplines; the process will be driven by patients, professionals and healthcare providers alike.

Malcolm J Underwood Professor Department of Surgery CA van Hasselt Professor Department of Surgery Hong Fung Cluster Chief Executive New Territories, East Chinese University of Hong Kong Prince of Wales Hospital Hong Kong SAR

A

quality assurance programme in surgical practice is quite simply a mechanism to ensure that the patient (consumer) is subjected to the least threatening journey through the hospital during a period of treatment, with an outcome that is deemed acceptable by international standards. This process inherently incorporates data collection and outcome analysis, but is in fact conceptually broader and includes assessment not only of patient outcomes, but institutional processes, appropriateness of care and patient and healthcare provider satisfaction.

All of these variables inherently, but not exclusively, affect the patient journey.

Historical perspectives and importance The concept of developing ‘quality assessment’ in surgery is historically attributed to the American surgeon Ernest Codman.

In the 1900s, he suggested that hospitals in

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general, and surgeons in particular, should collect their results sequentially over time, in order to provide comparative data on ‘end-results’. His suggestion was that these outcomes be made public, allowing patients to use the information and ‘choose’ their place of treatment and individual surgeon. It was his lifelong pursuit to establish an "end results system" to track the outcome of treatments, as an opportunity to identify and resolve clinical misadventures thus providing the foundation for improving the care of future patients. It was a recognition that both institutional and individual measures of ‘performance’ need to be recorded, aspects which are now widely recognised as being an important part of the provision of quality assurance in surgery. But, for surgical specialties in Asia, why do we need this process and how can it be achieved?

Quality assurance programmes in surgery are essential for patients, doctors, hospitals and healthcare providers (financiers) worldwide for a variety of reasons.

Patients need to be reassured that the process of surgical treatment to which they have agreed is appropriate, will be administered effectively, and results in an outcome acceptable by international standards. In order to achieve this, individual surgeons and individual hospitals should be able to provide information regarding outcomes after surgical treatment which is based upon validated data and also ‘risk-adjusted’ for casemix. For example, in cardiac surgery in the UK, a speciality which has led the way in providing outcome data and analyses, each centre providing cardiac surgical treatments submits data regarding patient risk profiles

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and outcomes to the UK Society of Cardiothoracic Surgeons. These are subsequently collated by the National body, published and made available to the public. This process has evolved more recently and in collaboration with the Healthcare Commission in the UK, institutional and individual surgeons' results are now published on the Internet. The quality assurance process is important for individual surgeons globally.

Advances in risk-stratification allow them to compare their case-loads and outcomes with other practitioners both locally and internationally, and ensure that the facility within their institution is enabling them to perform to an appropriate level. It is important for hospitals to be able to look at individual and group surgical outcomes, ensuring that their overall institutional process meets published standards. It is important that healthcare providers are reassured that their financial support of surgical programmes within institutions is being used effectively, not only in terms of patient outcome, but also in resource utilisation.

All of the above issues are pertinent and relevant to the provision of surgical care in Asia in view of the rapid rise of treatment availability, and importantly, the associated financial burden. Whilst it is perceived that all of the above processes can by default lead to consequential quality ‘improvement’, there are still many areas which require investigation and resolution.

Stratification and data collection Presenting information regarding outcome to the public (patients) requires an ongoing ‘educational’ aspect as there needs to be general understanding of the important

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differences between ‘crude’ and ‘risk-adjusted’ outcomes. A surgeon or institute with a comparatively high mortality for a given procedure may actually be performing exceptionally well when case-mix is considered. This represents a challenge in Asia.

The ‘risk-stratification’ process is well developed in cardiac surgery, but has accepted limitations and is more complicated to establish and consequently less developed in other surgical disciplines. Despite this, the Veterans Affairs Medical Centers in the US has produced risk-adjustment models for 30-day mortality and morbidity rates for both non-cardiac and associated surgical specialities. The ability of this model to detect variations in the quality of care has also been shown in a validation study. There are still, however, complexities to be resolved when defining ‘outcome’.

In cardiac surgery, mortality is routinely used as a measured ‘outcome’. For surgical specialities where this is unlikely to be a useful marker—e.g. plastic surgery—clinical indices which reflect quality in that particular service need to be identified. Mor-

tality alone may not be sensitive enough as a ‘quality’ outcome tool and recently, the concept of recording and analysing ‘near-miss’ episodes rather than death has been suggested as being a more useful mechanism to identify rectifiable performance problems at an early stage. It seems obvious that, despite apparent difficulties in defining surgical outcomes and applying risk-stratification, embracing the concept of quality assurance in Asia would be of benefit to all parties involved in the patient journey. But how could it be achieved?

The essential element for a successful quality assurance programme is without question, the determination and commitment of healthcare professionals (providers of direct clinical care as well as financiers) to embrace the concept. The most important practical aspect is the provision of an appropriate institutional infrastructure (system) which allows collection of relevant, validated data. Without this, any attempt to provide information regarding patient outcome is doomed to fail.

Computerised systems and information

technology are globally available, which provide the facility for clinical data storage and complex outcome analysis. It is essential that along with these systems, data validation procedures are undertaken. This will allow confidence in the accuracy of outcome reporting. The provision for these facilities should be given priority by healthcare providers. The natural progression of having these resources in place would be the development of national databases for different surgical specialties within the region, enabling institutional comparisons and ‘benchmarking’ exercises appropriate to the local population. The concept of quality assurance within surgery is not new. The process will continue to be driven by patients, professionals and healthcare providers alike. The provision of comparative systems in Asia, facilitating quality assurance, is a moral obligation of the whole healthcare community involved in the surgical treatment of patients and represents an ongoing challenge within the region.

Full references are available on www.asianhhm.com/magazine/

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Advances in Cardiac Surgery Yoshihiro Suematsu Assistant Professor Division of Cardiothoracic Surgery University of Tokyo Japan

The combination of new intra-cardiac imaging technology and tool-tracking systems with the dexterity and stability of robotic instruments will enable safe and reliable off-pump intra-cardiac repair, including Atrial Septal Defect (ASD) closure and the repair of mitral valve insufficiency.

I

n the past decade, minimally invasive surgical techniques have become prevalent in the field of cardiac surgery, including minimally invasive direct coronary artery bypass (MIDCAB), offpump coronary artery bypass (OPCAB), and minimal access atrial septal defect (ASD) closure and mitral and aortic valve surgery. In addition to the development of new technologies such as visualisation systems, specially designed retractors, stabilisers, and alternative methods of vascular cannulation and cardiopulmonary bypass, surgeons have become capable of performing simple cardiac procedures through much smaller incisions than with conventional approaches. However, the limited incision size has imposed a corresponding increase in the technical difficulty of the procedure accompanied by a potential for a reduced safety margin due to incomplete cardiac exposure.

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Recently, robotically assisted surgical systems have been introduced to increase the precision of endoscopic surgery and facilitate minimally invasive cardiac surgery.

These computer-guided systems can control both surgical instruments and endoscopic cameras. Robotic instrumentation provides access to the heart and offers the surgeon the ability to operate precisely in limited spaces, overcoming the lack of precision that results from the additive effects of instrument length and operator tremor by filtering high-frequency motion. Dexterity is further enhanced through computer motion-scaling, which allows the surgeon to make large, easy-to-perform macroscopic movements at the console and have these movements scaled down by the computer to microscopic movements of the instrument tip inside the patient. Endoscopic magnification also improves the accuracy of surgical maneuvers by providing enhanced visualisation.

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In 1998, Carpentier and colleagues reported the first cardiac surgeries (several kinds of mitral valve repairs) to be performed in adults using a prototype of the current da Vinci system (Intuitive Surgical, Sunnyvale, CA). These operations were performed through small thoracotomy incisions. Subsequently, endoscopic robotic coronary operations were described the following year; soon after, a totally endoscopic, robotically assisted cardiac surgery procedure for the repair of atrial septal defects was reported.

All the robotically assisted cardiac surgery procedures performed to date have either been extra-cardiac procedures or procedures that were performed inside an arrested heart. In the past, beating-heart procedures were attempted, but these approaches fell into disfavor after cardiopulmonary bypass (CPB) became available, which allowed direct visualisation of the intra-cardiac structures. Nevertheless, CPB is widely recog-

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nised as having a number of adverse effects, including the generation of microemboli and an inflammatory response associated with increased cytokine production and complement activation, which together can result in neurological dysfunction in adults and neurodevelopmental dysfunction in children.

Several investigators have recently attempted a variety of beating heart approaches for the repair of intra-cardiac pathologies, including atrial septal defects, ventricular septal defects, and mitral valve regurgitation, but the results were all suboptimal and not applicable in clinical situation.

On the other hand, the recently introduced real-time three-dimensional echocardiography (RT3DE) system with a 2D matrix array of piezoelectric crystals (Philips Medical Systems) provides clinicians and surgeons with a new perspective for visualising the heart non-invasively.

When RT3DE is used for image-guided surgical tasks, some complex tasks required for intra-cardiac repair can be performed using echo guidance alone. This system has sufficient spatial resolution and frame rate to give the surgeon a “virtual surgeon’s view” of the relevant anatomy. Currently, we have adapted RT3DE with specialised instrumentation to facilitate beating-heart repair of Atrial Septal Defect ASD and mitral valve plasty in animal experiments (Figure 1). In our preliminary experiment, we also examined the feasibility of robotic assisted RT3DE guided beating-heart repair of ASD. Compared to 2-dimensional echo guidance, completion times of performing clipping improved by 70% (p<.0001), and deviation of clipping by the robotic system was significantly smaller (2DE: 3.5±2.2 mm, 3DE: 0.2±0.3 mm, p=.0002) in RT3DE guided tasks. In water bath experiment of ASD closure, RT3DE provided satisfactory images and sufficient anatomical detail for suturing (Figure 2). All surgical tasks were successfully performed with accuracy. We therefore expect that the combination of new intra-cardiac imaging technology and tool-tracking systems with the dexterity and stability of robotic instruments will enable safe and reliable off-pump intra-cardiac repair, including ASD closure and the repair of mitral valve insufficiency.

Indeed, there still are several limitations.

Our RT3DE system provides adequate

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intraoperative images overall as an imageguided technology, but the spatial resolution of the RT3DE still needs optimisation to advance from simulation into a clinical setting. In addition, the transducer is too large to be applied directly to the heart through a small incision, since the operating field of instruments is restricted. Therefore, further technological development of the RT3DE system, such as by design of a highfrequency mini-transducer or trans-esophageal transducer, will probably be necessary to make minimal incision RT3DE-guided beating-heart surgery possible.

Other research and development We are simultaneously investigating the potential application of an electromagnetic tool tracking and navigation system as a complementary navigation tool in beating heart intra-cardiac surgical procedures.

Similar systems are currently in use for catheter tip tracking and navigation for arrhythmia ablation. This latter system combines an electromagnetic tracking system with a catheter-based sensor that can be used to create a 3D map of the atrial chamber. We have experimentally used such a tracking tool to navigate inside a beating heart. With further development, this system could be used together with RT3DE to confirm contact with the septal wall during patch placement in ASD repairs while ensuring the avoidance of conducting tissues.

The current size of the da Vinci surgical system is the most critical limitation for its application in pediatric cardiac surgery. To date, 5mm instruments and smaller 3D endoscopes have been developed. In the near future, more technological advances are likely to extend the application of robotic surgical systems to neonates and infants.

Determination of the optimal port placement is a significant issue. Mistakes at this stage of the operation lead to delays from

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frequent instrument conflicts and can result in additional unnecessary incisions if the ports must be re-positioned. Using computed tomography (CT) and magnetic resonance imaging (MRI), preliminary efforts toward the development of a three-dimensional virtual cardiac surgical planning platform have been initiated for use with totally endoscopic cardiac surgery to avoid these problems. We have also employed a new port placement planning platform for extracardiac operations in children. The planned setup enables excellent exposure in addition to patient positioning, with no internal or external instrument conflicts.

The absence of tactile feedback and the inability to regulate the force applied to the tissues comprises the most endoscopic surgical techniques and instrument manipulation by the robotic system will eventually become comparable to that by the human wrist. In addition, haptic exploration of preoperative image data sets facilitate surgeon intuition during the planning of complex reconstructions.

Current robotic systems were designed to complete a simple anastomotic suture line. Gulbins et al. reported that it required 30 minutes to finish a 10 suture throw in training simulators. The time required for anastomosis could be reduced using novel devices for joining tissues or anchoring a surgical prosthesis, such as the Tacker spiral tack (US Surgical), the SaluteTM (Onux Medical), the Sew-RightTM and Ti-KnotTM systems (LSI Solution), or the U-ClipTM Anastamotic Device (Coalescent Surgical). Combining any of these devices with the speed and precision of robotic automation could make minimally invasive tissue fixation exponentially more efficient.

Further manipulation of the digital visual interface may also make it possible to work on the beating heart in “virtual stillness”. Lately, we have also been developing integrated motion cancelling systems, including visual stabilisation systems and motion stabilisation systems. The movement of the robotic instruments and camera would be synchronised with each heartbeat, effectively cancelling cardiac motion and increasing surgical precision.

