Medical Device ASIA, May-June 2015

Vol.7 No.3 | May-June 2015 | New Delhi

Show Report!

THE WORLD’S LARGEST Healthcare Event - tHIS Hi-Tech logistics service

Future of India’s

Healthcare!

MEDICAL FAIR THAILAND 2015

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h i g h l i g h t s Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

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Vol.7 No.3| May-June 2015 | Annual Subscription: India: Rs.2000 ; Overseas: US$250

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Alex & Lilly - Netherlands

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Production Rakesh

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China Correspondents

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Utilization of major surgery in South India MEDICAL FAIR THAILAND 2015 A Big Success : The World’s Largest Healthcare Event tHIS Rhenus Logistics India launches Hi-Tech logistics service SOLED15–F Focusable LED lamp for examination and minor surgery Future of India’s Healthcare Tied To Homecare Xenex Germ-Zapping Robots Enhanced Cleaning Process FDA approves spinal cord stimulation system Adhesives and Material Technologies for Medical Applications Custom Cable, Tubing and Catheter Products Prolonged stress leads to multiple inner health problems Microneedles for Easy Delivery of Drugs into Eye Virtual Reality Hand Training with Haptic Technology Genteel Lancing Device for Pain-Free Glucose Testing Anywhere on Body Mobile medical app brings laboratory testing to the home FDA Encourages Medical Device Data System Innovation Ahead 100 device for detecting traumatic brain injury

Viscosupplementation market value will increase from approximately $1.76 billion in 2014 to a little under $2.64 billion by 2021 In addition to the US, the Asia-Pacific region represents a promising avenue for volume growth in the viscosupplementation sector, says analyst Viscosupplementation Market Value to Exceed $2.6 Billion by 2021, says GlobalData The viscosupplementation market value will increase from approximately $1.76 billion in 2014 to a little under $2.64 billion by 2021, across the ten major markets (10MM) of the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, and India, with the US continuing to hold the largest share, says research and consulting firm GlobalData.

The company’s latest report* states that growth in the viscosupplementation space will be driven by strong healthcare infrastructure, well-established reimbursement, and aggressive marketing efforts from the supply side, as well as the trend towards early intervention and the soaring demand for nonsurgical osteoarthritis treatment.

According to Linda Tian, MSc, GlobalData’s Managing Analyst covering Medical Devices, in addition to the US, the Asia-Pacific (APAC) region represents a promising avenue for volume growth in the viscosupplementation sector.

Tian explains: “In Japan, the second largest viscosupplementation market, it is common for patients to have hyaluronic acid injections on a regular basis,

with the therapy prescribed at a fraction of the cost to that in the US and Europe.

“China has also contributed to the significant increase in APAC viscosupplementation procedure volume over the past decade, and still has a substantial underserved population. The large patient pool, which is finally gaining access to advanced medical treatment as healthcare reform reaches China’s rural regions, will be a key growth driver during the forecast period.”

While the 10MM are expected to increase in terms of both procedure numbers and revenues, the market in the five European countries (5EU: France, Germany, Italy, Spain, and the UK) is fairly mature and will experience slow expansion, according to GlobalData.

The analyst continues: “Drug spending in Europe is currently limited by a weak economic recovery, low population growth, and continued efforts to reduce the public debt.

“Surgeons’ dampened enthusiasm about viscosupplementation, along with reimbursement challenges and cost-containment pressures, will continue to negatively impact the 5EU viscosupplementation market expansion, which will be compounded by suppliers focusing on the fast-growing US and APAC regions.”

Medical Device ASIA | May-June 2015 | 3

Utilization of major surgery in South India A retrospective audit of hospital claim data from a large community health insurance program Cardiovascular surgeries (8%) alone accounted for 21% of cost. Annual per capita cost of surgical claims was US$1·49[95% CI: 1·32-1·65].

I

n an effort to bridge the information gap in utilization of major surgery in India, the George Institute for Global Health has audited hospital claims from the Rajiv Gandhi Aarogyasri Community Health Insurance Scheme (RACHIS) that provides access to free tertiary care for major surgery through state funded insurance to 68 million beneficiaries with limited household incomes, 81% of population in states of Telangana and Andhra Pradesh.

Publicly available de-identified hospital claim data for all surgical procedures conducted between mid-2008 and mid-2012 were compiled across all 23 districts in Telangana and Andhra Pradesh. Beneficiary households receive an annual coverage of INR 200,000[US$3333] for admissions to any empanelled public or private hospital.

The findings reveal that even when free or subsidized access to surgery is made available by the state, allied costs make utilization difficult. A paper detailing the findings was presented at the launch of the Lancet Global Commission on Surgery on Monday. Researchers from the George Institute studied claims in Rajiv Aarogyasri Community Health Insurance Scheme (RACHIS) that provides access to free tertiary medical care across Andhra Pradesh and Telangana A total of 677,332 surgical admissions (80% at private hospitals) were recorded at a mean annual rate of 259 /100,000 beneficiaries, excluding cataract and caesarean sections. Males accounted for 56 per cent of the admissions. Injury was the most common cause for surgical admission (27%) with surgical correction of long bone fractures being the most common procedure (18%) identified in the audit.

Diseases of digestive (16%), genitourinary (12%), and musculoskeletal system (10%) were other leading causes for surgical admissions. Most hospital bed-days were utilized for injuries (31%), diseases of digestive (17%), and musculoskeletal system (11%) costing 19%, 12%, and 11% of claims.

4 | May-June 2015 | Medical Device ASIA

“It came as a surprise to us that despite universal access, the uptake of surgery was still at the level of a low-income country,” said Dr. Vivekanand Jha, Executive Director, The George Institute for Global Health, India. “Just making a scheme available doesn’t automatically mean utilization will happen. There are a number of factors preventing uptake, including that the scheme only covers the cost of the surgery, while there are a number of steps before the stage of surgery that are not trivial in terms of their implication on cost, and the person needing to be away from his or her livelihood. They might live in remote areas, or other family members might be prioritized,” Dr. Jha said.

The findings suggest in economically poor populations, even with near universal access for major surgery, utilization continues to remain low, and at levels expected in countries with per capita health expenditure below US$100, and lower than a tenth of rates estimated at spending levels comparable to financial access provided [US$400-1000].

Hence, strategies beyond traditional financing for care are required to improve utilization of surgery in LMICs. This even as the Lancet reported today that five billion people globally do not have access to safe, affordable surgery and anesthesia when they need them. A third of all deaths in 2010 — nearly 17 million lives lost in all — was from conditions treatable with surgery, such as

appendicitis, fractures and childbirth complications, the researchers found.

The Global Surgery 2030 Commission, published in The Lancet medical journal and released early on Monday, was written by 25 experts in surgery and anesthesia, with contributions from more than 110 countries, including India.

Even among those who are able to access surgery, its costs often lead to financial ruin, the commission said.

A quarter of people worldwide who have a surgical procedure incur costs that they cannot afford, pushing them into poverty.

Cost then becomes a significant barrier. Using data from the nationally representative Million Death Study, researchers found that postal code areas with high incidence of acute abdominal mortality in India were more likely to be located further from a hospital capable of providing appropriate emergency surgical care than areas with low mortality. The odds only grew with distance from the hospital.

“In the absence of surgical care, common, easily treatable illnesses become fatal,” said Andy Leather, Director of the King’s Centre for Global Health, King’s College London, and one of the commission’s lead authors.

Scale-up of levels of access to surgery will need investment, the commission’s authors said. “Although the scale-up costs are large, the costs of inaction are higher and will accumulate progressively with delay,” the commission’s lead author, John Meara, Kletjian Professor in Global Surgery at Harvard Medical School and Associate Professor of Surgery at Boston Children’s Hospital, USA, said.

“Scale-up of surgical and anesthesia care should be viewed as a highly cost-effective investment, rather than a cost,” he said.

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MEDICAL FAIR THAILAND 2015

– The Biggest And Most Influential Show Yet Disposal Systems, Fabrics/ Laundry, Laboratory Equipment, Medical Furniture and Equipment, Medical Consumables, Ophthalmic Supplies, Pharmaceutical Supplies, Rehabilitation Equipment/ Orthopaedic Supplies, and many more.

MEDICAL FAIR THAILAND 2015 is the prefect platform to inject medical and healthcare businesses with the latest innovations, technologies, products and solutions of the global and region’s flourishing medical and healthcare industry.

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he International Exhibition on Hospital, Diagnostic, Pharmaceutical, Medical and Rehabilitation Equipment and Supplies will take place from the 10 – 12 September 2015 at the Queen Sirikit National Convention Center (QSNCC) in Bangkok.

Part of the globally recognised and leading medical and health care trade event under the Messe Düsseldorf group – MEDICA; MEDICAL FAIR THAILAND is supported by prominent Thai and regional government and industry trade associations, including the Thai Ministry of Public Health and the Thailand Convention & Exhibition Bureau (TCEB).

With 50% increase in floor space to approximately 15,000sqm, the exhibition will feature more than 600 worldwide and regional exhibitors. MEDICAL FAIR THAILAND receives strong support once again from the national groups and pavilions from Austria, Belgium, China, France, Germany, Japan, Malaysia, Singapore, South Korea, Taiwan and Thailand and UK. New pavilions and country

6 | May-June 2015 | Medical Device ASIA

groups from Canada, Italy, Turkey and the USA will be making their debut this year.

Expected to draw over 8,000 visitors this year – MEDICAL FAIR THAILAND has established itself as the No.1 event by industry professionals such as Biologists, Pharmacists, Doctors (Surgeries and Hospitals), Health Ministry Officials, Hospital Managers and Employees and Nursing Officers. Visitors will discover new medical and health care solutions from around the globe and can anticipate products and technologies in Accident and Emergency Equipment, Building Technology and Services, Communication and Information Technology, Dental Equipment and Supplies, Diagnostics, Disinfection and

Aside from live product & technical demonstrations, MEDICAL FAIR THAILAND’s concurrent events will reflect the pulse of the Industry.

Two new platforms on Digital Healthcare and Rehabilitative Care are one of the key highlights of the industry driven conferences, forums and workshop. Visitors will have the opportunity to network with attendees of the CIO Forum organized by Thai Medical Informatics Association and learn at ARTec 2015 organized by the Thai Rehabilitation Medicine Association.

The highly successful Advanced Rehab Technology Conference returns at this year’s edition with a focus on ‘A New World in Rehabilitative Care’.

Visitors are encouraged to preregister, in order to benefit from a Business Matching service, that will assist in connecting industry professionals to relevant key exhibitors prior to the their visit.

Admission and pre-registration is free for all involved in the medical and healthcare industry.

For more information and preregistration, please visit www. medicalfair-thailand.com v

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Expanding the Care Continuum through SMART Homes and Intermediate and Long-Term Care (ILTC) Services HOW AGED WILL SOUTH EAST ASIA LOOK IN 2030?

SINGAPORE 2 working citizens supporting 1 elderly (2015: 4.9 workers to one elderly) MALAYSIA Will become an ageing population country, with 4.9 million (~15% of its population) 60 and above THAILAND Over 13 million (~19% of its population) will be 65 and above PHILIPPINES Over 14 million (~11% of its population) will be 60 and above INDONESIA 6.4 working citizens will support one elderly. (2010: 13 workers to every older person)

With pressing challenges bearing down on Asia such as rapidly ageing populations, shortages of hospital beds in acute care settings as well as low accessibility to care in rural regions, SMART homes and Intermediate and long-term care (ILTC) services enable remote care and take pressure off hospitals by expanding the care continuum through services such as step-down care. They are emerging trends that are here to stay.

SHORTAGE OF HOSPITAL BEDS AND LONG WAIT TIMES IS A GLOBAL ISSUE CHINA: In China, it is very common to see people waiting for hours in hospitals to see doctors. Now four provinces are introducing medical reforms to help deal with long wait times.

For example, top hospitals in Anhui have cut registration numbers by half and are sending experienced medical staff to smaller institutions in order to reduce workload, prevent overcrowding and provide better service for patients.

(Source: CCTV-America) GREAT BRITAIN: A&E waiting times in England are the worst in a decade. While the government has set a target of 95% of patients to be treated or discharged within four hours, the latest figures for Q1 2015 show that this target has been missed by the biggest margin in a decade at 91.8%. (Source: The Guardian) AUSTRALIA: Canberra Hospital’s emergency department has reported in March 2015 that they have close to 28 people waiting for treatment at one time, with some being treated in nursing corridors. ACT Health’s first quarterly report for 2014-15 also found that the waiting times at Canberra and Calvary hospitals’ emergency departments have increased on an average from 39 minutes to 49 minutes.

(Source: Canberra Times)

LOW ACCESSIBILITY TO CARE IN RURAL AREAS

50% of the World’s Population Live in Rural Areas, but Fewer than 38% of Nurses and 25% of Doctors Work There – UN World Health Organization

China: 80% of government health expenditures go to urban areas, but only 45% of China’s population lives there.

Myanmar: In rural areas – where 70% of the country’s 58 million people live – patients travel hours and sometimes an entire day to reach hospitals or clinics in towns.

Philippines: Twenty-four babies die for every thousand infants born in the urban areas, while the infant-mortality rate in rural areas is higher by 50 percent: 36 babies die for every thousand live births.

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A Big Success : The World’s Largest Healthcare Event - tHIS The 2015 Health Industry Summit (tHIS), an event that is predicted to transform the Chinese healthcare industry sector, ended successfully on 18th May, which witnessed a breathtaking crowd of over 210,000 visitors from 150 countries.

Held at the brand new National Convention & Exhibition Center in Shanghai, tHIS is a large-scale healthcare event that combines China’s three top medical equipment and pharmaceutical exhibitions CMEF, PHARMCHINA and API China into one mega healthcare event, in doing so completing the entire value chain for the health industry.

The exhibition occupied a total area of 290,000 sqm of exhibition space and showcases the latest cutting edge medical equipment and equipment manufacturing solutions, pharmaceutical formulations and ingredients, manufacturing technologies, natural health and nutrition products from over 6,800 exhibitors.

Well-known healthcare equipment giants like GE, SIEMENS, Philips, Mindray, and United Imaging had specially designed stands that served as a backdrop for the launch of the hundreds of new to market products, with GE Healthcare unveiling its Revolution CT 10 | May-June 2015 | Medical Device ASIA

imaging series, Mindray, with its flexible POC ultrasound system ‘mobiEye 700’, and ContextVision with GOPICE 2.0 software for imaging among a flurry of launch activities. Global Senior Vice President of GE/ President and CEO of GE China Ms. Rachel

Duan Shares her view on the event’s success: “Medical & healthcare equipment manufacturers highly value this platform, all bringing with them the latest and best technology to showcase. All the leading companies in the industry are here, all of the top industry talents are

here, there lies the explosive popularity of the event.”

