Asian Hospital & Healthcare Management - Issue 11

Lean in Healthcare

Wireless Sensor Networks

Issue 11 2006 ÂŁ5.95 â‚Ź8.00 $8.95

RFID in Hospitals

Molecular Diagnostics

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An accreditation is a way to distinguish a hospital.

Anne Rooney

Executive Director International Services Joint Commission International (JCI)

World-class Accreditations via

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Informa tion Technology

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Surgical Speciality

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Cardiology

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Oncology

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Facilities & Operations

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Contents Healthcare Management 10

Medical Tourism Preparing for the challenge

Bhaskar P Shah, Director, Asian Heart Institute, India

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Bariatric Surgery The minimal access approach

INTRODUCTION

World-class via Accreditations

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Minimal access surgery has come as a boon for bariatric surgery.

Pradeep K Chowbey, Chairman, Minimal Access and Bariatric Surgery Centre, Sir Ganga Ram Hospital, India

Diagnostics 29

Human Genome and the Molecular Diagnostics Market

Chee Gee See, Biomarker and Genetics Programme Manager, Roche Products Limited and Chris Chamberlain, Global Head, Medical Genetics, Roche Products Limited,h UK

Technology, Equipment & Devices

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Davide Lomanto, Director, Minimally Invasive Surgical Centre (MISC), National University Hospital, Singapore

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Makoto Hashizume, Director, Center for Integration of Advanced Medicine and Innovative Technology, Kyushu University Hospital, Japan

Oncology Ronald B. Herberman, Director, University of Pittsburgh Cancer Institute and Anna Lokshin, Assistant Professor of Medicine, University of Pittsburgh, USA

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Patient Monitoring Non-invasive is the way

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Gido M Karges, Director Marketing & Sales, SenTec AG, Switzerland

Surgical Speciality

Cancer Early detection strategies

IPR in Medical Equipment China’s rise

Allen Yeo, Principal Consultant, Thomson Scientific, Singapore

Akhil Tandulwadikar and Rajeshwer Chigullapalli Healthcare Editorial Team

Minimally Invasive Surgery Rise of the robotic systems

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MĂłnica Sagardoy, Brand Support Manager - Professional Asia Pacific, Ansell Healthcare, Australia

Medical tourism has played a catalytic role in making the Asian hospitals strive for world-class quality standards.

Minimally Invasive Surgery Emerging trends

Medical Gloves Going powder free

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Facilities & Operations 46

Infection Control The role of nonwoven textiles

Catherine Lennon, Communications Director, EDANA Group, Belgium

Cardiology

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Cardiac Surgery New techniques

The focus of new techniques has been on making cardiac surgery safe, minimally invasive and cost-effective.

Ramakanta Panda, Vice Chairman, Asian Heart Institute, India

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Asian Hospital & Healthcare Management ISSUE-11 2006

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CONTENTs

Interview 13

Lean in Healthcare

Issue 11

Healthcare Editorial Team Grace Jones Akhil Tandulwadikar Prasanthi Potluri

Copy Editors Srinivas G Roopi Sreenivasa Rao Dasari

Daniel T Jones, Founding Chairman, Lean Enterprise Academy, UK

Design Narsingoji Raju

Project Coordinators Sunny Roger Yuvraj Sahni

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Project Associates Stella Powell N Sweta Srikanth Katragadda

Circulation Manager S V Nageswara Rao

Circulation Executives Gagan Kumar Vallabhaneni Kevin Smith Kranti Kalidindi

Information Technology 56

Telesurgery in Asia Are we there yet?

Art Director M A Hannan

Anaesthesiology Anneke E E Meursing, President, World Federation of Societies of Anaesthesiologists, UK

Chief Editor Rajeshwer Chigullapalli

Lean focuses on the entire healthcare process itself whereas traditionally healthcare has focused on separately scheduled individual activities.

Anaesthesia The 21st century challenge

2006

Adam Chee, Industry Analyst, Healthcare (Asia Pacific), Frost & Sullivan, Singapore

Managing Director Vijay Chintamaneni

Director Sales & Marketing Ashok Ganguly

Marketing Manager Ahmed Tariq

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

Medical Errors RFID to the rescue RFID can provide an important contribution to improving the quality of treatment and increasing the safety of hospital routine.

54 Thomas Jell, Head, RFID Technology Department, Siemens Business Services, Germany

Asia’s Challenge to the Medical Manufacturers 58 Steve Stine, Director Life Sciences (Medical), TNT, Singapore

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Medical Care Wireless sensor networks

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New opportunities now exist where medical systems can be developed which offer preventative care and focus on delivering this directly to the person at home.

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Foreword Asia’s tryst with accreditations “Is it not also true that no physician, in so far as he is a physician, considers or enjoins what is for the physician’s interest, but that all seek the good of their patients? For we have agreed that a physician strictly so called, is a ruler of bodies, and not a maker of money, have we not?”

- Plato

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lato, surely was advising physicians not to be mere money makers. Enter international accreditations, Asian hospitals now have an opportunity to make money as well as put the patient’s interest as first and foremost. The National Heart Centre, Singapore on achieving the Joint Commission International (JCI) accreditation proudly proclaimed “We have learnt to look at healthcare from the patients’ point of view.” And here lies the core benefit of accreditation process.

While the accreditation drive began with the objective of attracting the attention of foreign medical tourists, they are bound to lay a platform for the hospitals in the Asian region to catch-up with the best global practices.

There is a sense of deja vu. It has happened before in the region, with mainstream outsourcing – in IT and ITES sectors. Having to satisfy the exacting demands of global customers made these companies build the capabilities to become world-class.

Asia’s tryst with accreditations began with the arrival of the medical tourist from the west. What began as a trickle, is all set to turn into a flood, with the Asian market predicted to reach US$ 4 billion by 2012. While underinsured and uninsured patients began to drive the market, soaring employee healthcare costs compelled the MNCs to join the bandwagon. A few multinational companies have begun sending their employees to Asian hospitals for treatment and also pass on a part of the huge savings in cost to them as well.

Accreditations are organization-wide efforts and require commitment of the organization’s leaders. The accredited hospitals vouchsafe the ability of standards to deliver results. They tend to reduce the risk of medical errors significantly, inculcate a culture of patient safety and lead to overall quality improvement. However, for a vast majority of medium to smaller size hospitals in the region, affordability of international accreditations remains an issue. The local governments could come up with their models of independent domestic accreditation agencies along the lines of international ones, customizing the frameworks to suit the size of hospitals. The global accreditation bodies could also come up with variants of accreditations to suit the smaller hospitals.

Global accreditations appear to hold the key to tap this emerging lucrative market. JCI, the leading international accreditation body, regarded as the gold standard, which has already accredited 30 Asian hospitals, is gearing up to strengthen its presence in Asia by setting up its first Asia Pacific office in Singapore. While the share of revenue lost by the US hospitals on account of the rise of Asia’s medical tourism still remains negligible, it is just a beginning. TIME magazine predicts that the trend will eventually turn the heat on the US hospitals. Reports TIME “It’s (medical tourism) one that could put greater competitive pressure on US hospitals as some of their most lucrative patients are siphoned off. Elective surgeries are key money makers for hospitals, and even a small drop-off can cut deep into their profits.”

The cover story, World-class via Accreditations, presents the scenario of accreditations in Asia. This issue also presents insightful articles covering Surgical Specialty, Cardiology, Diagnostics, medical equipment etc.

Rajeshwer Chigullapalli Chief Editor

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I NTR O D U CT I O N

Healthcare Management

World-class via Accreditations

T

he fact that medical tourism in Asia is happening, is no longer news.

But prediction of its huge growth potential certainly is. Abacus International, a UK-based healthcare consultancy believes that the lure of low-cost, high quality healthcare in Asia will attract more than 1.3 million tourists a year to the key locations – Thailand, Singapore, India, South Korea and Malaysia. The medical tourism market is expected to be worth US$ 4 billion by 2012.

Rising healthcare costs in the US have forced the un-insured and under-insured patients to look at cheaper healthcare alternatives outside the US. But while high costs have been an important driver, the factor that has actually pushed the patients to undertake the long journey is that the hospitals in Asia have made an effort to match the quality standards that exist in the US and other western countries. They did so by striving to achieve the global accreditations like Joint Commission International (JCI).

“An accreditation is a way to distinguish a hospital,” says Anne Rooney, Executive Director of International Services at JCI. However, the importance of international accreditations to Asian hospitals goes far beyond just attracting foreign tourists.

Better quality of healthcare and higher standards of patient safety help the hospitals to give the best treatment to a patient – irrespective of nationality - in the least possible time and with minimal wastage and lesser medical errors. While for the patients this means better treatment, for hospitals it is reduced wastage and lower costs in the

Medical tourism has played a catalytic role in making the Asian hospitals strive for world-class quality standards.

Akhil Tandulwadikar and Rajeshwer Chigullapalli Healthcare Editorial Team

long run. With accreditations, quality no longer remains the job of a few but it gets woven into the fabric of function involving all processes and people to pursue the same goal.

Accreditations Reshaping Asian healthcare Healthcare in Asia has emerged as a major focus area, with many nations recovering from the Asian Crisis as also the increasing prosperity China and India have begun to experience as a result of their policy reforms.

There is a greater need to revamp the healthcare systems for better quality of healthcare.

Attempts are on to benchmark with the best globally. India established the National Association Board for Hospitals and Health Service Providers (NABH) for accreditation of hospitals in the country recently. Absence of such standards always put the patients at risk. A survey by the World Health Organization (WHO) found the incidence of hospital-acquired infections to be highest in the Southeast Asian region at 10%, only marginally behind the Eastern Mediterranean region at 11.8%, which topped the list.

But there has been a gradual increase in the awareness regarding the importance of quality, thanks mainly to the increasing role of private players in the sector, especially in countries like India and China, where private sector hospitals have aggressively pursued accreditation. Medical tourism has played a catalytic role in making the Asian hospitals strive for world-class quality standards. Despite accreditations being a voluntary process, the competition to

attract foreign tourists has been driving hospitals towards them. This of course is good news for domestic patients as well since they will be able to access the best healthcare without having to travel a lot.

Among the various international accreditations available, the one awarded by JCI, the international arm of the US-based accreditation body Joint Commission on Accreditation for Healthcare Organisations (JCAHO), has become very popular. High standards, wide scope and rigorous process of evaluation have made JCI accreditation a ‘gold standard’ in hospital accreditation.

Already, as many as 30 Asian hospitals have got themselves accredited. And this number is only going up. While Singapore leads the Asian pack with 11 accredited hospitals, India, so far has 5 accredited hospitals with a few others preparing for it.

The other option that could soon be available for hospitals is the NIAHO-ISO certification developed by the TUVHS America. This program combines two independent sets of standards — ISO 9001 Quality Management standards and Hospital Conditions and Participation Chapters in JCI accreditation • Access to and continuity of care • Patient and family rights • Assessment of patient • Care of patient • Patient and family education • Prevention and control of infection • Staff qualification and education • Governance, leadership and direction • Facility management and safety • Management of information • Quality improvement and patient safety

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I NTR O D U CT I O N

The accreditation timeline ObtainJCIStandards manual and begin preparing for JCI Accreditation

12-24 Months Prior to Survey

6-9 Months Prior to Survey

Submit application for survey to JCI, andschedulesurvey dates with JCI

JCI Accreditation survey occurs

4-6 Months Prior to Survey

Submit revised application and schedule triennial JCI Accreditation resurvey

Receive and complete JCI Survey Contract & Travel Instuction Form Source: JCI

standards set by the Medicare program in the US. This new system has a wider scope than ISO 9001:2000 certification, which focuses largely on the administrative processes. However, it is yet to receive the final approval from the Centers for Medicare and Medicaid Services (CMS) of the US. Only then it will be able to accredit hospitals internationally.

The accreditation process For any hospital, the accreditation process represents bringing about a significant change in the way it functions. A comprehensive accreditation, such as that of JCI, needs to be implemented organization-wide, with the involvement of all the employees who take part in the patient’s journey from admission to discharge. In JCI, there are 565 standards divided into 197 core standards that must be met to achieve accreditation and 368 other standards that lead organisations to best practice levels. These standards are further divided into 1033 measurable parameters, which focus on aspects such as patient safety, patient rights, facilities, and physicians’ credentials besides policies and procedures of the organisation.

To get accredited a hospital will have to fully meet most of these parameters and the remaining ones at least partially. Singapore’s National Health Centre (NHC), which got accredited in November 2005, met 1013 of the 1033 parameters successfully. The JCI accreditation is valid for 3 years and has to be renewed on a regular basis.

The accreditation process typically lasts for about 2 years and involves two surveys by a team of consultants from JCI who

2 MonthsPrior to Survey

Survey Dates

ReceiveAccreditation Decision and Official Survey Findings Report from JCI

Within 2 Months After Survey

6-9 Months PriortoTriennial Due Date

Continuous quality improvement journey

JCI Survey Team Leader contacts your organization to determine survey agenda

also educate the hospital staff about various patient experience.” Further, as processes standards and their implementation. Here, get streamlined and designed around the the role of the top management becomes patient needs, there is also a better chance very crucial since it is their commitment for the hospital to provide evidence-based that in turn influences the commitment medicine to their patients. of the whole organization. “It takes strong Implementing the exacting standards of commitment from the top management” accreditation is usually a tough task to begin says Rooney and adds that the point-of-care with. With so many standards to deal with, staff, nursing staff, physicians and other there is a need for meticulous planning and employees of the hospitals too play a crucial thorough implementation, which involves role, as they have to adapt to a whole new active participation of all the employees. As way of functioning. the process aims to influence the functionThe benefits are multi-fold. Both the ing of the organisation itself, change manhealthcare provider and customer stand to agement – the process of generating a buygain if an organization complies with the in by all, attains utmost importance prior standards. The benefits that ensue accredito implementation. “Organizations that do tations include better care for the patients, this well really get to see a huge difference in a customer-centric approach, improved the way they manage their hospitals”, claims branding as a result of increased confidence Rooney. within the community, high employee morale and continuous monitoring of standards. Over a period of time the hospital would experiImplementation Requirements ence cost reductions as efficien• Standardise processes cy go up and more is achieved • Clearly communicate new policies to the employees through less effort. Medical • Improve documentation errors that cost hospitals thou• Improve facilities to increase patient safety sands of dollars every year could • ExpandthescopeoftheQualityManagementCommittee be reduced as well. The final • PlananddocumentContinuousMedicalEducation(CME) beneficiaries would be the pafor all staff tients since the new processes • Implementnewandstrictercredentialingandprivileging would be designed to meet their criteria for medical staff requirements and they have ac• Streamline the monitoring of clinical outcomes cess to the best treatment. Says • Change the maintenance records of medical equipment Rooney, “It’s interesting to note according to the standards that some organizations have • Improve communication with the patient reduced medication errors by • Practice strict control over patient information almost 75% to 80%. That obviously translates into a better

Asian Hospital & Healthcare Management ISSUE-11 2006

Healthcare Management

Affordability While the benefits of international accreditation are quite attractive, the fact is that accreditations such as JCI’s could be very expensive for a majority of medium-to-smaller hospitals in the region. A JCI accreditation would cost a hospital approximately US$ 100,000 and this does not include the expenses incurred for upgrading its facilities.

The Apollo Indraprastha Hospital in New Delhi, India – first hospital in India to get the JCI accreditation – spent close to Rs. 30 crore (US$ 600,000 approximately) to upgrade its facilities. Medium-sized hospitals may not have such financial muscle!

While this being the limitation, accreditations also give rise to another possibility – national level accreditations with standards designed on the lines of international accreditations and customized to the needs of the local hospitals. In this scenario, the cost tends to come down significantly.

The NABH could perform this very function helping smaller hospitals improve quality of healthcare and patient safety without having to spend huge amounts of money.

I NTR O D U CT I O N

While this may or may not result in them being able to attract international patients, it would certainly help in improving the quality of care in the hospitals.

"It is not just “we’ll get ready for getting the accreditation” and then getting back to business as usual. It is really about transforming an organization and its processes."

-- Anne Rooney, Executive Director International Services, JCI Full interview is available on www.asianhhm.com

The future With an opportunity worth US$ 4 billion around, competition for medical tourists is bound to heat up and more hospitals are likely to queue up for international accreditations.

Accreditation organisations would have to work closely with the governments of various Asian countries to make this happen lest the world-class healthcare facilities would be confined only to a small portion of the population. As more hospitals start acquiring accreditations, domestic patients too would prefer to opt the accredited hospitals for treatment. This scenario will eventually push a general move towards

improvement in quality of care. The peerpressure is two-fold – those who can afford accreditations start drawing blueprint for the same whereas those who cannot start learning about how to improve the status quo. This sort of a trend is already evident.

“A recently held five-day practicum at Singapore was fully booked about six weeks in advance! This shows that there is a very strong interest in education about quality standards in Asia,” points Rooney.

To be successful, the hospitals that are gearing up to acquire accreditations, would do well to remember what Phillip Crosby, initiator of the Zero Defect concept said, “It (quality) has to be the fabric of the organisation, not part of the fabric.”

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H e a l t h c a r e M ANAGE M ENT

Medical Tourism

Preparing for the challenge Medical tourism offers great potential for Asian hospitals, but they need to be thoroughly prepared in order to make best use of the opportunity.

Bhaskar P. Shah Interventional & Consultant Cardiologist and Director Asian Heart Institute India

M

edical tourism, where patients travel abroad in search of world-class medical treatment, is growing rapidly and gaining popularity in countries like Thailand, Singapore, Malaysia, India and South Africa. Since time immemorial medical tourism has been prevailing across the world right from the Neolithic and Bronze Age to Jet age (Table 1).

The global medical tourism market was pegged at a little over US$ 40 billion in 2000 and is growing at over 20% p.a. If these figures were to be projected forward it would be a US$ 100 billion opportunity today. Considering such lucrative potential, a former Indian Finance Minister called for India to become a “Global Health Destination”.

Overburdened healthcare infrastructure and high costs in the west are the key drivers for the boom in medical tourism.

The healthcare infrastructure in Europe and the United States is under severe pressure. In Britain, the National Health Service (NHS) has a long wait list of patients for surgery. In US the healthcare crisis has different dimensions — it has 50 million uninsured citizens while the insured have to pay dearly for healthcare facilities. To add to this the stringent visa regulations imposed by US and European countries after 9/11 episode has led to a growing number of foreign patients from Middle East to visit Asian countries for treatment.

All these factors have opened up avenues

for hospitals in various Asian countries to ultrasound) costs GBP 350. A comparable promote medical tourism. So we now need check up in India is available for US$ 84 at to look into meting the challenges of medithe Mumbai-based Asian Heart Institute. cal tourism.

The mortality rate of coronary bypass A low cost, robust and high value patients at Asian Heart Institute, Mumbai proposition would be to offer highly cost and Escorts, Delhi is 0.8%. According to a competitive medical treatment with world2002 study by the New York State Health class, cutting edge technology, by worldDept., in 1999 the New York-Presbyterian class medical specialists in accredited hosHospital had a death rate of 2.35% for pitals with world-class infrastructure and the same procedure. It is noteworthy that facilities. former US President Bill Clinton recently Cost of comparable treatment in Asia underwent bypass surgery at the same hosis on an average one-eighth to one-fourth pital. In India, the overall success rate of to those in western countries. A cardiac cardiac bypasses is 98.7% as opposed to procedure which costs anywhere between 97.5% in the US. US$ 40000 to US$ 60000 in the US, Hospital accreditations done by JCI, US$ 30000 in Singapore and US$ 12000 ISO, OSHA etc — the seal of quality, pato 15000 in Thailand costs only between tient safety, quality care, updated technolUS$ 3000 to 6000 in India. The associogy and organized systems — are a kind ated costs of the surgery are also low. Not of assurance that people look for in any only are skilled Indian surgeons available health institution with the two most imfor a lower cost, they are less susceptible portant parameters being patient care and to costly litigation. The cost of malpracpatient safety. tice insurance in New York is around Hospitals should concentrate on uniUS$ 100000 while in India it costs only form price range for various medical treatUS$ 4000. These factors reduce the overall ments across various hospitals across the cost of treatment. country and make it public (to establish Diagnostic tests in India are also comtransparency) in order to facilitate the enparatively inexpensive. A Magnetic Resotry of foreign patients seeking treatment nance Imaging (MRI) scan costs US$ 60 with us. in India compared to US$ 700 in New Table-1: Evolution of Medical Tourism York. The country also has the potential Neolithic & Bronze Age Mineral & Hot Spring visits to emerge as a hub Middle Ages Thermal Springs for preventive health screening. At a pri16th century “Fountain of Youth” vate clinic in LonSpa 17th/18th century don a routine health check-up (includ19th century Sea & Mountain Air ing blood-test, elec(TB sanitarium) tro-cardiogram test, 20th century “Health Farms” or “Fat Farms” chest X-rays, lung tests and abdominal

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An institute seeking foreign patients has to ensure: • Low cost and reasonable medical treatment • World-class treatment with cuttingedge technology and top medical professionals • An accreditation which 1. is patient focused 2. is result oriented 3. covers international and domestic patient centres • Apowerfulmarketingdepartmentwith aggressive promotion Facilities in hospitals seeking foreign patients need to be market driven i.e. attractive to patients, must deliver results and must be competitive. To attract foreign patients the hospital must have willingness and ability to build 5 star facilities, (Table 2), acquire state-of-the-art medical equipment and technology and the ability to attract medical professionals at the top of their respective fields. Full accountability to: a. Shareholders who are expecting results b. Patients who have high expectations c. Top medical professionals who have joined the hospital, ensures delivery of proper results Competitive imperatives would mean superior and excellent clinical outcomes to gain commanding market share and customer service focus to achieve patient satisfaction and customer delight.