Full references are available on www.asianhhm.com/magazine/

D iagnostics

Oral-based Diagnostics Oral diseases and beyond

Antoon J M Ligtenberg Assistant Professor Department of Oral Biochemistry Academic Centre for Dentistry Amsterdam (ACTA) The Netherlands

With modern proteomic and genomic techniques it is possible to fine-tune diagnostics of oral diseases and monitor other diseases by oral diagnostics.

I

n October 2006 the New York Academy of Sciences organised a conference in Atlanta on Oral-based Diagnostics dealing with the diagnostic potential of saliva and its constituents. Although blood is still the gold standard for diagnostics of diseases and drugs, oral diagnostics has the same and may be an even larger diagnostic potential. Principally, all substances that are present in blood may be monitored in saliva, since serum components leak from the gingival crevice into the oral cavity.

The concentration of serum components in saliva may be enhanced by normal actions like tooth brushing which results in a fourfold increase of serum albumin. In addition, not only saliva and serum components, but also oral bacteria and epithelial cells are present in the oral cavity. All these substances have their own specific diagnostic potential, but what they have in com-

mon is that samples can be collected noninvasively. This makes collection of saliva safe and patient-friendly. Since no trained staff or sterile equipment is necessary, oralbased diagnostics can be used quite well for point-of-care diagnostics, home testing and road side applications.

The current position of oral diagnostics can be illustrated by its role in oral diseases like dental caries and periodontal disease.

Dental caries is the demineralisation of teeth caused by acids that are produced by plaque bacteria. Bacteria accumulate as an oral biofilm called dental plaque, particularly at those dental surfaces that cannot be cleaned properly. The frequent consumption of fermentable carbohydrates results in the production of organic acids, primarily lactic acid, that are released into the plaque fluid. This lowers the pH in the oral biofilm, which favours the outgrowth of Streptococ-

cus mutans and Lactobacillus spp., resulting into an ecological shift to a more cariogenic plaque. Saliva secretion rate, buffering capacity and counts of mutans streptococci and lactobacilli, have proven to be sensitive parameters in caries prediction models.

High numbers of S.Mutans and Lactobacillus spp. indicate a shift in oral microflora from healthy to more cariogenic. Diagnostic kits for S. mutans and Lactobacillus spp. counting are widely used in dental practice and can be conducted without laboratory facilities. They are based on traditional culturing techniques in selective media but analysis by PCR is also possible.

In a healthy situation, there is no correlation between saliva secretion rate and dental caries. However, when the salivary secretion rate drops below a certain minimum, the amount of dental caries increases dramatically, also at smooth dental surfaces that are normally not prone to caries as well. Salivary secretion rate is easily measured by weighing the saliva volume that is collected by drooling or expectoration divided by the collection time. Low salivary buffering capacity is a risk factor for dental caries and also is indicative for low saliva secretion. Commercial kits are available for determination of the salivary buffering capacity.

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D iagnostics

Saliva plays an important role in the maintenance of oral health. For that purpose, it contains a large number of different components that kill or inhibit bacteria, prevent their colonisation, act as nutrient for commensal bacteria and promote remineralisation of the teeth. Therefore, numerous studies have aimed at finding a correlation between dental caries and saliva constituents with only weak correlations. Because dental caries is a multifactorial disease, there are several reasons for the weak salivary correlations. First, saliva output and composition are only two links in a whole chain of events that cause dental caries. Second, whole saliva composition doesn’t reflect the composition of the plaque fluid at sites where dental caries develops. Third, salivary proteins show overlap in function and many proteins have more than one function making it difficult to correlate dental caries to a particularly one, or a few salivary components.

Studies that have focused on functional aspects of whole saliva, rather than studying the quantities of individual proteins, have yielded more promising results. For example, high bacterial aggregation activity of saliva has been associated with low caries experience. Since there is a long list of salivary proteins that bind and may aggregate oral bacteria (e.g. S-IgA, mucins, agglutinin/DMBT-1/gp340, lysozyme, lactoferrin, amylase, proline-rich proteins, statherin and histatins) aggregation couldn’t be correlated with a specific salivary protein.

It requires modern proteomic techniques to take them all into consideration. NIH is investing millions of dollars in clarifying the human saliva proteome. At the conference on Oral-based Diagnostics in Atlanta Dr David Wong, UCLA, announced that a first version of the human salivary proteome is available at the website of UCLA in 2007 (www.hspp.ucla.edu).

Many oral bacteria bind carbohydrate chains on salivary glycoproteins. Therefore, the salivary ‘glycome’ might be an important pre-determinant for oral disease. This is illustrated by research of Paul Denny from the University of Southern California, who showed a difference in carbohydrate composition between children at low and high caries risk. Another oral disease for which several aspects of oral-based diagnostics are evaluated, is periodontal disease. Due to poor oral hygiene the dental plaque accumulates

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at the gingival margin and the composition of the plaque changes, inducing gingival inflammation (gingivitis). This progresses to periodontal disease characterised by breakdown of alveolar bone and connective tissue fibers, resulting in loss of attachment and deepening of the periodontal pocket.

Progress from gingivitis to periodontal disease is determined by genetic susceptibility, environmental factors like smoking, and the presence of pathogenic bacteria.

Diagnosis of periodontal disease is primarily based on radiographic analysis and measurement of the pocket depth with a sonde.

Though efficient, such clinical methods do not provide adequate information for identifying people at risk, disease activity, causative agents, and treatment outcome. This information could be provided by oral-based diagnostics. There is a large, genetically determined, variation in susceptibility for periodontal disease. Mutations in the cathepsin C gene have been identified as causal for the Papillon-Lefèvre syndrome, including severe forms of prepubertal periodontitis.

In addition, multiple genes have been associated with less severe forms of periodontal disease. People at high risk for periodontal disease might be determined therefore by genetic screening. DNA can easily be isolated from oral epithelial cells, collected by use of a buccal swab, one of the most common oral diagnostics.

The loss of attachment and deepening of the periodontal pocket leads to increased leakage of a serum-like fluid, designated gingival crevicular fluid, into the oral cavity. Since serum has a 50 to 70 fold higher protein concentration the average protein concentrations in oral fluid increases dramatically and the concentration of a typical serum component like albumin shows an 8-fold increase. At the conference on Oralbased diagnostics Dr Christoph Ramseier from the University of Michigan, and Dr Ira Lamster from the Columbia University, New York, showed that during active periods of the disease increased levels of inflammatory markers, like interleukins, can be demonstrated both in gingival crevicular fluid and in saliva. Several important marker bacteria have been associated with periodontal disease such as Porphyromonas gingivalis, Prevotella intermedia and Acinobacillus actinomycetemcomitans.

Eradication of these bacteria significantly

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enhances the chance of a positive outcome of treatment. As part of the therapy, antibiotics are applied frequently. However, different periodontopathogens are susceptible to different antibiotics. Therefore, prior to antibiotic treatment pathogens should be determined by culturing or PCR techniques. Oral fluid may be used for that, but since the bacterial numbers in saliva may be too low, small methylcellulose paper strips are used to collect fluid from the gingival crevice. Next to the salivary proteome, there is a salivary ‘transcriptome’ represented by RNA in saliva, as was shown by Dr David Wong. Approximately 3,000 different mRNAs have been found in saliva of which ~200 are commonly present in all people. Upon exploring the clinical utility of the salivary transcriptome in human oral cancer subjects it was found that 4 salivary mRNAs (OAZ, SAT, IL8 and IL1b) collectively have a 91% sensitivity and specificity for detection of oral cancer.

Going beyond oral diseases, oral-based diagnostics finds its way to other applications. A widely used test that is approved by the FDA is an oral test for HIV that detects antibodies against the p24 antigen of HIV. The applicator swab is gently rubbed along the outer gums­­—both upper and lower—and inserted into a vial containing the developer solution that detects the antibody to p24 antigen of HIV. In about 20 minutes, an indicator shows that it is working. A second signal appears if it detects the presence of the p24 antigen; those individuals are given a confirmatory test. Oral samples are also used for testing of illegal street drugs such as marijuana, cocaine, XTC and heroin. Unlike urine samples where switching may be possible, oral samples allow for observed, controlled sample collection.

Conclusively, it can be said that oralbased diagnostics already plays its own specific role in caries prediction and periodontal disease classification. Since blood components are leaking into the oral cavity, we expect that oral-based diagnostics will replace more and more of the current serum-based tests. In addition, microchips for multiple saliva analytes will become available in the near future, bringing proteomics, transcriptomics and genomics within reach of point-of-care diagnostics.

Full references are available on www.asianhhm.com/magazine/

innovations

In what appears to be the first step towards a radiation-free, non-invasive technology, Vibration Response Imaging (VRI) has arrived. VRITM, an innovative technology developed by the Israel-based company, Deep Breeze Ltd, can create images of the lungs based on the sound of air moving in and out of the passageways of the lungs, thereby preventing exposure to radiation in diagnosis.

Igal Kushnir, President and CEO, Deep Breeze Ltd Israel

Vibration Response Imaging A new methodology for measurement of lung vibrations

I

n the hands of a trained physician, the stethoscope has been an excellent tool to assess the air moving through a patient’s lung. But its usefulness is limited due to the range of audible frequencies as well as outside interferences. The VRIXP™ is a unique new lung imaging system developed by Deep Breeze in Israel. Based on the science of Vibration Response Imaging (VRI) technology, the VRIXP™ produces dynamic lung images at the bedside without the use of radiation.

The VRIXP™ is a portable system that uses an array of 42 multi-use transducers, which are placed on a patient’s back. The array is used to measure the vibrations generated from the acoustic energy developed as air passes through the lungs. The data for producing an image is acquired in seconds; it is a quick and easy procedure performed by a technician, much like an ECG. Along with producing an image, the ultimate goal is to correlate that image with a numerical scale namely Quantitative Lung Data (QLD).

Economical overview The first target of the VRIXP™ system will be the monitoring of lung sounds.

This will allow physicians to detect what is going on in a patient’s body and aid in evaluating the outcomes of procedures.

Future applications include the diagnosis and management of asthma, lung cancer, lung transplants, pneumonia, COPD, and the ICU management of mechanical ventilators. In the ICU setting, physicians will have an easy-to-use technology to assist them in determining the lungs’ condition, response to therapy and to evaluate optimum ventilation settings.

This should result in better outcomes by assisting the physician in the reduction of ventilator-related pathologies. This will also allow patients to be weaned off a ventilator more quickly—a key factor in improving outcomes for ventilated patients.

As with any technology used on an inpatient, the cost per use is important due to the capitated payment structure most hospitals face. Along with the system’s ability to offer a unique, safe and new technology for lung assessment, the VRIXP™ also has a very attractive cost per use. This is due to the reusable sensor array and the limited labour required. Based on 1,000 tests per year, a facility should expect to see costs of approximately US$24 per patient. Lower use applications such as long term monitoring would see costs of US$80 based on 200 tests per year over a five-year period. The system is currently selling for US$50,000 in Europe.

Under existing outpatient codes, the

VRIXP™ system could fall under pulmonary imaging or function codes. Pulmonary imaging using nuclear medicine technology currently reflects an average CMS payment of US$197 (APC 378, Level ll). Based on 1,000 procedures per year, a facility could see a New Technology for Lung Function, Ventilator Patients profit margin of over US$740,000 at the end of a five-year term.

Pulmonary function reflects an average CMS payment of US$57 (APC 368, Level ll). Based on 1,000 procedures per year a facility would see a profit margin of over US$134,000 at the end of a five-year term.

This reflects a revenue generating technology that does not directly compete with any existing revenue streams.

Market potential Lung disease is the third most common reason for hospitalisation in the US alone.

Lungs are an internal organ but are constantly exposed to the outside environment. Because of this, they are susceptible to multiple forms of disease. Over 35 million Americans are living with chronic lung diseases such as asthma, emphysema and chronic bronchitis. Each year around 350,000 die from these diseases.

These numbers will continue to grow as the population ages and environmental factors come into play more often.

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nosis of lung diseases. Asthma alone affects 5-10% of the US population. This equates to an estimated 14-15 million people in the US, including five million children. Asthma is also responsible for over 1.8 million emergency room visits and 500,000 hospitalisaFigure1: VRIXP™ Normal Image of a Figure 2: The VRIXP™ Image of a 12 19 y.o Female Healthy with Asthma. y.o Female with Bilateral Bronchiectasis tions annually. It is estimated Red Dots Indicate Wheezes. and Pulmonary Hypertension. that asthma alone costs the Blue Dots Indicate Crackles.