Meanwhile, anticipating a huge turnout and with a focus on APIs and formulations, China’s top pharmaceutical manufacturers and distributors were ready to welcome tens of thousands of domestic and international buyers, while fast-growing market segments such as natural health and nutritional products represented by Natural Health and Nutrition China have seen participation double in size, and the medical device manufacturing show ICMD has seen unprecedented 300% growth in exhibitor participation.

Organizer Reed Sinopharm, a joint venture between the world’s leading event organizer Reed Exhibitions and China’s leading stateowned pharmaceutical group Sinopharm, used their combined strength of international networks and industry connectivity to write a new chapter for China’s healthcare industry, as it transforms from localized industry developments into a maturing market with global reach.

conference mix, covering all the key fields and industry topics, with major conferences including the China Integrated Medical Imaging Summit, Asian Nuclear Medicine Academic Forum and Sino-Europe Pharmaceutical Forum.

Reed Sinopharm commented that tHIS will be held annually in Shanghai every spring and the event is anticipated to become the key platform to define the future trends of the healthcare sector in China and the world.

The next edition of the Health Industry Summit takes place from the 15-18 April in 2016.

For more information, please contact: James Wang, james.wang@reedexpo.com.cn; Sophie Zhang, jing.zhang@reedsinopharm.com

According to a state-issued strategic whitepaper in 2013, China expects the total market size of its health sector to triple to a massive USD 1.2 trillion by 2020. This growth potential in China is partly attributable to its growing ageing population, expected to account for more than 30% of the total by 2050. This coupled with increasing urbanization and the further loosening of the one-child policy will ensure a boom in the birth rate, putting the current health system and hospital facilities under strain.

Furthermore, the new top level investment forum - Healthcare China heads a grand list of 107 conferences which completes the expo and Medical Device ASIA | May-June 2015 | 11

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India’s definitive exhibition & conference on products & services that aid the inclusion of differently abled

19-20-21 November 2015 Bombay Exhibition Centre, Goregaon (E) Mumbai, Maharashtra

Highlights 150+ exhibitors from across the world Eminent speakers at 2 day Asia Rehab Summit Knowledge support from leading sectoral associations Intensive skill development workshops for professionals in the sector Training sessions for the differently abled and their families

www.IndiaRehabExpo.com

For more details, contact : Japesh Thakur +91 9599389544 japesh@infinityexpo.in

Rhenus Logistics India launches Hi-Tech logistics service • •

End-to-end logistics management of high-end equipment available as a one-stop solution for the first time in India German major commits technology support and know-how transportation besides last-mile support and after sales service.

Vivek Arya, Managing Director of Rhenus Logistics India mentioned that “The market in India is growing rapidly and the customer is demanding better handling of such equipment. With the government’s vision expressed through ‘national health assurance mission’, we expect the demand to increase exponentially. In banking, it is expected that over 4,00,000 ATM machines are to be installed in near future.”

Sharing a lot of cases where the Hi-Tech arm of Rhenus Logistics has played an important role, Andreas Pistner, Regional Director, Hi-Tech Logistics, added, “India runs a huge investment programme to modernize existing infrastructure. Personally I am very impressed by the way India is trying to address her logistics challenges such as building roads, ports, etc. For a logistics player to succeed here, you need a perfect blend of global expertise and local knowledge’

T

he Indian arm of the German world leader Rhenus Logistics, today introduced its renowned Hi-Tech logistics in India. The services include an integrated offering to manage transportation of sophisticated machines like ATMs, computer servers, data centers, medical diagnostic machines such as the CT Scans, MRI Scanners, X-Ray Machines, etc. The new service from Rhenus Logistics offer end-to-end solutions and include suitable packaging, transportation from seller’s factory to the nearest port, shipping into India, upto the installation and training in the buyers premises. Since most of such products are imported, the Hi-Tech logistics is addressing a huge gap in the specialised transportation and delivery. This level of integration is being offered for the first time in India. The launch comes immediately after the teaming up of India and Germany during the Hannover Fair and the visit of Prime Minister Narendra Modi to Germany.

Rhenus Logistics is currently giving prominence to healthcare sector and plans to extend its services for banking, retail, fitness & wellness, IT and data storage industry, immediately.

“India is one of the rapidly growing market for high-tech and sophisticated technologies in the world. We see a great potential in handling logistics of high value products,” says Michael Boos, Managing Director of Rhenus Midi Data (Hi-Tech Logistics division in Europe).

Rhenus Logistics will use modern fleet of vehicles which will be specially designed to transport the high value equipments. Rhenus Logistics has been training technicians past two years help them become certified engineers, especially for their medical customers. The Company will offer the entire supply chain solutions, including custom clearance, warehousing and

14 | May-June 2015 | Medical Device ASIA

About Rhenus Midi Data:

Digital applications dominate the lives of many people in western industrial nations and developing countries too. High-resolution information displays at railway stations and cinemas, highly complex medical engineering devices, integrated solutions in the banking and trading sectors and many other hightech products are used to improve living conditions in a wide variety of fields.

The logistics services provided by the Rhenus Group in the high-tech sector therefore go far beyond just transport and warehousing operations because of the complexity of the processes needing to be handled.

Rhenus Midi Data, which is part of the corporate group, is one of the pioneers in this special field of the logistics market. The high-tech logistics specialist has been working closely with its customers and offering them perfect solutions since the late 1960s – and this guarantees that products are handled carefully during every phase: from delivering the goods to installing and commissioning them or servicing and repairing them and even disposing of old devices. But Rhenus Midi Data not only provides innovative transport and technical services: it also offers a wide variety of value-added services to complete its product portfolio.

About Rhenus Logistics India: Rhenus Logistics, an integrated Logistics Company has an annual turnover of Euro 4.2 billion globally. In India, Rhenus is a Joint Venture with the “Arya” Family which has been in the business of Domestic Transport & logistics services for over six decades.

Rhenus India is an ISO 9001:2008 certified company and is active in all modes of transport which is road, rail, air and ocean. They also provide Customs Brokerage, Project Logistics & Warehousing Services to their customers through both dedicated and shared facilities. Their services cover the entire process chain; from procurement of raw materials to distribution of finished products. They also provide in-plant services by helping their customers outsource some of their internal processes.

Currently Rhenus Group in India employs more than 1000 employees across 50 locations in the country and are growing over 50% year on year. With professionally qualified employees across verticals, Rhenus India provides logistics solutions for a large variety of shipments encompassing almost all industry segments including chemicals, petro- chemicals, automotive, pharmaceuticals, electronic goods, etc..

Rhenus employs over 24,000 people at more than 390 locations worldwide. The Rhenus business areas – Contract Logistics, Freight Logistics, Port Logistics and Public Transport – manage complex supply chains and provide a wealth of innovative value-added services.

For further details, please visit - www.rhenus.com

SOLED15–F Focusable LED lamp for examination and minor surgery

increasable up to 77.000 lux (small spot light beam) and a low power consumption (24 W).

The LEDs layout gives a visual comfort and produces a uniform, homogeneous and shadowless light.

SOLED15–F is the focusable LED examination light for diagnostics, minor surgery and universal applications.

It can be used for minor precision surgery, intensive care, recovery room, first aid, cosmetic surgery and dental sector. Soled15-F supplements the Starled Series range of lamps manufactured by ACEM Medical Company. SOLED15 – F contains all the advantages of LED technology and is suitable for multi purpose uses thanks to its flexibility.

It assures: • excellent light intensity • IR-free light beam • colour temperature (CCT) of 4.500°K • colour rendering index (CRI) of 95 • long life • low power consumption SOLED15-F grants a uniform distribution of light and can focus the light beam with a perfect illumination both on the surface and in depth providing the operator with the best working conditions.

The high technological level combined with the use of high-powered LEDs allow the lamp to have a very linear yield and a negligible performance decay for its entire life duration.

SOLED15-F has a light intensity of 50.000 Lux (large spot light beam)

SOLED15-F has a round shape that makes it handy and functional both in use and move.

Its easy-to-move structure is suitable for diagnostics, test labs and dental surgery and its easy-to-grip removable and sterilizable handle makes it suitable even for critical sanitary applications.

SOLED15-F is provided with an I-Sense@ touch panel to control all the functions of the lamp: • ON/OFF • Light intensity adjustment • Light beam focusing This last function makes SOLED15-F particularly suitable for applications in the dental sector, minor surgery, gynecology where a focused and deep illumination is required.

SOLED15-F is available in the following versions: Ceiling mounted (single or double configuration) , Wall mounted, Trolley mounted (with ABPS battery on demand) For more information, please contact: ACEM SpA Medical Company Division Via della Tecnica 29 - 40050 Argelato Bologna – ITALY Ph +39 051 721844 Fax +39 051 721855 Email: info@acem.it Website: www.acem.it Medical Device ASIA | May-June 2015 | 15

Excellent Atmosphere at the MEDICAL FAIR INDIA 2015 in New Delhi Medical Trade Fair registers in excess of 10,400 Trade Visitors

I

n excess of 10,400 international trade visitors, i.e. some 2,400 more than at the previous event, visited the Pragati Maidan exhibition centre to learn about product innovations in the Indian health care sector from 21 to 23 March. However, the MEDICAL FAIR INDIA 2015 not only scored outstanding results in terms of visitor attendance. Exhibitor figures have also been on the constant rise over the past few years. At this event 447 exhibitors from 18 countries presented a comprehensive product portfolio on net exhibition space that has now risen to over 5,250 m². 289 exhibitors from abroad underscored the international importance of the MEDICAL FAIR INDIA, which is held alternately in New Delhi and Mumbai every year. ”Medical Fair India is a one of its kind medical and healthcare event offering an ideal international platform to the medical and healthcare industry. It is on its way to becoming the most successful and exceptional exhibition to showcase medical technologies,” summed up Rajiv Nath, Chairman of AIMED, the Association of Indian Medical Device Industry.

This year the medical trade fair focalised the new segment “Hospital Infrastructure” and kicked off with an accompanying technical conference on the focal themes “Hospital Infrastructure & Planning” and “Medical Device & Technology”. Comprising high-calibre lectures and panel discussions the conference agenda offered decision-makers from clinics, medical professionals, retailers and industry and healthcare agents an ideal platform to learn about trends and network with experts. In addition to the conferences

16 | May-June 2015 | Medical Device ASIA

independent workshops allowed the exhibitors to present themselves to the visitors of the MEDICAL FAIR INDIA 2015.

The event benefited from the booming Indian health market which experts expect to grow to US$ 280 billion by 2020. Especially in the innovationdriven and export-oriented field of medical device technology India is developing a key position to which the Government reacted by drafting a new bill on standards in medical device technology.

Dr. Pradeep Bhardwaj, CEO of the Six Sigma Accreditation Board company from Delhi, praised the importance of the event for the Indian health business: “Nice to see the power of the 21st Medical Fair – 2015 in New Delhi, India. Really, this medical fair was an international platform, which has opened up new opportunities in the healthcare industry. The entire medical fair including awards, conferences and exhibitions was highly useful for every hospital, medical device company and diagnostics. I am proud of seeing this event as one of the largest medical fair in healthcare.”

Group, JETRO, Japan External Trade Organization, KMDICA, Korea Medical Devices Industrial Coop. Association, MIRDC, Metal Industrial Research & Development Centre from Taiwan, MREPC, Malaysian Rubber Export Promotion Council, SAMD, Shenzhen Association of Medical Devices, SPECTARIS as well as ZVEI, German Electrical and Electronic Manufacturers’ Association.

The trade fair comes with the MEDICAL FAIR brand that has been synonymous with well-established medical trade fairs organised by Messe Düsseldorf Group abroad. The growing success is also fuelled by the close cooperation with the Düsseldorf-based MEDICA, World Forum for Medicine, which paved the way for dialogue with other important target groups for the Indian market.

The next MEDICAL FAIR INDIA will be held in Mumbai from 11 – 13 March 2016. For further information go to: http://www.medicalfair-india.com

The leading trade magazine for medical professionals in India, Medgate Today, for the first time recognised particularly excellent enterprises, hospitals and physicians as part of the 21st MEDICAL FAIR INDIA. The renowned MT India Healthcare Award was awarded to fourteen Indian companies and individuals. Trade fair visitors included numerous top opinion-leaders from healthcare as well as well-known personalities such as Prof. Dr. Wali, Physician to the President of India, Shailendra Kumar, Director of the Ministry of Health & Family, Government of India, Prashant Kumar, Ministry of Communications & Information Technology, Government of India, Jürgen Maerschand, Government of Flanders, T.S. Srinivasan, Embassy of Belgium and Jan Luykx, Ambassador of the Kingdom of Belgium.

The MEDICAL FAIR INDIA 2015 was supported by national associations such as admi, Association of Diagnostics Manufacturers of India, AHPI, Association of Healthcare Providers India, MSAHITA, Medical Surgical and Healthcare Industry Trade Association, Indian Association of Sports Medicine, Indian Association of Physical Medicine and Rehabilitation and the hospitals Apollo Hospitals Group and Fortis Healthcare Limited.

The international partners attending included abhi, Association of British Healthcare Industries, CCCMHPIE, China Chamber of Commerce for Import & Export of Medicines & Health Products, Federal Ministry of Economic Affairs and Energy (BMWi), GHE, German Healthcare Export Medical Device ASIA | May-June 2015 | 17

Future of India’s Healthcare Tied To Homecare Private participation in healthcare has undoubtedly helped improve the overall situation in India. However, the ever-increasing population of the country, especially the burgeoning elderly count, will make things difficult going forward, putting strain on healthcare facilities, both state-run and private entities. Homecare, a proven concept in the West, holds promise in easing out the country’s future healthcare burden, writes Dr Gaurav Thukral, Head Medical Services, HealthCare at Home.

Attending to the healthcare needs of the 1.2 billionpopulation of the country is a herculean task. With population bomb ticking and the number of elderly people increasing substantially, the burden is only set to compound. Several healthcare policies devised by the government reflect its intent to give a fillip to the sector and provide quality care to its citizens. Though situation looks rosy on paper, the reality is different on ground.

The country is facing innumerable health challenges and is staring at crises particularly related to cancer- and cardiac disorders. Hospitals in metropolitan cities and big towns are teeming with patients who travel from far corners of the country in search for high-end healthcare facilities.