Each hospital should have a dedicated international patient centre which could match up to a 5 star hotel lounge. This centre provides foreign language services, transportation co-ordination including airport pick-up ground and air ambulance services, internet, fax and modem lines in patients rooms, long term lodging arrangements for patients families, VIP concierge services for shopping, dining, sight-seeing, visa assistance and special events.

Strict medical staff governance is the hallmark of a good medical institute. This governance needs to include proper credentialing of medical faculty, professional ethics, regular mortality and morbidity review, regular internal and external medical audits, continuing medical education programmes, professional training and clinical research.

A well-developed marketing depart-

ment in the hospital is a necessity for intense marketing and publicity of medical facilities. The west is more likely than not largely ignorant about hospitals in Asia and there is therefore a huge psychological hurdle. The promotional effort can be accomplished with a focus on specific countries through a well-organized word-of-mouth and media campaign (print or electronic) or referral network involving tie-ups with foreign governments, insurance companies and overseas doctors. However tie-ups with travel agents based abroad helps in better exposure and marketing. Road shows and exhibitions in targeted countries are good means for marketing.

Strategic tie-ups and alliances in the industry are now assuming greater importance. For instance Manipal Hospital has a tie-up with the governments of Tanzania and Mauritius. Further, agreements with foreign travel insurance providers give the hospitals a significant international exposure. Tie-ups with foreign insurance companies assures hassle-free cash-less benefits.

As hospitals upgrade their services to global benchmarks, the country’s medical care is increasingly gaining acceptance among international insurers, for instance, USbased private healthcare insurers Blue cross and Blue Shield and British health insurer BUPA now insure clients being treated at a number of private hospitals in India.

Bringing healthcare providers/hospitals with facilitator-tour operator together will help to develop suitable healthcare cum travel packages. Tour operators are playing a role greater than just arranging a patient’s tour itinerary, with their services covering everything from pre-treatment counselling to post-treatment care. The healthcare tourism packages typically include identifying the appropriate hospital for required treatment, appointment with doctors, travel arrangements, accommodation, logistics and facilities for those accompanying the patients and maintaining post-treatment assistance via e-mail.

There is a greater need for public-private partnerships as this will enable developing health infrastructure and policy, through sharing of technology, physical and human resources, and information. Part of the revenue generated through globalisation of this sector can be channelled towards the overall development of the healthcare system.

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There is also a need for taking a holistic approach towards healthcare and delivery.

For example, wellness tourism which is meant for rejuvenation of the body and mind involving services such as Herbal therapy, Naturopathy, Yoga, Aroma therapy, Reiki and Music therapy require no advanced medical expertise, and are highly sought after by many tourists coming in for treatment.

Setting up of an International Assistance Centre in a foreign country with the following goals is also necessary: The centre must be able to create awareness about medical tourism facilities among local populace. It must provide detailed information about facilities, procedures, and competencies and costs. It should have facilities for preliminary diagnostics and expert opinion through tele-medicine technologies. It should be able to manage complete travel & stay plan and co-ordinate appointments. It should give posttreatment patient management. Above all, it should build trust and confidence in the clientele.

Table-2: Service with style Someaddedamenitiesthatarebeingoffered as a part of the bouquet of healthcare services in large hospitals include: • 24 hour pharmacy that serves both patients and others • Spacious waiting areas • In-house cafeteria, sometimes outsourced to reputed restaurant chains • Coffee vending machines • Internet access • Prayer room • Florist, gift and book shops • Valet parking with ample car park space • ATM machines and banking counters • Travel desk and translators • In-hospital accommodation

And last, but not the least, understanding of the different cultural backgrounds of medical tourists is of paramount importance because the topic of healthcare is very personal and means different things to different cultures. Non-verbal communication, which is influenced by culture, is also an important part of diagnosis. Further, a good cultural understanding can help in speedy patient recovery.

H e a l t h c a r e M ANAGE M ENT

Interview

Lean in Healthcare The difference between lean and the previous methods is that lean focuses on the entire healthcare process itself whereas traditionally healthcare has focused on separately scheduled individual activities.

Daniel T Jones Founding Chairman Lean Enterprise Academy UK

What benefits does lean bring to the healthcare organizations vis-à-vis the older models of functioning?

The benefits of lean for healthcare organizations are that firstly, the quality of the outcomes in terms of mistakes and errors improves. The second is that the amount of time taken through the whole process significantly improves as a result the number of patients that can be put through the process increases i.e. the productivity or throughput of the process increases. While the initial gains come in terms of improved quality, reliability of the process and elimination of a lot of wastes associated with the process. The medium term gains come in the form of a significant increase in the throughput of the process. It improves Quality, Reliability and Productivity of a process; and it does so while making work easier for the medical staff by removing a lot waste and improving the customer experience as well. So actually this is a winwin opportunity for improving quality of healthcare, delivery of healthcare and the productivity of the staff. These gains are realized by focusing on the entire sequence of steps instead of individual activities.

The medical process is very much geared to the event where the patient and the doctor actually sit together, whereas if

you look at the actual sequence of events, there is a tremendous amount of unnecessary activity that goes on because of lots of delays, repeat tests and events not occurring in the right sequence. So lean really focuses on the patient’s journey on the one hand and the medical process that goes to make the journey possible.

So lean reduces the time taken by the patient to go through the process of treatment…

Time taken by the patient as well as the provider to deal with the patient. So there are two parallel processes going on: one is the patient itself and the other is the activities that have to happen in terms of the scheduling, maintaining the records, conducting the tests and so on. These are streamlined better by implementation of lean. The difference between lean and the previous methods is that lean focuses on the entire healthcare process itself whereas traditionally healthcare has focused on separately scheduled individual activities.

Do the benefits outweigh the costs?

Almost certainly, yes. The costs are initially an involvement of staff in coming together to look at and analyse the current process and improve it. So there is an investment

in time of the staff in actually looking together at the whole process and then going through several redesign activities.

However, the experience is that this is very quickly paid back by the improvements in the performance of the system. Initial gains can come within a few weeks of implementation but the real gains come in a period of eighteen months to two years, largely in terms of increased throughput with existing resources which means that you don’t need to invest in additional capacity, equipment and people. And that’s the typical situation being faced by healthcare organizations, there’s more demand than they can keep up with. So lean really helps save both in terms of current costs and capital costs.

While this is in terms of costs, in terms of staff morale, it has a very dramatic effect because people suddenly feel engaged in improving the way they work.

What steps does an organization need to take in order to implement lean?

There are various ways organizations have gone about implementing lean but any organization certainly needs to build a small group of staff, a lean team so to say, who first of all understand lean and then take responsibility for leading activities to look at individual processes. The team needs to

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H e a l t h c a r e M ANAGE M ENT

involve the clinicians, nursing staff and the management. Having done that, they need to pick key processes that are in trouble and begin to analyse them and engage the people involved. The key here is to build some kind of internal knowledge. Therefore, though the implementation of lean begins at the top level of the hierarchy it needs to be quickly passed down to the bottom.

It's top down in the sense that the initiative must be supported by the top management but the actual implementation has to involve the people right at the frontline since they are the people who know exactly what’s wrong with the current processes.

hospital.” I think we are still two or three years away from that.

I started walking around hospitals around six years ago because I thought this would come. I thought I needed to understand how the healthcare system works.

But it was too early. People were not really focused on the customer and were worried about quality rather than efficiency.

What challenges does the implementation of lean bring?

Initially it probably doesn’t change the organization a great deal but gradually as you start separating out the different flows of the hospital and start seeing the hospital as a collection of different flows — a short stay flow, a long stay flow, an out-patients flow rather than a series of departments, what you begin to see is a change in the orientation of the hospital, where the departments are increasingly supporting different flows rather than just managing

operating to improve the process. If lean is badly managed or is simply used as a tool for pressurizing people it will go backwards very quickly; people will stop collaborating. It’s very difficult to misuse lean as people get to see what you are doing and they will not be willing to cooperate. I know that there have been lots of criticisms of lean and look, not every lean implementation succeeds. Lean is quite hard and it sometimes goes forward and sometimes reaches a plateau, people leave, organizations change and you may have to go backwards again. In general, lean is a very positive step for an organization.

What kind of penetration has lean What are the limitations of lean with achieved in the healthcare sector? respect to its application in healthcare?

Lean has been taken up in the healthcare I think we are still experimenting with sector only in the last two or three years. what lean is going to mean. I think lean in In the US several hospitals got involved in the future is going to mean we will design try-and-apply lean by hiring Toyota experts our healthcare processes very differently. and experimenting with how lean applies And quite possibly, some of the things we to healthcare. In the UK, the do in the hospitals might well UK NHS modernization agency be done down closer to the pabegan work on applying lean to tients in what we call primary The really exciting prospect in the accident and emergency decare. Some of the more routine the future is that we design systems partment and cancer treatment activities can certainly be done about three years ago. In Australby nurses closer to patients but fundamentally from customer ia they started about two years we need smaller scale equipment backwards rather than trying to keep ago. So in those three countries to help them do that while at the a big hospital busy. it has already begun and they moment people are building bigwere initially really experiments ger and bigger and more expenwhere different hospitals tried to sive machines. translate the idea into language of healthcare from a language of manufactheir own activities. And you begin to see Would it be easier for a new hospital to turing. much better coordination and somebody implement lean than an older hospital?

But in the last year, especially in Austaking responsibility for coordinating each Theoretically yes. The knowledge of turntralia and UK, the interest has suddenly of these different flows across departments. ing around an existing hospital is quite a become huge and it has certainly now Therefore, a process focus as well as an acstruggle and it takes time but I don’t think become a big wave and we are getting intivity focus begins to appear. In terms of it's necessary to start with a clean sheet. terest from several other countries as well psychological change, this releases a tresuch as Germany, Holland, Denmark and mendous amount of energy. And if done Any other comments? of course, Asian countries as well. The well it can actually change the psychologiI think we are at the starting of a revolubest example in the Asia-Pacific region is cal atmosphere of the organization because tion in healthcare in the way healthcare the Flinders Medical Centre in Adelaide. people feel less stress and pressure and is delivered and lean is an important trigThey held the first redesigning healthcare begin to achieve much greater results than ger in doing that. I think it will lead to all conference last march that attracted over they actually thought possible. sorts of new thoughts about how healthcare 300 people from countries like Australia, is delivered in the future. And we need to New Zealand and Singapore. So these How valid are the criticisms of lean, engage the pharmaceutical companies, the ideas are trickling everywhere in healthlike, it doesn’t consider the human medical equipment companies as well as the care. However, it is fair to say that we are factor? hospitals and governments in thinking that still in the early stages of working out what Actually, you can’t consider going lean through. The really exciting prospect in the the full impact of lean on healthcare is. We without taking the human factor into future is that we design systems fundamendon’t yet have a possibility of pointing at consideration because lean depends upon tally from customer backwards rather than a hospital and saying “here is a truly lean people in the process who are willingly cotrying to keep a big hospital busy.

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C a r dio l o g y

Cardiac Surgery New Techniques

The focus of new techniques has been on making cardiac surgery safe, minimally invasive and cost-effective.

Ramakanta Panda Vice Chairman Asian Heart Institute India

C

ardiac surgery has witnessed major changes and rapid progress in the last 50 years, since the time of the development of cardiopulmonary bypass (CPB) for clinical use in 1953.

Constantly the focus of the improvement in the techniques and technologies has been on making cardiac surgery safe, minimally invasive and cost-effective. Major advances have occurred in the fields of off-pump surgery, video assisted surgery, surgical treatment for heart failure, robotic surgery and artificial hearts and prostheses.

Off-pump coronary artery bypass graft surgery (opcab) In off-pump coronary artery bypass graft, as the name itself indicates, surgery is done without putting the patient on a heart-lung machine. For nearly 25 years, the standard technique of conventional

CABG was to perform it on cardiopulmonary bypass (CPB), i.e. the patient is put on a heart-lung machine.

Cardiopulmonary bypass is an unphysiological state involving alterations in the flow properties of the blood, alteration in thermal regulation, protein denaturation, and exposure of blood to unnatural, non-endothelial surfaces triggering various enzyme cascades such as complement, kinins, coagulation systems and fibrinolytic systems.

There is a great disturbance of the homeostasis leading to various organ dysfunctions, thus accounting for the postoperative morbidity. Also the cost of the operation is high especially in the developing countries because of the cost of the import of various materials required for the conventional CABG on CPB. Hence, in a constant endeavour to make surgery safer for the patients and the attempts to do away with CPB, innovative surgeons with the help and support of the enterprising industries strived together to deal with the dual concerns of risks and cost of conventional CABG. This culminated in the development of Off-Pump CABG (OPCAB).

Off-Pump CABG is minimally invasive as compared to surgery on the heartlung machine. This method eliminates the use of CPB thus avoiding an unphysiological state and permits surgery on multiple arteries within the heart by mechanically stabilising it. The potential benefits include shorter hospital stay, less bleeding, less chance of infection, less risk of irregular heart beats (arrhythmia), less trauma, shorter recovery time, and greater cost

effectiveness. This procedure was initially created to avoid brain injuries attributed to the pump.

Off-pump CABG is performed with the help of various mechanical stabilisers.

They immobilize a small area around the coronary artery for the surgeon to operate while the heart continues to function.

The various commercial stabilisers that are available are the Medtronic Octopus device, Guidant suction device, etc.

Off-Pump CABG is further undergoing various modifications of techniques as a result of which many different terminologies and abbreviations are in use. However, the two main principles of OPCAB, minimally invasive and mechanical stabilisation of the heart, remain unchanged.

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C a r dio l o g y

Minimally invasive coronary artery bypass graft surgery (MICAS)

This refers to all techniques of CABG wherein there is no use of CPB. It also includes operations involving lesser incisions than a standard full median sternotomy.

Minimally invasive direct coronary artery bypass graft surgery (MIDCAB)

MIDCAB or ‘limited access coronary artery bypass’ is usually limited to patients with lesions in one or two coronary arteries, mainly the Left Anterior Descending Artery (LAD) and the Right Coronary Artery (RCA). In contrast with conventional CABG, this procedure is done through a smaller incision on the sides of the patients chest in the fourth left intercostal space and entering the pericardium through the bed of the excised cartilage. This approach avoids making long incisions, splitting of the sternum (breast bone) and subsequently the development of instability of the sternum and infection of the bone and cartilages and also the development of ugly scars (keloid), which is more prone in this location and in dark skinned people.

Lower end sternal split coronary artery bypass graft surgery (LESS)

In this procedure the bypass is done by cutting only half of the breast bone. This is done when there is blockage in one or two coronary arteries. The advantages include fast recovery of patient and quick return to work within 10-14 days.

Thoracotomy Off-pump coronary artery bypass surgery (TOPCAB)

In this procedure a left Antero-Lateral thoracotomy approach is employed.

Asian Heart Institute has been a pioneer in LESS, TOPCAB, and OPCAB procedures, which are being done over the last three years with excellent results.

Also, Asian Heart Institute is one of the few centers in the world where more than ninety-nine percent of the CABGs are done on beating heart (OPCAB).

Video-assisted port-access mitral valve surgery In this technique, the breast bone is not opened. The patient is put on heart lung machine by inserting pipes through the neck and the thigh. The heart is stopped by inserting the catheter retrogradely through the femoral artery in the upper part of the thigh up to the ascending aorta. The heart

is stopped by inflating the balloon inside the aorta and giving potassium to temporarily stop the heart. The operation is done through a small cut in the side of the chest.

Video assistance and shafted instruments help the surgeon to perform the surgery through small holes and fulfill the main goals of minimally invasive cardiac surgery, comfort, cosmesis, and fast rehabilitation.

Voice activated video camera gives excellent view of the mitral valve. Port-access mitral valve surgery is a very important minimally invasive technique.

Surgical treatment of heart failure Large number of heart patients develop and die from heart failure. Till recently most of these patients were managed with medicines without any surgical help.

Recently lot of new surgical techniques have evolved to help treat patients with end stage heart failure.They include the Surgical Ventricular Restoration (SVR), Acorn procedure,Myosling, etc Left ventricular reconstructive surgery (dor procedure) Left ventricle reconstructive surgery is a procedure sometimes used to treat heart failure.

When a heart attack occurs in the left ventricle (left lower pumping chamber of the heart), a scar may form. The scared area can become thin and bulge out with each beat. The bulging thin area is called aneurysm. The aneurysm, along with the other damaged myocardium makes the heart to work harder to pump blood throughout the body. Initially the heart is able to handle the additional work, but over time the heart becomes larger than normal and pumps less effectively

Left ventricular reconstructive surgery allows the removal of the scarred, dead area of the heart tissue and/or the aneurysm and return the left ventricle to a more normal shape. The goal is to improve heart failure and/or angina (chest pain) symptoms and possibly improve the pumping ability of the heart.

Other names of Left Ventricular Reconstructive Surgery:

• Endoventricular circular patch plasty repair • Dor procedure (to credit Vincent Dor, MD, who authored many articles on the procedure he began performing in the early 1980s) • Surgical Ventricular Restoration (SVR)

16 Asian Hospital & Healthcare Management ISSUE-11 2006

• Left ventricular infarct exclusion surgery • Left ventricular aneurysmectomy reconstruction • Surgical anterior ventricular endocardial restoration Left ventricular reconstructive surgery is a major open-heart surgery, requiring the use of the heart-lung machine. The damaged part of the heart is removed and it is reconstructed with an artificial patch.

In addition to this procedure, coronary artery bypass graft (CABG) surgery is often performed to improve blood supply to the heart muscle. Further, about half of the patients undergoing the left ventricular reconstructive surgery, mitral valve leaks are also repaired.

Some patients may require a special device called an automatic implantable cardioverter-defibrillator (AICD) to treat serious abnormal heart rhythm, which is a very common postoperative problem in this type of procedure. Under special circumstances, an EP study (electrophysiology study) will have to be done to evaluate the heart rhythm.

Cardiac wrap surgery This procedure uses a technique that wraps the heart in a mesh bag, helping to prevent further enlargement and failure. A mesh wrap is pulled over the base of the heart and is attached with stitches. The goal is to prevent a weakened heart from enlarging (dilating) and failing further. Initial results are very encouraging and it is hoped that in a few years these procedures will be routinely offered to patients with heart failure.

C a r dio l o g y

Enhanced External Counterpulsation (EECP)

This is a non invasive techniqe. Inflatable pressure cuffs are placed on the calves, thighs and buttocks. These cuffs are inflated and deflated in sync with the heart beat. This increases the blood flow back to the heart Arificial Heart Although the heart is conceptually a simple organ (basically a muscle that functions as a pump), it embodies complex subtelities that defy straightforward emulation using synthetic materials and power supplies.

The obvious benefit of a functional artificial heart would be to lower the need for heart transplants.

The total artificial heart (TAH) was first used in 1969 for a patient who was waiting for heart transplantation. An artificial heart is a prosthetic device that is implanted into the body to replace the original biological heart. It is distinct from a cardiac pump, which is an external device used to provide the functions of both the heart and the lungs. Thus, the cardiac pump need not be connected to both blood circuits. Also, a cardiac pump is only suitable for use not longer than a few hours, while for the artificial heart the current record is 17 months. Another problem is that an artificial heart requires an external power supply such as a battery pack worn on the patient’s waist; which carries a significant risk of introducing infection; no design so far has been able to use the body’s own natural biological energy. The first artificial heart patented was ‘Jarvik-7’, now known as Cardiowest C70 total artificial heart.

Robotic Cardiac Surgery The next advance in heart surgery is the robotic surgery which will revolutionise cardiothoracic procedures. Contrary to the popular belief, the robot does not do the surgery independently, rather the robot works as the extended arm of the surgeon. The surgeon sits on a computer control panel near the patient and controls the movement of various robotic arms. An assistant makes small holes in the patients chest wall through which the robotic arms are inserted.

The surgeon grasps and moves the highly sensitive instruments at the console while viewing the patient’s heart, greatly

magnified on a screen. The robot precisely matches the surgeon’s natural hand and wrist movements, and translates them into precise, real time movements to the tiny instruments placed inside the patient through small puncture incisions. The procedure, for e.g., a mitral valve repair, will require three small incisions between the ribs, two for the insertion of interchangeable instruments and another for a thin, cylindrical video camera, called an endoscope.

There are many systems available, the most popular being da Vinci™ system.The da Vinci™ Surgical System provides the surgeon with the intuitive control, range of motion, fine tissue manipulation capability and 3-D visualization characteristic of open heart surgery, while simultaneously allowing the surgeon to work through small ports of a minimally invasive surgery. The patients experience shorter inci-

sions, less pain and trauma and a quicker recovery time.

Stem Cell Therapy Stem cells have the ability to grow into other types of cells and thus represent great promise for treating a wide range of diseases. While harvesting of embryonic (fetal) stem cells is extremely controversial, the cells used in the heart study came from the patient’s own bone marrow. Injected into the heart muscle, the stem cells developed into muscle and blood vessels in the damaged areas, increasing the heart’s pumping capability and blood flow. Using the patient’s own stem cells also eliminates the problem of rejection of donated cells and organs.