US economy over US$20 Lung disease is also very costly to treat. It billion a year in both lost of productivity costs Americans US$81.6 billion in direct and treatment. healthcare expenditures plus US$76 billion in indirect costs. These combined factors The procedure make lung treatment and diagnosis of lung The system is designed to be portable and disease a major focus of researchers. Some easy to use. This will allow it to be used of the most common lung diseases are in multiple settings by a nurse, technician COPD, pneumonia and chronic asthma. or physician. As with an ECG, a physician These diseases account for over 750,000 will do the interpretation. The procedure hospitalisations each year. COPD is most takes approximately five to ten minutes common in patients over 47 years of age including preparing the patient, placing and treatment is reimbursed by a combithe sensor array on the patient’s back, and nation of Medicare and private insurance. reviewing the image. The actual recording The most serious and costly cases involve takes approximately 12 seconds. Once the the end stages of the diseases, which is array is placed over the patient’s lungs, the more common in Medicare patients. The transducers convert the sound data to an National Institute of Health (NIH) eselectrical signal. This is in turn digitised timates that the direct cost of treating and converted into a dynamic image. This COPD alone is US$18 billion a year. This is a simple process that offers real-time immakes it over 2.5 times more expensive to ages of lung function and can be done in treat than all other diseases affecting hosvirtually any setting without exposing the pitalised patients. One reasons for this patient to radiation.

Right

Left

Upper

4.35%

22.11%

Middle

5.68%

46.97%

Lower

1.06%

19.82%

Total

11.09%

88.91%

Figure 3a. VRIXP™ MEF of a 56 year old female 3.5 years post left lung transplantation, Figure 3b. demonstrates the VRIXP™ QLD configuration, and Figure 3c the posterior perfusion scan (regional assessment: right lung 23%, left lung 77%).

high cost is the expense of the mechanical ventilators required to treat the latter stages of the disease. Not including critical care cost, the ventilator therapy alone expenditures start at US$325 per day. This makes the reduction of ventilator use a major focus of both healthcare providers and payers. Another potential market for the VRIXP™ system is the assessment and diag-

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Functional lung imaging Normal image: healthy lung images appear with an almost symmetrical, simultaneous development of the Vibration Response (VR), which correlates with airflow dynamics.

VRIXP™ images of lung pathology: Lung tumour image results in an asymmetrical appearance and reduced VR and disturbed

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dynamics in the tumour area. Pleural fluid results in reduced meniscus shape in the lower lobes and absence of VR in the area of the pleural fluid.

Patients having various lung pathologies such as asthma and bronchiectasis, differed from normal images in symmetry, intensity and time sequence. In asthma patients the VRIXP™ image showed an asymmetrical vibration response distribution between lungs and lung regions (Figure 1). In 5 bronchiectasis patients the VRI™ revealed disturbed VR which affected the time sequence and symmetry (Figure 2).

Following Single Lung Transplantation, most of the ventilation and perfusion shifts to the transplanted side. A routine ventilation and perfusion (V/Q) scan is performed periodically to asses the graft function. In a well functioning graft, following single lung transplantation, most of the ventilation (V) and perfusion (Q) shifts to the transplanted side (Figure 3a).

Chest auscultation usually discloses a difference between the transplanted and nontransplanted lungs; however, no quantitative or regional assessment can be done by the physical examination. The VRIXP™ offers a quantification of regional assessment lung function or Quantitative Lung Data (QLD) function in post lung transplantation patients (Figure 4b and c). Vibration energy collected throughout the breathing cycle can be quantified for any lung region by integrating the vibration energy over the 40 sensors of the V-Array.

Conclusion VRIXP™ provides a better understanding of lung function throughout the respiratory cycle, for improved diagnosis of lung condition. With the Quantitative Lung Data function of VRIXP™, the clinician can obtain immediately the regional assessment of right and left lung function, as the imaging modality quantifies the vibration distribution automatically during the procedure. The VRIXP™ also has the capability to visualise the location and distribution on the VRIXP™ image of the crackles and wheezes should it be recognised at any time throughout the respiratory cycle. The quick and efficient VRIXP™ procedure may be performed repeatedly for assessment and continued monitoring of lung status, providing instant results in any facility.

D iagnostics

Point-of-care Diagnostics Tapping the potential

Point-of-care diagnostics are a potentially profitable growth area for the healthcare industry. However, there are several issues to be overcome before any point-of-care instrumentation can be successfully commercialised.

Neil Butt Consultant Product and Process Engineering Richard Owen Consultant Product and Process Engineering PA Consulting Group UK

Figure 1. Projected growth in worldwide in vitro diagnostics

by Product Segmentation 2005-2010

POC - Professional/hospital POC OTC - Other POC OTC - Diabetes Flow cytometry Blood grouping/typing Nucleic acid test Histology/cytology

P

oint-of-care diagnostics—either for home use or for a “near-patient” environment such as the general practitioner's surgery—are a potentially profitable growth area for the healthcare industry. However, there are several issues to be overcome before any point-of-care instrumentation can be successfully commercialised. These include the demonstration of clinical benefit, arrangements for reimbursement, delivery at acceptable cost, meeting regulatory requirements, assurance of acceptable quality, and dealing with stakeholder perceptions. We discuss each of these areas in turn and suggest ways of addressing them.

For both large and small diagnostic companies, today’s diagnostics market is challenging. Large players typically have many products that are mature and moving into a phase where profit margins are being squeezed as competition becomes more intense. A 2006 study by Kalorama Information projected a compound annual growth rate in clinical chemistry of only 2% until 2010. Figure 1 shows predicted growth over the period 2005-2010. The slow growth rates in some sectors has resulted in a period of divestment by the larger companies to

Coagulation Radioimmunoassays Microbiology - ID/MIC Hematology Immuno assays - Blood banks Immuno assays - Other Immuno Immuno assays - Infect Dis Clinical Chemistry -1

smaller companies who are happy with the steady revenue these areas can provide—this can be reflected in the disposal by Roche in some of their Opti blood gas analysis businesses to Osmetech in 2005.

An alternative way to extract additional value from mature testing technologies is to move them closer to the patient. In this way the tests can be potentially sold in greater volumes. This offers both the clinicians, and increasingly healthcare accountants, the opportunity to identify a disease earlier and potentially reduce the number of days an individual patient may be incapacitated and therefore, avoid using expensive hospital facilities. However, this area has been highlighted as a potential growth area for many years, but recent market surveys predict growth to be only 7% over the next 5 years, whereas areas such as molecular diagnostics are predicted to grow at around 16%.

4

9

14

19

Barriers to success, and how to overcome them The US market consists of approximately 900,000 physicians and approximately 25,000 offices have some level of Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver and the number continues to grow. However, that still leaves at least a further 200,000 potential POC sites including physician offices and clinics. To enable uptake of POC testing by these facilities, we suggest that several key strategic issues must be addressed: Clinical benefit Reimbursement Cost Regulation Test quality and quality control (QC) Perception

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D iagnostics

Clinical benefit To make a POC proposition viable, it is necessary to develop a business case that will convince both regulators and reimbursement bodies of the value of the new test.

As with any diagnostic test, proven clinical benefit will provide the strongest motivation for adoption. Diagnosis in general has an obvious clinical benefit since over 70% of healthcare decisions are made following a diagnostic result; in this context, however, it is necessary to show an advantage to POC diagnosis.

That advantage differs somewhat depending on whether the condition being tested for is acute or chronic. In the case of an acute condition, POC diagnosis can improve the patient outcome by allowing a reduced time to result, and hence faster initiation of treatment. Group B Streptococcus (GBS) provides an example. One in 20 babies infected with this common condition dies, while many others suffer longterm health problems. The availability of a 15minute test in the delivery room would allow physicians to prescribe intravenous antibiotics prior to delivery. Clinicians tell us that POC testing in this case would confer considerable benefits. However, the use of tests for STDs and H. pylori would, on the surface, appear perfect candidates for POC testing. This has not been the case and reasons are not totally clear, but the expectations of a 30 minute wait could be one issue, along with the fact that many of these tests at this time are not as sensitive as the laboratory based methods.

In the case of a chronic condition, the POC advantages again include a reduced time to result in comparison with a lab test.

In addition, there is likely to be a decreased use of hospital resources and a lower risk of sampling errors. Patient compliance and satisfaction is likely to be enhanced, especially with a home test. Roche reports a recent clinical trial which has shown that patient self-monitoring with a new coagulation test, Coagucheck S, “can reduce the risk of severe complications and minor haemorrhages by up to 70% in patients on oral anticoagulant therapy… and that it can reduce mortality after heart valve replacement by 60%.”

It is also necessary for the business case to show how any potential disadvantages of POC diagnosis can be offset. One possible objection concerns the management of data

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collected remotely; for successful follow-up, records need to be kept of the test readings.

Data collection is harder, but not impossible, in the home setting. The device might need to have a wireless communications adapter, or to be plugged into a telephone line. Now that communication is relatively inexpensive and governments (in the UK at least) are favourably disposed to central integration of patient data, this proposition is quite realistic.

Reimbursement Without reimbursement, there is no incentive to use any diagnostic tool, and hence no market. This is a problem area because in many countries there is chronic underreimbursement for diagnostic tests, with prices pegged so that, for example, Medicare is effectively paying less each year for better tests.

In addition, the structure of reimbursement is often inimical to diagnostic tests. In the US and Germany, authorities reimburse hospitals for the entire cost of treating a disease, so that if the patient stays in hospital longer than anticipated the hospital has to bear the cost. That structure can discourage the use of diagnostic tools if they see extra testing resulting in reduced profit, or worse still potential financial loss per patient.

There is little doubt that reimbursement practices and structures constitute a barrier to development of better tests—a fact that arguably affects clinical practice for the worse, since it faces both a reluctance to use diagnostics with a lack of better tests in the future. In short, the global reimbursement situation vis-à-vis diagnosis is in urgent need of review, something it has not received since the 1980s.

There are already encouraging signs in the US. The Lewin Group delivered a report on diagnostics for the Advanced Medical Technology Association in July 2005. It found that diagnostics were underused half the time in connection with diseases like cancer, heart problems and diabetes, and that more testing would avoid many adverse events and could save almost $900 million in avoidable healthcare costs.

In the meantime, for organisations that are considering developing a POC test, it is important to communicate with reimbursement authorities early on in the development process; there is no point in

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continuing development unless reimbursement is assured. Developers should present reimbursement bodies with a compelling business case showing why the test will add value. This can be enhanced by, wherever possible, embedding reimbursement experts into the development team from the outset of any new programme. From our experience it is not unusual for these individuals to have little input into a diagnostic development until late in the process.

Perhaps, novel means of reimbursement may also enhance the opportunity to extract maximum value from any new diagnostic.

Different interest groups may enhance the value of a test and therefore act as a convincing lobby in generating reimbursement at an appropriate level. For example, home tests may be influenced by advertising and marketing a product directly to a patient, thereby, generating a new interest body in establishing reimbursement.

Cost POC testing brings savings that may justify a somewhat higher per-test cost than is acceptable for a centralised test. Laboratory and hospital testing usually involves expensive equipment (though the consumables are cheap). A POC test usually eliminates that high cost of equipment. In addition, some of the overheads of monitoring by a specialist physician or technician are saved by a POC test, especially a home test. Any organisation that brings testing nearer to the patient may be able to argue for a higher price because of these savings, in particular where a rapid intervention offers a significant clinical benefit. However, for this to ring true the Point-of-Care systems must carry an inherent low manufacturing cost to justify the placement of several systems (for the same purpose) in a single medical facility. In the case of a doctor’s surgery or emergency room, an excessive hardware cost is likely to prevent market penetration. In conclusion, any point of care system would have to be of low complexity with low hardware costs.

Regulation Most countries have special regulatory requirements for POC tests, since they must be capable of accurate administration and interpretation without the aid of technicians. If a test is sufficiently reliable and easy

D iagnostics

to use, it can in the US be exempted from ongoing regulatory oversight under the CLIA law. In most cases the FDA requires both home and near-patient tests to have this “CLIA waiver”.

For tests of “moderate complexity” those not simple enough to qualify for the waiver there is in the near-patient environment the alternative of setting up quality systems to ensure that the system is correctly used. However, this alternative is likely to be unappealing for most doctors’ surgeries, so manufacturers of POC tests should aim for the CLIA waiver.

To obtain a CLIA waiver, manufacturers have to show that POC users generate data equivalent to those that would be produced in a lab. They also have to show that the system is failsafe, that is to say that a failure will not give any information that may be interpreted as a data point; it is better to convey no result than a wrong result.

sicians. These experts could encourage patients to comply with their therapy and could adjust treatment in response to the patient’s condition.

The other difficulty with new tests is that they still have to be compared to “gold standards”. This means the laboratory will have to continue performing upto the gold standard, even if it is less efficacious. This has resulted in an environment where new tests do not replace the old, but merely add to the menu, and result in diagnostic groups continuing to order the old as well as the new. This is clearly reflected in the use of CK-MB as a cardiac marker gold standard.

It is widely viewed that troponin is a superior marker but sales of CK-MB have not diminished at all.

Perception The attitudes of various stakeholder groups will influence the acceptability of a POC test. For a home test to be accepted, patients must want to test themselves, while doctors must be willing to relinquish control.

otherwise. Finally, clinicians set a high priority on turnaround times. Again, this perception mitigates in favour of POC tests since they are usually designed to deliver a “while you wait” result—ideal particularly in the case of patients being tested for a condition such as HIV, who often do not come back for their test results.