While, participation of private sector has improved the condition by several notches, the burden is too gigantic to handle. Beds are either full, leaving no space for other 18 | May-June 2015 | Medical Device ASIA

patients in dire need, or hospitals bills are too high for the patients to afford. Patients find themselves in lurch and the government is struggling to find a concrete plan.

When World Health Day is being observed across globe on April 7, there is an urgent need in India to provide quality and cost-effective care to patients. Amidst the clamor for creating a patient-friendly healthcare set-up, many forces at public and private sector level need to work in tandem to achieve the goal.

Homecare services can play a significant role in perking up the sagging condition of healthcare in the country. The high-end services being provided by homecare providers, like HealthCare at Home, addresses one big major issue of creating capacities in hospitals, among several others.

After preliminary treatment at

hospitals, patients can get further treatment at their homes which is on a par with the care being provided at the hospital. While such facility empties beds in hospitals, for patients too it is affordable as it cuts down various indirect expenditures, including the cost of hospital stay and travelling to and fro to hospitals.

At HealthCare at Home, at all times the doctor is kept in loop and the treatment is led by his/her prescription only. Due to this the patients’ doctors have a complete control over the treatment and at the same time they can focus on others patients in hospital.

Homecare services can change the way healthcare is delivered in India.

Healthcare needs to be patientcentric, which benefits them in more way than one. Providing treatment, along with mental peace, is the need of the hour. Homecare services offer these twin benefits simultaneously.

Homecare Services – the way forward!

The home care market in India is valued at $2 billion and is growing at 20 per cent annually, according to Pricewaterhouse Coopers (PwC). Rise in income levels and awareness about diseases and its care is swinging the pendulum in favor of patient care to home than in hospital.

Creating capacities: As per a 2012 report by McKinsey and CII, the hospital bed density (per 1000) stands at 1.3 in 2010 against the World Health Organization’s standard of 3.5. Due to non-availability of beds, patients remain devoid of treatment, and in severe cases succumb to the diseases. The availability of home care creates capacities in tertiary hospitals. Post a major-surgery or when a patient is staying at hospital for the sake of care which can be easily replicated at home, then he/she is occupying a bed which can be used by a critically-ill patient. The availability of world-class care at home addresses this concern to a great extent.

Access to care: In India, patients move to metropolitan cities and towns from far and beyond for getting the treatment done due to lack of quality healthcare infrastructure at the respective places. After the initial treatment, they continue to stay in hospitals for further treatment and care which could be handled at home if there are proper channels and arrangements for the same.

The scenario is challenging. Homecare services successfully plug such loopholes. For example, HealthCare at Home

at all times keep treating doctors in the loop and the treatment which is carried by it is led by their prescriptions only. Doctors are kept updated about the patients’ conditions, so the treatment is your doctor- driven. Homecare services bring high-end care to the doorsteps and increases the access to quality healthcare facilities even beyond the metros.

Cost effective: Home care services are cost-effective as it reduces the burden of indirect expenditure on travel to hospital and spend on hospital bed, among others. There is continuous monitoring and so the chances of developing complications are remote, which at the same time cuts the probability of re-admission to hospital. Homecare services are 50-70% cheaper than hospitals.

Also, the services reduce the overall burden of disease on patient, family and hospitals.

Empowering healthcare manpower: The growth of homecare services market has expanded the horizon for healthcare professionals. As

homecare service providers are present in segments ranging from oncology (cancer care), pulmonology (lung care), post-operative care (orthopedics, to cardiac, bariatric -- weight loss surgery-- etc), critical care and palliative care, the scope for professionals in the respective fields has grown manifold. Even a 12th pass student can be trained to become a healthcare assistant. This helps in bridging employment issues as well.

It is providing an altogether new stream of growth to all healthcare providers.

Besides, the chances of contracting infections are higher in hospital than at home, so homecare facilities are much safer. The level of confidentiality is also high when a treatment is being done at home than at hospital.

When India is gaining ground as a medical tourism hub, serious measures are required to provide quality and affordable healthcare facilities to the citizens also. The concept of homecare facilities will turn out to be a big game changer.

Medical Device ASIA | May-June 2015 | 19

Recurrent Headaches: When to See a Neurologist?

Dr. A K Sahani, Sr. Consultant, Neurology, Indian Spinal Injuries Centre

than men suffer from intense bouts of pain, and continue to believe them to be just another form of headaches.

Migraine headaches are caused by a complex interplay of nerves, neurotransmitters and blood vessels in the brain. By interfering with the normal functioning of the central nervous system, such headaches cause much discomfort in the body.

H

eadaches are one of the most common health problems we experience in our daily lives. Given the high paced, stressdriven, unhealthy and addiction laden lives we lead, occurrence of headaches is not an uncommon phenomenon. Most of us experience headaches once in a while. While some pains abate on their own, others force us to gulp an over-the-counter painkiller.

Headache is a non-specific symptom, and can arise due to several possible causes. It is often difficult to tell why you are suffering from a headache at any particular point of time. The causes may be anything benign or serious ranging from stress, skipping of a meal, sleep deprivation, fatigue or recreational drugs. Headache is common when a person is suffering from a viral infection or common cold. Often, headaches also occur due to an eye condition or vision problem. Getting your eyes examined and correcting your lens’s refractive index can alleviate such a pain. When a sinus becomes inflamed, often due to an infection, it can cause headache too.

Other factors associated with frequent headaches include depression, stress or anxiety, sleep disturbances, excessive weight and heavy dependence on stimulants such as caffeine and nicotine. People who are addicted to smoke also experience headaches if they refrain from cigarettes or attempt to quit smoking.

Medication overuse or rebound headaches are another form of pain which happen to people who indulge in excessive consumption of painkillers.

Another common form of headaches is tension headaches. They exhibit in the form of a constant pressure of tension in the head or the neck. They are sometimes caused by excessive stress, and resulting contraction of the muscles and nerves in the neck, back and head.

More often than often, a headache once a while is not a serious concern, and can be cured by ensuring rest. However, there are several instances when a headache can be due to a more serious underlying cause, and needs medical intervention.

In India, people have a habit of taking headaches lightly and self-treating them with over-the-counter analgesics, even when the pain is recurring and causing discomfort and loss of productivity. In fact, we come across people who have been living with chronic migraine for several years without seeking medical attention due to lack of awareness. In case of migraine, more women 20 | May-June 2015 | Medical Device ASIA

Lack of awareness also means that the society remains indifferent and unsympathetic to the condition of the patients suffering from such a neurological disorder. Even family members may be disdainful or apathetic, often refusing to understand the condition.

The question many ask is when shall a headache be reported to a doctor?

Some of the serious conditions that may cause headaches of concern include infections such meningitis, brain tumor, stroke, brain hemorrhage ( sub arachnoids hemorrhage due to rapture of abnormal blood vessels), an inflammation of the blood vessels inside the brain, migraine or a head injury.

Here is when headaches should be taken seriously and reported to a neurologist: • If a headache occurs after a head injury, it has to be taken very seriously. In some cases, it might

be just a minor concussion but it may also be an indication of serious trauma inside the brain.

• A headache associated with symptoms such as dizziness, loss of balance, numbness in limbs, blurred vision or speech difficulty may indicate a brain stroke. Such a condition needs emergency medical help.

• If headaches are becoming too frequent, they should be reported to a neurologist who will examine you thoroughly and may put you under a CT scan or MRI to rule out a serious issue. Frequent intense and long lasting headaches are often migraine.

• A headache accompanied by nausea or vomiting should never be ignored. Some migraine patients also experience nausea with throbbing pain. However, it may also indicate a worrisome development inside the brain.

• If you suffer a new type of unexperienced, excruciating headache suddenly at any time in your life, make sure you immediately visit a neurologist.

• People suffering from depression or severe anxiety also experience headaches. When accompanied by a change in personality or behavior, listlessness, a tendency to cry or persistent fatigue, it is advisable to visit a doctor. You might be suffering from depression.

Hematopoietic Progenitor Cells (HPC) Novel Parameter in Hematology Analyzer important resources. Since the introduction of the HPC software in 1997 in the high end Sysmex analyers, many studies of HPC determination versus CD34+ cell enumeration have been performed.

The HPC parameter serves as an inexpensive and fast alternative for quantification of the circulating HSC Cells.

P

eripheral blood stem cells (PBSC) are increasingly used to restore hematopoiesis as an alternative to bone marrow transplantation. It is important to determine the precise time for HSCs (hematopoietic stem cells) to be collected for a reliable, rapid and successful hematological recovery.

HPC and HSC express high levels of the cell surface glycoprotein,adhesion receptor CD34. The levels of CD34 expression decreases with cell maturation and differentiation.

Expression of CD34+ is thus a defininghallmark for hematopoietic stem cells (HSCs) andprogenitor cells (HPCs) in bone marrow (BM),peripheral blood (PB) and cord blood. An accurate quantification of circulating CD34+ stem cells is important to decide the optimal time for collection.

Flow cytometric enumeration of CD34+is the standard method of counting. The International Society of Hematotherapyand Graft Engineering (ISHAGE) gating strategy isused for CD34+ cell detection. An alternate method for quantification of circulating HSC minimizes the number of CD34 determination, thus saving

Sysmex Corporation, Japan offers the latest and best technology in hematology analyzers. Marketed in India, exclusively by Transasia Bio-Medicals Ltd., Sysmex offers a whole range of systems ranging from 3 to 6 Part Differential Analyzers.

Infact the newly launched Sysmex XN series is equipped with a White Precursor Cell (WPC) channel to differentiate abnormal lymphocytes and blasts by using the optical detection system and Fluoroscence flowcytometry.

A study (published in December, 2013, in the International Journal of Laboratory Hematology) conducted by the scientists at the National Cancer Center Hospital (Tokyo, Japan) concluded that the HPC count obtained on a Sysmex XN analyzer correlates accurately with the enumerated CD34 cells.

Cells expressing the CD34+ and hematopoietic progenitor cells (HPCs) were compared in 76 granulocyte colony-stimulating factor (G-CSF) mobilized blood or apheresis samples taken from 18 healthy donors and 6 patients undergoing autologous PBSCT. CD34+ cells were isolated using MACS magnetic cell separation kits (MiltenyiBiotec – BergischGladbach, Germany).

The investigators found a strong correlation between the numbers

- Kanchan Jeswani, Product Manager - Hematology, Transasia Bio-Medicals Ltd.

of HPCs and CD34+ cells. The expected total number of HPCs in the final product was estimated from HPCs in pre apheresis peripheral blood (PB) or mid apheresis product. This count was found to correlate well with the total number of CD34+ cells in the final products.

Moreover, the change in HPCs in PB closely resembled that of CD34+ cells during mobilization. Further, studies using immunomagnetic beads suggested that majority of CD34+ cells existed in HPCs, and vice versa.

antibodies • Sensitivity of flagging of blasts is enhanced in the WPC channel of the instrument. It gives a clear demarcation between the blasts and the abnormal lymphocytes.

• The total number of HPCs in the final products, as well as from pre apheresis PB and intermediate products during apheresis, can be used to predict the final amount of collected CD34+ cells.

• The detection and number of HPC in the peripheral blood could possibly provide a standard and rapid alternative for predicting the yield of stem cells collected by apheresis.

• HPCs may also be a good indicator to know the optimal timing for collection of the peripheral blood stem cells.

• The HPC count can thus be a useful potential parameter in optimizing timing for CD34+ enumeration prior to leukapheresis.

Figure 1- Caption- No HPC detected

Figure 2 –Caption- HPC detected

Conclusion • The Sysmex XN analyzer can carry out an HPC enumeration without the use of monoclonal

References: 1.

Bali Medical Journal (Bali Med. J.) 2014, Volume 3, Number 3: 112-115\PISSN.2089-1180, E-ISSN.2302-2914 www.balimedicaljournal.org or www.ojs. unud.ac.id 112 HEMATOPOIETIC PROGENITOR CELLS AS A PREDICTIVE OF CD34+ ENUMERATION PRIOR TO PERIPHERAL BLOOD STEM CELLS HARVESTING1Zefarina Zulkafli, 2Rapiaah Mustaffa, and 2Shafini Mohammed Yusoff 2.

Hemopoietic Progenitor Cell (HPC)Enumeration: A Comparitive Study betweenFlowCytometry and Sysmex XE2100Hematology Analyzer-Salem H. Khalil, Barbara GengJournal of Appplied Hematology 2010 3. http://www.bloodjournal.org/ content/122/21/2032November 15, 2013; Blood: 122 (21) 4.

December 27, 2013, in the International Journal of Laboratory Hematology.

Medical Device ASIA | May-June 2015 | 21

MedStar Franklin Square Medical Center Reduces C.diff Infections by 29%

Xenex Germ-Zapping Robots Enhanced Cleaning Process by broad-spectrum antibiotics and proton-pump inhibitors. A person with C. diff may contaminate their hospital room and bathroom, leaving C. diff spores on the walls, handles and other high-touch surfaces that can be easily transferred to the next patient or healthcare worker in that room.

A

recent Centers for Disease Control and Prevention (CDC) report provided a scary snapshot of the threats posed by antibiotic-resistant germs in the U.S., with special focus paid to pathogens such as Clostridium difficile (C.diff) – termed an urgent threat.

According to the report, each year in the U.S., at least two million people become infected with bacteria that are resistant to antibiotics and at least 23,000 people die each year as a direct result of these infections.

C.diff is a serious intestinal infection that can cause diarrhea, colitis and even death. Many hospital patients, especially those on antibiotics, are susceptible to C. diff, which can live for up to five months on surfaces in the hospital. Reproduction in a patient’s intestines is aided

22 | May-June 2015 | Medical Device ASIA

Xenex Disinfection Services’ patented pulsed xenon Full Spectrum™ ultraviolet (UV) disinfection technology has proven to quickly destroy the viruses, bacteria, mold, fungus and bacterial spores (like C.diff) that cause infections. A new study published in the Journal of Medical Microbiology in January 2015 demonstrated the efficacy of pulsed xenon ultraviolet light (UV) for reducing environmental C.diff contamination on high-touch surfaces in C.diff isolation rooms. In the last two years there have been 10 peer reviewed studies published confirming the efficacy of Xenex Germ-

Zapping Robots™ in the healthcare environment, including three studies showing a decrease in C.diff, MRSA and multi-drug resistant organism (MDRO) infections in patients when the hospital utilized the Xenex robot for room disinfection.

New data presented by MedStar Franklin Square Medical Center at the Healthcare Systems Process Improvement Conference demonstrates how the facility dramatically reduced its C.diff infection rate after it implemented a variety of infection prevention solutions including the use of Xenex germ-zapping robots to disinfect their patient rooms. According to the poster[1], in 2013, MedStar Franklin Square assessed its hospital acquired C.diff infection rates and set goals to reduce the rate from a baseline of 11.4 infections (per 10,000 patient days). They calculated that 88 C.diff infections were responsible for more than $572,000 in potential cost avoidance to the facility annually.