Total arterial revascularisation In this procedure, coronary artery bypass graft surgery is done using all arterial grafts. Vein grafts are very rarely used. The various arterial conduits are the Internal Mammary Arteries, Radial artery, Gastroepiploic artery, and Inferior epigastric artery. The arterial grafts have longer patency rates unlike the vein grafts which start degenerating after 8 to 10 years, thereby necessitating the need for a second time (re-do) CABG. Asian Heart Institute has been doing almost all total arterial revascularisation with excellent patency rates.

Valve repair surgery Prosthetic valves came as a boon to patients with valvular heart disease, but with it came a new set of prosthesis-related problems.

Awareness of these problems has refocused attention on developing techniques to preserve the patients narive valve. Surgeons developed renewed interest in reparative techniques to preserve mitral valve and devised methods to debride and reconstruct aortic valve.

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Surgical Speciality

Minimally Invasive Surgery Emerging trends

Technological innovations in the field of robotics, and telemedicine will drive the future of minimally invasive surgery.

Davide Lomanto, Department of Surgery, Yong Loo Lin School of Medicine, National University of Singapore and Director, Minimally Invasive Surgical Centre (MISC), National Univesrity Hospital, Singapore

T

he substantial developments in surgery, over the last century with the advent of antiseptic substance, anaesthetic agents, antibiotics, surgical nutrition, and organ transplantation, did not modify the basic tools of surgery and even the surgical techniques remained basically unchanged.

But in the last few decades, “invasiveness” has been the focus of surgical practice gaining the momentum especially because of the better outcome in terms of postoperative pain, fewer complications and quicker return to functional activity. The change was initiated with the advent of the laparoscopic surgery, and because of the rapid acceptance and success of such operations as laparoscopic cholecystectomy, over the last two decades a revolution has taken place in general surgery. Since then, a variety of surgical operations in the entire

surgical speciality have used endo/laparoscopic techniques.

The modern era of laparoscopic surgery ushered in when a miniature video camera was attached to the eyepiece of the laparoscope, which allowed multiple observers to view an operative field from the same vantage point. But the major push happened when many large series were reported in the literature highlighting main advantages of the laparoscopic approach over traditional “open” surgery (in terms of reduced postoperative pain, shorter hospital stays, periods of disability and cost-effective for hospitals and patients).

The media quickly portrayed laparoscopic surgery, with its small incisions, as a panacea, inventing different name as “key-hole surgery”, “minimally invasive”, “band-aid” or “Nintendo surgery” (Image-1). Hence, the success among patients was great which helped in the growth of minimal invasive surgery supported by the development of new high-tech instrumentation and devices.

The evolution During the initial years, laparoscopic surgery was limited by a number of factors such as: two-dimensional vision, the control of the surgical field by an assistant. The laparoscopic port, restricted the freedom of movement of the instruments which themselves were straight without articulated movements like human wrist. Moreover, the instruments utilized, did not provide any tactile or force feedback. Nevertheless, the number of operations grew, surgeons became skilled over the limitation imposed by laparoscopy and along the years this gap was almost recovered.

The new high-technology equip-

Image-1

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ment not only resulted in changes to Hospital design — as OTs had to be redrawn according to the new devices — but the surgical training programmes also had to be re-organized. Together with technological development new approaches comeout.

The size of ports used to access the abdominal cavity decreased over time from 10 mm to 2 mm. The 2-mm ports, called “needlescopic” ports, have proven to be feasible, safe, and effective when an enlarged port is not required for extraction of a specimen. Benefits include less postoperative pain and improved wound cosmesis. The use of “hand-assisted” ports, in which a hand is inserted into the peritoneum to assist the performance of the surgical procedure, allows for tactile assessment by the surgeon. This different surgical approach is particularly advantageous when a larger incision is needed to remove the surgical specimen like donor nephrectomy, splenectomy or gastric surgery or for cases that are too complex or take too long to be managed with the total laparoscopic technique. The application of the minimally invasive procedure to more complex surgeries will require new technology and techniques. In general surgery, techniques such as hand-assisted laparoscopy attempt to bridge the gap between open and completely endoscopic procedures. Other possibilities include developing new ways to perform conventional surgical tasks as a way to adapt these procedures to an endoscopic or less invasive surgical approach.

Inanimate trainers (Image-2) or simulators (Image-3) are being used as teaching tools to improve surgeon performance, and the use of self-retaining retractors has enabled the surgeon to use fewer assistants in the operating room. More recently, robotassisted surgery has emerged as a popular

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Surgical Speciality

Image-2

Image-3

method. Robotic arms allow the surgeons for finer control and remote presence and provide a computerized interface between the patient and the surgeon. The DaVinci Robotic system (Intuitive Surgical, USA), provides enhanced dexterity, motion scaling, articulation, 3-dimensional vision and the potential for telesurgery. However, the number of surgical applications of robot-assisted surgery are increasing slowly, mainly due to the high investment and running costs of the devices even though the initial benefits exist. But new applications must be developed as the full range of robotic application is still to be implemented. The initial concept of robotics in surgery involved operating at a remote site from the surgeon. The ability to transpose surgical and technical expertise from one site to a distant site (i.e.: proctorship,

assisting developing country or remote area like) was thought to expand surgical application. Although simple surgical procedures have been performed remotely, there are some difficulties for an extensive clinical use because of high costs, transmission delay and medical and legal issues.

The future Application of telepresence surgery in the foreseeable future will probably be limited to telementoring rather than to remote manipulation. Telementoring will allow the surgeon to teach or proctor performance of an advanced or new technique at a remote site using real-time teleobservation and monitoring. New broadcasting technologies such as highspeed broadband telecasting - a technology that allows the users to utilize non-com-

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pressed audiovisual signals keeping high quality, low delay (Image-4) that are now in the early stages will soon be available worldwide. However, a robotic development in the area of software simulation and virtual reality could be expected. Also surgical operations and that need dexterity enhancement and motion microscaling will need robotic assistance.

Other possible roles for computer and robotic assistance in surgery include voice control over surgical manipulators and information manipulators. At present, technology exists to give the surgeon voice control over virtually all operating room equipment including electrocautery, operating table position, laparoscopic movement-control, lighting and telephone.

Future developments promise the overlay of additional data to the operative field including 3-dimensional magnetic resonance imaging reconstructions and physiologic data acquisition, especially for preoperative virtual simulation.

In conclusion, efforts are now focussed on those techniques that facilitate more complex tasks by the minimally invasive approach. Other aspects are the clear role of audio-visual telementoring in future training concepts and of telemanipulation/telesurgery. New technological concepts promote the development of hand-held mechanical manipulators used in combination with mono-tasking computerized robots like AESOP, resulting in a significant cost reduction. Advancements in microchip and wireless technology may allow the development of microrobots for completing surgical procedures and magnetically controlled implants that can be navigated remotely.

Image-4

The technological innovations in surgery are only beginning, the future will be very attractive, the potential is enormous and the path is minimal.

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Surgical Speciality

Bariatric Surgery

The minimal access approach Minimal access surgery has come as a boon far bariatric surgery.

LaparoscopicAdjustable Gastric Banding

Pradeep K Chowbey Chairman, Minimal access and Bariatric surgery centre, Sir Ganga Ram Hospital President, Obesity Surgery Society of India (OSSI) and Secretary general, Asia Pacific Bariatric Surgery Society (APBSS) India

M

inimal access technology is a giant leap forward in delivering surgical care to patients.

The underlying principle of minimizing the trauma of surgical access met with such wide spread acceptance that there was an uncontrolled and unmonitored surge in its practice and application. This resulted in accidents, which nearly put this technique to disrepute. However, increasing experience and dedication of surgeons firmly believing in the technology’s principle helped minimal access surgery achieve the status it enjoys today.

There is no surgical speciality (belying obstetrics) where minimal access surgery has not made inroads. One such surgical speciality where minimal access surgery has come as a boon is bariatric surgery.

Bariatric surgery deals with surgical management of patients suffering from an extreme degree of obesity. An obesity which has crossed the boundary of being a mere cosmetic problem to a life threatening dis-

ease. This disease is termed as morbid obesity and is defined as a patient with a BMI (body mass index) of > 40 Kg/m2 (Asians > 37.5 Kg/m2) or 35 Kg/m2 (Asians 32.5 Kg/m2) with significant associated obesity related comorbidities. The disease has developed stealthily and has been declared the worst pandemic of the 21st century.

The world health organization in conjunction with the Regional Office for Western Pacific (WPRO), International Association for the study of obesity and the International Obesity task force have formulated an extremely well researched and crisp perspective of obesity in the Asia Pacific region. Extensive recommendations are detailed on medical management of obesity. The perspective documented in February 2000 makes a reference to the role of bariatric surgery in the management of obesity in the Asia Pacific region.

Bariatric surgery in fact is the only treatment option which has reported effective, consistent and sustained prophylaxis and improvement of obesity related complications.

The two basic principles underlying bariatric surgery are restriction and malabsorption. These are at two extremes of a spectrum with a combination principle lying in between. Classification of bariatric procedures based on restriction and malabsorption is described in Figure-1.

The data on obesity from the Asia pacific region brings to light certain differences in behavior patterns of obese individuals here as compared to that

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observed in the west.

1. The most glaring difference is the onset of obesity related complications occurring in this population at much lower BMIs. 2. A higher percentage of body fat for a given weight.

3. Predisposition to abdominal adiposity.

Accumulation of visceral fat occurs at lower BMIs increasing risk of hypertension dyslipidemia, diabetes and metabolic syndrome.

4. Predominantly large vegetarian population e.g. India.

5. Lack of adequate data on childhood obesity.

This makes extreme malabsorptive procedures like Biliopancreatic Diversion (BPD) unsuitable for this patient population, Laparoscopic Adjustable Gastric Banding (LAGB) and Laparoscopic Rouxen-Y gastric bypass (RYGBP) are the two most popular procedures practiced in India today.

Laparoscopic Adjustable Gastric Banding (LAGB) This is a purely restrictive procedure in which an adjustable silicon band is placed on the stomach just below the gastroesophageal junction to create a 15cc pouch. The balloon lining the band is connected by a hollow tube tunneled through the abdominal wall to a small reservoir known as access port which is placed subcutaneously and fixed to the muscle sheath

Surgical Speciality

in the epigastrium or left hypochondrium.

By injecting saline into this reservoir, the balloon lining the band can be inflated to narrow the passage between the gastric pouch and remaining stomach. The procedure of gastric banding works on a simple principle of decreasing the intake capacity of the patient and slowing the rate of emptying the gastric pouch to prolong the time interval between meals. As the entire digestive tract is intact in this procedure, digestion and absorption is normal. Success therefore relies significantly on the patients motivation level and adherence to dietary guidelines. The weight loss in various reported series ranges between 40-60% EWL by end of five years.

Complications associated with LAGB include gastric perforation, access port infection, access port leak, outlet obstruction, pouch dilatation, band slippage / erosion. The overall incidence of these complications is 3-5%. A significant advantage of this procedure is its reversibility.

It is a simple and safe procedure which is rapidly gaining popularity the world over.

gestive juices and food consumed decreases Laparoscopic Roux-en-Y Gastric Bypass (LRYGBP) absorption.

The gastric bypass is considered the gold The weight loss varies from 50-70% standard in treating morbid obesity. The EWL at five years following surgery. Comprocedure is performed both laparosocpiplications of gastric bypass occur in 7-10% cally and by conventional open access. of patients. Morbidity and mortality are The procedure involves division of the both higher as compared to LAGB. This stomach using staples to create a 15-20cc is directly related to the multiple anastogastric pouch. A 100-150 cm roux-en-y mosis required in performing the gastric jejunal loop is created using staples. The jebypass. Complication include anastomotic junum is anastomosed to the gastric pouch leak, haemorrhage, stricture, DVT, PE and dumping syndrome. The latter occurs due creating a 1.2 – 1.5 cm wide anastomosis. to concentrated food rapidly reaching the This gastrojejunostomy may be performed small gut causing nausea, vomiting, palusing a circular stapler / linear staples or pitation, dizziness and diarrhea. This unintra corporeal suturing. pleasant event usually results in the patient The principle underlying gastric bypass has a combinaFigure-1: CLASSIFICATION OF BARIATRIC PROCEDURES tion of restriction and malabsorption.

Restrictive Procedures Combined Procedures Malabsorptive Procedures The small size of the gastric pouch re• Roux en Y gastric bypass (RYGBP) stricts the intake, the • Long limb RYGBP narrow outlet delays • Laparoscopic adjustable • Biliopancreticdiversion(BPD) the emptying and gastric band (LAGB) • Biliopancreaticdiversionwith delayed mixing of di• Verticalbandedgastroplasty(VBG) duodenal switch (BPD-DS)

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Surgical Speciality

Gastric Bypass Roux-en-Y

abstaining from foods which may cause this to happen.

Patients of morbid obesity have been effectively treated by bariatric surgery and life style management in the west for the past 50 years. Open bariatric surgery on these patients with a high surgical risk is associated with significant perioperative morbidity and a prolonged convalescence.

Technical difficulties include an incision through an anterior abdominal wall, of increased thickness working in a depth with difficulty in accessing areas like the oesophageal hiatus, bulky and heavy intraabdominal contents, abdominal wall clo-

Biliopancretic diversion

sure, delayed ambulation due to surgical incision with increased risk of DVT and pulmonary embolism. All complications related to an open incision such as wound dehiscence, incisional hernias, hypertrophic scars etc. An event such as post-operative bleeding or bowel leak requiring re-exploration have a very high incidence of morbidity and mortality.

Introduction of minimal access surgery has significantly shortened convalescence and perioperative morbidity. The laparoscope is able to access and provide excellent vision of nearly the entire abdominal cavity. Appropriate placement of trocars makes handling of entire GI tract comfortable.

The puncture wounds made by the trocars do not require a layered closure. The post operative pain is significantly decreased and majority of patients are ambulatory in the post-operative period. This results in rapid recovery of the patient.

Any surgeon performing bariatric procedures must be well versed with diagnosis and management of complications of these procedures. Surgeons should possess

appropriate and adequate surgical expertise and technical skill to perform the procedure by laparoscopic and open approach.

Bariatric surgery in India is at an infancy stage. Patients of morbid obesity require to be managed by a multidisciplinary team comprising the surgeon at the helm with help from, physician, nutritionists, physiotherapists, psychologists and counselors.

Protocol based management provides for safe surgery and yields the best results.

Bariatric surgery is slowly growing popular in India. The technology of minimal surgery has made this surgical option for treating obesity more acceptable.

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Surgical Speciality

Minimally Invasive Surgery Rise of the robotic systems

The reason why MIS has so explosively spread all over the world is that there is a significant difference in postoperative quality of life of the patients with MIS vis-à-vis open surgery.

Makoto Hashizume Director Center for Integration of Advanced Medicine and Innovative Technology Kyushu University Hospital Japan

S

ince the widespread introduction of minimally invasive surgery (MIS) in the early 1990s, initially with laparoscopic cholecystectomy, extensive evidence has demonstrated its advantages over open surgery — faster recovery with less pain and fewer complications. The reason why MIS is so explosively popularized all over the world is that there is a significant difference in postoperative quality of life of the patients with MIS from that with open surgery. The patients who underwent MIS not only had less incision on the skin surface or less postoperative pain, but also could receive earlier recovery to normal life or normal activity after MIS than after conventional open surgery.

Although there are clear benefits, MIS also has some disadvantages for the surgeons. Long instruments placed through fixed entry points creating a fulcrum effect, with the surgical field viewed on a 2-D screen and with the camera under an assistant’s control, create an unnatural environment where the surgeon loses orientation, the eye-hand-target axis, and visual depth perception. All these obstacles reduce the surgeon’s normal dexterity and limit his ability to deal with difficult situation. Surgeons are now put into a tough condition since more strict and correct preoperative evaluation of the patients, less complica-

tion rate or less operation mistakes are mandatory. Because it is different from open surgery, once complications occurred it led to more invasive major operation, by following a life-threatening incident. This new phenomenon was due to MIS. It is mainly because of the technical difficulties in movement of instruments or limitation of surgical field through the endoscope, and no tactile sensation or force feedback sensation. The surgeon has to perform complex procedures such as intra-corporeal ligature or suturing in the limited condition. However, a systematic training system has not yet been established for MIS all over the world because MIS had developed so quickly since early 1990s.

Computer-enhanced surgery This technology has been proposed to overcome some of the drawbacks of traditional MIS . This technology includes masterslave telemanipulator systems. The goals of these surgical systems are to enhance manipulation capabilities and to increase the performance precision. Robotic surgery is what is called computer-aided surgery. It provides secure and precise procedure that the operator wants. The surgeon has control over the system’s functions by means of a computer interface that creates an intuitive environment when he is sitting at the console. The movement of the instruments is controlled by motion-scale function, elimination of tremor, remote master-slave manipulator system. The self fail system is supported by checking the total system about 1200 times every second, or by quick Makoto Hashizume and Kouji Tsugawa: Robotic surgery and cancer: the present state, problems and future vision, Jpn J Clin Oncol 2004: 34 (5) 227- 237.

retrieval of the instrument from the body and it allows us to shift to conventional surgery within 10 seconds. The operative field is provided by a high resolution 3dimensional viewer. The camera has two eyes composed of 3 CCD tips. However, the present commercially available surgical robotic systems do not provide tactile sensation or force feedback, nor give you anything more than what the human eyes can see and recognize through the camera.

The image-guided surgical robotic system is the complete system with navigation and simulation capabilities. It is expected to be the breakthrough to overcome these technical difficulties.

Robotic systems still have great difficulty identifying objects on the basis of visual appearance or feel and they handle objects clumsily, so they are far from ready to perform complex tasks such as surgery on the soft tissues autonomously. We have recently developed a software system to overlay or superimpose the pre-operative or intra-operative images on the real-time intra-operative endoscopic view. It is really helpful for the operator to recognize the vascular structure or the tumor location by seeing the superimposed images on the endosocpic monitor. When CT or MRI is taken before surgery a few specific points are marked on the skin surface as reference points. The pre-operative and intra-operative reference points as well as endoscopy with marks are registered in a 3D space with an optical sensor. All these points are matched on the images in a personal computer. Finally the pre-operative images are superimposed on the real time endoscopic image. The advantage of the superimposition is that it might compen-

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Surgical Speciality

sate for the lack of haptics by giving the surgeons more accurate manipulative skills with a highly reliable image.

The merits of image-guided system are also to prevent the intra-operative complications or surgical mistakes and to navi-

thermal damage and other undesirable effects. However, MRI may be ideal modality to target the lesion precisely. Our group has recently developed an MRI-compatible image-guided surgical robotic system.

Through information processing, masterslave robotic systems can filter our physiologic tremor and alIn the future, it could be possible low finer movement that controllers with artificial by motion scaling. The real time information intelligencewillallowrobotstothinkon of the patient’s surgical their own or even program themselves, anatomy and function thereby making them more self-reliant is now available durand independent. ing surgery.

The medical information can be gate the surgeons to an errorless, safer and used to improve surgical planning, intramore precise operation, resulting in higher operative decision-making, and real-time quality of medical care to the patients. control of surgical instruments. The curImage-acquisition systems can introduce rent study could visualise lymph nodes compatibility issues, especially when usaround the GI-tract as well as nervous sysing MRI. Although MRI yields excellent tem on the open MRI. This shows that for soft-tissue images, its high magnetic fields lymph node removal in GI surgery and for may generate forces, produce substantial preservation of the function of the organ.

Conclusion The goal of surgery will be to change the function rather than the structure of the organ or disease . In this concept, termed biosurgery by Randall Wolf, MD, the purpose will be to change the biological processes of the body through direct modification of cellular, molecular, metabolic, and perhaps even genetic processes.

Almost all robots are preprogrammed by people and will only perform programmed tasks. In the future, it could be possible that controllers with artificial intelligence will allow robots to think on their own or even program themselves, thereby making them more self-reliant and independent. Finally, the robotic systems, coupled with sophisticated decision-support systems, will be able to monitor surgeon performance in real time, and act as a mentor to suggest alternative or alert the surgeon when there is a deviation from normal behaviour.

Richard M. Satava: Robotic surgery: from past to future- a personal journey, Surg Clin N Am 83 (2003) 1491- 1500

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oncology

Cancer

Early Detection Strategies Using biomarkers representing proteins with different biological functions may allow complementarity in cancer detection, resulting in increased sensitivity without compromising specificity.

Ronald B. Herberman Director University of Pittsburgh Cancer Institute Anna Lokshin Assistant Professor of Medicine University of Pittsburgh, and Director LUMINEX Core Facility University of Pittsburgh Cancer Institute USA

C

ancer is a significant health problem in Asia and around the world, being the leading cause of mortality in Taiwan, Thailand, Singapore, Korea, Hong Kong, and Japan. The disease is becoming an increasingly important health concern in countries such as Malaysia and The Philippines as the impact of communicable diseases decreases with the widespread supply of clean water and sanitation facilities. Cancer currently is the third and fourth leading cause of death in The Philippines and Malaysia, respectively.

For most cancers, detection of asymptomatic early-stage disease, when the tumors are still localized, is critical for effective treatment and possibly full recovery. Unfortunately, most cancers are detected at later stages, after they have invaded the surrounding tissue or metastasized to distant sites. Current screening methods include imaging (e.g.mammography), endoscopy (e.g.colonoscopy and sigmoidoscopy for colon cancer), cytology ((e.g.Papanicolau or Pap test for cervical cancer), and blood test (e.g.PSA test for prostate cancer). Of all currently used screening methods, the Pap test developed for cervical cancer is the most effective, resulting in a dramatic

decrease of mortality from this cancer.