What about the perceptions of technicians in centralised laboratories? They are concerned that decentralised tests may not be as accurate as lab tests, a consideration that can be addressed by either the CLIAwaiver route or with remote monitoring, both of which can ensure that all systems operate to the same level of safety, quality and reliability. Technicians too, may see POC tests as more expensive, but again this perception arises from a partial view of current costs.

The perceptions of patients are also extremely important. In general, the public likes POC testing, and they could constitute the strongest force in pushing for acceptance by the medical profession. The trip to a local hospital or clinic in order to have a routine test performed can be more stressful than the actual output of the test in today’s congested cities. Maybe it is time to let the patient take more control over their well being. However, many of the current tests are blood based, and although diabetics perform blood analysis daily, many find this approach unattractive.

In many cases individuals are also unwilling to find out what is wrong with them. But, like statins, marketing direct to customer may change the perception of self-testing and open up the “over the counter” (OTC) market before the technology is widely adopted in clinical settings. This can be illustrated with OraSures move to generate a self test HIV kit and developments is this area may open opportunities that will allow for the much publicised growth rates of 20-25% heralded in the late 90’s.

All things considered, if manufacturers can prove a clear benefit from a POC test and ensure issues of reimbursement and quality are satisfactorily resolved, then physicians, conservative as they are, likely to accept the test.

Test quality and QC In the POC environment, there are likely to be no technicians present to insist on proper control and calibration. Instead, it will be necesAt present, clinicians tend to perceive sary (except perhaps in the case POC tests as expensive, but this is of CLIA-waivered equipment) to instigate centralised control usually because they operate in cost systems that communicate elecsilos and do not yet appreciate the full tronically with the equipment costs associated with late diagnosis or and collect performance data. A poor monitoring. diagnostic group should have responsibility for monitoring based on this data, and should also have the ability to manage the system, for Let us first consider the perceptions of example locking out individual operators, clinicians. They want to offer the best clinior even shutting down the entire system, if cal option, but are starting to talk in terms of performance falls below an acceptable level. “the best option at the best price” a change This, of course, leads to issues over systems which opens up the possibility that they will potentially “being failed” in critical situabe receptive to home tests. At present, clinitions. However, it may be less harmful to a cians tend to perceive POC tests as expenpatient to wait for a result rather than have sive, but this is usually because they operthe wrong information reported from poorly ate in cost silos and do not yet appreciate performing operator or piece of equipment. the full costs associated with late diagnosis This type of centralised monitoring requires or poor monitoring. Doctors also want to connectivity between POC equipment and keep control of data interpretation, an oba centralised facility. Such connectivity is jective which near-patient testing supports, now cheap and easy to achieve. since it can present raw data for interpreFor home tests in particular, remote tation by the physician rather than having monitoring could have the additional benit processed first by a technician. However, efit of allowing the data to be interpreted, doctors often believe that the best-quality and the patient’s condition managed, by testing is performed in labs, and so it is up Full references are available on remote experts, whether clinicians or phyto suppliers of POC tests to convince them www.asianhhm.com/magazine/

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Fibre Optic Plethysmography For Non-invasive Cardiac Monitoring Fibre optic plethysmography for cardiac monitoring is a significant advance on previous designs.

Andy T Augousti Professor Applied Physics and Instrumentation Faculty of Science Kingston University UK

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he use of cardiac monitoring is an essential diagnostic tool for patients in a critical condition. The most widely used modern method of cardiac monitoring is the electrocardiograph, which produces the well known electrocardiogram (ECG). Experienced operatives can interpret the ECG to reveal not only the heart rate, but also subtle information relating to the condition and function of the patientâ&#x20AC;&#x2122;s heart. However, the use of electrocardiographs in electrically hostile environments is difficult, and so an alternative technique that is resistant to such interference is desirable.

As the heart contracts, it undergoes changes in volume as well as varying in its positions within the chest. This combination of movements can be detected by a fiber optic plethysmograph (FOP) sensor placed near the heart at the thoracic level. Such a device can also detect small variations in circumference produced by the beating of the heart.

Although these minute signals are also detectable when superimposed on normal respiratory motion of the chest, for the purposes of simplified signal processing, only cardiac monitoring during apnoea will be discussed here.

A new system has recently been developed for monitoring such motion. It is based on the use of a novel single fig-

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ure-of-eight fiber optic coil, which shows increased linearity of response, a wider dynamic range, and reduced hysterisis. This is a significant advance on previous designs, which utilised a series of simple coils; a trade-off between the attenuation characteristics of individual coils, and the resulting stiffness of the overall assembly, had to be achieved in this earlier design. The principle of operation of such systems is similar to that of the respiratory inductive plethysmograph (RIP), a wire-based system that utilises variations in the self-inductance of a metal coil looped around the torso to monitor cross-sectional area variations, and hence infer volumetric changes in the chest.

In the case of the fiber optic respiratory plethysmograph (FORP), it is variations in the chest circumference that are measured and utilised to infer volumetric changes.

The RIP, like the ECG, suffers from its susceptibility to electromagnetic interference (EMI), due to its metallic nature.

Absolute calibration in both systems is achieved by calibration against a true volumetric system such as a spirometer, but the latter suffers from being an invasive system.

In many situations, an absolute measure of volumetric changes, such as for respiratory tidal flow, is not essential; rather, it is relative measurements and their variation with time, as well as measurement of simple respiratory rates or cardiac rates, that are the key. These variations are often indicators or precursors of diminished respiratory or cardiac performance.

Principle of operation As light from a high-power light emitting diode (LED) (operating at a peak wavelength of 950nm, in the near infra-red) passes through the optical fiber coil, the curvature of the loop causes some of the

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light to be lost from the fiber, and hence the transmitted light is attenuated. The ends of the coil are attached to an elasticated bandage that can be placed over the subjectâ&#x20AC;&#x2122;s torso, and as the heart beats, the minute changes in chest circumference stretch or relax the bandage. This motion is transferred into a small variation in the bend radius of the fiber coil. Fortunately, the transmission of light through this coil can be highly sensitive to small variations in this bend radius (this is usually a problem in light transmission for optical communication purposes!), and so the motion arising from the beating heart can be detected. This is termed the macrobending loss effect (MBLE), and in this particular implementation of the technique a 0.4mm diameter silica glass step index fiber was employed.

One of the key advantages of the figure-of-eight coil, apart from improved optical performance in terms of linearity and hysteresis, is the improved mechanical robustness and behaviour. Previous multiple simple-loop coils (imagine a simple twist in a fiber, like making a simple knot but without threading the end through the loop), suffered from a tendency to pop out of the plane of the coil and had to be confined by being sewn onto the bandage within restraining sheaths. The figure-ofeight coil, due to its geometry, balances its out-of-plane forces internally and hence retains its shape as it is stretched or relaxed.

Whatâ&#x20AC;&#x2122;s more, it provides a useful small recoil force upon stretching, which helps to return it to its relaxed form with a minimum of hysterisis or sticking. The single coil is mounted on soft, robust skin-compliant polymer rubber, similar to that found in wetsuits, which renders the monitor comfortable to wear, even over extended periods.

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Performance This system was tested using 4 healthy subjects, 3 male and one female, with no previous record of cardiac or respiratory disorders. All of these test subjects were capable of holding their breath without chest convulsion for 30 seconds, but they had not been trained in maintaining their chest in a stable position during this period of apnoea. Each trial consisted of 4 acquisition sessions of 33 seconds each in which the subject was required either to breathe or to hold their breath. The subject remained quietly seated throughout the experiment, and began by sitting still for 5 minutes prior to the start of the monitoring period. The FOP transducers were attached around the chest slightly above the xiphoid process and at navel level of the abdomen. Two transducing channels were utilised, to investigate whether the cardiac output could be detected farther afield than simply nearest the heart itself. The signal arising from the thoracic channel we term a thoracocardiogram (TCG), and that from the abdomen is an abdominocardiogram (ACG). The system was interfaced to a computer running Matlabâ&#x201E;˘ to acquire and process the signals. Also utilised was a 3-lead ECG system for recording simultaneous measurements for reference and comparison purposes.

The FOP system compares very well against the ECG system for cardiac

period monitoring. Extraction of the cardiac period involves the use of substantial signal processing, due to the small size of the signal and its relative irregularity of form compared to the ECG, but it is nonetheless achievable. The results demonstrate that for individual subjects there is a high degree of correlation between the period measured by the ECG and those arising from the TCG and ACG signals. This correlation is higher than 90% in offline measurements, and nearly 90% in real-time TCG measurements. In both cases there is a consistent, subjectspecific lag between the ECG signals and the TCG and ACG signals, as would be expected from the effect of the motion of the heart propagating throughout the torso. The subject specificity arises from the individual placement of the transducer bands. The systems demonstrated at present are, however, still susceptible to spurious chest wall motions (arising from coughing, for example), and extraction of the signal in real time with a success rate approaching 100% remains a challenge. However, part of the difficulty lies in the use of transducing bands that are optimally localised for simultaneous respiratory and cardiac monitoring; pre-

liminary measurements have already indicated that a reliable cardiac signal is achievable from other parts of the body where the interference arising from respiratory motion is eliminated.

Conclusion The use of optical fiber-based systems for non-invasive monitoring of key physiological parameters such as cardiac rate is undergoing continuous development.

Although such systems are still not quite ready for introduction into a real clinical environment, they are well described as near-market. Their key feature compared to established techniques such as the ECG is their potential for application in electrically noisy environments, or in regions where the metallic composition of the ECG would itself interfere with other measurements; both of these conditions are found in the interior of magnetic resonance (MR) scanners, and it is envisaged that the earliest application of FOP-based systems would be for non-invasive monitoring of respiratory and cardiac rates of trauma victims undergoing MR scans. The use of related artefact-free FOP-based systems for monitoring the location of the chest wall, and providing feedback to subjects during repeated MR measurements, to improve image averaging and reduce blurring, has already been demonstrated.

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TED

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T echnology , E q u ipment & D evices

Networking Implanted Medical Devices Ensuring security as well as effectiveness Implanted medical devices present different security issues than traditional information systems, and require different security risk analysis and mitigation techniques.

George D Jelatis Security Architect Parkway Associates USA

O

ver the past fifty years implanted medical devices have undergone at least four major, technologydriven paradigm shifts—major changes in world-view for designers, users, and recipients of such devices.

The first was the miniaturisation of electronics and batteries that allowed devices to be implanted entirely within the body. The second was the addition of flexibility with multiple device configuration parameters settable by an external “programmer”. The third was the replacement of hard-wired control circuitry with programmable microprocessors, making implanted devices much more flexible, powerful and sophisticated.

The fourth is upon us: it is the introduction of “real-time” autonomic networking of implanted devices, allowing them to communicate with other medical devices at a distance, and “at will”, without any action on the part of the patient.

It is the operational and design consequences of this fourth paradigm shift that we will discuss here. Our focus will be on the implications of the networking of implanted medical de-

vices (IMDs) for device and patient data.

Our model will be IMDs for cardiac-rhythm therapy—pacemakers, cardioverter-defibrillators, resynchronisation devices, etc.

Paradigm shift from standalone to networked IMDs Until 2000, IMDs were mostly isolated, standalone, electronic devices, communicating infrequently with external devices, and then only by near proximity (5cm to 10cm) inductive telemetry. Some of these IMDs can emit sounds to alert the patient to an abnormal condition, but all other external communication requires that the IMD be “interrogated” by an external device (a programmer) under human control. External device telemetry allows a caregiver, in a clinical setting, to modify IMD therapy parameters, check the IMD status and retrieve stored device and physiological data.

The newest families of IMDs are microprocessor controlled and, most important for our discussion, equipped with radio-frequency (RF) transceivers allowing them to communicate with distant (2m to 20m) external devices, and to do so autonomously. We refer to these IMDs capable of distant RF telemetry as “Networked” IMDs or NIMDs. The newest types of external devices may be clinical programmers in the traditional sense, or “read-only” home monitoring devices. They may also be in-home monitors with limited IMD programming capabilities.

NIMD products, related services and the system view The latest generation of (cardiac-related) NIMDs, all of which use RF telemetry to network with external devices, include devices from Biotronik, Guidant and Medtronic (introduced in 2000, 2005 and 2006 respectively). Remote (usually in-home) monitoring enabled by NIMDs is growing, as demonstrated by the rapid deployment and growth of such systems as Biotronik’s Home Monitoring, Medtronic’s CareLink® Network, St. Jude Medical’s Housecall Plus™ and Guidant’s LATITUDE® Patient Management System (introduced in 2000, 2002, 2003 and 2005 respectively).

These new NIMD products and related services lead us to take a much broader view of the networked IMD as part of a large, distributed information system, as illustrated below. Therefore, the obvious question this raises is: “What security measures do these devices actually use?”

Information security consequences of NIMDs A critical security consequence of the isolation of IMDs within their patient’s bodies is that the effective boundary for security concerns, or the “security perimeter” is an imaginary envelope about 10cm outside the patient’s body. A critical consequence of networking IMDs to external devices is that the effective boundary for security concerns, the security perimeter, is greatly expanded.