Analysis of the C.diff infections showed that 20 percent of the cases were resulting from a single unit within the facility.

After implementing a bundled infection prevention strategy, the facility was able to reduce C.diff infections on that unit by 64 percent (from 14.3 C.diff infections per 10,000 patient days to 5.1).

“We are extremely proud of our C.diff reduction results.

We were able to take the hospital unit with the highest rate of C.diff infections and make it one of the lowest in the hospital,” said Matt D’Agostino, BSME, LSSBB, Senior Operational Excellence Specialist at MedStar Health. “C.diff is a global problem and it’s our hope that sharing our C.diff infection reduction success story will educate other facilities about what they can do to achieve similar results in their hospital.”

MedStar’s multi-disciplinary Lean Six Sigma team identified three top causes of C.diff infections. First, precaution supplies were being used inconsistently because they were located in multiple locations and took too long to locate.

In response, they bundled the supplies for a C.diff patient into a single pack that the nurse could grab and take into the patient’s room. This cut the time to get supplies by 90 percent. Second was the overuse of broad-spectrum antibiotics. MedStar created an Antibacterial Stewardship Education program that educated doctors and empowered nurses and pharmacists to speak up about antibiotic usage.

This cut the facility’s broad-spectrum antibiotic overuse dramatically.

The third root cause of C.diff infections was human error in the room cleaning process. The team determined that there were numerous cleaning gaps (untouched surfaces), especially on high-touch surfaces like door knobs and light switches.

Recognizing that they had to destroy the C.diff spores before they could be transmitted to other patients and workers, the hospital began using Xenex’s pulsed xenon UV technology as part of their terminal cleaning process. The robot quickly

eliminates superbugs like C.diff in a five-minute disinfection cycle.

than 250 hospitals, Veterans Affairs and DoD facilities in the U.S. are using Xenex robots, which are also in use in skilled nursing facilities, ambulatory surgery centers and long term acute care facilities.

With this bundled approach to infection control, MedStar Franklin Square was able to reduce its C.diff infection rate by 29 percent facilitywide from a rate of 11.4 to 8.1.

“I am pleased that Xenex customers continue to experience and publish reductions in infection rates after using Xenex to disinfect the patient environment,” said Dr. Mark Stibich, Chief Scientific Officer of Xenex. “Our robots are proven to eliminate C.diff spores in less than five minutes. Hospitals like MedStar are example of the benefit to patients of a bundled approach to infection control that includes Xenex robots.

Xenex is proud to be a partner with MedStar in a shared mission to enhance patient safety and stop these unnecessary C.diff infections.”

Uniquely designed for ease of use and portability, a hospital’s environmental services staff can operate the Xenex robot without disrupting hospital operations and without using expensive chemicals.

With a five-minute disinfection cycle, the robot can disinfect 30-62 hospital rooms per day (according to Xenex customers), including patient rooms, operating rooms, equipment rooms, emergency rooms, intensive care units and public areas. More

The Xenex robot is the only UV disinfection technology that uses xenon, an environmentally-friendly inert gas, to create UV light. The intense, broad-spectrum light penetrates the pathogens’ cell walls, causing the DNA to fuse instantly, rendering them unable to reproduce or mutate. Xenex is the only UV disinfection provider that has hospital customers publishing infection reductions of greater than 50 percent in peer-reviewed journals.

About Xenex Disinfection Services Xenex’s patented pulsed xenon Full Spectrum UV room disinfection system is a pesticidal device used for the advanced cleaning of healthcare facilities. Due to its speed and ease of use, the Xenex system has proven to integrate smoothly into hospital cleaning operations. The Xenex mission is to eliminate harmful bacteria, viruses and spores that can cause hospital acquired infections in the patient environment, and to become the new standard method for disinfection in healthcare facilities worldwide. For more information, visit www.xenex.com.

Medical Device ASIA | May-June 2015 | 23

New global study on Acute Kidney Injury (AKI) shows the way to eliminating preventable deaths by 2025 – early detection and management are key

T

oday, the International Society of Nephrology (ISN) will present the findings of a new global study on Acute Kidney Injury (AKI), seen by experts as a key step forward in their efforts to eliminate preventable deaths from the condition by 2025 (0by25).

AKI is a worldwide problem, killing affected patients who have no means to reach appropriate therapy in developing countries, and who could be saved with as little as $150.

The AKI “Global Snapshot” is the first in a series of landmark projects to be launched by ISN under the 0by25 Initiative. The far-reaching, cross-sectional, global cohort study was designed to better understand the growing burden of AKI and how it is identified, managed and treated in different settings worldwide.

The study was carried out from September to December 2014 with over 320 participating centers in 72 countries globally. Data was provided for over 4000 pediatric and adult patients, with significant new information coming from Africa, Asia, and Latin America.

“This is the first time that ISN has carried out a web-based, prospective data collection exercise, simultaneously, in hundreds of centers around the world,” remarks ISN President, Dr. Giuseppe Remuzzi. “The Global Snapshot has helped us address the information gap on AKI and moves us a step closer to our goal of zero preventable deaths. We are excited to share these findings with our international colleagues and the wider global

health community.”

According to the study, nearly 2/3 of the AKI cases were reported to be community-acquired, rather than developing in the hospital setting.

This is a significant new finding, which points to an opportunity and need for early recognition and detection in these out-of-hospital settings.

The most common causes of AKI reported across all countries were: hypotension (low-blood pressure) and shock, infections, dehydration, cardiac events and nephrotoxic drugs. It was also reported that over 2/3 of the AKI cases had one or more of the recognized risk factors for AKI, e.g. diabetes, heart disease and anemia, and patients with these risk factors experienced a higher mortality and lower rate of recovery of kidney function.

“This study provides us with clear evidence of the need to identify and target high risk groups to improve the prevention and early detection of AKI,” comments Dr. Ravindra Mehta, 0by25 Project Leader and Global Snapshot Coordinator. “This essential new information can now be used to design targeted education and training to enable the rapid recognition of AKI based on these key indicators.”

The Global Snapshot also found that an average of 1/4 of the AKI patients seen by the participating centers required dialysis, but did not receive treatment. This was predominantly due to the late presentation and disease severity of patients, adding further weight to the argument for early detection and management of

24 | May-June 2015 | Medical Device ASIA

AKI. In some cases, a lack of healthcare resources and an inability to pay were also reported as barriers to treatment.

Finally, the data findings suggest that over 1/3 of AKI patients were not managed by a nephrologist (kidney expert), a finding that was even more prevalent in low-income countries. “The ISN recognizes that AKI is a multidisciplinary problem and this data just confirms that education and training collaboration with other healthcare disciplines to raise awareness and educate and train non-nephrologists will be essential to reducing the global burden of AKI,” remarks Dr. Mehta.

The preliminary findings of the study are being presented at the ISN World Congress of Nephrology in Cape Town, South Africa on Saturday March 14, 2015.

Acute Kidney Injury

Acute Kidney Injury is an extremely serious illness with a high mortality risk and can have many underlying causes. Some of these include hypertension and

diabetes and numerous infectious diseases and agents (e.g. malaria, Shigella

Dysenteriae type 1, Hantavirus, dengue and leptospirosis), as well as poisoning, septic abortion, community-acquired diarrhea, intake of infectious waters,

and some syndromes often affecting the kidneys such as hemolytic-uremic syndrome, pregnancy-related syndromes and acute glomerulonephritis.

The International Society of Nephrology is a global not-for-profit society

dedicated to improving kidney care and reducing the incidence and impact of kidney disease worldwide. Through its global network and programs, ISN

brings together the developing and developed world in a collaborative effort in

fighting and treating kidney disease on a global scale. For more information, visit the ISN website: www.theisn.org.

The 0by25 Initiative aims to eliminate preventable deaths from AKI by 2025.

A global human rights initiative, 0by25 places a strong emphasis on low and

middle-income countries in Africa, Asia, and Latin America with disadvantaged populations and poor access to care.

The International Society of Nephrology (ISN) provides funding through

unrestricted grants to the 0by25 initiative and gave logistic support for the

Global Snapshot study. Further support has been provided through unrestricted grants from 0by25 founding partner Astute Medical (San Diego, CA, USA) and partners Danone Nutricia Research (Palaiseau, France) and Bellco (Mirandola, Italy).

0by25 is endorsed by many regional and national nephrology societies

worldwide and welcomes support from partners across the global healthcare

community. More information about the study and the 0by25 Initiative can be found on the dedicated website: www.0by25.org.

FDA enters consent decree with Medtronic, Inc. Synchromed II Implantable Infusion Pump System is medically necessary for a patient’s treatment.

The consent decree also requires Medtronic to retain a third-party expert to help develop and submit plans to the FDA to correct violations. The consent decree will remain in effect until the FDA has determined that Medtronic has met all the provisions listed in the consent decree.

Once Medtronic receives permission from the FDA to resume the design, manufacture and distribution of these products, the company must continue to submit audit reports so the agency can verify the company’s compliance. In addition to these audits, the FDA will monitor the company’s activities through its own inspections.

The FDA first approved the Synchromed II Implantable Infusion Pump Systems in 2004, and first identified problems with the manufacture of these pumps in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients.

Between 2006 and 2013, FDA investigators conducted five inspections at Medtronic’s Neuromodulation facilities, resulting in three warning letters notifying the company of major violations. The violations included inadequate processes for identifying, investigating, and correcting quality problems with the Synchromed II Implantable Infusion Pump Systems; failure to document design changes; and failure to ensure that finished products meet design specifications.

The U.S. Food and Drug Administration announced the filing of a consent decree against Medtronic, Inc., and two of the company’s officers—S. Omar Ishrak and Thomas M. Tefft —for repeatedly failing to correct violations, related to the manufacture of Synchromed II Implantable Infusion Pump Systems, medical devices that deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. These violations occurred at the company’s Neuromodulation facilities in Columbia Heights, Minnesota, where the devices are manufactured.

The consent decree cites violations of the quality system regulation for medical devices, which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use.

The legal action requires the company to stop manufacturing, designing and distributing new Synchromed II Implantable Infusion Pump Systems except in very limited cases, such as when a physician determines that the

“The FDA expects that all patients will be treated with safe, effective and high-quality medical devices,” said Jan Welch, acting director of the Office of Compliance in the FDA’s Center for Devices and Radiological Health. “We will continue to stop distribution of devices made by firms that fall short of regulatory requirements.”

Patients who are implanted with a Synchromed II Implantable Infusion Pump System should maintain regular follow-up appointments with their physicians. Patients who experience a change or return of symptoms, or hear a device alarm, should contact their physician immediately.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety and effectiveness of human and veterinary drugs, biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Medical Device ASIA | May-June 2015 | 25

FDA approves spinal cord stimulation system that treats pain without tingling sensation

R

ecently, the U.S. Food and Drug Administration approved the Senza spinal cord stimulation (SCS) system (Senza System) as an aid in the management of chronic intractable pain of the trunk and/or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The Senza System can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes.

“The FDA has approved several other totally implanted spinal cord stimulators for pain reduction, but this system is unique because it delivers a high frequency output of 10 kHz that does not cause a tingling sensation— called ‘paresthesia’—in patients,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at FDA’s Center for Devices and Radiological Health. “Since some patients don’t like the paresthesia associated with traditional SCS, this device offers another treatment option.”

Back pain is a common disability for many Americans. Acute pain begins suddenly and is usually sharp in quality. Acute pain might be mild and last just a moment, or it might be severe and may last three to six months. In most cases, acute pain disappears when the underlying cause of pain has been treated or has healed.

Unrelieved acute pain, however, might lead to chronic pain. Chronic pain is pain that lasts more than 12 weeks and may persist for years. Chronic pain might have originated with an initial trauma/injury or infection, or there might be an ongoing cause of pain.

However, some people suffer chronic pain in the absence of any past injury or evidence of body damage.

Before receiving treatment with the Senza System, patients participate in a one- to two-week simulation using an implanted trial lead and a model of the stimulus generator that is worn outside the body. Once the doctor determines the stimulation works well based on the patient’s reporting of symptoms, 26 | May-June 2015 | Medical Device ASIA

the system is implanted via a minimally invasive surgical procedure. The system delivers electrical stimulation to the thoracolumbar area of the spinal cord (in the region of the mid to lower back) via leads implanted through a small incision in the patient’s back. The lead is connected to a rechargeable, implantable pulse generator that is implanted in the patient’s upper buttocks region or abdomen. A clinician initially programs the device, and patients can use a remote to control the pulse generator within the output ranges programmed by the clinician.

FDA’s review of safety and effectiveness included data from a clinical study. During the study, 198 subjects with chronic intractable pain of the trunk and/or limbs were randomized to either the Senza System test group or a control group. The control group was made up of 97 subjects treated with another FDA-approved device that delivers stimulation in the two to 1,200 Hz frequency range that produced paresthesia.

Seventy-five percent of subjects treated with the Senza System achieved a 50 percent reduction in pain from baseline at three months, which was the primary target of the study, and an approximately 55 percent reduction at 12 months.

There were no stimulation-related neurological deficits, such as weakness in the limbs or tremors, observed for either treatment group.

The most common adverse events associated with the Senza System included pain at the implant site and dislocation of the device lead under the skin.

The FDA also approved the Senza System for stimulation parameters below 10 KHz. For stimulation parameters, similar to those used in the control group and other traditional SCS systems, paresthesia is required.

The Senza System is manufactured by Nevro Corp., based in Menlo, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA approves first-of-its-kind corneal implant to improve near vision in certain patients

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he U.S. Food and Drug Administration approved the KAMRA inlay, a device implanted in the cornea of one eye (the clear, front surface) to improve near vision in certain patients with presbyopia. It is the first implantable device for correction of near vision in patients who have not had cataract surgery.

Presbyopia is the loss of the ability to change the focusing power of the eye. It occurs with normal aging and results in difficulty with near vision, generally in adults 40 to 50 years of age. The KAMRA inlay is an opaque, ringshaped device intended for use in patients 45 to 60 years old who, in addition to not having had cataract surgery, are unable to focus clearly on near objects or small print and need reading glasses with +1.00 to +2.50 diopters of power—but do not need glasses or contacts for clear distance vision.

“Presbyopia is a natural part of aging and can make reading and performing close-up work difficult,” said William Maisel, M.D., deputy center director for science in the FDA’s Center for Devices and Radiological Health. “The KAMRA inlay provides a new option for correcting near vision in certain patients.”