Other routine screening methods, mammography for breast cancer, serum prostate specific antigen (PSA) testing for prostate cancer, and fecal occult blood testing and colonoscopy for colon cancer, have also reduced mortality through early detection although to a lesser extent. Unfortunately, none of these tests possesses high sensitivity (probability that someone with cancer will have a positive test) for early disease or specificity (probability that someone without cancer will have a negative test).

As a result, only about 50% of breast cancers, 56% of prostate cancers, and 35% of colorectal cancers are diagnosed at the early stages, and these cancers remain the three leading causes of cancer death, respectively, after lung cancer . In another example, over 80% of the two deadliest cancers, ovarian and pancreatic, are diagnosed at late stages, where the chances of survival are dismal, due to asymptomatic nature of these cancers at early stages.

Biomarkers - Improving cancer detection Most detection methods in use to date identify fully developed cancer, not the pre-malignant or early lesions amenable to resection and cure. For example, imaging methods, such as mammography or transvaginal ultrasound, visualize tumors at >1 cm diameter, fecal occult blood is the result of invasive tumour. On the other hand, Pap test and endoscopy (colonoscopy, sigmoidoscopy, and others) are sometimes able to detect pre-cancerous lesions. Another problem is that in many organs, for example, prostate or colon, pre-neoplastic lesions are much more common than aggressive cancers, and only 10% or less de-

velop into a malignant tumour. Therefore, the development of a screening modality that (i) will have high sensitivity for early disease, and (ii) would diagnose cancers at very early, possibly pre-clinical stages, and (iii) would be capable of discrimination of aggressive cancers vs. benign or non-aggressive tumors, is strongly desired.

Blood-based tests may be good candidates as early cancer screening tools, since: (i) blood collection is simple and minimally invasive; (ii) tumour biomarkers may come not only from the tumour but from other organs and tissues and may represent the systemic response to tumour growth. As such, these proteins may be secreted into the bloodstream at the very early stages of tumourigenesis, when tumour itself is undetectable by conventional imaging methods. Presently, very few blood biomarkers have proven useful for diagnosing primary cancer. Only three biomarkers, including serum PSA for prostate cancer, and bladder tumour antigen (BTA) and nuclear matrix protein-22 as diagnostic markers for bladder cancer are currently approved by FDA and are sensitive enough for screening and early detection in selected populations.

Despite the success of PSA in detecting early stage prostate cancer, its use to screen patients for prostate cancer remains controversial due to overdiagnosis. Three other serum markers have been approved by the FDA for cancer diagnosis: alpha-fetoprotein (AFP) for hepatocellular carcinoma and testicular cancer, catecholamines for neuroblastoma, and immunoglobulins for multiple myeloma. Because the assays for these proteins are neither sensitive nor specific enough for use as the sole screening method for early cancer detection, all are used as an adjunct to other direct detec-

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tion and diagnostic methods. The identification of a new class of cancer associated serum proteins, and the validation of sensitive and specific predictive assays, would expand the current clinical capabilities for early cancer detection and diagnosis and further reduce cancer mortality.

The intensive search for new biomarkers that would allow overcoming the hurdles of early cancer detection is currently under way. Recent advances in biomarker development using gene arrays in addition to proteomic technologies, including two-dimensional electrophoresis and mass spectrometry, have facilitated the discovery of several new biomarkers. Recently, the FDA has approved a small number of new urine-based biomarkers, including bladder tumour antigen (BTA) and nuclear matrix protein-22 as diagnostic markers for bladder cancer (7, 8). Three serum biomarkers of ovarian cancer, apolipoprotein A1, truncated form of transthyretin, and a cleavage fragment of inter-alpha-trypsin inhibitor heavy chain H4, were identified using mass spectrometry approach.

After new promising biomarkers are discovered, they must be validated for their ability to discriminate patients with cancer from healthy individuals. No single biomarker is likely to have 100% sensitivity and specificity for a specific cancer. Instead, combinations (panels) of several biomarkers seem to be a promising alternative for the use in clinical laboratories. There are several benefits of using combinations of multiple biomarkers. First, since each cancer is represented by several histologies, and even each histologic type is heterogeneous, several biomarkers may help to recognize all cancer subtypes. As mentioned earlier, multiple biomarkers should represent not only proteins secreted directly by tumour but also proteins representing systemic host response to tumour growth. These latter biomarkers will depend less on tumour size and may be measurable early in the tumour development. Finally, using biomarkers representing proteins with different biological functions may allow for complementarity in cancer detection, resulting in increased sensitivity without compromising specificity. Usefulness of combining three serum biomarkers along with CA125 for increased sensitivity and specificity in ovarian cancer was demonstrated in three

publications. Two biomarker combinations, CA 125, CA 72-4, CA 15-3, and M-CSF (13), and CA 125, apolipoprotein A1, truncated form of transthyretin, and a cleavage fragment of inter-alpha-trypsin inhibitor heavy chain H4 (13) substantially improved test accuracy over CA 125 alone, with a sensitivity of 70-73% at a specificity of 97-98%. A panel of 4 biomarkers, leptin, prolactin, IGF-II, and osteopontin, reportedly exhibited a sensitivity of 95% at a specificity of 95% (14).

At the University of Pittsburgh Cancer Institute, we have developed highly sensitive and specific biomarker panels for early diagnosis of a variety of cancers, with preliminary results appearing very promising for ovarian (sensitivity 90%/specificity 98%), pancreatic (sensitivity 96%/specificity 98%), and endometrial (sensitivity 98%/specificity 98%) cancers. These assays are able, in addition to distinguishing cancer cases from healthy controls, to also discriminate malignant from benign tumors, thus increasing the specificity of assays. Importantly, each panel was able to identify a specific cancer but not other cancers. Furthermore, work is in progress for developing an assay for breast cancer in premenopausal women that substantially surpasses the results of mammographic screening. These assays will be further validated in retrospective trials in which large populations of healthy individuals were screened yearly and blood samples were obtained from them over the course of over 10 years. Among the individuals who were diagnosed with cancers, blood samples preceding the diagnosis are now available to determine the interval prior to diagnosis when biomarker panels indicate the presence of cancer. Subsequent prospective clinical trials will determine the effect of early detection on mortality from these cancers.

Conclusion Serum-based panels of multiple biomarkers hold a great promise for better and more efficient early diagnosis of cancers.

Such tests are not only more convenient and less expensive, but also may demonstrate superior sensitivity and specificity in comparison to conventional screening methods. Blood-based assays may detect cancer at very early, potentially pre-clini-

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cal stages when the probability of efficient therapy and complete cure is the highest.

Development of such assays for early detection may shift cancer therapy towards the development of new strategies aimed at treatment of very early or pre-cancerous lesions.

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

BOOK Shelf IASLC Textbook of Prevention and Early Detection of Lung Cancer

Edited by: Fred R. Hirsch Year of Publication: 2005 Pages: 416 Description: IASLC Textbook of Prevention and Early Detection of Lung Cancer examines the variousmethodsandinterventionsusedin screening lung cancer.

Fundamentals of Cancer Prevention

Edited by: David S Alberts, Lisa M Hess Year of Publication: 2005 Pages: 397 Description: An authoritative work that provides a detailed review of the current status of practiceandresearchincancerprevention and control an essential reference guide and tool for primary care physicians, the researchcommunityandstudents.Written asacollaborativeworkbythefacultyofthe renownedCancerPreventionandControl Program at the Arizona Cancer Center, this book harnesses the expertise of researchers,investigatorsandcliniciansin cancerpreventionandcontrol,toprovide insights into this field for the benefit of non-specialists.

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

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Human Genome and the Molecular Diagnostics Market Molecular technologies will drive the expansion in market size and the range of applications in the molecular diagnostics market.

Chee Gee See Biomarker and Genetics Programme Manager Roche Products Limited Chris Chamberlain Global Head Medical Genetics Roche Products Limited UK

Molecular Img (DNA)

T

he unravelling of the main bulk of the human genome in 2000 led to a feverish explosion of ideas of how genetic information could be used to improve the identification and management of human disease and enhance human health through improved therapeutics. Target-based drug discovery immediately received a shot in the arm for more molecular-based approaches. In part, these ideas re-evaluated the massive costs involved in the drug discovery process and streamlined the targeted strategies already employed by pharmaceutical and biotechnology development companies. The agreed estimate of 26,000 to 30,000 genes in the human genome has probably 3,000 to 5,000 gene targets which are potentially amenable to pharmacological intervention, the so-called druggable genome. However, 5 years after the initial euphoria, all pharmacological-based disease intervention is still restricted to a select group of around 500 targets. The challenge for the postgenome era remains to break through this select group and to capitalize on the potential of the druggable genome.

Coupled with empirical sequence data on the human genome has been the recent surge of basic biological information and the advent of various genomics-enabling

platforms to test disease hypotheses. Taken together, this continues to be a powerful cocktail for new discoveries. Constantly improving genomics technologies such as RNAi have satisfactorily validated targets that would have taken much longer (and at greater cost) with traditional knock-out transgenics, and sometimes with the added bonus of detecting both on and off-target effects.

A new approach The search by pharmaceutical and biotechnology development companies for newer, safer and more efficacious pharmacological compounds has also led to a renewed appraisal of the value of diagnostics. The pressure to be first-to-market for safer, more efficacious and cost-effective medicines has meant that, increasingly more companies are integrating diagnostics across their pipelines in parallel to drug development. It is clear that this approach makes a significant difference. Arguably

the most notable historical milestone can be traced back to the early nineties. In 1991, when Roche acquired patent rights to the Polymerase Chain Reaction (PCR) technology from the Cetus Corporation, PCR was not positioned or envisaged for diagnostic purposes.

With inspirational foresight, Roche quickly developed and launched the PCRbased Amplicor system as standard kits for clinical diagnosis within a year. With a strong licensing strategy for its newly acquired PCR technology and a very carefully engineered commercial emphasis, Roche launched in 1992 the Amplicor system for detecting pathogens of two sexually transmitted diseases, Chlamydia trachomatis and HIV. The matching of an appropriate diagnostic tool to the critical need of the clinical environment ensured that this was a timely delivery that was readily accepted. Current refinement of the Roche Amplicor system now not only detects HIV presence but also provides ultra-sensitive measurements of the viral load of individual patients ensuring that physicians are able to clinically manage their patients’ personalized treatment regime. Roche has therefore optimally utilized the combination of a clear diagnostic tool with its drug portfolio, making a significant material difference both to the patient and pharmaceutical company.

Another example of a pharmacodiagnostic partnership is the Aventis/ Pharmanetics story. Aventis has had approval for Lovenox, a low-molecular weight heparin for treatment of dangerous blood clots in the arms and legs, in the US and Canadian markets since 1993. The decision by Aventis to invest $5 million to tailor the development and regulatory approval of Pharmanetics’ Enox test for the point-of-

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di a g n os t i c s

use of Lovenox created the potential to proach. The commercial cost of segmentis an area of the market where growth is double the $1 billion per annum sales of ing the breast cancer market by following likely to continue. SNP information on Lovenox. Concurrently, following the apthis approach is more than offset by the key genes involved in drug metabolism proval for the Enox test in August 2002, superior effectiveness of providing the apor transport has also been exploited in the 90% of Pharmanetics’ revenues in 2003 propriate drug to the appropriate patient design of microarray chips for pharmacocame from sales of the Enox test itself. The and at the appropriate dosage – the dogma genetic studies. This is an area where pharcommercial potential in such pharmaco of the safety and well-being of the patient maceutical companies in their quest for in vitro diagnostic partnership is therefore coming first. safer, more efficacious and cost-effective huge. The Aventis/ Pharmanetics story is Whilst Herceptin is a good example of medicines require indicative answers as to a good example of how such partnerships the use of a specific molecular diagnostic how subjects are metabolizing or excreting can generate huge opportunities, although test in combination with clinical utility, their drugs or to discover if there may be sadly the current relationship between the relatively few companies are devoting their genetic reasons for pharmacokinetic outtwo companies has fallen on hard times. resources to developing molecular technollier effects. Again, the market indications Within the in vitro diagnostics inogies for use in the actual clinical setting. are that tools for pharmacogenetics will dustry, molecular diagnostics is the fastest The high costs in validating any such mopotentially provide rich pickings for the growing segment. In little more than a lecular diagnostic tests to the FDA and the diagnostic market. decade, the clinical market for molecular extended lag-time from initial introducEven more informative are expression diagnostic products has surged from $50 tion to eventual adoption by the clinical microarrays which are used to interrogate million to over $1 billion in the US, and community are key factors in discouraging and compare transcripts from case-conis anticipated to reach a global market of many companies from taking this plunge. trol studies. Developments in proteomic $35 billion by 2015. These are astonishing Instead, most of the developmental interplatforms now also allow the comparison exponential figures and they are an indiests for such molecular diagnostic tests lie of proteins from such case-control studies. cation of the profitability of the molecular in the discovery and research arena, where Taken together, these molecular diagnosdiagnostics market. Even more indicative the FDA hurdle is considerably lower. In tic tools allow pharmaceutical companies is the market belief that a major to either generate or validate portion of this will be attribbiomarkers in their drug develuted to advances in genetics, opment programs. The incisive Market indications are that tools for genomics and proteomics. It molecular diagnostic partner will pharmacogenetics will potentially provide is therefore clear that molecucontinue to seek out these specific lar technologies will drive the requirements to match the need. rich pickings for the diagnostic market. expansion in market size and The need to trim down the the range of applications in the massive costs involved in bringing molecular diagnostic market. a drug successfully to market and Driven by the perceived commercial benthe research environment free from reguthe high attrition rate in the drug developefits pharmaceutical companies are increaslatory constraints and associated costs, ment pipeline are two reasons biotechnolingly interested in developing tests that can both diagnostic and pharmaceutical-based ogy and pharmaceutical companies are inbe used to guide the eventual prescription companies can actively exploit the rich creasingly looking to molecular diagnostics of their drugs. Take the case of Herceptin. coal seam of the molecular diagnostic marto provide early leads and guidance as to a Herceptin is indicated for metastatic breast ket. This is the arena where sequence data program’s likely fate. The incredible syncancer and in late May 2006 also gained from the Human Genome and Proteome ergy that can be found in such pharmacodiUK approval for early-stage breast cancer.

Project is making an enormous impact. For agnostic partnership is likely to grow as we Herceptin treatment is seriously considered example, single nucleotide polymorphism clock up more mileage on the human geonly when a patient scores a +2 or greater (SNP) data from both the Human Genome nome data. Such a synergy is clearly exemon the pre-requisite Her2/ neu protein project and the HapMap project has been plified by the Roche-Affymetrix partnership over-expression diagnostic test. The Her2/ and continues to be exploited in the design in the design, execution and marketing of neu diagnostic test is therefore a targeted and construction of microarray chips used the AmpliChip diagnostic kits. Making use clinical test as it indicates to the physifor whole-genome association studies. Afof Affymetrix’s expertise in microarrays and cian as to who should be appropriately fymetrix has been an astute leader in this Roche’s PCR technology, this is an ongoing considered for Herceptin. In this respect, area and has produced GeneChip mapping partnership that seeks to create diagnostic the Her2/ neu diagnostic test selectively sets now extending to 500,000 SNPs. It is tests both for research and clinical use. As identifies a subgroup from breast cancer envisaged that genetic association tools targeted medicine and personalized healthpatients who may benefit from Herceptin such as these GeneChips will continue to care become more relevant topics for conand equally importantly, identifies those be major players in the next few years. As sideration, these could be the low-hanging patients for whom Herceptin will not be long as there is a demand in discovery refruit that molecular diagnostic companies useful. Herceptin is the epitome of persearch for the identification of key genes should keep a watchful eye on. sonalized medicine in its fundamental apinvolved in common disease etiology, this *Clinical data available upon request.

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We have everything for your lab animals Founded in 2004, MFD Diagnostics GmbH has reached its goal to act as a one-stop service provider for laboratory animals. With a team of competent veterinarians, biologists and technicians, we cover most requirements concerning animal science.

Our state-of-the-art laboratories and the animal facility are equipped to meet S1 and SPF conditions respectively. Our services include animal care, animal husbandry, genotyping and extensive health monitoring according to FELASA. We take care of a variety of laboratory animals including mice, rats, hamsters, rabbits and guinea pigs. All fields of microbiology, parasitology, serology and pathology are covered by our team of scientists and technicians. To guard your most valuable animals we keep your inbred, transgenic or knock-out lines in an autonomous SPF environment and offer embryo cryopreservation for your precious mice.

If your transgenic / knock-out mouse needs to be evaluated before you start your experiments or applications, we can analyze various parameters starting from serum / blood parameters over detailed histology (following the RITA guidelines if desired) to behavioural analysis (SHIRPA I and II).

If you need a specialized animal model for in-vivo applications, our expert scientists chose the right model, set up a precise experiment and provide a significant report – all under one-point supervision.

Here are a few of our range of in-vivo possibilities: • Tumor models (xenografts / orthotope models) • Toxicity (acute / subchronic / chronic) • Reproductive / teratogenic • Pharmaco-/toxicokinetics To provide customers from pharmaceutical / biotechnological background with various animal models, our scientists start the project with a competent evaluation of our customers needs and demands, set up the appropriate animal models and conduct all experiments in-house or with our selected partners.

We have companies as well as academic institutions with excellent skills and reputation as our partners. Naturally all data collected for our customers are kept confidential as we run our own archive for data gained under regulations of good laboratory practice.

Laboratories and animal facilities at MFD Diagnostics are fully equipped to conduct non-clinical in-vivo studies, safety evaluations or LADME studies. To top off the enfolding through specific portfolio, MFD offers customized antibodies generated in mice and rats. If you are in search of a tailor-made antibody assay, ELISA or immuno-fluorescence based, we are the right source for you.

We set up your desired assay and evaluate and manufacture in-house. Experienced scientists discuss your needs and visualize solutions for your antibody-based assays.

For further details visit www.mfd-diagnostics.com Advertorial

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ZOLL Medical Corporation: Working to Help Hospitals Advance the Practice of Resuscitation The Pervasiveness of Sudden Cardiac Arrest

Estimates are that nearly 460,000 adults die each year in the US from sudden cardiac arrest (SCA). At least this many die outside the US Survival rates are alarmingly low—only 6 percent—because care in the form of CPR and defibrillation is not administered quickly enough. Time is the most important factor; with every passing minute after SCA occurs, a victim’s survival rate decreases by 10 percent. It is vital that victims requiring defibrillation receive it as soon as possible.

And those who do not require immediate defibrillation need quality CPR. Recent 2005 American Heart Association/European Resuscitation Council (AHA/ ERC) Guidelines emphasize performing effective, high-quality CPR. More specifically, AHA/ERC Guidelines increased the recommended compressions to 30 compressions for every two rescue breaths. The Guidelines stress a focus on CPR because of studies showing that “blood circulation increases with each chest compression in a series and must be built back up after interruptions.”* Updated Guidelines also discuss data that show the critical role of early, high-quality CPR in increasing cardiac arrest survival rates. Furthermore, there is data that also show few victims of cardiac arrest receive CPR, and even fewer receive high-quality CPR. Without immediate intervention, an SCA victim has a very low chance of survival.

However, if CPR and defibrillation are provided within the first three minutes after collapse, survival rates can reach as high as 75 percent.

Even in the best of conditions, meeting Guidelines’ recommendations during a cardiac arrest event can be challenging. While administering CPR, rescuers can become fatigued and, in the urgency of the moment, do not always perform CPR to the ideal depth—pressing 1½ to 2 inches on the chest—and at the ideal frequency—about 100 compressions per minute. Fatigue can also inhibit frequent, uninterrupted delivery of continuous chest compressions.

ZOLL Medical Corporation has developed prod-

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ucts that are designed to help rescuers improve resuscitation efforts. With its global headquarters in the US and offices worldwide, ZOLL has one focus: improve and advance the practice of resuscitation. ZOLL is a company devoted to developing life-saving resuscitation devices and support solutions so that lay rescuers and healthcare professionals can improve patient outcomes.

The company founder, Paul M. Zoll, M.D., was a practising physician throughout his life, with a reputation for careful and dedicated attention to his patients. His accomplishments include the first successful use of external defibrillation to regulate heart rhythms in patients. This year marks the 50th anniversary or Paul Zoll’s first successful external defibrillation in a patient. His accomplishments also include the ability to display the heart’s cardiac electrical activity on an oscilloscopic screen. This development eventually led to cardiac monitors and other programs found in modern cardiac care units today.

Staffed with dedicated employees, many of whom hold backgrounds in healthcare and emergency rescue, ZOLL takes a deliberate and forward-thinking approach to new product development, and carefully studies the needs of the market, along with prevailing medical data and research. From its beginning in 1983, ZOLL has had a clear clinical understanding of the needs of rescuers and their patients.

For example, in advance of the 2005 AHA/ERC Guidelines for resuscitation (both announced in November 2005), ZOLL understood the importance of circulation and chest compressions to move oxygenated blood quickly to an SCA victim’s heart and brain. In 2002, ZOLL was the first manufacturer to provide real-time CPR feedback technology, known as Real CPR Help™, in its automated external defibrillators (AEDs). This technology provides rescuers with real-time feedback on the rate, depth, and effectiveness of administered chest compressions. This much-needed information can help rescuers perform

more effective CPR. To date, ZOLL estimates more than 500,000 rescuers worldwide have access to ZOLL AEDs with Real CPR Help that can assist them in performing high-quality CPR. The 2005 AHA/ERC Guidelines call for more chest compressions to better revive SCA patients. The ZOLL AED Plus™ and the ZOLL AED Pro® with Real CPR Help capability, are helping rescuers enhance the effectiveness of CPR by letting them see and hear in real time how well they are performing the rate and depth of CPR chest compressions.