These old and new security perimeters are illustrated in the figure below.

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This should make it clear why, in the past, access to sensitive IMD information required either very close proximity (essentially, physical access) to the IMD or access to printed reports or charts. Data availability only required the patient and a suitable programmer, and data confidentiality and integrity were assured by operational procedures characteristic of good clinical practice.

Today, with the introduction of RF telemetry for device interrogation and programming, access to sensitive IMD data becomes much harder to control. Data availability, confidentiality and integrity depend upon the security of the RF data link, the ability of the IMD itself to verify the suitability of an RF external device, and the ability of the RF external device to verify that it is communicating with the right IMD. The staging of device data and programming commands in external, networked devices also raises access control issues, depending upon the location and physical control of the external devices.

The result of these differences is a significant increase in the risk of data confidentiality, integrity or availability compromise; this is precisely the definition of information security risk.

This increase in information security risk makes information security management a much larger concern for new NIMDs because, as discussed above, their sensitive data are transmitted over an open channel (RF) and stored in (relatively) uncontrolled external medical devices. There are three drivers for this heightened concern with information security: • Safety of patients may depend upon the security (integrity and availability) of the NIMD and its data • Patient data privacy has become a regulatory requirement (e.g., EU Directive on Data Protection, 1998; HIPAA Rules on Privacy, 2003, and Security, 2005; Japanese Data Protection Act, 2003) • Marketability of NIMDs will depend upon compliance with new security regulations and laws and upon public attitudes and acceptance The result is that the networked “medical device system” (NIMDs and the external devices they communicate with) need to be designed not only to ensure patient safety, but also to ensure patient and device security.

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Addressing the NIMD information security risk Medical device manufacturers and the caregivers (who prescribe and manage medical devices) need to understand that the clinical benefits of networking IMDs (with external systems) bring with them not only new benefits: • Surgical Implant - Monitoring of the IMD without intruding on the sterile field • Clinic Follow-up - “Wandless” device interrogation (and possibly programming) • Home Monitoring - Wireless communication between NIMDs and external remote monitors, without patient intervention (compliance) These benefits are accompanied, however, by new responsibilities placed mostly on device manufacturers. Foremost of these is the responsibility to understand and manage the information security risks introduced by such networking. These information security risks could be described as (broadly speaking):

IMD Firmware Dev.

Security relevant steps in medical device development process All of the above risks need to be considered in the light of a thoughtful information security risk assessment • Risk concept analysis • Risk trade-off decisions • Security requirements

IMD Management Site

IMD Web/App. Server

IMD Dev System

Internet

• Theft of data • Corruption of data • Injection of false data • Interference with data access or communication Fortunately, information security risk management is an established discipline, with methods and processes that are easily adapted to the world of IMDs. Such an analysis will identify the highlevel information security requirements for NIMDs and external devices, as well as any centralised medical information servers they communicate with. By identifying and implementing technical mitigations, device manufacturers can eliminate or significantly reduce these information security risks.

The obvious question this raises is “What security measures do these devices actually use?”

Programmer

External Device

Patient

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are useful parallels with safety and hazard analysis. There is also a rich source of knowledge on information security risk management in the information security literature, on the World Wide Web, in books and in magazines and journals.

New Security Perimeter Communication Link

Old Security Perimeter

External Medical Device

• Device implementation • Security verification against requirements These security relevant steps are very much like the safety relevant steps in the classic IMD development process. As with Safety Risk, information Security Risk needs to be considered early in the process.

Suggestions for NIMD developers (from the trenches) Based upon my own professional experience, and upon research into the experience of others, in the management of security in NIMD-based systems, I have derived the following observations: • IMD Security Changes are driven by non-technical issues: > Regulations on security and privacy

> Legal statutes on privacy > Customer expectations regarding privacy • IMD and external device hardware changes may be needed to implement security requirements • IMD and external device firmware changes will be needed to implement security requirements Which leads to my gentle suggestion that early consideration of privacy and security issues in the device development process is essential to contain the cost and limit the schedule impact of implementing of security requirements.

While the terminology or information security is probably new and somewhat foreign to many IMD developers, there

Conclusions In conclusion, we see that networking implanted medical devices introduces a new type of risk—information security risk—that can have both safety and legal consequences. Even as a clearly beneficial technology advance, medical device networking must pass a marketplace acceptance test; that is, its benefits must be acceptable to its users, patients and caregivers.

Patients and caregivers are more aware of, and concerned with, risks to safety and to privacy, than at any time in the past. Addressing information security risk is, thus, essential to marketplace acceptance of networked medical devices.

This is why information security risk assessment and mitigation are becoming part of the networked medical device development and approval processes. Much like Safety Hazard Analysis, Information Security Risk Analysis is most effective when performed early in the device development process. In this new medical device paradigm, patient and caregiver acceptance of information security risks follows from the same type of assurances as their acceptance of safety risk.

Product Showcase

ZOLL AutoPulse Non-invasive Cardiac Support Pump Cefepime and Amikacin

T

References: he AutoPulse®—the only device of its kind—delivers uninterrupted ombination of the theseconsistent, two different antibiotics act 1.synergistically to Improved providehemodynamic total solution Timerman S et al. performchest compressions that new AHA/ERC Guidelines are calling for. It is an automated, ance with a novel chest compression device during against multi resistant bacteria like P.aeruginosa, S.aureus etc. The main advantages of treatment of in-hospital cardiac arrest. Resuscitation. portable device with an easy-to-use, load-distributing LifeBand® that squeezes the entire 2004;61:273-280. this combination: Wide range of bactericidal activity, better efficacy, safety, lesser dose, least chest, improving blood flow to the heart and brain during car2. Halperin HR et al. in development reduction in Cardiopulmonary hospitalizationresuscitation time 1-3 Additionally,minimization diac arrest.nephrotoxicity, it offers the benefit of freeing ofupresistance, with a novel chest compression device during a porcine model of cardiac arrest.

Journal of the American Coland cost.

Our organization VENUS REMEDIES is in grant of a patent for this drug combirescuers to focus on other life-saving interventions. lege of Cardiology. 2004;44(11):2214-2220.

4 nation as a singlestudy compound which in canthe be administered parentally. Our product exists as a dry A recent independent conducted United 3. Ikeno F et al. Augmentation of tissue perfusion by a States, using the AutoPulse, showed that survival ratesinjection of car- with anovel powder form which is reconstituted before suitable solvent, reconstitution compression deviceafter increases neurologically intact survival in a porcine model of prolonged cardiac arrest. diac arrest it patients dramatically improved when treatedwith withpH in range is sterile, colourless to light straw coloured of 3.5 to 6.

It is preferably twice Resuscitation. 2006;68:109-118. an automated CPR device,depending versus manual CPR, priorcondition to reach- and severity of infection, Average period of a day product on the patient 4. Ong MEH, Ornato JP, Edwards D, et al. Use of an ing the hospital. Data showed a survival-to-hospital-discharge load-distributing band chest compression treatment is 9 to 10 days. It is provided in a sealed containerautomated, such as transparent glass vial capped device for out-of-hospital cardiac arrest resuscitation. rate of 9.7 percent using automated CPR, versus 2.9 percent JAMA. 2006;295:2629-2637. with appropriate halogenated stopper and seal. using manual chest compressions. There was also a 71 percent higher rate of return of spontaneous circulation with the use Further information Web: www.zoll.com of the AutoPulse than with conventional www.venusremedies.com CPR Further information:

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T echnology , E q u ipment & D evices

CyberKnife Radiosurgery

An emerging surgical revolution

John R Adler, Jr.

Professor Neurosurgery and Director Radiosurgery and Stereotactic Surgery Stanford University School of Medicine USA

The constellation of technologies that make up a modern CyberKnife system enable radiosurgery to be delivered with sub-millimeter accuracy to static lesions and better than 2 mm accuracy to targets that move with respiration.

S

urgery on the human body is almost as old as history. Evidence has been unearthed of surgery having been performed in ancient Egypt, Greece, India and China. Throughout the millennia surgical procedures have evolved into effective and precise therapeutic interventions.

However, the history of the surgical experience for patients is marked by pain, blood, and risk to life and limb. The evolution of surgery may have been driven as much by the need to reduce its fearsome accompaniments as to improve the therapeutic outcome. Nevertheless, surgery is still widely viewed as both a powerful form of medicine and, because of the attendant suffering and risks, something of a last resort that should be reserved for the gravest of illnesses. Many of these deeply entrenched perceptions are being challenged by the rapidly growing scope of radiosurgery.

The concept of radiosurgery is attributable to the Swedish Neurosurgeon Lars Leksell, who described its basic elements in the 1950s. Simply put, radiosurgery precisely targets many cross-fired pencil beams of ionising (therapeutic) radiation to deliver large doses to destroy diseased tissue without injuring adjacent anatomy.

In the 1960s and 70s, Leksell combined stereotactic frame-based targeting (using the frame he invented which was attached

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to the skull) with a specialised radioactive cobalt-charged apparatus and created Gamma Knife radiosurgery. Over the past 3 decades, the Gamma Knife and radiosurgical technologies developed since have literally transformed the treatment of brain disorders ranging from tumours to vascular malformations to facial pain. Despite the huge impact of the Gamma Knife on brain surgery, the biologic principles of radiosurgery are not inherently restricted to the head.

Although the frame-based design of first-generation technology restricted radiosurgery to lesions outside the cranium, if pathologic lesions could be targeted without stereotactic frames, extra cranial lesions might also be treated radiosurgically.

The CyberKnife was invented at Stanford University and Silicon Valley in the early 1990s grounded in the belief that radiosurgical ablation could significantly benefit many patients with extra cranial disorders if skeletally attached frames could be eliminated. The invention of computerised image guidance proved critical to achieving the objective of a universal targeting apparatus. The CyberKnife utilises a targeting technology developed specifically for this instrument called x-ray image-to-image correlation. This localisation method automatically compares live orthogonal x-ray images with digitally reconstructed radiographs

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(DRRs) made from the patientâ&#x20AC;&#x2122;s original CT scan. Because a rigidly fixed frame of reference is not required, the CyberKnife system is uniquely able to aim a beam of therapeutic radiation at virtually any anatomic site with radiosurgical precision.

The CyberKnife system also includes a robotic delivery mechanism, capable of flexibly and accurately targeting a compact LINAC source without a defined isocenter; all other radiation delivery systems are constrained to delivering radiation beams around and through a fixed point in space known as the isocenter. Taken together, these attributes make the CyberKnife system the first device to offer autonomous image-guided radiosurgery, a technology that was commercialised by Accuray Incorporated (Sunnyvale, CA, USA). The CyberKnife was awarded FDA clearance to treat tumours throughout

T echnology , E q u ipment & D evices

the head and neck region in 1999. This clearance was expanded in 2001 to allow radiosurgery throughout the body.

Because many tumours in the chest and abdomen move with breathing a new system, the Synchronyâ&#x201E;˘ Respiratory Tracking System (Accuray, Inc.), was added to the CyberKnife System in 2002. This technology correlates real-time chest wall movements sensed by LED camera arrays on the patientâ&#x20AC;&#x2122;s chest with the position of gold seeds placed in or near the tumour and detected in orthogonal x-rays that are shot periodically during the procedure. The tumour position is calculated based on this correlation and fed back to the robot, which dynamically adjusts the aim of the radiation beam to compensate for the movement of the tumour. The constellation of technologies that make up a modern CyberKnife system enable radiosurgery to be delivered

with sub-millimeter accuracy to static lesions and better than 2 mm accuracy to targets that move with respiration.

The CyberKnife was initially approved for brain applications, and treatment parameters were based largely on Gamma Knife experience. Since similar pathologies occur throughout the central nervous system, CyberKnife radiosurgery was rapidly expanded to include a broad range of lesions along the spinal axis. A growing body of medical literature now demonstrates the efficacy and safety of CyberKnife spinal radiosurgery for a range of intra and para-spinal tumours, and such treatment is entering the mainstream of clinical practice. Because no frame is required for accurate targeting, the CyberKnife permits a new approach to radiosurgery for certain brain lesions. For example, a multi-session approach (performed over 3-5 days)

has been shown to result in higher rates of hearing preservation among patients with acoustic neuroma while a similar fractionated approach permits larger lesions and peri-optic tumours to be treated safely. Although such flexibility has greatly expanded the scope of neurosurgical diseases treated with radiosurgery, the impact of the CyberKnife has been even greater in other surgical disciplines.

In its initial years, most CyberKnife treatments were intracranial. However, thanks in part to an emerging group of participating surgical specialists, such as urologists, thoracic and general surgeons, an expanding percentage of CyberKnife treatments now target tumours within the chest, abdomen or pelvis. Moreover, there are a growing number of peer-reviewed outcome studies that document the effectiveness of such treatment for non-neurological neoplasms.

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For example, outpatient radiosurgery for unresectable pancreatic cancer achieves very high levels of local control and palliation; some of the more important endpoints compare favourably with much more invasive alternative therapies. In addition several published studies utilising less precise (than the CyberKnife) high dose irradiation to treat early-stage lung cancer patients now demonstrate long-term survival that mirrors open surgical resection.