The device works by blocking unfocused light rays entering the eye in order to improve near vision. It blocks peripheral light rays while allowing central light rays to pass through a small opening in the center of the device, making near objects and small print less blurry.

To insert the device, an eye surgeon uses a laser to create a pocket in the cornea of one eye of the patient and implants the device in that pocket.

This is intended to allow the patient to have improved near vision in the eye containing the implant, while not affecting the distance vision of the two eyes working together.

To evaluate the safety and efficacy of the KAMRA inlay, the FDA reviewed the results of three clinical studies. The results of the main study showed

that 83.5 percent of the evaluable 478 participants achieved uncorrected near visual acuity of 20/40 or better at 12 months. This is the level of vision needed to read most text in magazines and newspapers.

The device is not intended for patients who have had cataract surgery or patients with severe dry eye; an active eye infection or inflammation; corneal abnormalities related to thinning and irregular shape of the surface of their eyes; insufficient corneal thickness to withstand the procedure; a recent or recurring herpes eye infection or problems resulting from past infection; uncontrolled glaucoma; uncontrolled diabetes; or active autoimmune or connective tissue disease.

The labeling warns that the device’s safety and effectiveness in patients who have had LASIK or other refractive procedures is unknown.

The KAMRA inlay may cause or worsen dry eye and various vision-related problems, such as glare, halos, night vision problems, and blurry vision. It also can cause corneal complications such as swelling, clouding, thinning and potential perforation, and challenges evaluating and managing eye problems.

For patients experiencing vision problems after the surgery, removal of the device may improve vision in some cases. In other cases, decreased vision could become permanent. There is also a potential risk for the focusing power of the eye to change, causing blurry vision and requiring glasses.

The KAMRA inlay is manufactured by AcuFocus Inc., based in Irvine, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Medical Device ASIA | May-June 2015 | 27

SCHURTER Electronic Components - Fuses, Connectors, Circuit Breakers, Input Systems and EMC Components

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CHURTER is a leading innovator and manufacturer of fuses, connectors, circuit breakers, input systems and EMC products, as well as a PCB assembly service provider for the electronics industry worldwide.

We focus on components and systems that ensure the clean and safe supply of power and ease of use of medical equipment according to IEC 60950 or 60601-1.

Fuses: approximately 4,000 components - fuse links, resettable and non-resettable versions, fuse-holders in panel mount versions clips and block style in through hole and SMT-technology

successful cooperation with all partners.

FUSES AND FUSE-HOLDERS This range contains fuse links and fuse-holders for appliances for rated currents from 0.25A up to 16A. The fuses are separated within resettable, non-resettable fuses and telecom fuses. Fuse-holders are available closed for front panel mounting and open or closed for PCB mounting.

Connectors: approximately 3,600 variants of AC power entry components, including IEC-connectors, power entry modules with and without line filters and distribution units

Fuse links and fuse-holders are available for discrete as well as for SMD mounting style and are suitable packed for automated assembling.

Circuit breakers for equipment: comprise approximately 5,800 components, including thermal and thermalmagnetic circuit breakers for equipment

CONNECTORS, POWER ENTRY MODULES AND EMC LINE FILTER

Input systems: comprise approximately 1,000 components, includes keyboard systems, membrane keypads, touch screens, switches and pushbuttons EMC components: comprise approximately 1,000 components, includes line filters for one to three-phase systems, impulse transformers, chokes driver modules The broad product range suits perfectly for use in medical, measurement and test equipment as well as for other industrial electronic devices. The excellent image and the well-established brand name of SCHURTER mean 28 | May-June 2015 | Medical Device ASIA

The assortment of connectors contains connectors and plugs and power entry modules according IEC 60320-1 for rated currents of 2.5A up to 25A @ 125VAC respectively 250VAC. The power entry modules are based on the mentioned connectors and enclose already wired components as switch, fuse-holders, voltage selectors and/or line filters.

The line filters support electromagnetical compatibility (EMC)

according IEC 60939. Line filters are also available for chassis mounting.

They are designed for rated currents from 0.5A up to 30A at the mentioned voltage for AC and DC sources.

All mentioned product suits perfectly for appliances according IEC 60950 and meet the medical filter standards IEC 60601-1 respectively UL544.

CIRCUIT BREAKERS FOR EQUIPMENT The thermal and magnetic hydraulic circuit breakers for equipment are designed as over current protection for appliance according IEC 60950.

They are all resettable and available for one, two, three and even more poles. The hydraulic magnetic circuit breakers are less sensitive to environmental temperature than the thermic types. Additional accessory

SoSafe is the Ideal Packaging Configuration by Operating Room Nurses at UNAIBODE Exhibition

as under voltage protection modules, diverse actuators and IP56 covers are available.

VANDAL PROOF OR CUSTOMIZED INPUT SYSTEMS The input systems contain switches, push buttons, vandal proof keypads, tactile input systems based on membranes and touch screens. The push buttons and the metallic keypads are specially designed for harsh environment.

The membrane input systems are customer driven and can be offered together with the touch screens as complete input devices.

EMC PRODUCTS The EMC product range contains line filters for three phase systems from 1A to 1,000A. A standard range will be available for common applications while specific design is offered upon requirement. The chokes and the pulse transformers support the power quality of different power supply within the same range. The control of semiconductor power bridges will be supported by the offered power stage driver modules to assure galvanic separated operation of control and power circuit.

ADDITIONAL PRODUCT SERVICES Thousands of industrial partners through out the world rely on the years of expertise and highly innovative capacity of SCHURTER. A vast network of industrial agencies and distributors in virtually every place of the globe ensures a global market presence and a continuous open dialogue with customers.

Product availability, distribution and approval information is offered on the SCHURTER website, as well as additional design information, supported product selection, and application information.

In order to gather operating room nurses (IBODE) and ensure training, UNAIBODE set up the National Days of Study and Development (JNEP).

These days allow nurses to meet, exchange or learn surgical techniques.

During the May 2014 edition, which was held in Dijon, Selenium Medical met 200 IBODE and surgeons.

Through this meeting, the objectives for Selenium Medical were to introduce SoTube packaging and its various configurations.

After the exhibition, IBODE said they preferred the SoSafe configuration. In addition, the NoTouch configuration was considered an ‘ideal method’ for its sterility assurance.

SoTube and SoSafe got a score of 9.2/10 based on a survey of 160 people at the UNAIBODE 2014 exhibition, which included criteria such as ease of opening and speed of transferring.

Results reinforce Selenium Medical’s aim to provide innovative sterile packaging in operating rooms.

The patented packaging of SoTube/SoSafe, which is CE Marked and approved by US Food and Drug Administration, offer a solution for aseptic and secure transfer of medical devices in the operating room.

Two plastic tubes of a biocompatible material, phthalate or latex-free, are nested one inside the other, providing a 100% no touch application.

The device is an alternative to traditional pouches and blisters. Dual tubes are less bulky than traditional packaging and provides unique visibility of the implant due to its transparent material.

Medical Device ASIA | May-June 2015 | 29

Protomatic Medical - Precision CNC Medical Machining and Prototype Development

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rotomatic Medical specializes in CNC precision medical machining. We manufacture complex orthopedic medical devices such as hip, pedicle and maxoclofacial screws; locking pins and nails; bone plates; and mandibular joint replacement devices.

We also specialize in cardiovascular medical equipment, such as trocar devices, tunnellers, peristaltic pump components, and import and outport connections for left ventricular assist devices (LVADs).

We create outstanding medical prototypes that are used by orthopedic surgeons all over the country.

Medical prototypes and medical device design

Protomatic Medical also offers medical prototypes and medical device design. We regularly manufacture components and our CNC capabilities include 4-axis and 5-axis milling as well as 3-axis turning.

Fine precision machining and laser engraving are also available.

We continue to grow by creating more types of components needed for artificial joint replacements, also known as orthopedic implants.

Prototype testing of orthopedic implants Our capabilities for rapid prototype testing of custom orthopedic implants enable us to constantly enhance our product quality. Our testing capabilities help speed time to clinical trials and commercial launch.

Protomatic Medical specializes in CNC precision machining for medical devices and components

We are able to take orthopedic implants from design concept to medical device prototyping and on to production in record time. Our medical devices are guaranteed for accuracy and precision, from the orthopedic implants to the surgical tools used to install them.

Our product range includes:

Components for left ventricular assist devices and aortic punches

• Plates and screws • Locking pins and nails • Locking plate systems • Pedicle screws • Circular external fixation systems • Cannulated lag screws • Cannulated othopedic screws • Maxillofacial devices • Maxillofacial screws and implants • Components for cytometers

Protomatic Medical often supplies components for left ventricular assist devices (LVADs) - pump-like devices that are surgically implanted to maintain the pumping ability of a heart that can no longer function on its own. We can also provide components for aortic punches, which are used to implant replacement heart valves in the heart as well as arterial bypass grafts in order to repair damaged arteries.

Protomatic Medical manufactures components for many medical instruments, including cytometers or ‘cell counters’. A cytometer is similar to a microscope, except that instead of producing an image of the cell, it offers high-throughput for a large number of cells. This is just one area in which we have become an innovator in the machining of medical devices.

LVADs and aortic punches are just a couple of examples of the cardiovascular instruments we manufacture. We are a leading supplier of a range of instruments used in cardiovascular procedures and treatments, including:

In addition to our specialties in cardiovascular and orthopedic medical devices, our skilled designers and craftsmen are ready to assist you with the development of any other medical product.

Protomatic Medical is a ‘one-stop shop’ for all your medical device machining needs. Our team can work with a wide range of materials, including aluminum, steel, plastic, rubber, ceramics, titanium, refractory metals and superalloys.

• Trocar devices • Tunnellers • Peristalic pump components • Specialized surgical tools • Medical prototypes for orthopedics Recent advances in the medical machining industry have led to an increased number and variety of products for orthopedic uses. We are at the forefront of this technology, creating outstanding medical prototypes that are used by orthopedic surgeons all over the country.

30 | May-June 2015 | Medical Device ASIA

Protomatic Medical supplies components for left ventricular assist devices (LVADs) and aortic punches.

For more details, please contact: Protomatic, Inc. 2125 Bishop Circle West Dexter MI 48130 United States of America Tel: +1 734 426 3655 Email: sales@protomatic.com URL: www.protomaticmedical.com

Vancive Medical Technologies Adhesives and Material Technologies for Medical Applications

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e bring more than three decades of expertise to the development of innovative adhesives and material technologies for medical applications. Our work addresses unmet needs of medical device manufacturers, clinicians and patients in segments including wound care, vascular access, surgical, ostomy, electromedical and wearable sensors.

The materials, laminates and adhesive constructions offered in our ostomy portfolio include microporous coated adhesives and absorbent acrylics for high breathability, as well as conformable foams, films and soft nonwovens.

Metria™ Informed Health

In the years ahead, we’ll see a greater emphasis on expanding the health care continuum wherein consumers and patients are always connected to, and being informed about, their health. Vancive Medical Technologies is developing the Metria Informed Health platform to enable and accelerate this transformation by providing innovative physiologic sensing solutions delivered primarily through mobile interfaces for various applications, including health, wellness and clinical diagnostics.

A key component of the Metria platform is the sensing device. The device is intended to be adhered to the body and its unique form factor is designed with user comfort and quality of life in mind, and leverages Vancive’s expertise in adhesive chemistries, materials and process technologies.

Skin-friendly adhesive tapes, strips and films for surgical applications We offer bordering, assembly and fenestration tapes, and OP strips that are compatible with various drape substrates, as well as incise film solutions. Our surgical portfolio leverages proprietary skin-friendly adhesive technologies, including Wetstick™, a patented medical synthetic rubber adhesive that maintains adhesion to wet skin.

Bordered hydrocolloid dressing with odor control Bordered sacral hydrocolloid dressing with odor control *Features TASA™ (Thin Absorbent Skin Adhesive™) technology The highly integrated wound contact layer remains intact in the presence of wound exudates, minimizing wound bed disturbance. This also makes handling easier after dressing removal. The dressings also meet ISO 10993 biocompatibility requirements for use as a medical device and are formulated to be gentle to periwound skin.

Skin-friendly adhesives for wound care Our chronic and acute wound care solutions feature patented skinfriendly adhesives that support optimal healing conditions and extended wear, including highabsorption hydrocolloids that remain integrated when applied to light to moderate exuding wounds. Our new Vancive thin absorbent skin adhesive unites high-performance adhesion and fluid management.

Adhesives and barrier film for ostomy applications The Vancive portfolio of ostomy products includes adhesives and materials for multi-layer flanges, charcoal filter mounts and moldable rings. We leverage our proprietary hydrocolloid formulations to support optimal wear time and help maintain skin integrity.

Vancive PU, EMA and PE thin surgical incise films are transparent, conformable and feature non-sensitizing acrylic adhesive. Easy application systems, heavy-duty liners and branding options are available.

Our new InteliShield™ barrier film for ostomy applications is PVC-, PVdC- and plasticizer-free and is as strong, quiet and soft as current products.

Conductive gel-resistant adhesives Solutions offered through our electromedical portfolio include materials designed for mounting devices onto the skin that conform to most body surfaces, conductive gel-resistant adhesives that are gentle to the skin and clean on removal, and products that are printable and made for easy conversion.

Notes ^Patent pending. **Metria products have not been evaluated by regulatory agencies. Metria features sensor technology from Proteus Biomedical.

BeneHold™ Absorbent Wound Dressing The BeneHold™ Absorbent Wound Dressing portfolio of sterile wound dressings is indicated for management of lightly to moderately exuding chronic and acute wounds.

The dressings support moist wound healing and feature a self-adherent wound contact layer with a low-friction polyurethane top film that is water resistant and acts as a barrier to external contaminants and bacteria. There are four types of wound dressings in the portfolio, each offered in multiple sizes: Thin absorbent wound dressing* Standard hydrocolloid dressing

Our wound care range features soft and pliable carriers for optimal comformability, as well as highly breathable transparent films, foams and nonwovens. We also offer converting solutions to meet a broad range of application needs, such as wound care dressings, IV placement and NPWT cover drapes.

Medical Device ASIA | May-June 2015 | 31

ROFIN Medical - Precise Laser Material Processing only in building lasers but also in application development, in laser systems manufacture and in the entire range of material processing technologies.

Flexible metal and alloy cutting rod and fibre lasers

The StarCut Tube is an all-in-one system that is flexible in configuration and provides excellent, userfriendly operation

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OFIN has been developing laser systems for the medical device industry for more than three decades and can provide all necessary technologies – from laser sources to customised construction – from a single source.