Given the importance of early defibrillation, hospitals have made an effort to place AEDs outside clinical areas (i.e., lobbies, car parks, and cafeterias). The AED Plus, designed for infrequent rescuers, is an example of just such an AED. The AED Plus supports the complete rescue event through instructional graphics on the front of the device.

The AED Plus can help coach a rescuer with step-by-step CPR instructions and Real CPR Help. This coaching can help a rescuer provide the best manual CPR possible.

Along with the AED Plus is ZOLL’s AED Pro for professional rescuers. The AED Pro features ECG monitoring with standard ECG electrodes, as well as AED capability combined with manual defibrillation and controlled access for professional users. The device’s unmatched ruggedness and durability have been proven, as it is the only AED in the industry to pass a 1.5-meter drop test. The AED Pro includes 2-button functionality and an intuitive interface.

Its high-resolution display provides operating information for defibrillation and can also be used to monitor a noncardiac arrest patient’s ECG. In addition to the AED Plus and the AED Pro with Real CPR help, several of the top cardiac hospitals have chosen the ZOLL M Series® based on several factors, including better efficacy with a low energy biphasic waveform, improved safety with hands-free defibrillation, and the opportunity to collect data.

Many of these hospitals have standardized on one brand of defibrillators in an attempt to decrease the “callto-shock” time. This is the time when a cardiac arrest event is called and when the first shock is administered.

Precious time is saved if the responders work with equipment that has a uniform operating system. ZOLL is entering its third decade of supplying ALS defibrillators with a uniform operating system. While many advances have occurred in technology, one constant is that the operating controls of all ZOLL ALS defibrillators made since 1983 remain consistent. Any operator trained on one ZOLL defibrillator model can easily operate any other model. This unique aspect of ZOLL defibrillators could have life-saving benefits during a cardiac arrest event.

Successful defibrillation is determined by the average electrical current delivered to a patient. There are two types of waveforms used to deliver electrical current to the heart: monophasic and biphasic. Monophasic waveform

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defibrillators deliver current that flows in one direction— from one defibrillating pad to another. Biphasic waveform defibrillators deliver current that flows in two directions— from one electrode to another and then back again.

Since 2000, ZOLL defibrillators have been equipped with its proprietary Rectilinear Biphasic™ waveform (RBW), which is clinically proven—in more than 11,000 patients—to improve patient outcomes when compared to conventional monophasic waveforms. ZOLL’s RBW is an exclusive innovation that delivers more current than other biphasic waveforms, improving efficacy while reducing the risks associated with high energy. At 200J, the ZOLL RBW delivers more current to high impedance patients than any other biphasic device—even ones that escalate to 360J. M Series defibrillators also offer the possibility of collecting all ECG data from the defibrillator after an event.

This information creates a more complete patient record.

More importantly, the data can be used to review cases and discover opportunities for process improvement.

At the Forefront of Circulatory Support Advancing CPR performance technology further is the ZOLL AutoPulse® Non-invasive Cardiac Support Pump.

The AutoPulse is a revolutionary device that moves more blood more consistently* than is possible with human hands. As an adjunct to CPR efforts, the AutoPulse can help medical professionals deliver consistent and continuous compressions, and improved blood flow to the heart and brain during SCA. The automated, portable device is comprised of a backboard and a simple LifeBand® that fastens across the victim’s chest. The AutoPulse compresses the entire chest in a unique, consistent “hands-free” manner. Additionally, it offers the benefit of freeing up rescuers to focus on other life-saving interventions. EMS agencies and hospitals worldwide are employing the AutoPulse as part of their resuscitation protocols.

In addressing precisely what the new AHA/ERC Guidelines call for—namely faster, stronger and more chest compressions—ZOLL believes that the AutoPulse can have a major impact on resuscitation protocols and significantly improve SCA survival rates globally.

A Forward-thinking Approach to Resuscitation Technology

ZOLL has made numerous advances in its understanding of defibrillation, pacing, circulation, fluid resuscitation, and documentation technology. By encompassing multiple facets of resuscitation and working as a system to help improve survival rates, ZOLL has helped customers move resuscitation from science to evidence to practice.

As ZOLL works with its customers, the company continues to grow and provide products that improve life-saving efforts anywhere sudden cardiac arrest strikes.

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Medical Glove Manufacture Going powder free

The amount of aero-allergens in areas where powdered gloves are worn can increase 5-10 fold when compared to those where only powder-free gloves are used.

Mรณnica Sagardoy Brand Support Manager - Professional Asia Pacific, Ansell Healthcare Australia

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love manufacturing has changed dramatically in the last 20 years with the advent of powder free gloves technology. This technology was developed due to the issues arising with the use of powder in gloves as well as the changing needs of the end-users such as the need for double gloving and intra-operative donning.

Powder free gloves are seen by many as a more expensive choice than powdered gloves. However, this is not true when the need for washing powdered gloves prior to use is considered. The US Food and Drug Administration made mandatory for manufacturers to place a warning label on the glove packaging to indicate the need for washing off the glove powder.

Unfortunately, studies have shown that washing of powdered gloves prior to use is inefficient in totally removing glove powder and can lead to clumping of the powder particles, creating even less absorbable aggregates. It has also been reported that the cost of washing powdered gloves can be at least seven times higher than the cost of using powder free gloves.

Unfortunately, some surgeons do not wash powdered gloves prior to use, which can lead to complications. Exposure to starch powder from both surgical and examination gloves can cause a number of undesirable reactions for both patients and the healthcare workers, which vary from well-known allergy symptoms and upper respiratory-tract disorders to adhesions, granulomas, pleuritis, myocarditis, irritation of the central nervous system or even carcinoma or tuberculosis misdiagnosis.

These complications can lead to an increase of the hospitalisation time or even require extra surgery.

A well documented consequence of the use of starch powder in gloves is its capacity to bind with natural rubber latex (NRL) protein antigens. These allergen/protein coated powder particles can be aerosolised when the gloves are donned or removed, thus contaminating the hospital environment. Inhalation or ingestion of these powders can lead to sensitisation and many diverse allergic reactions to NRL (e.g. upper respiratory tract symptoms or eye irritation). It is es-

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timated that the use of powdered gloves within a theatre will deposit in excess of 2kg of glove powder within the theatre environment per year. The amount of these aero-allergens in areas where powdered gloves are worn can increase 5-10 fold when compared to those where only powder-free gloves are used. However, glove powder acts not only as a vehicle for NRL antigens but can also be a vehicle for opportunistic and pathogenic micro-organisms, which increases the occupational risks to both healthcare workers and patients.

Another common problem that can arise from the use of starch glove powder is the development of adhesions, which are likely to occur after most surgical procedures and granulomas. These effects have been very well documented concerning the peritoneal cavity, but they have also been reported in almost every anatomical site including the oral region. Despite glove washing with saline, the glove powder can enter the body during surgery, which may trigger an inflammatory response by the immune system, leading to the formation of fibrous bands and post-operative adhesions. Adhesions are the major cause of post-operative intestinal obstruction (more than 40 per cent of all causes with 60-70 per cent of cases involving the small bowel). Uterine and fallopian tube adhesions, resulting from glove powder, are a significant risk to female fertility, with papers advising that powder free gloves should be used even for routine vaginal examination.

Analysis of adhesions occurrence showed that between 69-93%, were due to foreign micro-bodies, which include starch powder.

Researchers have also shown powdered gloves to be a risk factor for post-operative wound infections. As with most foreign bodies, glove powder decreases the inoculum of bacteria required to produce abscesses, being reduced in this case by a

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factor of at least 10 fold. In addition, powder also delays wound healing and alters the normal reparative process while at the same time increasing the wound’s inflammatory response. Surgical Site Infections (SSI) are the second most common cause of hospital-associated infections, with studies showing that compared to similar risk patients undergoing the same surgery, a patient who develops a SSI is twice as likely to die, 5-6 times more likely to require re-admission, and likely to stay in the hospital twice as long. For major orthopedic or cardiac surgery, the costs of these complications may range from US$ 30,000-US$ 50,000.

All these problems, together with the lack of an efficient removal of the glove powder by means of washing, prompted the development and adoption of new powder free technologies.

Chlorinated Powder Free Gloves The first generation of powder free gloves were the double-sided chlorinated gloves, where both the inside and outside surfaces are chlorinated. Untreated latex gloves (both NRL and synthetic latex), are too tacky to be donned without any further treatment, therefore a surface treatment is required if the powder, which acts as a lubricant is removed. The first powder free gloves were treated with a chlorine solution which modifies the surface texture and reduces the natural tackiness. However, over chlorination can deteriorate the gloves and can affect the grip properties during use. As such the chlorination process has to be optimised and controlled with great care.

There are two main methods of chlorination: “Batch Chlorination” and “Piece

by Piece Chlorination”. Batch chlorination is more economical, however it will produce a product with more grip variability as the chlorine contact with each of the glove cannot be controlled as precisely. On the other hand, piece by piece chlorination is more precise as it ensures glove chlorine contact equally on all the glove surface for a predetermined amount of time, ensuring a more reproducible result and less variability amongst batches or even gloves within a same batch.

Polymer Coating Powder Free Gloves Another alternative to powdered gloves is a NRL glove having a synthetic polymer lining on the internal surface of the glove.

The slippery surface of such a lining facilitates donning of the glove. Due to its low coefficient of friction, the lining facilitates donning with either damp or dry hands.

This is the technology used in the Gammex Powder Free family of products, which uses a hydrophobic/hydrophilic polymer lining in order to ensure improved donning qualities and undergoes external carousel chlorination to guarantee a consistent grip.

Recent Advances in NRL Manufacture Manufacturers of NRL medical gloves have also investigated and implemented manufacturing processes to reduce the NRL protein allergen and chemical accelerators content of their products.

Some manufacturers have developed leaching/washing processes either on-line or in the post processing of the gloves, which reduce the NRL protein allergen content of the gloves.

The on-line leaching process reduces the protein allergen content considerably,

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however, the leaching only occurs from one side of the film. In order to ensure a more complete reduction of the extractable proteins, Ansell uses a unique high temperature post-washing process called P.E.A.R.L (Protein and Endogenous Allergen Reduction Leaching Process). This process can eliminate more of the extractable proteins as both sides of the film are exposed to the cleaning process. The hot water also hydrates the rubber film and as the film’s intersticial spaces are enlarged the allergens are easily extracted. As a result, the final film has a lower protein allergen content than the film formed using other processes such as ‘de-proteinised’ natural rubber latex.

Ansell’s P.E.A.R.L. process not only reduces the extractable proteins levels but also decreases the chemical residues, another cause of contact dermatitis. This is an area where manufacturers have focused their efforts not only to develop processes aimed at decreasing the overall content of accelerator residues, but also developing new processes aimed at eliminating the use of some accelerators, such as thiurams, which is the accelerator most frequently linked to contact dermatitis. Ansell, not only has discontinued the use of Thiurams in its powder free range, but it has also developed alternative options for healthcare workers suffering from accelerators sensitivity, such as the use of PV100, an accelerator that becomes volatile gases completely consumed during vulcanisation therefore minimising the risks of contact dermatitis and the complete elimination of accelerators in Ansell’s DermaPrene Ultra, a neoprene latex free glove.

Conclusion Powder free gloves are a more cost effective and safer alternative to powdered gloves.

Today’s manufacturing technology ensures powder free options with similar comfort, donnability, tactile properties and grip than the powder equivalent but with the advantage of less post-operative complication and allergy problems.

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

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IPR in Medical Equipment China’s rise

China is no longer copying Western medical devices, but is now benefiting from government funding to create its own, next-generation, medical devices.

Allen Yeo Principal Consultant Global Sales Support Thomson Scientific Singapore

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he East Asian surge in patenting of medical device equipment began in Japan during their period of economic crisis in the late 1990s. At this time there was a US$ 200 billion gap between demand and supply, and a need for a £ 500 billion package of restructuring measures from the Japanese government.

In tandem with such fiscal measures was the perceived need for economic growth through innovative technical and scientific development, and the pursuit of Intellectual Property Rights (IPR).

Japan as a leader in IPR and medical device development IPR have been pursued in Japan, followed by the rest of East Asia, through the commercialisation of universities, the trading of existing IP portfolios, and IP judicial reform.

Japan has a rapidly ageing and shrinking population. It is estimated that by 2015 just over 25% of the population will be over 65 years of age. The diseases of old age and the need to involve the elderly in society, coupled with an unprecedented drive (that commenced roughly in 2000) to promote IPR through patenting, has led to an explosion in medical device technological capability in Japan.

Increased developFigure-1: Asian Electrical Medical Device Patenting ment and use of nanin ‘000s otechnology is help18 Japan ing drive this change: 16 for example scien14 tists in bioscience 12 centres in Kanagawa Australia 10 and Osaka have in8 jected nano-cameras 6 into human blood China 4 streams to help them better understand Korea 2 0 cardiovascular dis2000 2001 2002 2003 2004 ease.

Sleep Apnoea - an inSource: Derwent World Patents Index, Thomson Scientific creasingly common disease in the elderly - has given rise to the development of China as the new emerging market for developing medical devices masks to enable sufferers to breath and sleep at night. Telemetric platforms in Japan has a clear lead in Asia in both dethe home are connected to medical centveloping and patenting medical devices. ers where any deviation in the routine of A similar meteoric rise in medical device an elderly patient will alert the medical development in China can be understood staff. only when you consider the economies of A significant contribution to the exscale involved in meeting the huge demand tensive development of medical devices is within the country: being made by the 26 Technical Licensing The Republic of China’s 1.3 billion popOrganisations based in Japanese universiulation is served by 320,000 healthcare ties, coupled with 34 new intra–university institutions, 65,000 hospitals and 8 milIPR units that give every type of assistlion healthcare professionals. ance. In 2004, over 16,000 medical device China has 3000 medical device compapatents were filed in Japan (see figure 1), nies, and a medical device market valwith many more in the pipeline: the AIST ued at approximately £5 billion-this is (National Institute of Advanced Industrial growing by a staggering 15% per year.

Science and Technology) alone has ten China will spend £50 billion in the thousand potential ideas (including medicourse of the next five years on a major cal devices) at different stages of developtransformation in the healthcare delivery ment. system that will create a huge demand Olympus is currently the leading for medical devices. applicant for medical devices patents in China, like Japan, is prioritising mediJapan. (see table 1) cal manufacturing, and facilitating progress

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Pillars supporting increased development in China’s medical device development The conversion of specific Research Institutes from government-owned to commercially funded and privatelyowned entities IncreasingR&Dexpenditure:forexample the RMB 128.8 billion (£9.16 billion) spend in 2002 was a 23.5% growth on the previous year, and was 1.23% of China’s GDP in 2002 (compared to 0.6% in 1995) Less government direction in Science andTechnology planning, to promote a more market oriented approach Taxbenefitsforthedevelopmentofnew productsbasedonR&Dinvestment,with anachievementofrealgrowthoutofnew products, including software Education regarding IP, shown in the increase of IPR university courses Encouragement of overseas Chinese graduates to contribute to homeland developmentintechnologicalR&D.Many overseas Chinese are skilled medical researchers. by commercialising research institutes and university departments. One example is the General Research Institute for Nonferrous Metals (GRINM). It was founded in 1952, but transformed in 2000 to become a self-sustaining large-scale high tech enterprise. To date, GRINM has six spin out companies which are involved in materials for medical use, and generate over £100 million a year.

Research with human tissue is still seen as socially unacceptable in Japan because of taboos relating to the use of human body parts. In contrast China’s Shanghai Hospital, has recently secured funds for a tissue engineering facility.

As in Japan, China is no longer simply copying Western medical devices, but is now benefiting from government funding for nanotechnology, information technology and advanced materials to create their own, next-generation, medical devices.

Emerging areas of expertise in China As China’s medical device development becomes increasingly commercialised and R&D focused, the emphasis on IPR is in-

creasing in proportion. Emerging areas of implantable medical devices are: Orthopaedics Orthodontics Vascular (grafts and stents) Pacemakers Implantable cardioverter-defibrillators Drug delivery Cell and tissue engineering Regenerative medicine has become a primary focus of research, with innovation and clinical application in numerous centres across China. The Chinese intend to build on their home-grown technology by placing academic and clinical teams in close proximity to purpose-built production facilities. Although their level of basic science is still not as advanced as Western medicine, this combination is driving rapid development and commercialisation of medical devices.

China’s patent legislation reforms are intended to protect against infringement of the value it anticipates adding to its products, including medical devices. The experience of Japan and Taiwan shows us that once a country achieves a certain level of development, interest in protecting their own IPR means they are far more likely to abide by laws that protects foreign companies’ innovations as well. So China’s IP reform should also help reduce infringement

by Chinese companies of Western goods.

Generally, China is catching up with western capabilities in medical devices. Indeed China is expected to take a lead position in some of the newer, rapidly emerging areas such as regenerative medicine and nanotechnology. Although there are still major infrastructure problems, for example in relation to regulatory, reimbursement and clinical innovation, the evidence suggests that China is well advanced in embracing the commercial and clinical potential of these new medical technologies.

In 2005, Siemens and General Electric were the top holders of published medical devices patents in China – see table-1.

The ageing population in China fuels demand As China’s One Child Policy begins to have an effect on subsequent generations, coupled with decreasing fertility and decreasing mortality, China will have to address the social and economic problems associ-

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ated with an increasingly elderly population. The proportion of those aged over 65 will increase from 7% of the population in 2000, to about 14% in 2025 -and 20% in 2040. While the very old (those aged over 80) are expected to increase from about 8 million to about 50 million, there will be a parallel decrease in the ratio of working age people to support each elderly person from 5:1 to 3:1. These issues will be further compounded by the increase of westerntype chronic disorders such as diabetes and obesity, plus the emergence of an AIDS epidemic among the younger population (which is already beginning in both rural and urban areas of China).

Conclusion IP is growing in importance in China, whose participation in the World Trade Organisation (WTO) is driving government organisations to both protect their Table-1: Top applicants for Electrical Medical Devices patents in 2005 China

Japan

Siemens Olympus General Electric General Electric Philips Philips Toshiba

Toshiba

Matsushita

Canon

Canon

Hitachi Medical

Omron

Fuji Photo Film

Johnson & Johnson

Siemens

Olympus

Matsushita

Hitachi Medical

Asahi Optical

Source: Derwent World Patents Index, Thomson Scientific, using Derwent Patent Assignee Code rankings.

own IP and respect that of others. Western organisations can now be less wary of technological collaboration with China because of this change in position over IPR, and engagement with government organisations is one route to ensure continued protection.

The number of published Chinese patents reached a peak in 2003 at just over ten thousand, dipping slightly in 2004. Over one third of these (see figure 1) were for medical devices, illustrating the growing importance of this technology. To maintain their current lead in medical device technology, both Japan and the USA will need to keep looking over their shoulder at Chinese developments in this area.

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Ventilation Monitoring Non-invasive is the way

Non-invasive methods to monitor ventilation are valid surrogates for arterial blood gas analysis.

Gido M. Karges Director Marketing & Sales SenTec AG Switzerland

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rowing use of non-invasive ventilation, growing numbers of procedures carried out under conscious sedation and growing awareness of the adverse effects of sleep apnoea are only three of various trends in modern medicine that call for continuous monitoring of ventilation, preferably continuous non-invasive monitoring of ventilation.

A variety of methods to monitor ventilation are available. For a better understanding of the advantages and limitations, it might prove helpful to recall the link between ventilation and the basic physical phenomenon of passive diffusion, i.e. the movement of molecules from a region of high partial pressure to a region of low partial pressure. This phenomenon is utilized even by the most primitive forms of life in order to ensure the necessary gas exchange between the medium surrounding the organism and the internal metabolism. For the multi-cellular human organism, however, diffusion through the body surface alone is insufficient, especially in order to supply adequate oxygen to and to eliminate carbon dioxide from cells and tissues. Therefore the respiratory system facilitates the passive diffusion of these gases by providing a huge additional respiratory surface, the walls of the alveoli. Ventilation, which can be spontaneous (breathing) or artificial (e.g. mechanical ventilation), describes the movement of air between the environment and the alveoli walls, where the gas exchange by passive dif-

fusion can occur between blood and air at high rates. The purpose of ventilation is to ensure the efficiency of the passive diffusion through the walls of the alveoli by maintaining higher concentrations of oxygen and lower concentrations of carbon dioxide in the alveolar gas than those prevailing in the blood flowing in the alveolar capillaries. In other words, ventilation enables the organism to use the phenomenon of passive diffusion to maintain physiologically normal partial pressures of oxygen and carbon dioxide. The efficiency of ventilation can be monitored well by assessing the resulting arterial levels of oxygen and carbon dioxide.

Methods of monitoring ventilation: Invasive Analysis of arterial blood samples has been the standard method to measure ventilation parameters like arterial oxygen partial pressure (PaO2), arterial oxygen saturation (SaO2) and partial pressure of carbon dioxide (PaCO2). But sampling arterial blood is invasive, carries the risk of infections, involves big amounts of disposables and provides only snapshot information. In the case of intermittent arterial puncture, it is also associated with pain and discomfort for the patient.

Non-invasive Pulse oximetry (SpO2), end-tidal capnography (PetCO2) as well as transcutaneous oxygen partial pressure (PtcO2) and transcutaneous carbon dioxide tension (PtcCO2) measurement are used as noninvasive approaches to either continuously estimate arterial levels of these parameters or determine trend changes.