Although the total number of prostate cancer patients treated with a 5-day course of CyberKnife radiosurgery to date is modestly small, recent preliminary data from Stanford University suggests that the incidence of side effects and tumour control as judged by prostate specific antigen (PSA) compare favourably with more invasive or lengthy procedures. The emergence of these new extra cranial procedures is gradually validating the CyberKnifeâ&#x20AC;&#x2122;s original vision.

As the scope of practice expands, it is clear that the field of radiosurgery embodies dimensions of both surgery and radiation therapy. The aggressive application

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of anatomically precise ablative radiation against small early stage lesions has much in common with other forms of surgery.

However, the basic use of therapeutic radiation, the frequent necessity to site CyberKnife systems in existing radiation departments, and the heavy focus on the management of cancer is more akin to the traditional domains of radiation therapy.

Most of CyberKnife radiosurgery is practised as a multi-disciplinary procedure involving both surgical specialists and radiation oncologists, thereby reflecting its surgical and radiation therapy dimensions.

At present, more than 80 CyberKnife systems have been installed worldwide, with 24 of them in Asia, and something in excess of 20,000 patients have been treated. Moreover, more than 100 peer-reviewed publications have detailed both the performance of image-guided radiosurgery and clinical outcomes for a wide spectrum of disorders.

What is the future of the CyberKnife likely to encompass? Reminding oneself that the essence of radiosurgery is merely the non-invasive destruction of tissue with

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precision radiation, one can readily envision numerous technical improvements to the CyberKnife over the next decade that will facilitate this primary goal. Incremental improvements in targeting accuracy combined with ever better shaping of the field of radiation and appreciably faster treatment times will allow continued extension of radiosurgery into new clinical realms. For example, the more efficient treatment of metastatic disease may allow radiosurgery to effectively substitute for chemotherapy in patients with limited metastases, thereby precluding the complications of systemic treatments. Furthermore, clinical studies are being conducted that involve treating benign conditions ranging from painful facet syndrome (back pain) to atrial fibrillation with the CyberKnife.

If only some of these studies demonstrate the utility of the CyberKnife, the field of radiosurgery could expand far beyond even the most ambitious of current expectations, and further challenge conventional notions about the nature of surgery.

T echnology , E q u ipment & D evices

China’s Medical Device Industry Expansion time

Domestic medical device manufacturers' extensive push to raise capital is indicative of their intention to expand. It would only be a matter of time before they start competing outside their home turf.

Andrew Wee Research Analyst APAC Healthcare Frost & Sullivan Singapore

G

overnment healthcare expenditure has more than doubled in the past decade in China, most of it attributed to a stable economy that has grown at an average rate of around 8-10% annually. The expanding economy has also enlarged available household incomes of the burgeoning middle class in China. Such a situation has resulted in increasing health problems like obesity, cardiac diseases, diabetes, and high blood pressure. According to the World Health Organization, the numbers of people who are obese in China have increased more than 3 times from 1992 to 2006.

With the population getting significantly richer, more Chinese are putting increased emphasis on healthcare and are demanding access to medical treatments that improve their quality of life. Currently, the development of the healthcare sector in China follows a two-pronged approach, one geared for the urban area and another suited to the rural area.

Driving Factor of the Chinese Medical Device Industry With a population of more than one billion, China has seen hospital admissions rising every year. In 2004, the China Statistical Yearbook recorded a total of 66.7 million inpatients in China’s hospitals across the country, compared to 60.9 million in-

patients in 2003. A growing middle class population and better medicare scheme in China is expected to provide more access to medical treatments for Chinese citizens.

Currently, less than a quarter of China’s population are covered under some kind of medical insurance and the government is expected to roll out a more comprehensive medicare scheme which is expected to provide more coverage to residents in China.

Increasing modernisation of hospitals and healthcare delivery systems across China is expected to make China one of the fastest growing markets for medical devices for the next decade. In a speech by Gerard Kreisterlee, CEO of Royal Phillips Electronics, he mentioned that China’s medical device market is expected to grow up to 10% for the next 3 years and by the next 5 to 7 years, China could become the world’s second largest medical device market and Asia’s largest.

This growth has led to many investments in the medical device industry in China and also the rise of several new medical device manufacturers, which will be poised to grab a slice of this rapidly growing market.

Healthcare is also one of the key highlights in China’s key 5-year plan which was ratified by the National People’s Congress (NPC) late last year. In the plan, China highlighted the need to close the gap between the living standards of the rural regions and the urban, coastal regions of China for the sake of a harmonious society. This is expected to be a boost for the healthcare sector and could signify the modernisation of medical equipment in 2nd and 3rd tier cities in China. Another feature worth noting in the plan was the push by the government to invest more

in R&D efforts to develop products ‘innovated-in-China’ that could be able to compete globally. This would mean more financial investment in technological startups which would include medical technology companies.

Domestic manufacturers: Outsourcing and distribution partners or competitors?

Even though with the influx of international brand name manufacturers of medical devices, the local medical device industry is far from dead. Due to the increasing demand for medical devices from China’s rural area, local medical device manufacturers have mushroomed over the past few years, supplying medical equipments, instruments and devices to second and third tier city hospitals. Figure 1 lists some prominent medical device manufacturers that are active in the Chinese market.

Two of the most closely watched are China Medical Technologies, a Beijingbased manufacturer of oncology therapy devices that is listed on NASDAQ and Shenzhen Mindray, a Shenzhen-based patient monitoring devices manufacturer which was recently listed on the New York Stock Exchange (NYSE). China Medical Technologies, is backed by General Electric, that holds a significant stake in the company.

In mid-2006, MicroPort Medical, a cardiovascular devices manufacturer based in Shanghai, with links to Japan-based Otsuka Pharmaceuticals has shown keen interest to list on the US bourses as well.

While these companies have most of their sales in China, their extensive push to raise capital shows their desire to expand,

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T echnology , E q u ipment & D evices

and it would only be a matter of time before they start competing with foreign medical device manufacturers outside their home turf.

New medical device being manufacturers established in China are no longer confined in the development of low cost medical disposables. Both China Medical Technologies and Shenzhen Mindray have sophisticated product lines and the latest technology. China Medical Technologies has research collaborations with Beijing University, one of China’s premier universities. Another university spin-off is Beyonder Technologies which has researchers coming from Tsinghua University. Shenzhen Mindray, on the other hand has partnered with Masimo Corporation, incorporating their SET pulse oximetry technology into Mindray’s variety of products.

Chinese medical device companies have also licensed technologies to be used in conjunction with their proprietary products. MicroPort Medical has a licensing agreement with AST Products to use their coating systems in MicroPort’s PTCA balloon catheters. In some cases, local medical device manufacturers like Trident Medical have acted as distributors and agents for high-end and specialised hospital equipment manufacturers from Germany and Finland, while producing and selling lower-end products. Companies like Shandong Weigao and Changzhou Kanghui have also provided OEM services to other medical device companies.

In other words, the growth of Chinese medical device companies has presented new opportunities for technology companies in terms of technology licensing, business development and manufacturing expertise.

Top 5 Trends in the Chinese Medical Device Industry 1. Modernisation of hospitals in 2nd and 3rd tier cities

In China’s 11th five-year plan, the government stressed on the need to focus development on the western and inner regions, which are less developed than the eastern coastal region of China. Thus, in an effort to minimise the widening urban-rural gap and provide steady development in terms of a united society, the government is expected to increase funding to 2nd and 3rd

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tier city hospitals for them to upgrade their equipments. This modernisation would benefit local and foreign medical device manufacturers who would be able to supply cost-effective, quality hospital supplies.

2. Increase in the number of admissions for surgeries

General surgeries and number of inpatients is expected to rise, especially in the eastern coastal regions. The increasing household incomes in these regions will bring in demand for a better standard of living. Plastic and cardiac surgeries are two types of surgeries that are expected to post a jump in the number of surgeries conducted. This would mean an increase in sales of ablation equipment and cardiovascular devices.

3. Foreign investments in private hospitals will increase market size

Private hospitals and medical centres in China are expected to see a record in terms of the number of patient visits in 2007.

Chindex International, a NASDAQ listed healthcare company is one of the first few private healthcare providers in China and is planning its 3rd site in Xiamen. Singapore listed Pacific Healthcare Holdings has also started operations in China. This has shown the government’s willingness in allowing the entry of foreign companies to invest in healthcare in China.

4. Government tenders for bulk purchases of hospital supplies

More public hospitals in China would be expected to group together for bulk purchases of medical disposables and equipments. China could potentially look upon Hong Kong’s Health Authority tendering model in order to ensure a more cost-effective procurement method. Around 90% of China’s major healthcare providers are public-owned and operated and by China’s classification, these facilities are not-for-profit, which could push the need for a more cost-effective procurement of supplies and equipments.

5. Focus on oncology, cardiac, and respiratory therapeutic systems and devices

A United Nations study in China stated the increase in the diseases of the circulatory system amongst Chinese residents. In 2003, cerebrovascular, cardiac-related and respiratory system-related diseases comprised around 37.7% of morbidity in all

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Figure 1: Sample List of Medical Device Manufacturers in China, 2007

Name of Company

Main Products

China Medical Technologies

Oncology Therapy

Shenzhen Mindray

Patient Monitoring

MicroPort Medical Co. Ltd.

Cardiovascular Devices

Shandong Weigao Group

Medical Disposables

Changzhou Kanghui

Orthopaedic Implants

Jiangsu Kaishou

Medical Disposables

Guangdong Well Medical

Oncology Therapy

Vascore Medical

Cardiovascular Devices

Shenzhen Lifetech

Cardiovascular Devices

Trident Medical

Hospital Beds

Beyonder Technologies

Surgical Systems

Source: Frost & Sullivan

of China’s hospitals. With increasing obesity and pollution in urban areas, cardiac and respiratory diseases are expected to post an increase. Meanwhile, as with most developing countries, malignant tumours are also expected to be a rising problem in China.

Renaissance of the Chinese medical device industry With so much changing in China’s medical device industry landscape, there is much to be gained by companies who are already in this huge booming market. Stable economic growth with a committed government in providing quality healthcare will increase healthcare expenditure.

However, one of the most important changes will have to be increasing access of China’s rural residents, which comprise of around 60% of the population, to quality healthcare. The medical device industry should use this opportunity to gain market share and access to more than 700 million new end-users.

More regulation is expected to change the market, albeit for the development of the healthcare sector as a whole. Liberalisation of the sector is also beginning to materialise, with more private firms entering the healthcare sector and Chinese medical device companies listing their firms for expansion.

All these changes contribute to a larger pie and benefits all stakeholders in China’s medical device industry, which could be undergoing a renaissance of sorts.

F acilities & O perations

Hospital of Tomorrow The design perspective

Henning Lensch Managing Partner RRP architects+engineers and CEO DANDCA Design+Consult Alliance Healthcare Projects Germany

T

he field of healthcare designs is currently undergoing an exciting transformation that will significantly change the appearance of our hospitals. More and more healthcare administrators and medical professionals are becoming aware of the need to create a healing environment that supports the needs of patients, family and staff. The key factor motivating this awareness has been

growing scientific evidence supporting the view that physical environment in which medical care is provided has an impact on health and well-being.

This knowledge base contains some evidence for the health impacts of classical elements of healing environments, such as nature, daylight, and fresh air.

Hospital architecture has to create a comfortable space for nursing and treatment, thus contributing to a patient’s positive mental attitude. A healing environment for spaces designed can affect both the physiological and psychological well-being of the patient.

We are facing a time-shift in the design of modern hospitals. Hospital management and design teams of architects and engineers have to consider short term circumstances such as the rapidly changing technical aspects of medical treatments; and long term building parameters—providing space and flexibility for future up-

The speciality of the Hospital of Tomorrow will be a combination of features for the well-being of not only the patients and their relatives, but the doctors, nurses and all the staff of the hospital as well.

grades, improvements, and adaptations of the existing facility to future requirements which can not be anticipated only a few years earlier when the “new” hospital is being planned.

The Hospital of Tomorrow is supposed to be a green hospital. Architects have to make developments on the site for macro and micro expansion. The speciality of the Hospital of Tomorrow will be a combina-

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tion of features for the well-being of not only the patients and their relatives, but the doctors, nurses and all the staff of the hospital as well. Other exciting features would include good connection and way-finding, the walkway to the hospital, shopping malls and the location where teaching facilities as well as natural features could be combined in the holistic approach of the new hospital.

Environmental pollution and resource exploitation are vital issues in many countries as they are dependent on foreign energy and resources, and are just as much in need of a healthy environment as any other nation. The development of buildings and building systems has been

opportunity for architects and engineers.

Integrated planning, however, goes beyond the long established, and at least partially fulfilled, mandate of integrating building systems into architectural concepts. Here integrated planning for the Hospital of Tomorrow means full and unified collaboration between different disciplines in the pursuit of truly optimum total building concepts.