Industrial lasers and laser-based material-processing products ROFIN is a global leader in the development and manufacture of industrial lasers and laser-based products used in material processing applications. With a variety of CO2, rod, disc, fibre and diode lasers, pulsed or cw, ROFIN offers the widest and most powerful product range for industrial materials processing. The company combines the benefits of an experienced laser manufacturer with application-specific professional competence.

Rod and fibre laser technology cut almost all kinds of metals and alloys commonly used in medical device technology. The minimal heataffected zone prevents damage to temperature-sensitive materials; e.g. shape memory alloys like nitinol.

The flexibility in cutting geometries is almost unlimited, including edges with variable cutting angles.

Through a CAD system any new outline can be defined and cut in a matter of minutes.

High-strength welding lasers Lasers create high-strength and helium leak-tight welds in metals and polymers with pore-free surfaces and in this way make this joining technique the ideal solution.

Excellent beam quality, high pulseto-pulse stability and flexible pulse shaping are the preconditions for the finest seam and spot welds.

Laser-welded joints can be used for high-temperature sterilisation and exhibit pore-free surfaces even without finishing. This is a crucial requirement for biocompatible

components.

Micro structuring with Q-switched solidstate lasers Each application is in principle a material ablation produced by short and high-energy laser pulses. The precise process control allows micro structures smaller than 15µm and ablating complete surfaces layer by layer. In this way small areas in polymer layers on catheters can be removed selectively.

Tailor-made surface structures can also be realised in order to optimise bonding characteristics of implants.

Q-switched solid-state lasers allow the production of filigree micro mould dies designed with extremely narrow channels.

Bio-compatible marking Lasers apply consistent marking to metals and polymers without any filler material. Marking by modifying the material colour, annealing on metal, carbonisation or foaming in polymers provides corrosion-free marking without creating burrs or debris. There are almost no technical limits to the marking outline and content. Individualisation is easy due to the flexible computer control of the complete process, and on-the-fly marking can be carried out even on fast-moving workpieces.

Minimally invasive surgery techniques and miniaturised implants are among numerous products in the medical device industry that are becoming increasingly smaller.

Lasers are ideally suited for cutting widths and weld seams in the range of only a few microns, and provide extremely gentle processing.

Turnkey laser surface-cleaning systems Products in the medical device industry have to meet the highest quality demands. Laser technology as a precise and extremely selective material processing method is steadily gaining importance in this industry. A major reason is that laser technology fulfils the high quality requirements to perfect, hygienic, clean surfaces without dross or any material residues. As laser cutting or welding is a wear-free process, the quality of cuts or joints and hence the quality of the workpieces is constantly high.

ROFIN has always developed not only laser sources but also complete turnkey laser systems for most diverse applications. That means 30 years of experience – not 32 | May-June 2015 | Medical Device ASIA

Finest cuts <20µm in nitinol with a material thickness of 380µm.

FDA approves closure system to permanently treat varicose veins

Device is first to use adhesive to cut off blood supply

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he U.S. Food and Drug Administration today approved the VenaSeal closure system (VenaSeal system) to permanently treat varicose veins of the legs by sealing the affected superficial veins using an adhesive

agent.

There are two types of veins—deep veins and superficial veins. Superficial veins are those that are close to the skin. Veins contain one-way valves that open to let blood flow through and then shut to keep blood from flowing backward. When valves of the superficial system are weak or damaged, blood can back up and pool, which can cause varicose veins that are enlarged, swollen or twisted.

Varicose veins often cause no symptoms but some patients may experience mild to moderate pain, blood clots, skin ulcers or other problems, according to the National Heart, Lung, and Blood Institute at the National Institutes of Health. If these issues occur, health care professionals may recommend treatment such as compression stockings or medical procedures to remove or close the affected veins.

The VenaSeal system is intended for patients with superficial varicose veins of the legs that cause symptoms. The sterile kit is made up of an adhesive, a specially formulated n-butyl-2-cyanoacrylate, and delivery system components that include a catheter, guidewire, dispenser gun, dispenser tips, and syringes.

The device must be used as a system and differs from procedures that use drugs, laser, radio waves or cuts in the skin to close or remove veins. A trained healthcare professional inserts the catheter through the skin into the diseased vein to allow injection of the VenaSeal adhesive, a clear liquid that

polymerizes into solid material. The healthcare professional monitors proper placement of the catheter using ultrasound imaging during delivery of the adhesive into the diseased vein to seal it.

“This new system is the first to permanently treat varicose veins by sealing them with an adhesive, thereby giving patients another treatment option for this common condition,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “Because the VenaSeal system does not incorporate heat application or cutting, the in-office procedure can allow patients to quickly return to their normal activities, with less bruising.”

The FDA reviewed data for the VenaSeal system in a premarket approval application, the agency’s pathway to evaluate safety and effectiveness of Class III medical

devices. Data supporting the FDA approval included results from three clinical studies sponsored by the manufacturer. The U.S. clinical study assessed the safety and effectiveness of the VenaSeal system in 108 participants compared to radio-frequency ablation in 114 participants. The trials showed the device to be safe and effective for vein closure for the treatment of symptomatic superficial varicose veins of the legs.

The VenaSeal system should not be used in patients who have a known hypersensitivity to the VenaSeal adhesive, acute inflammation of the veins due to blood clots or acute whole-body infection. Adverse events observed in the trial—and generally associated with treatments of this condition—included vein inflammation (phlebitis) and burning or tingling (paresthesia) in the treatment zone.

The VenaSeal Closure system is manufactured by Covidien LLC, based in Morrisville, North Carolina.

Medical Device ASIA | May-June 2015 | 33

New England Wire Technologies Custom Cable, Tubing and Catheter Products Examples include high-strength alloy conductors for superior flex life and foamed dielectrics for reduced size and attenuation. By utilizing high-quality low dielectric constant materials New England Wire is able to reduce size without sacrificing signal integrity. In addition, we have the capability to combine multiple coaxes with other components into larger instrumentation cables. With short lead times and low minimum quantities New England Wireâ&#x20AC;&#x2122;s custom coaxial cable is the superior choice.

Multi-conductor cables for medical devices

Tubing and catheter products custom-designed for your application, .030in-.500in diameter, prototyping and production capabilities, short lead times and a wide variety of raw materials in stock for your project

New

England Wire Technologies manufactures custom wire and cable, braid or spiral reinforced tubing, lined catheter shafts and hybrid tubing. Our engineering and design experts assist in the development and testing of wire and cable products built for the most technologically advanced cables in the industry.

Advanced extrusion expertise and extensive wire processing capabilities include thin-wall, close tolerance tubing, bonding layers of thermoplastic to fluoropolymer and braiding all types of round and flat wire.

Our highly customized multiconductor cables utilize a wide range of conductor, shielding, and insulation materials, chosen to suit your specific medical device requirements.

Typical characteristics of our custom multi-conductor medical cables include: finely stranded conductors for ultimate flexibility, extended flex-life and resistance to fatigue, miniaturization (as low as

46 AWG), high or low temperature performance, low triboelectric noise and signal integrity, parylene coating to prevent tacky materials from tugging on skin, hair or fabric, and extruded insulation options that allow your device to be subjected to 250°C sterilization.

Hybrid cables for medtical devices Our creative engineering staff can design cable incorporating dissimilar components to suit your medical product requirements. We offer cables combining insulated conductors with one or more vent tubes, lumens, thermocouple leads, resistance wires, strength members or any combination of complex configuration.

Lumens / vent tubes can be utilized to transfer liquids or gases. Other cable components such as fiber optic filaments can be combined with multiple insulated conductors.

Strength members can be anything from stainless-steel cables to monofilaments to aramid fibers with a non fray extrusion. They can be

Our medical product offerings include micro-miniature coax cables, reinforced silicone rubber cables, low-noise and parylene-coated cables, multi-conductor cables and custom profiles including ribbon cable, zip cord and woven cables; most are built to exacting customer specifications.

Custom coaxial cables for medical device and electronics manufacturers New England Wire Technologies designs, manufactures and tests a wide range of coaxial cables to meet the custom needs of medical device and electronics manufacturers.

Our miniature and micro-miniature coaxes are manufactured to meet the impedance, capacitance, or other exacting electrical requirements of the medical industry with custom options for the center conductor, shield and jacket.

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Extruded ribbon cable - ultra flexible, conforms to any contour, space and weight saving, any number of conductors, bends around small diameters

Multisorb to Focus on Driving Profitability through Efficiencies at Pharmapack North America Multisorb Technologies will highlight how the efficiencies of its sorbent dispensing systems and simulation technology can help pharmaceutical companies and drive profitability at Pharmapack North America from 9-10 June at the Jacob K Javits Convention Center, New York.

On-site demonstrations of a dispensing unit will allow attendees to experience first-hand how Multisorb’s technology results in cost savings.

It’s custom right down to the color- exact color match, low minimum order, vast array of raw materials, all available for your custom requirement

cabled with other components to yield high tensile strength and low elongation.

Communications components including USB, Cat 5, HDMI, fiber optics or other configurations of coax or twisted pairs can be easily incorporated into the design.

Improved versions like autoclave capable, low attenuation, or high flex life can be designed, built and tested in house.

Thermocouple extension wires using ANSI standard materials can be bundled into a cable or added with a jacket for breakout.

High-frequency power can be supplied using our custom litz wire preventing heating and saving space and energy.

Magnet wire twisted pairs for low-voltage signal can be bundled into many pairs or insulated for breakout with other components such as strength members or power leads.

Resistance wire can be placed in a cable for heating components or placed around tubes to heat the contents.

Medical braided products, catheter tubing, and braid and spiral reinforced tubing Our subsidiary, New England Catheter, focuses on manufacturing braid and spiral reinforced medical tubing, lined catheter shafts and hybrid tubing. We work closely with our customers offering them custom-designed components, collaborative product design, prototyping and production capabilities. Our large variety of raw materials and short lead times help them through product design, prototype development and manufacture of their final components in the shortest design-to-market time possible.

Send us your wish list…our design team will surpass your expectations.

Pharmapack provides an ideal forum for companies to meet with technical experts to discuss their drug and healthcare packaging stability challenges, and how to leverage technological efficiencies and innovations to save money, while maintaining quality.

Multisorb Packaging viceAdrian said: “By innovative help companies while getting to have been able to greatly achieving their goals.”

Healthcare Group president Possumato providing solutions that reduce costs market faster, we assist our customers in

The company will feature its proprietary Calculations through Operations simulation, which uses a QbD-based modelling programme to identify the optimal sorbent required to achieve desired shelf-life for pharmaceutical formulation and dosage forms.

Since 2004, more than 1,000 simulations have been completed using this consultative service, helping pharmaceutical companies reduce their development time by six to 12 months by eliminating sorbent ranging studies.

By pairing sorbent packets and canisters with their respective dispensers, Multisorb delivers a reliable and low-cost sorbent/ dispenser system for the market.

Since sorbent packets and dispensers are designed to operate together at an efficiency exceeding 99.997%, typical downtime issues related to incompatible system components are eliminated.

The net result is the lowest total cost of ownership available for sorbent dispensing.

Medical Device ASIA | May-June 2015 | 35

FDA releases final guidance on reprocessing of reusable medical devices

Agency to hold panel meeting to discuss recent cases associated with duodenoscopes “This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective and clear to the healthcare community that uses them. Doing so should provide greater assurance to patients that the devices used on them are safe and effective.”

The U.S. Food and Drug Administration announced new actions to enhance the safety of reusable medical devices and address the possible spread of infectious agents between uses. -The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.

devices makes it harder to remove contaminants.

Medical devices intended for repeated use are commonplace in health care settings. They are typically made of durable substances that can withstand reprocessing, a multi-step process designed to remove soil and contaminants by cleaning and to inactivate microorganisms by disinfection or sterilization. While the majority of reusable devices are successfully reprocessed in health care settings, the complex design of some

A device manufacturer’s reprocessing instructions are critical to protect patients against the spread of infections. As part of its regulatory review for reusable medical devices, the FDA reviews the manufacturer’s reprocessing instructions to determine whether they are appropriate and able to be understood and followed by end users. The guidance lists six criteria that should be addressed in the instructions for use with every

FDA’s guidance document, titled “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” includes recommendations medical device manufacturers should follow premarket and post-market for the safe and effective use of reprocessed devices.

36 | May-June 2015 | Medical Device ASIA

reusable device to ensure users understand and correctly follow the reprocessing instructions.

The guidance also recommends that manufacturers consider reprocessing challenges early in device design.

Manufacturers will be expected to conduct validation testing to show with a high degree of assurance that their cleaning and disinfection or sterilization instructions will consistently reduce microbial contamination.

“Despite the recent concerns about multi-drug resistant bacteria infections associated with duodenoscopes, patients and health care providers should know that the risk of acquiring an infection from a reprocessed medical device is low” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health.

The FDA issued a draft guidance discussing the reprocessing of reusable medical devices in 2011, and considered almost 500 comments before issuing the final guidance. The final guidance provides more clarity about testing protocols and what data should be submitted to the agency for a premarket submission, such as the data FDA needs to evaluate substantial equivalence for a 510(k) premarket submission.

Manufacturers seeking to bring to market certain reusable devices, such as duodenoscopes, bronchoscopes and endoscopes, should submit to the FDA for review their data validating the effectiveness of their reprocessing methods and instructions.

Separately, the FDA also announced in the Federal Register that the agency’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will hold a public meeting on May 14 and 15, 2015 to discuss recent reports and epidemiologic investigations of transmission of infections associated with the use of duodenoscopes in endoscopic retrograde cholangiopancreatography (ERCP) procedures in hospitals in the United States.

FDA approves

CPR devices that may increase chance of surviving cardiac arrest Device Evaluation in the FDA’s Center for Devices and Radiological Health. “The ResQCPR System may increase oxygenated blood circulation during CPR, which in turn may improve the likelihood of survival in adult patients with outof-hospital, non-traumatic cardiac arrest.”

The FDA reviewed data supporting the approval of the ResQCPR System, including a randomized clinical trial that compared survival rates of 813 subjects who received standard CPR to 842 subjects who received CPR with the ResQCPR System. The clinical trial results showed that a larger number of subjects who received CPR with the ResQCPR System survived cardiac arrest.

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he U.S. Food and Drug Administration approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation (CPR) on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.

The Centers for Disease Control and Prevention estimates that approximately 300,000 Americans experience an out-of-hospital cardiac arrest each year. CPR is an emergency procedure that can be life-saving for people in cardiac arrest. During this procedure, rescuers manually compress the patient’s chest and manually ventilate the lungs to keep blood oxygenated and circulating until the heart and breathing restart— or until the rescuers can apply advanced life-saving techniques, such as defibrillation. If provided immediately after cardiac arrest, this standard CPR procedure increases a patient’s chance of survival.