Pulse oximetry Pulse oximetry optically assesses the colour of the blood, which changes with the oxygen saturation (SpO2) of the haemoglobin.

The method is used to detect hypoxia,

while over-oxygenation remains undetected due to the S-shape of the oxygen-haemoglobin-dissociation-curve. Arterial oxygen partial pressures of above 60 mmHg correlate with arterial oxygen saturation readings above 90%. Further increases of PaO2 cause the saturation readings to near or equal 100%, but will not cause them to exceed 100% even in the case of extreme

oxygen partial pressures. This particular shape of the oxygen-haemoglobin-dissociation-curve is also the reason for one of the major limitations of the method in terms of ventilation monitoring: while supplemental oxygen is administered to the patient, the partial pressure of oxygen might be elevated above physiologically normal

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levels. Then, in an event of hypo-ventilation, the oxygen saturation readings provided by optical pulse oximetry will remain above 90% until the partial pressure of oxygen has dropped to less than approximately 60 mmHg. Clinical research shows that a decline in SpO2 appears to be a reliable indicator of ventilatory abnormalities during room-air breathing, while the detection of such abnormalities may be delayed or even

remain undetected in the presence of supplemental oxygen. Under the administration of supplemental oxygen, the detection of adverse physiological trends in ventilation might be facilitated by additionally monitoring arterial carbon dioxide partial

pressure, as the adverse physiological trend may be reflected by changes in the PaCO2 despite the still adequate arterial oxygen saturation displayed by an oximeter.

End-tidal capnometry End-tidal capnometry measures PetCO2 in the exhaled gas during expiration. The flow of the exhaled gas diminishes towards the end of the expiration, and is inexistent during inspiration, leading to the typical waveform recorded by capnometers. Closest to alveolar PCO2, and thus to blood gas levels, is the ultimate reading obtained at the end of one expirational tide, on the verge of the next inspiration. This end-tidal value, although representing a mixture of tracheal, bronchial and alveolar gas, can be used to estimate arterial PCO2. The accuracy of this estimation seems to depend on various criteria, of which dilution by room air or supplemental oxygen and, in case of nasal cannula, mouth breathing are un-

derstood to have major significance. The error levels in terms of absolute PCO2-values estimated can infringe with medically tolerable inaccuracy. Technical development and improved algorithms constantly reduce the inaccuracies, and a sufficient accuracy of the trend in PCO2 changes indicated by this type of measurement seems to explain the widespread use of end tidal capnometry.

Transcutaneous measurement Transcutaneous measurement of blood gas levels is possible because the above mentioned gas diffusion through the body surface, while not sufficient for our multicellular organism, nevertheless takes place. Under adequate perfusion and skin conditions, the gas diffusion through the skin is closely correlated with vascular gas pressures. Transcutaneous gas pressure sensors heat the measurement site to normally 41°C to 45°C to increase gas diffusion speed. When the site is warmed, the sensors collect the gas diffusing through the skin. Within minutes a pressure equilibrium between the skin and the sensor is

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established. From this moment on, a continuous and very accurate estimate of e.g. the arterial PO2 and or PCO2 is provided for by elaborate algorithms.

Recent microelectronic developments have allowed the components of transcutaneous PCO2 and pulse oximetry sensors to be integrated within one digital sensor.

Concomitant pulse oximetry and PtcCO2measurement is possible by applying one single sensor to the earlobe. Sensing gases in immediate proximity to the preferred central circulation of the cranium, the digital technology assures fast and reliable measurements. Validation studies have shown excellent correlations of transcutaneous measurements in comparison with arterial blood gas analysis for both pulse oximetry and PtcCO2. The single sensors are heated to warm up the measurement site and thus to increase the local blood flow. A good perfusion does not only add to PtcCO2-measurement accuracy but also improves the quality of the SpO2 signal. Modern PtcCO2-sensors, which only heat up to 42°C, can be kept safely on one measurement site for periods of up to eight hours. Digital sensors amplify, digitise and pre-analyse the measurement signals directly at the measurement site. Combined earlobe sensors were found to detect changes in SpO2 5 to 37 seconds faster than an analogue finger sensor, and changes in PtcCO2 9 to 48 seconds faster than a cutaneous sensor fixed to the upper arm. In centralised patients, a warmed sensor applied to the earlobe might be less affected by low signal conditions than peripheral sensors. PtcCO2-values can be influenced by factors such as hypoperfusion at the site of measurement, shock, oedema, skin thickness and vasoconstricting drugs.

The clinical applications of combined pulse oximetry and transcutaneous PCO2-measurement potentially include all settings when ventilation needs to be monitored, especially when supplemental oxygen is administered. A combined non-invasive sensor for pulse oximetry and PtcCO2, measuring all three parameters continuously and in real-time, might enhance patient safety in a variety of clinical situations. During medical and surgical

procedures, sedatives are very commonly used and are often administered in the absence of an anaesthetist. Following the administration of sedative medication, respiratory depression can occur, potentially requiring treatment with antidotes to the sedative and eventually causing need for assisted ventilation. PtcCO2 rises reflecting hypoventilation have been reported e.g. in patients undergoing various endoscopic procedures (thoracoscopy, bronchoscopy, colonoscopy) under sedation and administration of supplemental oxygen. Measuring the trends of oxygenation and carbon dioxide elimination might be useful to monitor the success of extubation and the adequacy of non invasive ventilation. Diagnosis of suspected hyperventilation can be evaluated by studying the trend of PtcCo2. Recently, combined pulse oximetry and PtcCo2 have been used along with polysomnography studies to titrate non-invasive positive pressure ventilation during the night in patients with chronic respiratory failure.

Conclusion Non-invasive methods to monitor ventilation are valid surrogates for arterial blood gas analysis when SaO2 and PaCO2 are to be assessed, and additionally provide continuous information. The different approaches have distinct limitations and should therefore be chosen carefully. Combined pulse oximetry and transcutaneous monitoring of estimated arterial PCO2 can provide the clinician with information on respiratory status that can assist with decisions to provide ventilation support. In situations where supplemental oxygen is administered to the patient, a combined measurement might facilitate the detection of ventilation abnormalities. Continuous monitoring with a combined pulse oximetry and PtcCO2 sensor has the potential to enhance patient safety in clinical settings where, without limitation, the ventilation of patients is impaired by overmedication or sedation, by obstructive or neurological causes, in patients with acute or chronic pulmonary diseases or where patients receive assisted ventilation or oxygen supplementation.

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

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Infection Control

The role of nonwoven textiles Using the right surgical barrier and protective gowns, masks, head and footwear are some of the key means to achieving optimal protection from infection.

Catherine Lennon Communications Director EDANA Belgium

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pidemics and pandemics have shaped our history and today they continue to threaten us by causing death, suffering and fear, and in doing so also place sudden intense demands on national and international health systems throughout the world. The last 25 years have brought new diseases to the world, including HIV Aids, SARS, Ebola and, more recently, avian flu, which, with the globalisation of trade and travel, has increased their rapid spread.

In addition to this, the incidence of Healthcare Associated Infection (HCAI) due to causes such as Methicillin Resistant Staphylococcus Aureus (MRSA), while by no means a new situation, has apparently rocketed (perhaps due to increased awareness ) in the past decade and is today hitting the newspapers with headlines such as ‘Killer bugs’, ‘Menacing microbes’, ‘Thousands of avoidable deaths’.

It is estimated that in the European Union (EU) alone, HCAI affects one out of every 10 patients, causing roughly 3 million infections, resulting in longer convalescence periods, increased suffering, and some 50,000 deaths per year. It is estimated that about one third of HCAIs, of which roughly 30% are discovered after discharge from the hospital, are preventable by improvements in infection control.

Whereas infection is making the headlines, infection prevention is not!

There are a number of areas, especially in patient-care practices such as hand hygiene which, while not headline material, have proven to significantly contribute to

decreased nosocomial infection.

In surgical procedures, where the potential of infection is high, risk can be greatly minimised by adopting best practices in several critical areas ranging from the environment, design and preparation of the operating room to the pre-operative preparation of personnel and the patient.

Using the right surgical barrier and protective gowns, masks, head and footwear are some of key means to achieving optimal protection from infection.

Nonwovens in the operating theatre The majority of postoperative surgical site infections are acquired at the time of operation when there is a possibility for microorganisms to reach the open wound. Routes of infection are via contact (dry or wet) or air-borne. Transfer of bacteria occurs mainly by the contact route via staff’s hands or clothing. A healthy individual may disperse thousands of skin particles per minute and each particle can harbour an army of bacteria. The role of drapes and gowns is to minimise the spread of infective agents to and from patients’ operating wounds thereby helping to prevent postoperative wound infections.

Patient drapes Patient drapes are used to provide a microbiologically clean working area around the wound. If they enclose the wound tightly and are fixed to the skin, they also prevent transfer of the patient’s own skin flora into the wound.

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Surgical gowns Surgical gowns are used to prevent direct contact transfer of potentially infective agents from the surgical team to the operating wound and vice versa. Operating gowns prevent dispersal of skin scales if they are made of a suitable material and used in combination with ultra clean air systems. Fabrics with interstices greater than 80µm, such as traditional cotton, do little to prevent dispersal of skin scales.

Increased protection for the patient and surgical team Protection against dry or wet contact Nonwoven single-use gowns and drapes offer a variety of properties that provide a safe barrier against bacteria, such as: • Repellency • Self-adherent edges • Aseptic folding Protection against air-borne particles

By using nonwovens to reduce the amount of lint produced in the operating room, and to block the passage of skin particles, the particle count is reduced by 90% Single-use = 100% certainty

The principal advantage of nonwovens is that they are used only once on one single patient, and incinerated after use, thus avoiding the need for handling and the consequent potential for spreading contaminants. As single-use fabrics are new for each

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procedure, there is no need to worry about the quality of the material. Because of their single-use property the same level of barrier effect performance is always guaranteed whereas it is possible that a multipatient reusable fabric may lose some level of performance after reprocessing.

Custom-made for the operating theatre

By using a combination of different fabrics, materials and designs, single-use operating room nonwovens are custom-made for the O.R. staff by offering the following characteristics: • Procedure-specific design • Optimum wearer comfort • Strong yet light in weight • Optimal fluid absorbency • Exchange of air, body heat and moisture Exceeding Stringent European Standards A recent Frost & Sullivan report (August 2004) shows that the market for disposable surgical drapes and gowns in Europe has seen steady growth in the recent past owing to the high standards of infection control enforced by the new European Union Medical Devices Directive (MDD) and EU standard EN 13795.

The need for preventing the transfer of infection between patient and medical staff has never been greater. The introduction of the three-part European standard for surgical drapes, gowns and clean air suits, used as medical devices, EN 13795, has been put in place for the protection of patients, clinical staff and equipment.

The norm, a globally recognised guideline, is designed to establish uniform standards for single-use and reusable surgical drapes and gowns, in order to minimise the spread of bacteria and other micro-organisms during invasive procedures, thereby helping to prevent post-operative wound infections.

After nearly 10 years of European standardisation work, the final section, Part 3 - relating to performance requirements - has been approved in April 2006 and will be published shortly. This work was accomplished with the full support of EDANA’s Medical Devices Committee, ‘MEDECO’, whose experts fully contributed to and participated in the CEN Working Group responsible for the development of the norm.

The EU Standards emphasise the importance of the barrier performance of the materials used, insisting that: “The use of surgical gowns with resistance to the penetration of liquids can diminish the risk to the operating staff from contact with infective agents carried in blood or other body fluids.”

EN 13795 further outlines the need for rigorous standards in terms of manufacture and processing throughout a prod-

What are nonwovens and what is their contribution to healthcare?

Nonwovens are uniquely engineered and versatile materials which are extensivelyusedinthemedicalfieldand inprotectionagainstbiologicalagents in other sectors. For example, they can be designed to deliver critical safety properties, such as protection against infections and diseases. With today’s multi-drugresistantstrainsofbacteria and virus, nonwovens can help in the fightagainstcross-contaminationand the spread of infection in a medical or surgicalenvironment.Nonwovensare also increasingly a major component in the design of “smart” wound care products, providing such functions as the creation of a moist wound healing environment, with controlled vapour transmission,absorbencyandlowskin adhesion.

Most recent nonwoven innovations include the design of new scaffolds for 3D biological tissue engineering, implantable fabrics that can reinforce natural tissues, and nanofibre nonwoven filtration media offering enhancedparticlecaptureproperties.

Newnonwovenmaterialswithimproved finishesincludingliquidrepellentand bacterial barrier properties are also beingdevelopedforapplicationssuch as surgical masks, gowns and drapes, especiallyinviewofthehighdemands of the new European Standards, EN 13795.

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uct’s useful life, as well as for the testing and re-validation of reusable materials.

Nonwoven fabrics have excellent liquid resistance, tensile strength and hydrophobic/hydrophilic properties and are, therefore, highly suitable for surgical drapes and gowns. On the other hand, the use of traditional multi-patient cotton and cottonpolyester mixed textiles has gradually been decreasing and once the Standard comes into operation, they will no longer be on the market as their low performance, will not meet the stringent requirements of EN 13795. More information on EN 13795 is available on www.medeco.edana.org.

Better economics for hospitals Infection prevention must be seen in a holistic way, so cost should not be the main factor in making decisions regarding products to reduce the risk of infection. By looking at the whole picture preventing infection will ultimately save money.

Single-patient operating room nonwovens contribute to reduced healthcare spending. Not only is a patient significantly less likely to acquire a nosocomial infection, with all its associated medical care and treatment costs, but when compared to all the hidden costs of re-processing, single-use nonwoven products quickly prove to be a cost-effective solution.

The choice of materials, in both singlepatient-use and multi-patient-use drapes, gowns and apparel, is wide-ranging. The degree to which they resist penetration by potentially infective material is a crucial factor, and should be the major concern when different material options are being considered.

Conclusion Despite growing infection rates in hospitals, there are effective ways to combat this alarming trend. New and innovative applications of nonwovens are increasingly being used by healthcare professionals as they provide efficient and cost-effective solutions in many critical applications. As today’s surgical techniques become more and more complicated and save lives in way that could never have been imagined, even a decade ago, it is imperative that this technical progress is matched with a similar quantum leap forward with regards to infection prevention.

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Anaesthesia The 21st century challenge The challenge for the 21st century anaesthesia leaders will be to bridge the widening gap in practice and education within the speciality whilst at the same time increasing its safety.

Anneke E E Meursing President World Federation of Societies of Anaesthesiologists UK

A

naesthesia and its practice has developed enormously following WW II, thanks to an explosive growth of anaesthesia equipment and tools, shorter acting drugs, electronics and sophisticated monitoring equipment. Anaesthesia education, training and licensing has not grown at the same pace, certainly not globally. In the last two decades, anaesthesia in the more affluent world has further evolved into perioperative medicine, the practice thereof is still emerging. The challenge for the 21st century anaesthesia leaders will be to bridge the widening gap in practice and education within the speciality whilst at the same time increasing its safety.

The first Harvard Medical Practice study demonstrated a substantial loss of resources (taxpayers money) by medical negligence and errors whilst awareness about this seemed low or absent amongst practising professionals. To Err is Human emphasised that safety and quality of care of the patient should be underpinned by improving standards and incorporating safety in training, education and maintenance of registration. The Joint Learning Initiative not only revealed a worldwide physician shortage but also discussed and advised on how to overcome this obstacle.

The World Health Organisation made patient safety a number one priority. The awareness and emphasis on patient safety

and quality of care have focused attention on developing different approaches to training (skills), education (knowledge) and competencies (attitude) required for the safe practice of medicine in general and in anaesthesia specifically.

Since the successful public demonstration of anaesthesia (1846) in Boston, USA and the comment made by the surgeon in charge: “Gentlemen, this is no humbug”, dentists, physicians and paramedical cadre have mastered the technique to render patients unaware of the detrimental effects of surgical or other, less invasive procedures.

Obstacles for anaesthesia to become a physician practised only specialty • Insufficient undergraduates to enter medical school • Insufficient number of qualifying physicians • No existing recognised anaesthesia curriculum • Brain drain to other more affluent specialties or countries (greener grass) • Insufficient remuneration as compared to colleagues in other medical specialties • Competition with higher professionally trained non academic cadre • Preference for physicians to remain in the urban areas

The first administrations were mostly done by physicians. Physicians administered anaesthesia In the Anglo-Saxon influence sphere, some as specialists some as general physicians whilst on the American and European mainland, surgeons often induced anaesthesia and then handed the care over to an assistant supervising the anaesthetic. Hence, the contemporary administration of anaesthesia is practised by a variety of trained individuals around the world.

50 Asian Hospital & Healthcare Management ISSUE-11 2006

Surgeons, cardiologists and radiologists were able to develop new techniques through the serendipity of inventive, creative and persistent anaesthesiologists to adapt and adjust to new circumstances in the best interest of the patient and in close cooperation with technicians, pharmacists and engineers. Non-physician anaesthetists have mostly concentrated on care rather than on the cure of the patient and always required a formal prescription - in the widest sense of the word - of the administration of anaesthesia by a physician.

The introduction of anaesthesia as a physician practised only speciality world wide has met with a number of obstacles such as described in table-1. All of these are the result of a global physician workforce shortage but why is anaesthesia more affected than other specialities such as radiology or surgery? Radiologists cannot function without adequate and wellmaintained equipment and assistance and will therefore rarely flourish in the district hospital. However, a radiographer can take simple X rays that the district physician can use in their practice. The same is true for anaesthesia: with simple means basic anaesthesia can be administered. It does not require a specialist, a general physician or an assistant thus trained can safely administer. However, this mode of practice will not facilitate difficult cardiac surgery or safe anaesthesia for a 63 year old cardiac compromised patient with diabetes and hypertension for a cholecystectomy. History in the more affluent world has shown that a critical mass, a core of dedicated, enthusiastic individuals is required to further improve the quality of care in the speciality establishing the speciality in its full breadth. Moreover, advances in surgery and its outcome are inextricably linked and influenced by the quality of anaesthesia

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care and cure. Additionally, populations are ageing demanding regular orthopaedic, plastic, transplant or oncology surgery.

Moreover, younger physicians do not wish to work the same number of hours commonly practised in the recent past by their predecessors.

These factors have opened the floor to develop and strengthen non-physician anaesthesia training and practice, filling the void. Evidence-based planning, decision making and re-assessing the process of recruitment, training and re-registration of anaesthesia providers are urgently required.

The scope of anaesthesia Anaesthesia has become an integral part of the practice of perioperative medicine.

Not only surgeons have come to realise that good anaesthesia improves the surgical outcome, psychiatrists prefer anaesthetists to look after the vital functions of their patients during Electro Convulsive Therapy.

The list of physicians whose patients need anaesthesia is too long for an individual call out; just rest assured that all doctors

aim to keep their patients in optimal condition whilst undergoing any procedure.

Perioperative medicine encompasses perioperative care from pre-operative assessment until discharge from the hospital.

The different phases are: • Pre-operative assessment and optimalisation of the patient before a procedure can be carried out, be it surgical or interventional • The administration of anaesthesia per se (drugs, circuits, regional block and airway maintenance) • The maintenance of physiologic balance and treating of imbalances during induction, maintenance, emergence and recovery from anaesthesia • Maintenance or treatment of fluid (im) balance, arrhythmia’s, or organ failure • Oxygenation through a variety of methods • Tardio-pulmonary and brain resuscitation of patients of all ages • Treatment of acute and chronic pain inclusive of the obstetric and emergency patients • Trauma management on site and in

the emergency room with emphasis on maintaining and improving vital functions, resuscitation and emergency and intensive care medicine.

As more and more medical practitioners require safe sedation and anaesthesia for their patients, anaesthesiologists are in much more demand and particularly more outside the operating room. Quality of anaesthesia providers must not be sacrificed on account of increased need.

How to cope with a growing demand for the speciality Several stake holders play a role in providing solution to this problem. Having adequately trained professionals providing anaesthesia is important to patients in the first place. They would like to sustain their surgery with minimal side effects followed by a speedy recovery. Secondly, physicians and other para-medical cadre aiming to practice anaesthesia as a career need an appropriate curriculum, qualification and registration in order to practice safely.

Lastly, government is not only charged with

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the control of training programmes but at the same time committed to improve the quality of care for patients nationwide at all levels: rural, district and central.

A first step for all parties involved is to agree on who may practice anaesthesia under which conditions. An anaesthesiologist is a physician further trained as a medical specialist who masters all aspects of cure and care at the conclusion of their training. Certain aspects of perioperative medicine can be delegated - in some parts of the world - under clearly described conditions and limitations to para-medical trained personnel. These individuals function as the extended arm of the physician, preferably an anaesthesiologist. Education and skills training should be based on close cooperation with physician anaesthesiologists. Therefore, a national curriculum, with set standards both of training and examinations must be agreed on. Following ongoing assessment and maintenance of a logbook, further enhances the high standards. In some countries, re-certification and re-registration have already found a place such as is commonplace in aviation.

Who should train the future anaesthesia administrators The medical background of the anaesthesiologist is essential to comprehend the full picture of disease, possibilities of treatment and quality of long-term cure and care for the patient. Anaesthesiologists must naturally contribute to the education of the non-physician anaesthetists. This is however not common practice in the world.