Hospital design - A holistic approach The architecture of a hospital is the shell for all operational processes, the room for recovery for patients and the daily workplace for doctors and staff. You might com-

Healing Environment Green

Light

Water

Consult

Diagnostics

Special Diagnostics

Operational Clinical workflow and patient path integrating the latest IT-Technical infrastructure (HIS, PACS, ETC) Meets an healing environment

characterised for many years by linear thinking and planning. In the past, single products and systems were targeted at specific building components and is still practised to some degree although it has been proven to be unsustainable in the future.

It is high time, therefore, to remember what we do know, or rather what we must know in the future, so that we may find solutions for the problems that we face, some of which are clearly of our own doing. Environmental protection, sustainable resource management, re-usable instead of single-use buildings, utilisation of natural resources and flexible real estate use will be the key.

Integrated planning is a challenge and an

54 Asian Hospital & Healthcare Management

pare a hospital with a city—having all the functions from the residential area next to the park, over the workplace for hundreds of employees up to the disposal area and energy central. Cities are always changing, they have to adapt to new technologies and new requirements, which means that the hospitals have to be able to change as well.

Teaching facilities must also be designed to encourage learning and exchange of information with a pleasant and longer stay for teachers and students.

Hospital architecture has to create a comfortable space for nursing and treatment, thus contributing to a patient’s positive mental attitude, in an atmosphere of a

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healing environment, for spaces designed can affect both the physiological and psychological well-being of the patient.

All experts, managers and planners agree that flexibility must be a basic feature of any healthcare facility to keep it safe from rapid obsolescence and ready to face changing needs and technologies. Needs of healthcare facilities are evolving rapidly, and the direction of that evolution is difficult to forecast with any certainty.

If we consider and compare the hospital architecture conditions today to tomorrow´s conditions, there are a few aspects which must be considered in the design brief of the Hospital of Tomorrow: • Rapidly changing needs and technologies, reason: direction of evolution is nearly impossible to forecast • Changing regulations (government, insurance) with direct impact on the hospital design • Lifecycle-costs determining a changed method of construction and architecture • New standard of the inpatient wards: Short Stay (Day-Care), Inpatient Ward up to 5 days, low and high-class hotels, nursing home, home for the elderly (long stay)—which means more variety in inpatient wards • More focus on preventive medicine • Patients with complex diseases and more than one disease (comorbidities) will determine the functions of future hospitals • Hospitals have to be able to attract medical tourists • Hospitals must be capable of handling patients of all cultures and religions • Clinical Patient Path Way Implementation is a MUST • Hospitals have to cope with the implementation of information and communication systems, IT networks like HIS, RIS and PACS • Changed room requirements, e.g. imaging PACS, due to new workflow procedures (film-less / paperless / wireless hospital) • Rapidly growing expectation of the patients / customers • The healing environment is playing a central role • Architecture as a branding tool—architecture must be updated and upgraded • Natural light—natural ventilation for most of the buildings, especially for the

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inpatient wards and workplaces • More importance of easy way-finding • No more a place for sickness and sick people but a place for health and recreation!

As a first result, it is already proven that changes in a hospital's architecture have to be considered as a constant need and that the flexibility of a house is a parameter of economy and affects the economic success of a hospital directly. Today, the rate of change is occurring more frequently with

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even more uncertainty.

Increasing pressures form technology, changing business strategies and changes in the overall healthcare system are, especially in parts of Europe and Asia, more obvious than before.

The rate of change is becoming a constant part of a building´s life.

The focus on the overall lifecycle-costs of a building like a hospital is also a more static parameter, not able to give predictions or exact estimates about the very important ability to change departments or even whole parts of a house.

To make sure that the change of parts of the hospitals will be appropriate, in terms of the level of change of interiors, technical installation and medical equipment in general, hospital planners have to be able to distinguish between the following categories:

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• Departments like OT, ICU, nuclear medicine, ambulant surgery, emergency department and laboratory • Less installed parts like wards • Departments like administration, offices, OPD consultation rooms with less technical installation or medical equipment, training facilities etc.

To respect the compliance of the technical environment, the diversification of the different levels for interior planning and the life-cycle aspects of the three categories must be considered in every healthcare and hospital project, starting with the phase of the master-plan itself.

The Hospital of Tomorrow will pay respect to all these issues and also define a new quality in hospital design—for India, South-East-Asia and rest of the world­—by combining all features of hospital design, environmental protection, energy saving and healing environment design, included in an highly economic hospital following clinical patient path ways and defined workflow procedures, for the benefit of quality control, for patients and staff.

information technology

Building a

e-Hospital Min-Huei Hsu Chief Information Officer and Consultant Neurosurgeon Wan Fang Hospital Taipei Medical University Taiwan

Lessons from Taiwan

B

efore computers became popular, calculating rulers used by engineers and abacuses invented by Chinese have both been used as calculating tools.

In 1943, John Mauchly led the development of ENIAC (Electronic Numerical Integrator and Calculator). ENIAC was the first programmable electronic calculator in the world, and it replaced the original mechanical components with vacuum tubes.

In February 1946, the public saw the ENIAC for the first time in Philadelphia, and a new era of electronic computing began.

In the last 60 years, computers have changed drastically. The changes were in the form of smaller sizes, larger storage, higher speed, higher accuracy, more functions and cheaper prices.

With the advent of Internet, people were brought into the information era.

In the last 20 years, the development and application of information technology has deeply affected the world economy and various industries, and the healthcare sector is no exception to this.

As a result, hospitals have implemented various computer systems, such as medical record management systems, insurance claim systems, patient billing systems and computerised physician order entry (CPOE) systems. At the Wan Fang Hospital we divided hospital information systems (HIS) into 4 categories according to their functions. The 4 letters in the word â&#x20AC;&#x153;CAREâ&#x20AC;? could stand for these 4 categories: C for clinical care, A for administration, R for research and E for education.

Clinical care In recent years, there has been a growth of computer-based tools to improve physician decision-making and clinical effectiveness.

There are several islands of progress, particularly in applications designed to reduce

The application of information technology has improved the quality and lowered the cost of medical services in Taiwan. medical errors, improve access to knowledge and telemedicine. Our hospital has instituted a variety of such technologies, and they are already producing a substantial reduction in the incidence of dangerous errors.

In 1999, we began to replace paperbased physician ordering (including orders for drugs, diagnostic tests, and the setting of ventilators and other devices) with

computer-based order entry. Among other functions, this system automatically suggests appropriate dosages to physicians and checks for drug allergies and drug-to-drug interactions.

We instituted an alert system whereby a computer constantly scans new data, including patient laboratory results, as they are generated. If it encounters a critical

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information technology

value—for example, a dangerous potassium level in a medication—the computer will automatically send a short message to the mobile phone of the patient’s attending physician.

In 2004, we implemented a Surgical Patient Safety System (SPSS) in our hospital to prevent three important surgery-related problems: wrong site, wrong procedure and wrong patient surgery. Although only 17% of adverse surgical events are judged to be preventable, wrong site, wrong procedure, wrong person surgery are totally preventable. Using computers in the operative room, surgeons access this system to key in patient’s data before operation. It takes about two minutes to complete this procedure.

The system checks this data with the database of operating theatre schedule. If there are any mismatches, an alert is displayed on the screen. The transactions log is stored in the server. The patient safety committee of the hospital reviews the records with mismatches on a weekly basis. Mismatches have been detected in about 5% of all operations. A final verification of the correct site, procedure and person by this system helps in preventing complications.

Telemedicine can involve technologies as simple as a radio, or as advanced as a digital video and data transmission, but the key aspect is that it allows physicians to practice medicine from a distance. The potential benefit for isolated areas—where the much needed physicians, particularly specialists, are unavailable—is believed to be substantial. Taiwan is a heavily populated country, with small land area and many mountains and isolated islands. Unequal distribution of medical resources has made high-quality accessible medical care for all a major problem in rural areas. Medical personnel are unwilling to practice in rural areas because of fear of isolation from peers and lack of continuing medical education in those areas. Telemedicine provides a timeless and spaceless measure for teleconsultation and education. We have established computer networks between our hospital and 10 rural primary care centers through high-speed networks and high power computer processing to electronically exchange medical information and to conduct clinical examination and consultation. Our system provides teleconsultation of good quality and is cost-effective.

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Administration In Taiwan, computers were first introduced into hospitals for managing administrative activities. Earlier systems focused on admissions / discharge / transfer (ADT), patient billing, claims processing and materials management.

In 1995 the government of Taiwan introduced universal health insurance to cover all citizens. The policy of Bureau of National Health Insurance (BNHI) has become the biggest influence in the development of Taiwan’s healthcare industry since then. BNHI has launched a nationwide project for replacement of its paperbased health insurance cards by smart cards (or NHI-IC cards) since November 1999. These cards have been used since July 1, 2003, and they fully replaced paper-based cards after January 1, 2004.

Hospitals must support the cards in order to provide medical services for insured patients. Health smart card system has to be linked into the hospital information system for patient registration, billing, examination and prescriptions. Because of frequent changes to the claim rules, hospitals have to invest large resource to maintain their information systems.

Quality has become an important issue to the healthcare sector. Information systems are increasingly important for measuring and improving quality. The Taiwanese government also recognises the need to implement a nationwide healthcare quality indicator system to strengthen quality surveillance. In 1999, the Department of Health funded a 2-year project led by the Taiwan Healthcare Executive College to develop a comprehensive performance assessment system, later named Taiwan Healthcare Indicator Series (THIS). It includes four categories of indicators, namely, outpatient, inpatient, emergency care and intensive care, and has 139 items in total. The system was officially launched in 2001. In light of the success of the indicator series, BNHI of Taiwan has proposed participation in the series as being one of the criteria to be reimbursed for quality.

Research Information technology is responsible for data management and providing critical statistical support to research studies.

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We have developed the “Clinical Research Information Management System” to facilitate the data management of studies in our hospital. Using this system, investigators can integrate clinical, molecular, genetic and other translational and clinical research data. This system supports collaborations among clinicians and statisticians from the design stage through analysis and final report stage.

Education We opened the clinical skill center 2 years ago. The center’s mission is to promote and provide high-quality clinical education and reliable assessment of skills and procedures, with the ultimate intent being to advance patient care. This center provides simulation-based medical education. Through new approaches to healthcare training and practice, the clinical skill center strives to improve patient-safety and the clinical skills of healthcare providers. By proactively exposing trainees to challenging clinical and humanistic encounters, this center aims to reduce errors and improve teamwork and quality of care. This center serves the needs of all sectors of healthcare providers in our hospital and is involved in the development of simulation-based medical curriculum to produce courses to answer the needs of these sectors.

An IT-driven future In 2003, health expenditure as a percentage of gross domestic product (GDP) was 6.8% in Taiwan, which is lower than 14.6% in America, 9.6% in Canada, 7.7% in UK and 7.8% in Japan, but medical care of high quality was provided to all nationals.

One important factor was the good information management in the healthcare industry in our country. Medical care, hospital management, health insurance, public health and health promotion are now digitised to a certain extent in Taiwan. In fact, information technology not only raises the efficiency but also improves medical quality to a great extent. Hospitals with excellent information technology service can have innovative processes to break through the limit of traditional service, and thereby save the time wasted and raise the low efficiency to effectively improve the quality of medical service.

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spotlight

Information Technology in Healthcare

Creating a stronger healthcare system While improving computer systems would not eliminate all medical errors, researchers believe it will reduce the errors dramatically. Now is the time to share progress, challenges and best practices to enable interoperability and link the ecosystem in the delivery of better quality care.

Madhav R Ragam Director - Healthcare and Life Sciences IBM Asia Pacific Singapore

R

ising costs, ageing population and antiquated healthcare systems have put pressure on governments, businesses and society to make significant changes in the delivery of care.

These challenges, combined with the emergence of a new environment driven by globalisation, consumerism, demographic shifts, increased burden of disease, expensive new technologies and treatments are expected to force fundamental change on healthcare within the coming decade.

One of the great ironies of modern medicine is that while many of us enjoy the benefits of scientific discovery and sophisticated equipment, many patients across the globe do not receive adequate standards of quality care due to a variety of issues underpinned by the application of insufficient resources and fundamental technology inefficiencies.

In countries where information technology is commonly used for services such as banking, telecommunications and entertainment, many medical organisations today still rely on paper records for the delivery of their service.

Furthermore, most existing medical electronic systems don’t interact, which means that important information is often

60 Asian Hospital & Healthcare Management

isolated and disconnected. While physicians keep their own records, they do not have access to information about the care their patients receive outside their offices.

Hospitals rarely have access to these patient records and emergency room doctors know little about patients’ pre-existing conditions. This often results in redundant tests and assessments, increasing the cost of care and missed diagnoses or treatment resulting in injury.

Such disconnects across the world’s healthcare systems are causing an increase in poor health outcomes and in some cases even death.

A recent Institute of Medicine (IOM) report found that preventable medical errors kill up to 98,000 people each year in the United States alone. While improving computer systems would not eliminate all medical errors, many researchers believe they will reduce them dramatically.