The ResQCPR System consists of two devices that are intended to be used together to assist in performing CPR on adult patients with out-ofhospital, non-traumatic cardiac arrest. The first device, the ResQPump Active Compression Decompression CPR Device, has a double-grip handle that attaches to the patient’s chest with a suction cup, allowing the rescuer to push to deliver compressions and lift for decompressions, which is different than standard CPR. It also includes a pressure gauge to help rescuers maintain recommended compression depth and a timing mechanism to help the rescuer maintain the necessary compression rate.

The second device, the ResQPod 16.0 Impedance Threshold Device, fits onto a rescue face mask or breathing tube. When placed on the patient, it impedes airflow into the chest during chest decompression with the ResQPump, reducing the pressure inside the patient’s chest and drawing more blood back to the heart, a concept known as preloading. A greater volume of blood being drawn into the heart can mean a greater volume of blood flowing out of the heart during the next compression which may improve overall blood circulation as compared to standard CPR. When used together, the two devices may increase the amount of oxygenated blood circulated through a patient’s body during CPR. “Most people who suffer cardiac arrest outside of a hospital die,” said William Maisel, M.D., M.P.H., acting director of the Office of

Adverse events associated with the ResQCPR system were similar to those associated with standard CPR; however, pulmonary edema (the accumulation of fluid in the lungs) was more common in ResQCPR subjects than in standard CPR subjects.

The ResQCPR System is manufactured by Advance Circulatory Systems, Inc. in Roseville, Minnesota.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Medical Device ASIA | May-June 2015 | 37

FDA expands use of CoreValve System for aortic “valve-in-valve” replacement

Device is first of its kind for this use and eliminates need for open heart surgery

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he U.S. Food and Drug Administration expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one.

This first-of-its-kind use is called aortic “valve-in-valve” replacement, and today’s approval expands the authorized use of the device to patients in need of this replacement who also are at high or extreme risk for complications associated with traditional open-heart surgery.

The heart’s four valves are tissue flaps that open and close with each heartbeat to ensure blood flows properly through the heart’s four chambers and to the body. The aortic valve is one of the four heart valves. Some patients whose own aortic valve failed to work properly in the past undergo open-heart surgery to replace the faulty valve with an artificial heart valve. Over time, artificial valves that are made of animal tissue wear out—becoming narrowed, leaky or both—and may need to be replaced again.

“The CoreValve System offers a less invasive treatment option for a significant number of patients with failed tissue aortic valves whose medical teams determine that the risks associated with repeat open-heart surgery are high or extremely high,” said William Maisel, M.D., deputy center director for science and chief scientist in the FDA’s Center for Devices and Radiological Health. “The approval is an important expansion of the authorized use of the transcatheter aortic valve replacement technology.”

The CoreValve is an artificial heart valve made of tissue obtained from the heart of a pig. For support, it is attached to a flexible, self-expanding metal frame made of nickel-titanium alloy. To implant the device, a doctor compresses the valve and puts it on the end of a delivery catheter (a tube-like device), and then inserts it via an artery in the leg or neck or via a small cut between the ribs. The catheter is pushed through the blood vessels until it reaches the failed tissue aortic valve. The CoreValve is then released from the end of the catheter and expands on its own so it anchors to the old failed valve. Once the device is in place, it opens and closes properly, restoring the 38 | May-June 2015 | Medical Device ASIA

aortic valve function.

To evaluate the safety and efficacy of the CoreValve System for aortic “valvein-valve” replacement, the FDA reviewed clinical data collected from a clinical trial conducted in the U.S. of 143 participants. In the clinical trial, the estimated rate of survival without major stroke was 95.8 percent at 30 days and 89.3 percent at six months. This compares well to the corresponding rate reported previously for trial participants who received the same device to replace their own, native diseased or damaged aortic valve.

The major risks observed in the clinical trial included death, stroke, acute kidney injury, heart attack, bleeding, complications with the arteries used to insert the valve and the need for a permanent pacemaker.

Bleeding and major complications with the arteries were the most frequently observed early adverse events.

Medtronic, the manufacturer of the CoreValve System, will continue to follow study participants up to five years in a required post-market study to assess the longterm performance of the device.

The aortic “valvein-valve” use of the CoreValve System should be limited to patients who need replacement of a failed tissue aortic valve but are at extreme or high risk of death or serious complications from traditional open-heart surgery. The decision regarding whether the product and procedure is appropriate for a particular patient should only be made after careful evaluation by the patient’s heart medical team, including a cardiologist and a cardiac surgeon. The CoreValve System should not be used in patients who have any infection; have a mechanical aortic heart valve; cannot tolerate blood thinning medicines; or have sensitivity to titanium or nickel or contrast media (the fluid used during the procedure to see internal structures).

The FDA previously approved the CoreValve System to treat patients whose own aortic valve has become severely narrowed as a result of calcium buildup around the heart valve (aortic stenosis) and who are considered to be at “extreme risk” or “high risk” for surgical aortic valve replacement.

Medtronic is based in in Minneapolis, Minnesota.

FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures

System intended for certain patients undergoing treatment for severe coronary artery disease

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he U.S. Food and Drug Administration approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention (HRPCI) procedures, such as balloon angioplasty and stenting, which re-open coronary arteries that are narrowed or blocked due to severe coronary artery disease (CAD).

Coronary artery disease can lead to chest pain and heart attack and is the leading cause of death for both men and women in the U.S. It occurs when one or more of the major arteries on the surface of the heart become narrow or blocked, reducing blood flow that supplies the heart muscle with oxygen-rich blood.

The Impella 2.5 System is a heart pump intended for temporary use by patients with severe symptomatic CAD and diminished (but stable) heart function who are undergoing HRPCI but are not candidates for surgical coronary bypass treatment. In patients with diminished heart function, the heart pumps less blood than normal every time it beats, which is sometimes associated with CAD. Throughout an HRPCI procedure, the Impella 2.5 System helps maintain stable heart function by drawing blood from the left lower chamber of the heart (left ventricle) and pumping it into the aorta, the main blood vessel leading away from the heart that supplies oxygen-rich blood to the body.

Prior to starting a procedure, the interventional cardiologist places the Impella 2.5 using a catheter (a long narrow tube) with the pump loaded into the tip. The heart is accessed by inserting the catheter into one of the body’s large arteries, usually in the leg, and then guiding the tip of the catheter through the patient’s arteries and into the left ventricle. Once in place, an external controller and monitor turns the pump on and off, measures heart function, and allows health care providers to adjust the pump as necessary to maintain stable heart function and circulation during the procedure.

All patients undergoing HRPCI are at some risk for complications related to decreased heart function and lowered blood pressure during the procedure, but patients in need of treatment for extensive or critically located CAD who are already experiencing diminished heart function are at high risk. Unstable heart function that occurs during performance of an HRPCI procedure can result in serious complications or prevent completion of the procedure.

“Use of the Impella 2.5 System is intended to prevent episodes of unstable heart function, including unstable blood pressure and poor circulation, in patients who are at high risk for its occurrence,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

The FDA reviewed data for the Impella 2.5 System in a premarket approval application, the agency’s pathway to evaluate a reasonable assurance of safety and effectiveness for class III medical devices. Data supporting the approval of the Impella 2.5 System included clinical data from the manufacturer’s PROTECT II clinical study with supporting information obtained from the USpella Registry, a multicenter, observational registry.

The overall data provided evidence that, for patients with severe CAD and diminished heart function, the temporary circulatory support provided by the Impella 2.5 System during a HRPCI procedure may allow a longer and more thorough procedure by preventing episodes of hemodynamic instability (e.g., poor circulation, low blood pressure) due to temporary abnormalities in heart function. Moreover, fewer later adverse events (e.g., need for repeat HRPCI procedures) may occur in patients undergoing HRCPI with the pump compared to patients undergoing HRPCI with an intra-aortic balloon pump (IABP). The Impella 2.5 System can be used as an alternative to the IABP without significantly increasing the safety risks of the HRPCI procedure.

The Impella 2.5 System is manufactured by Abiomed, Inc., based in Danvers, Massachusetts.

Medical Device ASIA | May-June 2015 | 39

FDA approves

breath test to aid in diagnosis of delayed gastric emptying Test can be performed in a general clinical setting; does not require radioactive material

The U.S. Food and Drug Administration recently approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis.

Current tests used to diagnose gastroparesis typically involve the use of a small amount of radioactive material or imaging equipment, so testing must be conducted in specialized outpatient centers. The GEBT can be used in broader settings.

“The GEBT is another option for aiding in the diagnosis of gastroparesis,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

“It can be performed in any clinical setting since it does not require the health care professionals administering the test to undergo special training or to take special precautions related to radiation emitting compounds.”

Gastroparesis is a disorder that slows or stops the movement of food from the stomach to the small intestine when muscles in the stomach are not contracting properly. It is caused by damage to the vagus nerve that controls the muscles of the stomach and small intestine, often as a result of intestinal surgery, neurological diseases such as Parkinson’s disease and multiple sclerosis, or high blood glucose levels due to diabetes. If left untreated, gastroparesis can lead to problems such as severe dehydration due to persistent vomiting, difficulty managing blood sugar levels in people with diabetes, and malnutrition due to poor absorption of nutrients or a low caloric intake.

The GEBT, conducted over a four-hour period after an overnight fast, is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath. Patients have baseline breath tests conducted at the beginning of the test. They then eat a special test meal that includes a scrambled egg-mix and Spirulina platensis, a type of protein that has been enriched with carbon-13, which can be measured in breath samples.

40 | May-June 2015 | Medical Device ASIA

Carbon-13 is a naturally existing non-radioactive form of the common element carbon-12. Both carbon-12 and a very small amount of carbon-13 are normally found in exhaled carbon dioxide. By adding carbon-13 to the test meal, the GEBT can determine how fast the stomach empties the meal by measuring the ratio of carbon-13 to carbon-12 collected in breath samples at multiple time points after the meal is consumed compared to baseline.

To support the safety and effectiveness of the GEBT, researchers conducted a clinical study using data from 115 participants who would typically undergo a gastric emptying test. All participants underwent testing with both the GEBT and gastric scintigraphy, the standard of care for measuring gastric emptying that requires ingestion of a test meal containing a radioactive material.

Researchers compared diagnostic results from both the GEBT and scintigraphy and found that GEBT results agreed with scintigraphy results 73-97 percent of the time when measured at various time points during the test.

No deaths or serious adverse events occurred during clinical studies. Some study participants reported nausea and stomach discomfort during the test. People with hypersensitivity to Spirulina, egg, milk or wheat allergens should avoid the GEBT. The test also should not be administered to people with certain lung diseases or conditions that cause small bowel malabsorption.

The GEBT is manufactured by Advanced Breath Diagnostics, based in Brentwood, Tenn.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Prolonged stress leads to multiple inner health problems

By Dr Sonali Kolte, General Manager, MedicoMarketing,Metropolis Healthcare system. During stress, cortisol suppresses the inflammation process and over a period of time the body develops resistance to cortisol. Additionally, cortisol and corticosteroids suppresses lymphocytes and puts the body at an increased risk of infection such as influenza and other diseases.

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tress — just the word may be enough to set your nerves on edge. Everyone is stressed in some form or other. Some people handle stress effectively or recover from stressful situations quicker than others.

Stress is good if it is a short term phenomenon and pushes you to achieve your goals or targets, but it is harmful, if it prolongs or becomes routine.

Stress can be defined as a physical, mental, or emotional factor that causes bodily or mental tension. We usually tend to think that stress can lead to negativity, but that isn’t the case always. However, anything that puts high demands and forces you to adjust accordingly can be stressful. Stress may have adverse effect on your health, but one may not realize it. Chronic unrelenting stress has become so common in modern life; provoking feelings of hopelessness; what is usually termed as a defeat response.

Stress and emotions related to stress trigger chemical reactions in the body and leads to increased fat storage, abdominal obesity, tissue breakdown, suppression of the immune system, increased risk for heart disease etc.

There are multiple ways to cope up with stress; which begins with identifying the sources of stress and dealing with it. Since stress has a direct impact on health, it is important to regularly monitor health parameters to make sure your vital organs are performing well. A typical health package to monitor stress and its effects would include tests to measure blood sugar, cholesterol, lipids, cortisol etc. This tells you if you are at risk for heart disease, stroke and gives an overall indication of your inner health.

The human body is wired to react to stress in a particular manner which helps you prepare for a situation. Imagine a close encounter with a speeding car; this is when you encounter a perceived threat.

The hypothalamus, which is a small portion of the brain, sets off your body in to an alarm mode. A combination of nerve and hormonal responses signals the adrenal gland to release hormones that includes Adrenaline and Cortisol.

To conclude: “It’s not stress that kills us, it is our reaction to it”, Says Hans Selye, author of The Stress of Life.

What is your reaction to stress?

When stressors are always present and the subsequent exposure to these hormones, especially cortisol for a prolonged period leads to a lowered BMI, increased fat storage and increases risk for hypertension, heart disease and stroke. Furthermore, stress also wrecks the immune Medical Device ASIA | May-June 2015 | 41

Syrris launches novel quantum dot synthesis system Syrris, a world leader in chemistry product innovation, has launched the Atlas Nanoparticle System for the automated synthesis of quantum dots. This fully automated solution offers complete control over temperature, mixing, dosing and sampling, allowing the production of nanoparticles with a narrow size distribution.

The Atlas Nanoparticle System is ideal for the production of complex particles, including both core-shell and multi-layered quantum dots.

It has an extremely small footprint and integrates all the required elements – dosing, heating, mixing and sampling – to enable continuous operation for up to 72 hours. Builtin magnetic stirring ensures uniform heating of the 250 ml reaction vessel up to 300 °C, with a Heated Syringe Pump and Heated Lines to maintain reagents at temperatures of up to 120 °C. The three syringes can dose up to 25 ml each in volumes ranging from 0.1 to 5 ml and, following synthesis, the system’s Sample Collection Carousel enables automatic sample collection into 10 vials.

Temperatures, pumping volumes, pumping rates and the timing of additions are easily controlled via the Syringe Pump or PC software. Real-time and complete reaction data can be monitored using optional absorption/ fluorescence spectrophotometry, as well as temperature and turbidity probes, enabling truly optimized, reproducible synthesis of quantum dots.