Some medically trained colleagues feel able to teach or supervise the administration of anaesthesia. Regarding this practice, let it suffice to have a surgeon speak: Robert Monod was a surgeon and the chairman of the international congress preparing the foundations of the World Federation of Societies of Anaesthesiologists (WFSA): “It is time anaesthesia freed itself from the tutelage of surgery� were the words he said at their opening ceremony in 1951. His words became reality when WFSA saw its inauguration on 9th of September 1955 adopting as their motto: to make available the highest standards of anaesthesia, pain treatment, trauma management and resuscitation. To make anaesthesiologists

responsible of delegating their responsibility and set the standards of those professionals, that seems to follow naturally.

Can workforce be compared to equipment?

The previous WFSA president Dr TCK Brown designed a table to function as a guideline of tools and equipment required for different levels of anaesthesia administration. To connect different levels of trained professionals to each of the equipment standards in the rows seems logical. Basically, the WHO knows three levels of medical care: the rural health centre, the district hospital and the central hospital. Teaching or academic hospitals are mostly linked to universities and thus to the Ministry of Education. These organisations are primarily charged with the education of healthcare professionals rather than providing healthcare in all its forms such as the Ministry of Health.

It could be envisaged that such as aviation has different education and licenses for the different aircraft, anaesthesia could acknowledge different levels of licensing

Anaesthetic Facility

General Facilities

EEquipment

Minimal

Running water, electricity, oxygen, operating room absent

Intravenous access, face masks and Guedel airways, spinal needles, boiler for sterilizing, Laerdal self inflating bag, foot pump for suction

Basic draw over

Water, electricity (at times), operating room, tilting table

All of the above and draw over vaporizer, face and laryngeal masks, suction catheters

Draw over, Oxygen, Mechanical IPPV for simple use

Water, electricity (at all times and emergency replacement), Oxygen in cylinder or through concentrator. Autoclave

All of the two above and O2 concentrator or cylinders laryngoscope & endotracheal tubes, introducer, bougie, laryngeal masks, double cuff tourniquet

Plenum systems

Piped gases, Nitrous oxide, Air, Oxygen

All of the above and anaesthetic machine with ventilator, breathing system, paediatric arrangement, HME filter, Humidifier

Complying with national minimum standards

Air conditioned O.R. suite & air filters

All of the above and syringe pumps, warming and cooling devices. Systems for pain treatment

Sophisticated international minimum standards

Workstations

Translated into education in anaesthesia administration, the table would look as this: Anaesthetic Facility

General Facilities

Training, background and assistance

Minimal ~ rural health centre Running water, electricity, oxygen, operating room absent

Anaesthetic clinical officer, assistant and/or nurse with unskilled assistance

Basic draw over ~ rural Water, electricity (at times), operating room , health centre or < 100 beds tilting table hospital

All of the above and (general) physician available to help with diagnosis and treatment or referral decision. Locally trained assistance

District Hospital

Water, electricity (at all times and emergency All of the above and physician anaesthesiologist available for consultation. replacement),O2incylinderorfromconcentrator. Nationally or regionally trained assistance Autoclave

Complying with national minimum standards ~ Teaching Hospital

Air conditioned O.R. suite & air filters, Central Sterilising Department

Sophisticated minimum standards ~ University Hospital

Top of the pops, both in cure, care, education and All of the above and specialised consultant anaesthesiologists for all areas of research special interest Skilled and qualified assistance.

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All of the above and a critical mass of physician anaesthesiologists available to teach, assist, support, supervise and manage all anaesthesia locations or emergency airway care required. Skilled assistance

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related to a particular level of equipment and whether one would be licensed to operate this independently or under supervision.

Dilemma What surfaces is the debate why patients in some parts of the world should be satisfied with cure and care different from their counterparts in the more affluent world? Is it because they have no money to spend?

Or does prosperity bring different health problems and solutions with it?

Manpower shortage in medicine has set in all over the world regardless of the speciality. The influx of more female physicians desiring to work part-time in combination with an increased workload created less satisfying working conditions.

Moreover, it resulted in lower salaries than expected or earned by their peers in non-medical profession. This diminishing workforce increases in addition to a growing, greying population in need. Additionally, these patients desire more surgical and interventional procedures demanding

quality and safety both in cure and care.

The dilemma: who and how to train in anaesthesia to provide ongoing safe care has evoked widespread interest around the world amongst governments and professional organisations.

Future If surgeons and other physicians demanding quality anaesthetic support for their patients were to accept the idea of the anaesthesia team and embrace perioperative medicine as the field practised, then anaesthesiology could develop as the proverbial umbrella under which all providers may develop whilst physician anaesthesiologists guarantee the quality and safety of care.

Time has come for anaesthesia administrators to agree on the entry and exit criteria for each level of qualification of anaesthesia administrator, their licenses and limitations and their respective nomenclature.

After all, the practices of many aspects of medicine know and accept their respective non-physician assistants such as the midwife or the intensive care nurse.

Conclusion Africaâ&#x20AC;&#x2122;s initiative of coping with a physician shortage by training non-physician clinical officers may prove to be the frontrunner of a development needed in the more affluent world. In the not-too-distant future few countries in the world will be able to afford fully trained and qualified physician anaesthesiologists for all aspects of perioperative medicine. Those in more affluent countries would be wise to investigate whether the perioperative medicine model with the anaesthesiologist in charge delegating some of their tasks to non-physicians can be implemented in their current practice. Anaesthesiologists should supervise, guide and help set the standards of practice. Anaesthesiologists have proven to be the best team leaders in the past 160 years. There is no room to go back to the days when surgeons supervised non-physician anaesthetists.

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

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Medical Errors

RFID to the rescue Against the background of medication errors and wrong treatments costing the health system several million dollars every year, RFID can provide an important contribution to improving the quality of treatment and increasing the safety of hospital routine.

Thomas Jell Senior Principal Consultant RFID Technology department Siemens Business Services Germany

I

n the Internal Medicine departments of German hospitals, 29,000 patients die each year as a result of being given the wrong medication, according to a study by the Medical University of Hanover. Health experts are hoping to remedy this with the introduction of high-tech radio-frequency identification, or RFID for short.

Modern medicine combines a host of complex processes. Medical and administrative services have to go hand in hand and be well coordinated, and both highly sensitive information and medical equipment must be available round the clock.

Added to this is the central goal of consistently increasing the quality of care and customer orientation and looking after patients in the best possible way. In addition, the pressure of higher economic efficiency increases from day to day. In short: Modern medicine means managing more and more tasks with fewer and fewer resources.

Against the background of medication errors and wrong treatments costing the health system several million dollars every year, RFID (Radio Frequency Identification) can provide an important contribution to improving the quality of treatment and increasing the safety of hospital routine.

The non-contact radio technology is made up of two components â&#x20AC;&#x201C; a reader

RFIDallowsreliablepatientidentificationviaradioandsafeapportionmentofmedicationandbloodproducts.

Source: Siemens Business Services.

and a so-called transponder or tag â&#x20AC;&#x201C; both of which communicate via radio waves. Between the antenna of the tag and the reader there is an electromagnetic energy field. If the chip gets within range of the reader antenna, it allows the reading or writing of information. The data is either processed on the spot or transmitted to a central computer. Unlike barcodes, RFID tags can reveal large quantities of data within a few seconds over long distances and without a direct line-of-sight.

In hospitals, the RFID chips are useful in three key areas. Firstly, they can be used to track objects like beds, wheelchairs and operating instruments or medical items such as Infusomats. The second application area concerns the patients, in that their treatment information can be accessed more quickly using the tags. And the third field

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is personalized medication, where RFID ensures safe distribution of drugs.

RFID chips in use The Klinikum Saarbrucken Hospital, which is situated in the west of Germany in Saarbrucken, is already trying out these applications. Immediately before a drug is administered, the nurse checks whether the patient is getting the right medication in the right dosage at the right time. This is made possible by the non-contact radio technology RFID. The principle behind it is quite simple. At the heart of the system is an intelligent chip, also called a transponder or tag, which is about half a square millimeter in size and contains a number similar to a barcode. The nurse uses a mobile terminal such as an RFID-capable PDA or tablet PC to read the number,

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using it to call up information such as the patient’s age, weight and size as well as basic medical readings and lab results.

An expert program from RpDoc Solutions checks the proposed medication and dosage. If there is any danger, it switches to red and explains why. This artificial intelligence can thus turn out to be a life saver, for example with diseases such as renal failure, where even minor discrepancies in dosage can be fatal.

Proper medication and dosage is the focus of the RFID pilot project launched in Saarbrücken in April 2005, which also involves Siemens Business Services, Intel and Fujitsu Siemens Computers. With over 695 beds, the hospital treats some 27,000 inpatients and 84,000 outpatients every year. Since the beginning of this year, units of stored blood for around 1,000 patients have also been fitted with RFID. On arrival at the hospital, each blood bag is given a tag with an appropriate code. This code corresponds to an entry in a secure database detailing the origin, purpose and recipient. When the nurse takes the bag containing the blood donation to the patient, she reads the chips on both the package and the patient’s RFID armband with a PDA, and will only administer the blood if the data matches. The patient receives the correct transfusion in exactly the prescribed quantity. The information is then entered in the clinic’s process system and the patient’s records.

Armbands transmit patient data The modern radio technology is also making its mark at New York’s biggest pub-

lic hospital in the Bronx, where patients carry their medical history with them in a radio-tagged armband. When they are admitted to the Jacobi Medical Center as in-patients, they are issued with a paper armband with an integrated RFID chip, in which are stored their name, date of admission and patient number. All other patient data is kept in an electronic file on the central database server. Using mobile devices, the doctors can access all the medical data, such as case history, diagnoses, lab reports, allergy results or x-rays, via the patient number and WLAN at any time. “This immediately gets them up to speed on the patient,” comments Daniel Morreale, CIO at the Jacobi Medical Center.

The multi-award-winning solution from Siemens has been in use since 2004.

Morreale praises the quality of the collaborative partnership: “Siemens has delivered a solution that not only satisfies our current requirements but also gives us enough scope to think further options through.

This partnership is of great value to us.”

With the aid of PDAs or tablet PCs, hospital staff can update the patient data during the actual treatment. Because they save on paperwork, the doctors and nurses have more time to attend to the individual patients. The patients too are better informed, thanks to RFID. Using special terminals in the day room, they can consult their armband to look up on screen many of the questions that were not dealt with during the ward round. On the screen patients will find information on their blood pressure, about their ailments and appropriate therapies, as well as treatment times or discharge dates.

AttheKlinikumSaarbrückenHospital,some1,000patientscarrytheirmedical history with them in a radio armband.

Source: Siemens Business Services

Beds get radio IDs too But it’s not only the medical history that can be accessed more quickly thanks to RFID: A special sensor on the patient’s chest measures heart rate and sends the results to an RFID clock, which in turn transmits the data to the doctor.

To allow the wearer’s location to be pinpointed to within two meters,

several antennae are distributed around the hospital premises. Should the patient’s condition take a sudden turn for the worse, the medics can immediately head to their location and take appropriate action.

RFID technology also offers potential for optimisation when it comes to the management of hospital beds. RFID chips attached to the beds automatically log information on their movement, which relieves staff of routine tasks in housekeeping, transport, repairs, accounting and maintenance.

Dispelling doubts about data protection In view of the many positive factors that speak in favour of RFID, it is not surprising that analysts see radio technology as a billion-dollar market. Market researchers at In-Stat anticipate a rise in the number of tags produced from the current 1.3 billion to over 33 billion by 2010. However, as a study carried out by Berlecon in July 2005 reveals, the health sector is still hesitant about using RFID. This is mainly because of concerns about data protection.

However, it is unlikely that RFID will turn its users into ‘transparent patients’.

After all, the data on the chips can only be read within a range of a few meters at most. Furthermore, the zones covered

by RFID chips can be securely protected against unauthorised access. At the Klinikum Saarbrücken Hospital, this protection is guaranteed by sophisticated encryption technology.

There is no question of mass application of radio technology as yet, partly due to current chip prices, which are in the region of 20 cents. But new technologies, for example from PolyIC, could soon deliver the breakthrough. This company, which is based in Erlangen, Germany, is working on simply printing the radio chips – rather than manufacturing them from expensive silicon and copper. For this they are using soluble high-tech synthetics, which can be produced quickly and at low cost. So it will be some time before RFID really catches on in the hospital sector. In the light of greater transparency in hospital procedures, improved patient safety and constantly upto-date information, there is no doubt that the RFID initiative is worthwhile for both patients and hospitals.

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Telesurgery in Asia Are we there yet?

Telemedicine has traditionally been more popular with countries of huge geographical distances where access to medical care for patients living in remote areas is scarce. However, telemedicine has also proven itself to be viable in a land-scarce place such as Singapore.

Adam Chee Industry Analyst Healthcare (Asia Pacific) Frost & Sullivan Singapore

T

elemedicine, which involves the use of telecommunications technology to deliver healthcare services to patients and providers at a distance, is recognised by the World Health Organization (WHO) as a cost effective and practical method for healthcare delivery. In Telemedicine, there are two categories of technologies, real-time and store-and-forward.

Real-time (Synchronous) In real-time telemedicine, patient’s medical data/information is transmitted as it is being acquired (e.g. video conferencing with attachment of medical equipment).

This allows an expert opinion to be sought instantly.

Store-and-Forward (Asynchronous) In store-and-forward telemedicine, patient’s medical data/information are acquired and stored locally before being forwarded to an expert doctor at other centre at a later time. This is usually implemented for non-emergency use or in situations where the doctor’s presence is not required at the time of data transfer.

cal distances where access to medical care for patients living in remote areas are scarce, however, telemedicine has also proven itself to be viable in a land-scarce place such as Singapore.

The National Healthcare Group (NHG), a major public healthcare provider in Singapore started a teleradiology project in early 2006 where X-rays are sent digitally to radiologists in India for reporting. The results were definitely cheaper and the service was surely faster in comparison to what the local resources can provide, in return, the local hospitals are contemplating on tendering for similar X-ray reading contracts proposed by hospitals in the US and Canada.

Telesurgery, surgical procedures carried out at a distance enabled by advances in robotic and computer technology is another sub-discipline of telemedicine that may soon be available at healthcare facilities in Singapore.

Robotics Surgery Systems

The da Vinci Surgical System, a robotic surgery system from Intuitive Surgical is a descendant of the 1980s US Department of Defence project that was initiated to create a robot that would allow surgeons to operate on critically wounded soldiers

TeleMedicine in Singapore

Telemedicine has traditionally been more popular with countries of huge geographi-

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Present Surgical Video Conferencing

Robotics Surgery

from a safe distance is already widely available in various public and private hospitals for minimally invasive procedures.

Surgeons using the system perform the operation through a console located a few feet away from the patient where he/she is provided with an immerse view of the actual operating field in real-time three-dimension. The surgeon’s hand movements at the console instrument are seamlessly translated into corresponding micro-movements of instruments positioned inside the patient with high precision and accuracy.

Patients operated through the da Vinci Surgical System usually experience less pain and bleeding as also faster recovery as the surgery is less intrusive compared to open surgery. The overall surgical performance is enhanced as the surgeon is positioned comfortably throughout the operation to reduce fatigue and tremor in the hands.

‘Live’ Surgery Video Conferencing

Apart from robotic surgery, the Minimally Invasive Surgery Center of both the Gleneagles Hospital and the National University Hospital (NUH) also holds ‘live’ surgery video conferencing with overseas healthcare facilities for teaching purposes and to promote exchanges in the medical communications among different countries.

Future Telesurgery

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Traditionally, transmission of medical images and live-video conferencing over the Internet has been plagued with costly software, equipment, and bandwidth only to produce low-quality images, audio, and video. To overcome these problems, NUH utilises the Digital Video Transfer System technology (DVTS) to broadcast live sur-

presence in countries like India, Malaysia and Thailand.

Telemedicine in India

With its abundant supply of IT talent and huge geographical surface, it is not surprising that Telemedicine has already been widely adopted throughout India. The Apollo Hospitals Group (the single largest Telemedicine solution provider in India), is credited with With a worldwide shortage of medical being the first to set expertise and rapid advancement in up a Rural Telemeditechnology, it is only a matter of time cine Centre in India.

Although the imbeforetelesurgerybecomesacommon plementation of Telenecessity for major healthcare facilities. medicine in India has been pioneered by private hospitals, gery using high-speed bandwidth of at things look to change as the Department least 30 Mbps per line to ensure high-qualof Information Technology (of the Minity digital video. istry of Communications & Information Taking it further, the Singapore NaTechnology) had taken up the initiative tional Eye Centre (SNEC) hosted a live vitfor defining the “Standards for Telemedireoretinal surgery transmission from Japan cine Systems” together with various other in February. The doctors under training organisations related to health and techwore special 3D/three-dimesional viewing nology. glasses, which enables them to see exactly Telemedicine in Malaysia what the operating surgeon sees through In 1996, the Malaysia government emthe microscope in true 3-dimension as opbarked upon the Multimedia Super Corposed to the conventional 2-dimensional ridor (MSC) initiative - a large-scale infratransmission. The improved visualisation structure and services project. Part of this greatly enhances the doctor’s surgical traininitiative includes the implementation of ing as they can now pick up knowledge Telemedicine to enhance the quality of and techniques obtainable only through a healthcare in both urban and rural areas. surgeon’s view through the microscope.

To facilitate the implementation and Telesurgery is not limited to robotic utilisation of telemedicine, the Malaysia surgery or providing training sessions over government implemented legal framework the Internet. In September 2001, the Euwith new cyberlaws such as Telemedicine ropean Institute of Telesurgery in StrasAct 1997 and Digital Signature Act 1997. bourg conducted a telesurgical operation Selayang Hospital, a government hospital where doctors in the US performed a sucin the state of Selangor became the first cessful gall bladder removal from a patient paperless and filmless electronic hospital in France by remotely operating a surgical in Malaysia in August 1999 and the latest robot arm. Such a procedure indicates that hospital to share the same/improved capait is now possible for a surgeon to perform bilities is the Pandan Hospital in the state an operation on a patient anywhere in the of Johor. world.

Telemedicine in Thailand Similar to India, the adoption of technolTelesurgery in Asia ogy in Thailand hospitals has so far been (India, Malaysia and Thailand) While Singapore enjoys a reputation of driven by the private hospitals. Private hosbeing technologically advanced, it is not pitals located in Bangkok (the capital city) the only country in Asia that is adopting like Bumrungrad Hospital and Bangkok technology advancements in its quest to Hospital Group (network of 15 private provide quality patient care with affordhospitals) are famous for their utilisation able prices. Telemedicine has also found its of technology to improve healthcare. The

good news for public hospitals is that Thailand’s Ministry of Public Health has plans in the pipeline to develop electronic health information systems that will link the public healthcare facilities across the country to improve patient care and increase efficient use of resources.

Conclusion Effective deployment of telemedicine can translate ultimately into patient benefits as medical and technological resources can be utilised to enhance patient care, while reducing the cost. With telesurgery, the need for patients to travel physically to another healthcare facility can be reduced since teams of top surgeons from around the world could be assembled to perform an operation or provide consultation or obtain second opinions.

With a worldwide shortage of medical expertise and rapid advancement in technology, it is only a matter of time before telesurgery becomes a common necessity for major healthcare facilities.

In the quest to establish itself as the regional medical hub, medical centres across Asia may soon find it necessary to start leveraging on Surgical Networking Systems in the bid to be number one.

BOOK Shelf Human and Organizational Dynamics in e-Health

Edited by: David C Bangert and Robert Doktor Year of Publication: 2005 Pages: 342 Description: Healthcareprofessionalsandgovernment policyplannersbelievethattelemedicine holds the promise of decreasing the cost of healthcare services. Human and Organizational Dynamics in e-Health is a uniqueguidedesignedtohelphealthcare professionals resolve organizational resistance to telemedicine.

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

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Asia's Challenge to Medical manufacturers The era of passive sales to local distributors is rapidly drawing to a close.

Steve Stine Director Life Sciences (Medical) TNT Singapore

M

edical products manufacturers take heed! There’s a quiet revolution stirring throughout the Asian healthcare sector, and unless you are privy to these changes, the impact on your bottom-line could be severe.

“How can this be?” you ask. The region’s economies are on the rise. Out-ofpocket spending by a more health-conscious middle class is propelling demand for improved healthcare services. Innovative prescription drugs and medical devices hold promise of improving the lives of millions. With such market dynamics in play, you might say it would be easy to take a “business-as-usual” stance by pushing an ever-increasing litany of products on local distributors and logging sales, accordingly.

Unfortunately, this old-school reliance on small and specialist distributors now comes with a new batch of risk. On the one hand, consumers are becoming increasingly savvy about new medical products, treatments, and thousands of times a day, are using the internet to “shop” for information on the latest developments and treatments, and then demand them from their physicians. On the other hand, governments are getting smart. Stemming demand won’t be easy. But curtailing supply is possible. How? By exacting new guidelines and regulations designed to lower the cost of procuring advanced drugs and medical technologies and insisting upon improved efficacy and reliance of these products.

Take China for instance. As the fastest growing healthcare market in the world, the country’s State Drug Administration (SDA) and the State Food & Drug Administration (SFDA) have issued some 40 statutory regulations that monitor the import, sale and usage of pharmaceutical and medical products. Such regulations – in China and elsewhere in Asia – are an attempt to stem the rise in public and private healthcare spend, reduce misappropriation of these products, and safeguard – wherever possible – those who seek out these advanced and high-cost treatments.

58 Asian Hospital & Healthcare Management ISSUE-11 2006

Oddly enough, it is the advent of economic change in Asia that drives demand for new medical treatments. With greater prosperity come environmental pollution, over-population, dietary changes and stress, all of which contribute to changing disease patterns. In less than two decades, chronic illnesses, such as cancer and heart disease have overtaken infectious diseases, such as malaria and cholera, as the leading cause of death among Asians.