In addition to saving lives, we at IBM believe between five and 20% of all healthcare costs could be saved by eliminating unnecessary tests. This view is supported

by The Economist, which recently reported that redundancy and inefficiency account for between 25% and 40% of the US$3.3 trillion the world spends on healthcare every year and that this could be eliminated with proper IT implementation.

Change must be made. Healthcare systems that fail to address the challenges of the emerging environment will “hit the wall” and require immediate and major forced restructuring.

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The choices left to stakeholders of today’s healthcare systems are when and how.

If they wait too long or do not act decisively enough, their systems will be unable to continue on the current path. This is a frightening, but very real prospect.

Which direction will the industry take?

The answer is complicated. The healthcare ecosystem is extremely complex, based on intricate relationships, often with differing motivations. Most agree the chief goal is to improve healthcare systems to provide better quality service to more people, more efficiently and at lower cost. How to achieve that goal, however, varies widely by stakeholder. These complex factors create an urgent need to break down industry silos, establish partnerships and increase collaboration to drive progress.

That’s why IBM has taken a leadership role in the global healthcare transformation. It is working with major ecosystem stakeholders—ranging from healthcare providers and standards bodies to governments and other employers—to influence the adoption of a consumer-driven model.

This emerging, patient-centric model focuses on improved outcomes through disease management, prevention and well-being programmes. It gives consumers greater control over their healthcare, including in the selection of primary care providers and access to information needed to make better healthcare decisions.

Clearly, technology plays a key role in

information technology

patient-centric healthcare by enabling the fast, efficient and secure flow of digital information between patients and their doctors.

Moreover, it provides the tools to improve clinical decision making, collaboration, efficiency and administrative processes.

Fortunately, much of the technology needed to enable patient-centric networks is available today. But the transformation to a patient-centric model will require more than technology—it requires innovation and a shift to more open, collaborative and integrated systems. There remains a great deal of work to be done around standards, governance and workflows, which is critical to the easy flow of information within the healthcare ecosystem.

An Asia Pacific portrait Asia Pacific Healthcare market is currently the smallest in size out of the 3 geographies—the US and Europe being the other two. However, it is exerting a tremendous influence on the global healthcare scene, for example:

- There is an expanding interest in medical tourism across Asia with India, Thailand and Singapore paving the way - Many of the leading pharmaceutical companies are moving clinical trials from the US and Europe to India - The Philippines is renowned as a leading exporter of highly skilled nurses around the globe - The US has turned to Indian and Australian companies for the outsourcing of radiology readings and - Australia has enhanced the US’s Diagnosis Related Groups (DRG) system, which was subsequently adapted by Singapore, France and Germany.

According to the World Health Organisation (WHO), the Health Systems Statistics vary significantly across the world’s developed and emerging countries. In the case of Asia Pacific, WHO claims inequitable health systems are preventing many Asia Pacific nations from meeting international goals set on health and poverty. Furthermore, the healthcare systems of many Asia

Pacific countries are failing to deliver services of adequate quality, often using resources inefficiently or inappropriately.

The graphs from the WHO 2005 statistics for Health Systems highlight the healthcare facts and figures of relevance to key Asia Pacific countries and compares them to some of the world’s most developed countries.

In these graphs, India, China and Malaysia clearly stand out as having a significant low number of beds, physicians and nurses for every 10,000 people in their respective Physicians per 10000 Singapore Republic of Korea New Zealand Malaysia Japan China Australia India Europe North America 0

5

10

15

20

25

30

Source: WHO

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Nurses per 10000 Singapore Republic of Korea New Zealand Malaysia Japan China Australia India Europe North America 0

20

40

60

80

100

Source: WHO

countries. As a result, we expect to see exponential growth of the healthcare industry in these three countries while the more developed countries will focus on reining in the healthcare costs and improving quality.

Linking the healthcare ecosystem In all of the worldâ&#x20AC;&#x2122;s markets, the healthcare industry functions as an ecosystem, with its various constituents, rules and interactions.

Currently, that ecosystem is plagued by a number of pervasive issues including:

poor communications among constituents resulting in fragmented patient data and poor coordination across the continuum of care; inadequate information on quality and outcomes; worrisome patient safety issues; and misaligned financial incentives that focus resources on episodes of care instead of preventive medicine and long-term care outcomes.

These ecosystem issues have resulted in a strong interest across several countries to leverage technology (healthcare interoperability) in order to create regional electronic patient information exchanges. The basic concept is that these exchanges will provide physicians with the patient information they need at the time treatment decisions are madeâ&#x20AC;&#x201D;e.g.: what prescriptions is this patient on?, what tests has he/she received? etc.â&#x20AC;&#x201D;which in turn permits a substantial increase in the quality of care, patient safety and efficiency gains.

More than just data sharing utilities, these regional electronic patient information exchanges are also envisioned as places

where community constituents can experiment with new business models to address the lack of incentives or the perverse incentives built in the existing reimbursement system, both for their own benefits and the greater good of the community.

To further illustrate these points, figure 1 indicates the typical stakeholders in a healthcare ecosystem, the initiatives that are of interest to them and the types of solutions that IBM can offer.

At the early stages of an initiative, it is key to carefully approach planning, Hospitals beds per 10000 Singapore Republic of Korea New Zealand Malaysia Japan China Australia India Europe North America 0 Source: WHO

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60

80

100

120

140

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information technology

aligned incentives and reconciled value perspectives across key stakeholders.

The rewards of successful transformation are high, but will require all stakeholders to actively participate, collaborate and change.

Much of the computing infrastructure for modern systems already exists.

What is now required is leadership, accountability 12 14 and collaboration among governments, businesses and the community to embrace healthcare ecosystem integration. If governments are prepared to initiate change, they will need partners to implement it. Companies like IBM already have the track record of implementing successful e-health integration projects.

IBM sees the industry progressing in steps—from today’s world of siloed processes and technologies, toward patient-centric Networks where information is shared seamlessly across the healthcare ecosystem.

IBM can provide end-to-end industry and

Total expenditure on health (% of GDP) Singapore Republic of Korea New Zealand Malaysia Japan China Australia India Europe North America 0

2

4

6

8

Source: WHO

constituent participation/buy in, governance, legal entity creation, and overall strategy in order to find the most effective and efficient path to success. Multiple technical options exist to set up a community and regionally based information exchange and IBM of course has strong competency in this area.

Establishing a sustainable multi-stakeholder business model is a bit more complex, given the well known value imbalance between providers and payers.

However, a range of potential redistribution mechanisms and incentive programs do exist and IBM is prepared with a methodology and financial model to assist with these critical planning and organisational milestones.

IBM’s financial model assists in creating a safe way for competitive constituents within the Healthcare Ecosystem to conduct meaningful and critical conversations regarding cost and benefits. The key and most elusive success factor in deploying a community or regional network is the will and ability for multiple constituents to work together on a sustained basis.

Leadership, accountability and collaboration for a win-win transformation The transformational challenge facing many healthcare systems globally is daunting. It often needs to be achieved with limited incremental funding in an increasingly competitive global economy and healthcare environment. The task will require the establishment of a clear, consistent accountability framework supported by

10

technology expertise to link business processes to IT. We can help with the business planning, funding, solution development and delivery of a full end-to-end national healthcare information networks (NHIN) initiative. We can assist with the promotion and adoption of open standards to help with the integration efforts of NHIN projects.

We have the capability to build and run the infrastructure for an NHIN system.

More importantly, leaders in the healthcare industry internationally are recognising the value of NHINs, as evidenced at The Asia Pacific National Healthcare Information Network Forum 2006. The forum, hosted by IBM Asia Pacific from 27 to 28 February 2006 in Beijing, China, brought together international thought leaders and practitioners in healthcare to discuss current industry challenges; the best approaches to NHINs; how to develop global NHIN standards; and share ideas about best practices for healthcare interoperability.

The change is definitely occurring. Now is the time to share progress, challenges and best practice to enable healthcare interoperability and link the ecosystem in the delivery of better quality care.

Figure: 1

Interest within the entire ecosystem to reduce cost and Improve overall value Healthcare Ecosystem's Primary Stakeholders 1. Empower Employees

2. Manage Payers

3. Incentivize Providers

2.1 Decrease Administrative Costs e-Claims & Audit

3.1 Improve Pharmacy e-Rx Pharmacy Management

4. Encourage Community based Collaboration

5. Promote Legislative Change

1.1 Self Benefits Management e-Benefits 1.2 Influence Healthy Lifestyle Wellness Programs 1.3 Promote Consumer Flexibility Consumer Driven Health Plans (CDHP) & Health Savings Accounts

2.2 Disease Management Disease Management Programs

1.4 Self Health Management e-Disease Management 1.5 Promote Consumer Choice Provider Selection Incentives 1.6 Health Record Portability Personal Health Records

2.3 Increase Buying Power Purchasing Coalitions

4.1 Promote Community Health Clinical Outreach Programs

3.2 Improve Quality of Care Pay for Performance 3.3 Promote IT Adoption Pay for Use e-MR

4.2 Promote Interoperability RHIO & National Health Information Network (NHN)

5.1 Promote New Legislation Lobbying

Most of these initiatives exist in multiple flavors. For example, chronic disease management typically covers 6-15 different conditions. Similarly, RHIOs vary widely based on the mix of stakeholders, or given communities’ priorities and approach. At this stage, the analysis remains at a high level and does not attempt to inventory each variation of a given initiative.

Source: IBM

w w w . a s i a n h h m . c o m 63

Products & Services Company

Page No.

Diagnostics PhenixVision Synthes Asia Pacific

61 OBC3

Facilities & Operations Management Dometic S.à.rl 16 Evolution Medicals 18 Faber Medi-Serve Sdn Bhd 55 Mocom Srl 56 Synthes Asia Pacific OBC3 Unomedical Pty Ltd 20 Venus Remedies Ltd 02 Healthcare Management B. E. Smith Dometic S.à.rl Evolution Medicals Faber Medi-Serve Sdn Bhd Messe Düsseldorf China Ltd Solvay Pharmaceuticals GmbH

13 16 18 55 IFC1 06

Company

Page No.

Information Technology PhenixVision SEED Infotech Limited Srishti Software Applications Pvt Ltd ZOLL Medical Corporation Medical Sciences Bloodline SpA Eurosets s r l Global Medisafe Holdings Pty Ltd (GMS) Shimadzu Asia Pacific Pte Ltd Synthes Asia Pacific Unomedical Pty Ltd Venus Remedies Ltd ZOLL Medical Corporation Surgical Specialty Dometic S.a.rl Eurosets s r l Pangiran Budi Services

61 59 62 04

25 33 26 22 OBC3 20 02 04

16 33 31

Company

Page No. IBC2 22 OBC3 02

Richard Wolf GmbH Shimadzu Asia Pacific Pte Ltd Synthes Asia Pacific Venus Remedies Ltd

Technology, Equipment & Devices Bloodline SpA 25 Dometic S.à.rl 16 Eurosets s r l 33 Global Medisafe Holdings Pty Ltd (GMS) 26 Menfis bioMedica Srl 50 Mocom Srl 56 PhenixVision 61 Richard Wolf GmbH IBC2 Shimadzu Asia Pacific Pte Ltd 22 SMEG SpA 44 Synthes Asia Pacific OBC3 Unomedical Pty Ltd 20 Venus Remedies Ltd 02 ZOLL Medical Corporation 04

Suppliers Guide Company

Page No.

B. E. Smith www.besmith.com

13

Bloodline SpA www.bloodline.it

25

Dometic S.à.rl www.dometic.lu

16

Eurosets s r l www.eurosets.it

33

Evolution Medicals www.evolutionmedicals.com

18

Faber Medi-Serve Sdn Bhd www.mediserve.com.my

55

Global Medisafe Holdings Pty Ltd (GMS) www.globalmedisafe.com.au Menfis bioMedica Srl www.menfis.it

Company

Page No.

Messe Düsseldorf China Ltd www.hospimedica-asia.com www.hospimedica-thailand.com

IFC1

Mocom Srl www.mocom.it

Company

Page No.

SMEG SpA www.smeg.it

44

Solvay Pharmaceuticals GmbH www.solvay.com

06

56

OBC3

Pangiran Budi Services

31

Synthes Asia Pacific www.synthes.com

PhenixVision www.phenixvision.com

61

Unomedical Pty Ltd www.unomedical.com

20

Richard Wolf GmbH www.richard-wolf.com

IBC2

Venus Remedies Ltd www.venusremedies.com

02

SEED Infotech Limited www.seedinfotech.com

59

Zoll Medical Corporation www.zoll.com

04

26

Shimadzu Asia Pacific Pte Ltd www.shimadzuasiapac.com.sg

22

50

Srishti Software Applications Pvt Ltd 62 www.srishtisoft.com

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1. IFC: Inside Front Cover

64 Asian Hospital & Healthcare Management

2. IBC: Inside Back Cover

ISSUE-12

2007

3. OBC: Outside Back cover

65 Asian Hospital & Healthcare Management

ISSUE-12

2007

66 Asian Hospital & Healthcare Management

ISSUE-12

2007