Initially, Asia’s healthcare systems were caught off guard. In recent years, governments have made a flurry of investments

I N F O R M AT I O N TEC H N O L O GY

in new hospital technologies, surgical procedures, and leading edge prescription drugs, resulting in soaring annual healthcare spend. In an attempt to stem the hemorrhaging of healthcare budgets, a new wave of strict procurement and regulatory changes are forcing suppliers to share the burden.

reagents as an example. The vast majority of chronic diseases are revealed through blood tests or other diagnostic methods, and chemical reagents are the means by which life-threatening diseases are tested.

Hospitals in the region (ex-Japan) purchase an estimated US$ 30-40 million of diagnostic reagents and instruments each year. Expired, defective, or inappropriately handled reaExpired, defective, or inappropriately gents can mean the handled reagents can mean the difference between difference between a correct and a correct and incorrect diagnosis, and in incorrect diagnosis, and in some cases, some cases, the life or the life or death of a patient. death of a patient.

So how are the majority of these In short, the pressure is on. Consumcritical, life-saving products handled toers, hospitals, physicians, and governments day when making their way from overseas are increasingly aligned against manufacmanufacturing centres to Asian hospitals? turers of modern medical miracles, and the Frankly, it varies. era of passive sales to local distributors is In some markets with clear regularapidly drawing to a close. The onus is now tions and careful monitoring, reagents are on these global giants to both find ways to delivered and, therefore, perform as inlower the cost of sales to Asian buyers as tended. But in developing markets, where well as enhance the quality and efficacy of demand is outstripping government ability their products. to monitor procurement and use, there are One sound way to get started is to reinevitable shortfalls in appropriate product think archaic supply-chains and distribumanagement, thus making the importance tion arrangements that traditionally have of logistics all the more apparent. kept manufacturers at arms length, and For instance, maintaining reagents at 2-8 left it up to distributors to manage the sale, degrees Celsius is critical if the chemicals support, and delivery of medical products are to perform their intended function. to hospitals. There is ample evidence to Manufacturers typically take charge of suggest that these traditional methods are moving a product from a factory location losing their vitality. to an Asian port of entry, but after that, the As a result, medical products manuefficient handling of a product is anyone’s facturers must search for the most costguess. We know, for instance, that drugs, effective, reliable answer. Take chemical devices and reagents can be held at Customs for days on end. On other occasions, incorrect documentation can stall transfer 1. TNT, a specialist provider of life science logistics soluof goods, and even when in-country distions, has seized the opportunity to modernise healthtributors do take ownership, controls on care logistics supply-chains, offering manufacturers an efficient, integrated supply-chain management with product handling and expirations are unend-to-end visibility. At TNT, we urge manufacturers even at best, and dangerous at worse. to consider a “direct ship” model where your existing distributors manage hospital accounts, market new The good news is that new service soproducts, invoice, and collect, but rely on a thirdlutions and IT platforms are available to party logistics provider, such as TNT, to coordinate track and safeguard your product from the physical distribution and inventory management.

TNT’s global network, leading edge IT platforms, point-to-point. RFID, or Radio Frequency and professional workforce are best suited to ensure Identification, is one technology that is your product’s integrity from point-of-manufacture to point-of-use. Without the end-to-end visibility to your proving both effective and cost-effective product made possible by TNT’s integrated healthcare (see sidebar). supply-chain solutions, you may be in violation of a growing litany of government regulations, and not even know it, until it’s too late. For more on TNT’s life science solutions in Asia see www.tntlifesciences.com

Using RFID to Safeguard the Integrity of Your Medical Products In March this year, TNT Asia embarked on a revolutionary new way to track and monitor the distribution of chemical reagents using RFID cold-chain technology.

As required by law in many countries in the region, reagents must be maintained at 2-8 degrees Celsius both in storage and in transit in order to ensure that upon use, these life-savings chemicals perform at their optimal level.

Operating out of a medically-approved Regional Distribution Center (RDC) in Singapore, TNT has established a revolutionary technique where battery-activated passive RFID tags are carefully placed in gel-packed and insulated boxes designed specifically for chilled shipment of reagents. The tags are activated at the RDC, scanned again at the Singapore hub, and programmed to “wake-up” and take a temperature read every 30 minutes until reaching its final warehouse destination at two pilot locations: Shanghai and Bangkok.

By observing the performance of the temperature-controlled boxes during the 2-3 day door-to-door transit period, we are able to make adjustments to the packaging by adding gel packs or layers of insulation.

The idea is to optimise the performance of the packaging, while minimizing the cost to our manufacturer customers.

One hundred shipments later, results are promising. Not only is TNT able to guarantee for the first time absolute temperature integrity, but also we are doing our part to raise awareness among distributors and hospitals that have a vested interest in ensuring reagents arrive at hospitals and into labs in the best possible condition.

For TNT, RFID applications for the Asia healthcare sector are unlimited.

What’s next? RFID readers strategically placed in hospital storerooms in order to allow remote inventory management and auto-replenishment of surgical products.

These high-value products are typically held on consignment by the world’s leading medical products manufacturers and their distributors. With RFID at the hospital level, gone are the days when patients suffer because storerooms weren’t properly replenished.

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I N F O R M AT I O N TEC H N O L O GY

Medical Care

Wireless sensor networks Wireless sensor networks are particularly relevant to preventative care offering patients the potential to enjoy their home environment, minimise their time in hospital, improve their quality of life and hopefully prolong their life expectancy.

Diana Hodgins Managing Director European Technology for Business Ltd and Project Co-ordinator Healthy Aims UK

T

he recent rapid advances in wireless communications, global digital systems, microelectronics, nano and micro-systems offer an ideal opportunity for major changes in medical care.

Organisations worldwide are now looking to capitalise on these technology advancements and move away from the conventional medical approach where people visit doctors and attend hospitals for treatment, focusing mainly on treatment rather than preventative care.

New opportunities now exist where medical systems can be developed which offer preventative care and focus on delivering this directly to the person at home.

An ultimate goal would be for people to live their life with non invasive sensor system monitoring critical parameters relevant to their genetic make-up, lifestyle and any medical condition they may have. Information will be transmitted directly to the health service provider for analysis and if a change has occurred which requires an alteration to any drugs or possible treatment, then the person is advised of this and the necessary appointment made.

To complement this preventative care monitoring will be advanced treatment.

This may, be in the way of intelligent im-

plants, minimally invasive surgery or drugs designed specifically for individualâ&#x20AC;&#x2122;s own genetic make-up.

Wireless sensor networks are particularly relevant to preventative care, offering the potential for people to enjoy their home environment rather than having to live in care or nursing homes, minimise their time in hospital, improve their quality of life and hopefully prolong their life expectancy. Whilst we are still many years away from the time when systems will be made generally available, there are already some pilot programmes developing. Once the clinical efficacy of new medical systems are demonstrated, these systems can be developed for general use.

Whilst this is likely to take up to 10 years to reach maturity and pass all the necessary clinical trials, it is encouraging that R&D programmes are pushing the technology barriers and preparing the way for many more medical systems in the future.

Topics that push the boundaries of technologies today are already in pilot clinical trials. Example of this are included in the Healthy Aims project1, an FP6 project funded by the EC, to develop a range of medical implants and diagnostic systems for a range of applications. Examples that could realistically reach pilot trials within the four year project were chosen. These include: Glaucoma sensor which can be worn like a contact lens Glaucoma is where the pressure in the eye is so high that it damages the retina and can ultimately cause blindness. This new system monitors the change in curvature of the eyeball which results from a

Image-1

build-up of pressure and this data can be transmitted directly to the health advisor (Image-1). An alarm will be triggered when the pressure reaches an unacceptably high level and the person would be called in for treatment. Currently, the only means of monitoring pressure is at the ophthalmologist where a spot pressure reading can be taken. This proposed new system will enable measurements to be taken over a 24 hour period and on a regular basis. It is hoped that those people suffering with glaucoma would all be provided with their own wireless system and be regularly monitored, ideally, preventing blindness.

Intra-cranial pressure sensor system This pressure sensor system would be permanently implanted and pressure readings taken remotely on a regular basis (Image-2). The data would be transmitted to the health provider and if the pressure exceeds the alarm threshold, then the person would be called in for immediate treatment. The pressure sensor needs to be stable for a lifetime as once implanted it should never be disturbed. Example applications include hydrocephalus patients fitted with a shunt to drain excess fluid from Image-2

60 Asian Hospital & Healthcare Management ISSUE-11 2006

I N F O R M AT I O N TEC H N O L O GY

the brain cavity. If the shunt blocks then the pressure can reach dangerously high levels that can result in death.

Body worn inertial unit for human motion detection This example shows a person being monitored whilst on the ‘BalanceMaster’2. This machine has been designed specifically to help people improve their balance. The sensor system is used to ascertain how they respond to treatment.

On-the-body sensor systems can be used to monitor a range of conditions. For the elderly, this could include monitoring their balance and ultimately determining if they have fallen. They can also be used to trigger intelligent implants, (for example, the upper limb FES under development in the Healthy Image-3 Aims project).

Sphincter sensor The human body has a number of sphincters which, if they fail, can cause embarrassment, discomfort or in extreme cases death. For example the oesophagea sphincter is at the top of the stomach. If this partially fails, then conditions like heartburn can occur and if not treated this can ultimately result in cancer of the oesophagus.

Using the sphincter sensor to monitor if the sphincter has fully closed would enable to correct treatment to be given to those that require minimally invasive surgery.

This is just a selection of sensor systems that can be used to monitor different aspects of a person’s health. There are many more products under development by clinical groups and medical device companies both in the EU and worldwide. (For example, a large niche market includes people suffering with urinary incontinence who are fitted with catheters). The Biomed HTC3 in Bristol, UK, is guiding the development of new diagnostic equipment and medical devices to help improve the quality of life and reduce hospital costs of patients.

Intelligent implants that improve the quality of life for people who have lost

specific functions are also being developed.

Some of these are within the Healthy Aims project, namely: • Retina implant to provide minimal sight to blind people • Cochlear implant to provide sound to deaf people • Functional stimulation to enable muscles to be activated when the nervous system has failed. Examples include upper limb motion, bladder and bowel control.

The development of intelligent medical devices like those described above requires the integration of a range of core technologies. At the generic level, these are equally applicable to a range of diagnostic systems and intelligent implants that could be envisaged within the next twenty years.

These include: • Wireless communications, in and on the body • Mobile communications • Power sources, implantable for in-thebody applications • Biomaterials, particularly for in-thebody applications • Nano and micro-systems and nano electronics, particularly to provide nerve stimulation within the body The 2 electrode designs shown in images 4 and 5 utilise micro and nanotechnology, with both having features in the order of microns, substrates down to 10 microns and electrode density constantly being driven down in order to improve the performance of the implant. For example the modulus electrode shown in figure 4 is used to trigger the nerves in the inner cochlear stem to improve hearing whereas the electrodes in image 5 are used to trigger the ganglion cells at the back of the retina.

It needs to be recognised and understood that whilst generic technology development is an essential part of any early stage R&D project, once the work progresses to the detailed design and fabrication level the work becomes product-specific. For example, the electrodes in images 4 and 5 use different substrate materials, the electrode structure and topology is different as are the interconnects to the electronics. Thus generic technology development can only be taken so far before specific design and fabrication work is required.

The Healthy Aims project is an excellent example of how a selection of key

people across Europe can form together to turn an academic road map for implants and diagnostic equipment into reality. A limited amount of core technology development is included. However, the majority of the work is focused on the integration of technologies to produce new medical products that are suitable for pilot clinical trials.

In the future, in order to be able to build upon the work already under way in the medical sector and generate critical mass in the area of medical care strong leadership from major medical organisations and national governments across the EU and worldwide is required. Infrastructures need to be put in place that can handle data from a range of sensor systems, medical implants and in the future drug delivery systems. Formulating strategies at the international level will stimulate demand for new systems and encourage innovations across the medical sector. For this to be done effectively and efficiently, road maps should be developed for both the ‘Business systems’ and the ‘Products’.

Image-4

Image-5

This approach is now being recognised within the EU as necessary when addressing major challenges such as the ‘Future healthcare in Europe’ and leading technologists and business groups are formulating their own future strategies around such models.

The questions yet to be answered are based around how well the technologists, clinical experts, purchasing groups and national bodies can work together to enable medical systems that are technically feasible to be commercially available within the next twenty years.

References: 1 Healthy Aims is a 26M€ EU funded project under the IST FP6 programme. It has 27 partners from across the EU, six of whom are SMEs. www.healthyaims.org 2 BalanceMaster is the trademark for the equipment shown. www.balancemaster.co.uk 3 Biomed Health Technology Co-operative is an organisation of patients and carers, health professionals, industry and academia concerned with improving continence management of elderly and disabled people. www.biomedhtc.org.uk

w w w . a s i a n h h m . c o m 61

Product Showcase COMPANION III

T

he Companion III is an advanced Transcranial Doppler system that provides non-invasive assessment of blood flow in the major arteries in the brain and throughout the body, including evaluation of numerous neurologic vascular problems such as vasospasm, and intra-cranial stenosis. The portability and light weight of the Companion III make it extremely valuable in the ER, OR and bedside locations in the hospital, clinic or in everyday office use.

The system has an integrated TFT and a convenient touch screen control panel. Data acquisition is done easily via our latest version 3.7 of WinTCD software and NicVue patient database. Data storage is a breeze with a sizeable hard drive and an integrated CDR/RW drive. The Companion III offers you everything you could ask for in a portable TCD machine: probes ranging from 1.6 to 20MHz, color M-Mode display, pre-programmed diagnostic protocols or advanced monitoring and trending capabilities.

PIONEER TC8080

O

ur Pioneer TCD system allows non-invasive assessment of the major arteries at the base of the brain as well as most arteries throughout the body. Transcranial Doppler applications include: detection of intra-cranial stenosis, detection and serial tracking of vasospasm, evaluation of Patent Foramen Ovale (PFI), intra-operative monitoring for changes in blood flow or potential embolic events during cardiac and Carotid artery surgery. Stand out features on the Pioneer include up to 4 simultaneous channels of Doppler, multi-depth options, the original SoundTrakTM utility, power and color Doppler M-Mode and a choice of quality 1.6, 2, 4, 8, 16 and 20MHz to suit practically every Doppler requirement.

The Pioneer operates on Windows XP using the latest version 3.7 of our proprietary WinTCD software. Networking capabilities and our exclusive NicVue patient management software allow communication with other VIASYS products for seamless data integration of multiple systems and labs. The Pioneer is powerful and flexible yet remains user friendly.

VasoGuard II

V

asoGuard II non-invasive vascular testing system delivers features you will not find elsewhere: Transfer Function Index (TFI), QuickConnect arm for cuff attachment, up to 10 channels of simultaneous Pulse Volume Recording (PVR) measurements and fourchannel PPG probes operating simultaneously. Our proprietary software makes the VasoGuard easy-to-use, combining intuitive commands with on-screen instructions and an on-line manual. All requested calculations for Doppler spectral waveforms appear on the screen at the touch of a button: rise time, maximum frequency, maximum velocity, pulsatility index and resistance index.

VasoGuard Autopick function allows the user to automatically select the moment when the pulse returns in a pressure study making the test virtually effortless. VasoGuard offers a variety of ways to store your data: a large hard drive and a built in CDR/RW drive. Networking capabilities, our exclusive NicVue patient management and Reader Station software allow for seamless data integration into HIS and remote review.

Further information Web: www.viasyshealthcare.com

62 Asian Hospital & Healthcare Management ISSUE-11 2006

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-tohospital-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

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 Web: www.zoll.com

Eliminate blood toxins with MARS®

T

he MARS® (Molecular Adsorbents Recirculating System) liver support therapy is a therapy for treating various types of liver failure. This procedure may be required in cases of acute liver failure, but also in cases of decompensation of a chronic liver disease.

In liver failure, blood detoxification carried out by the liver is severely compromised and albumin-bound toxins accumulate. The MARS® therapy permits the extracorporeal removal of these toxins via an albumin dialysate though a special membrane, thus eliminating them from the blood.

The MARS® system combines the benefits of extracorporeal renal substitution therapies with the possibility of removing albumin-bound substances: both water-soluble and albumin-bound toxins of small and medium size can be removed from the blood selectively and in a single step. To date about 5000 patients worldwide have undergone the MARS® Therapy with over 120 publications and 130 MARS® centres.

Further information Tel: +852 2576 2688 Website: www.gambro.com

Cefepime and Amikacin

C

ombination of these two different antibiotics act synergistically to provide total solution against multi resistant bacteria like P.aeruginosa, S.aureus etc. The main advantages of this combination: Wide range of bactericidal activity, better efficacy, safety, lesser dose, least nephrotoxicity, minimization in development of resistance, reduction in hospitalization time and cost. Our organization - VENUS REMEDIES is in grant of a patent for this drug combination as a single compound which can be administered parentally. Our product exists as a dry powder form which is reconstituted before injection with a suitable solvent, after reconstitution it is sterile, colourless to light straw coloured with pH in range of 3.5 to 6. It is preferably twice a day product depending on the patient condition and severity of infection, Average period of treatment is 9 to 10 days. It is provided in a sealed container such as transparent glass vial capped with appropriate halogenated stopper and seal.

Further information Web: www.venusremedies.com

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Products & Services Company

Page No.

Anaesthesiology Gambro China 16 Mediaid Inc 53 Medima Ltd 19 Synthes Asia Pacific IBC2 Unomedical Pty Ltd 51 Cardiology Eurosets s r l Gambro China Venus Remedies Ltd Viasys Healthcare Inc ZOLL Medical Corporation

39 37 02 OBC3 04

Diagnostics Gambro China Lifecare Surgical Instruments MFD Diagnostics GmbH PhenixVision Qiagen Sdn Bhd Radpharm Scientific Synthes Asia Pacific Viasys Healthcare Inc

37 24 IFC1 32 30 33 IBC2 OBC3

Facilities & Operations Akyol Medical Textile Co Ltd APS Medical Dometic S.à.rl

23 21 06

Company

Page No.

Elekta Ltd Faber Medi-Serve Sdn Bhd Gambro China Medima Ltd MFD Diagnostics GmbH Radicare (M) Sdn Bhd Synthes Asia Pacific Unomedical Pty Ltd Venus Remedies Ltd

26 49 37 19 IFC1 47 IBC2 51 02

Healthcare Management Banyan Hope Sdn Bhd Faber Medi-Serve Sdn Bhd Messe Düsseldorf China Ltd Saeplast Asia Ltd

09 49 11 06

Oncology Elekta Ltd Venus Remedies Ltd

26 02

Surgical Speciality Akyol Medical Textile Co Ltd APS Medical Dometic S.à.rl Eurosets s r l Gambro China Lifecare Surgical Instruments Medima Ltd

23 21 06 39 37 24 19

Company

Page No. IBC2 02 OBC3

Synthes Asia Pacific Venus Remedies Ltd Viasys Healthcare Inc

Technology, Equipment & Devices Apel Co Ltd 45 APS Medical 21 Dometic S.à.rl 06 Ekol Medikal 44 Elekta Ltd 26 Eurosets s r l 39 Gambro China 37 Lifecare Surgical Instruments 24 Mediaid Inc 53 Medima Ltd 19 MFD Diagnostics GmbH IFC1 PhenixVision 32 Qiagen Sdn Bhd 30 Synthes Asia Pacific IBC2 Toha Plast Gmbh 41 Unomedical Pty Ltd 51 Venus Remedies Ltd 02 Viasys Healthcare Inc OBC3 ZOLL Medical Corporation 04 Information Technology Gambro China ZOLL Medical Corporation

37 04

Suppliers Guide Company

Page No.

Company

Page No.

Company

Page No.

Akyol Medical Textile Co Ltd www.eurodrape.com

23

Gambro China www.gambro.com

37

Radicare (M) Sdn Bhd www.radicare.com.my

47

Apel Co Ltd www.apel.co.jp

45

Lifecare Surgical Instruments www.lifecaresi.com

24

Radpharm Scientific www.radpharm.com.au

33

APS Medical www.apsmedical.com.au

21

53

Saeplast Asia Ltd www.saeplast.com

06

Banyan Hope Sdn Bhd www.banyanhope.com

09

Mediaid Inc www.mediaidinc.com www.optosystems.com.sg www.osteomed.com.my

Synthes Asia Pacific www.synthes.com

IBC2

Dometic S.à.rl www.dometic.lu

06

Medima Ltd www.medima.com.pl

19

Toha Plast GmbH www.toha-med.de

41

Ekol Medikal www.ekolmedikal.com

44

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

11

Unomedical Pty Ltd www.unomedical.com

51

Elekta Ltd www.elekta.com

26

MFD Diagnostics GmbH www.mfd-diagnostics.com

IFC1

Venus Remedies Ltd www.venusremedies.com

02

Eurosets s r l www.eurosets.it

39

PhenixVision www.phenixvision.com

32

Viasys Healthcare Inc www.viasyshealthcare.com

OBC3

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

49

Qiagen Sdn Bhd www.qiagen.com

30

ZOLL Medical Corporation www.zoll.com

04

To receive more information on products & services advertised in this issue, please fill up the "Info Request Form" provided with the magazine and fax it, or fill it online at www.asianhhm.com by clicking "Request Client Info"link.

1. IFC: Inside Front Cover

64 Asian Hospital & Healthcare Management ISSUE-11 2006

2. IBC: Inside Back Cover

3. OBC: Outside Back cover

Circle 25

Circle 26