Syrris Limited Syrris is world renowned for excellence in chemical reactor systems and is a world leader in flow chemistry systems. Established in 2001, Syrris employs over 30 scientists and engineers at its facility in Royston (near Cambridge, UK) and has offices in the US, Japan, India and Brazil plus over 30 distributors worldwide.

Syrris develops laboratory automation products for research and development chemists in industries such as pharma, petrochem, agrochem, fine chemical synthesis etc. as well as academia. Syrris products are used in a wide variety of applications and laboratories including process, discovery, crystallization, process safety, scale-up and many more.

Syrris products include the innovative range of fully automated batch reactor products (Atlas), a manually operated jacketed reactor platform (Globe) and flow chemistry systems (Asia and Africa). In recognition of its technological achievements, Syrris has been awarded the “Eastern Region’s UKTI Best Established Exporter” and the “Most Outstanding Export Achievement” at the Global Opportunity Conference on International Trade. Syrris’ Asia Flow Chemistry system was the recipient of a prestigious 2012 R&D award.

For more information, please visit www.syrris.com.

42 | May-June 2015 | Medical Device ASIA

Fructose produces less rewarding sensations in the brain Fructose not only results in a lower level of satiety, it also stimulates the reward system in the brain to a lesser degree than glucose. This may cause excessive consumption accompanied by effects that are a risk to health, report researchers from the University of Basel in a study published in the scientific journal PLOS ONE. Various diseases have been attributed to industrial fructose in sugary drinks and ready meals.

Fruit sugar, or fructose, is a carbohydrate that occurs naturally in fruits and vegetables and is generally harmless in this form. Despite their similar structures, fructose and glucose – that is, pure grape sugar – affect the body very differently: an intake of glucose causes a sharp increase in blood insulin within minutes, whereas fructose stimulates insulin secretion to a limited degree only.

Teams of researchers led by Prof. Christoph Beglinger from the University Hospital and Prof. Stefan Borgwardt from the Psychiatric University Clinics (UPK Basel) have now taken a more in-depth look at how these two types of sugar affect interactions between the gastrointestinal tract and the brain. Their work was funded by the Swiss National Science Foundation. In their study, the researchers used combined pharmacological and imaging methods such as functional magnetic resonance imaging (MRI).

In the placebo-controlled, double-blind study, twelve healthy young men were given either fructose, glucose or a placebo by way of a feeding tube. Blood samples were then taken from the subjects to measure satiety hormones. The subjects were also asked about how satiated they felt, and their brain activity was monitored by MRI while at rest.

The findings of the pilot study were as follows. Unlike glucose, fructose is less effective at creating feelings of satiety and stimulating the reward system in the brain. An analysis of the MRIs in fact showed that the two types of sugar differed greatly in terms of network activation within the hippocampus and amygdala areas of the limbic system, i.e. the regions of the brain that regulate emotions and impulses. Furthermore, in contrast to glucose (which stimulated a strong signal) the levels of satiety hormones in the blood barely or only minimally increased following fructose consumption. The subjective feeling of satiety also tended to be less affected by the consumption of fructose.

“The study may provide the first key findings about the lack of satiety and rewarding effects triggered by fructose,” state lead authors Dr. Bettina Wölnerhanssen and Dr. Anne Christin Meyer-Gerspach. The role of the differing insulin levels and other effects will have to be demonstrated in further studies with more test subjects. Research is increasingly finding indications that isolated, industrially manufactured fructose – which is increasingly used in sugary drinks, sweets and ready meals – is problematic for the human body. It is suspected that fructose promotes the development of various disorders such as obesity, diabetes, fatty liver disease and gout.

Sesame Lets Seriously Paralyzed Folks Use Smartphones

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ur smartphones can both bind us and liberate us in a myriad of ways. They put us in touch with others, help us automate things, and guide us when we’re on our way. All this requires the basic ability to tap a finger on the phone’s screen. Yet, the very people that would most benefit from that capabilities of smartphones are the ones least able to use them. Specifically, paraplegics that can’t move their arms can’t make phone

calls, turn lights on and off, and direct a wheelchair through a single interface. To make this possible, project called Sesame is aiming to empower standard smartphones to be used by people who only have movement left above the neck.

The Sesame uses the phone’s built-in camera to track the person’s face motion, essentially coupling the person’s nose to the cursor on the screen. The software is adjustable to match the motor abilities of the person using it. The project is not far from commercial reality, as 10 beta users are already testing the technology, initially being designed for the Nexus 5, but is expected to eventually work on a variety of phones. The folks behind the Sesame are looking to raise some funds on Indiegogo to help them push it towards completion and allow them to begin shipping the ready-to-go Nexus 5 phones with the software pre-installed.

43 | May-June 2015 | Medical Device Asia

ViewRay Receives CE Mark for MRIdian MRIGuided Radiation Therapy System

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iewRay (Oakwood Village, Ohio) has received CE Mark approval for its MRIdian system, an MRI-guided radiation therapy system. The system

previously received FDA approval in 2012, and is still the only such system available on the market.

The MRIdian system combines MR imaging with radiation therapy to visualise the location where radiation is delivered in real-time during treatment. The software can track tumor tissue in order to only allow treatment when the target is in range. Other such systems exist based on CT or X-ray technology, however these systems have the disadvantage of introducing an additional radiation dose and not being able to visualize the tumor in real-time.

The MRIdian is primarily intended for treatment of tumors that are likely to move significantly during treatment. This includes thoracic, abdominal and pelvic malignancies, such as lung, prostate, liver, and head and neck cancer.

44 | May-June 2015 | Medical Device Asia

Microneedles for Easy Delivery of Drugs into Eye

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number of eye conditions can be treated by adminis tering drugs directly into the eye. Yet, conventional needles have a bunch of drawbacks, including the patientsâ&#x20AC;&#x2122; fear of needles entering such fragile parts of the body and the difficulty of accurately administering medication into a targeted region of the eye. For glaucoma, for example, eye drops are prescribed which have a shorter active lifetime and are often skipped by the patients. An easy injection that works for months at a time would help control the disease considerably better. microneedles more Microneedles for Easy Delivery of Drugs into EyeResearchers at Georgia Tech and Emory University have been working on microneedles and formulations to safely and effectively deliver drugs into the eye. The microneedles are designed to only penetrate to the correct depth and the formulations need to be viscous enough to stay

in place and release their therapeutic compounds in a controlled fashion.

The researchers have already tested the microneedles on laboratory animals and showed that they can place drugs within the targeted sections of the eye.

More from Georgia Tech: The microneedle therapy would inject drugs into space between two layers of the eye near the ciliary body, which produces the aqueous humor. The drug is retained near the injection side because it is formulated for increased viscosity. In studies with an animal model, the researchers were able to reduce intraocular pressure through the injections, showing that their drug got to the proper location in the eye.

Because the injection narrowly targets delivery of the drug, researchers were able to bring about a pressure reduction by using

just one percent of the amount of drug required to produce a similar decline with eye drops. To treat corneal neovascularization, the researchers took a different approach, coating solid microneedles with an antibody-based drug that prevents the growth of blood vessels. They inserted the coated needles near the point of an injury, keeping them in place for approximately one minute until the drug dissolved into the cornea.

In an animal model, placement of the drug halted the growth of unwanted blood vessels for about two weeks after a single application.

Medical Device Asia | May-June 2015 | 45

Close-up of the half-inch long multimicroelectrode array showing detailed circuitry leading to each individual electrode. The array is used to stimulate the spinal cord to enable locomotor and bladder function after paralysis.

Electrical Stimuli Induced Bodily Control in Spinal Cord Injuries

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atients who have had spinal

A second experiment was also done by the researchers on trained SCI rats that were held by a harness which

cord injuries suffer from not

allowed their lower limbs to touch the ground. A catheter was used to infuse a saline solution into their bladders.

only paralysis of their limbs,

Varying levels of eEmc stimulation were applied to determine the optimal amount for spontaneous release of the

but also from other complications

bladder. The researchers found that the emptying was best when there was a relatively low level of stimulation. This

often including a loss of bladder

study shows great promise for rehabilitation and improving the quality of life for those that suffer from spinal cord

control. In previous experiments, Dr.

injuries.

Edgerton from the University of California, Los Angeles and collaborators at University of Louisville, used electrical stimulation to allow four patients to voluntarily stand and perform simple movements. In a new study, partly funded by the National Institute of Biomedical Imaging and Bioengineering, researchers are using the previous findings to to help identify and optimize ways to use electrical stimulation to bring back bladder control in rats.

In the basic protocol, an electrical epidural stimulator is implanted into the spine which allows researchers to control electrical signals. In the study at UCLA, the researchers observed 10 SCI (spinal cord injured) rats that were trained for six weeks with electrical enabling motor control (eEmc) and a group of 5 untrained rats. The rats in the experimental group were trained to empty their bladders while stepping on a treadmill and the rats in the control were not. The group found that the extra sensory input provided by the treadmill training improved bladder response.

Detail of a single electrode of a multielectrode array.

46 | May-June 2015 | Medical Device Asia

Virtual Reality Hand Training with Haptic Technology

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eople with motor neuron diseases can benefit from repetitive training of their hands to improve strength, coordination, and ability to perform basic tasks. Virtual reality (VR) is a great enabler of this, allowing to create game routines where patients can practice hand motions in a mildly entertaining fashion. Clinical researchers at The Hong Kong Polytechnic University have created a system that takes advantage of haptic technology to boost the

effectiveness of VR training. vr hands Virtual Reality Hand Training with Haptic TechnologyThey are using a device from Sensable Technologies which delivers force feedback to the userâ&#x20AC;&#x2122;s hand in response to interactions with objects in the virtual environment. The system has different levels of play, allowing rehab patients to advance to more difficult tasks once easy ones are completed. The haptic device also measures the userâ&#x20AC;&#x2122;s performance in task execution, which can be used as a gauge of how well a person is responding to therapy.

From Hong Kong Poly: The effectiveness of this training programme was preliminarily confirmed, as a similar tool aimed to improve hand-writing was tested on the children at the Hong Kong Red Cross Princess Alexandra School. The results have shown a marked improvement in the time they needed to complete the task after two weeks of training. More tests and trials are on the way, and the team expect that a longer period of computer-assisted training will yield greater benefits.

Medical Device Asia | May-June 2015 | 47

Genteel Lancing Device for Pain-Free Glucose Testing Anywhere on Body

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iabetics checking their blood sugar levels usually have to prick their finger to get a sufficient draw for the glucometer to do its job.

Some newer glucometers work with smaller blood samples and are

able to take blood from the inside of the arm where there are fewer nerves to cause pain. Now a new device called Genteel can allow patients to take blood samples from just about anywhere on the body with little pain.

The device prevents pain by vibrating the skin just before the lance pierces it and by creating a vacuum around the sample site at the moment of penetration. The actual piercing of the skin is done much faster than with traditional devices, taking only .018 of a second for the needle to pop in and out. Additionally, the contact tip has six levels of depth control to accurately set the penetration level to match the location from where the blood is drawn.

The Genteel costs $129, a bit high compared to competing device, though it may prove quite valuable for kids and others not used to regular prickly blood draws. It uses standard FDA approved square lancets and works with whatever glucometer youâ&#x20AC;&#x2122;re used to.

48 | May-June 2015 | Medical Device Asia

Bionic Ears

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bout the time 1970s sci-fi spy Jaime Sommers put her cybernetic ear to work as a government eavesdropper on TVâ&#x20AC;&#x2122;s The Bionic Woman, a real-life experimental hearing device was beginning to turn the meaning of deafness on its ear. The cochlear implant, as close as it gets to a true bionic ear, hit the U.S. market following approval by the U.S. Food and Drug Administration in 1984-85.

The continually evolving technology doesnâ&#x20AC;&#x2122;t restore better, stronger, faster hearing, but for people with profound deafness, cochlear implants open a world of sound.

After 30 years, cochlear implants are still making significant noise in the

medical device world. Today more than 350,000 people who once lived in silence now use implants to understand conversational speech and hear environmental sounds.

The Ears Have It Standard hearing aids work by amplifying sound for people with partial hearing loss. For people who are deaf or have profoundly impaired hearing, thatâ&#x20AC;&#x2122;s not enough; their hearing loss is often linked to damage or other abnormalities in the thousands of tiny sensor hair cells that line the snail-shaped inner ear chamber called the cochlea. These hair cells play a crucial role in hearing, converting acoustic waves

from the outside world into electrical signals that stimulate the auditory nerve. The brain understands these signals as sound.

When these sensory cells are severely damaged or absent, sound waves literally fall on deaf ears, even if the rest of the ear is anatomically healthy. Cochlear implants work something like a telephone wired directly to the brain to replace the function of the sensory hairs.

transmitter attached to the side of the head by a strong magnet housed within a subdermal receiver/ stimulator device anchored to the skull. A length of wire connects the receiver/stimulator to the cochlea, where the electrodes deliver the converted electrical signals to key regions of the auditory nerve.

A wire connects the implant with a microphone/speech processor behind the ear. Image: MED-EL In a typical implant, a microphone/ speech processor unit is worn semi-discretely behind the outer ear.

It is connected by wire to a signal

The first device to gain approval was the landmark House 3M cochlear implant, a single-channel device developed by the House Ear Institute of Los Angeles and 3M Company. It helped users perceive nearby sounds and read lips with greater ease, but it was a far cry from real hearing. A multichannel alternative approved a year later

Medical Device Asia | May-June 2015 | 49

A wire connects the implant with a microphone/speech processor behind the ear.

beginning the current era of research and development. Today the U.S. cochlear implant market is dominated by three highly competitive companies: Advanced Bionics , Valencia, CA; Cochlear Corporation, Sydney, Australia; and MED-EL, Innsbruck, Austria. Each maker has its own formula, but the basic design of a modern system comprises some version of the same components.

Echoes of the Past, Signals of the Future

Their work built on efforts since the 1950s to electronically stimulate the auditory nerve. One of the first significant advances was by California otologist William House, whose simple single-electrode implant helped two test subjects make out sounds from their surroundings.

This 1961 prototype evolved into the House/3M implant approved in 1984. Independently in labs in Australia and Austria, Clark and Hochmair – along with her future husband, electrical engineer Erwin Hochmair – developed more sophisticated multichannel devices and experimentally implanted them in the late 1970s. Their common goal was a device that enabled deaf people to comprehend spoken language without reading lips or needing other visual cues. Most hearing experts wrote that off as impossible, but in 1991 Wilson’s continuous interleaved sampling approach to speech processing brought that dream to life, launching today’s commercial market.

Carmen A. Puliafito, dean of the University of Southern California’s Keck School of Medicine, summed up the impact of their work in his remarks at the award ceremony. “Fifty years ago, there was no effective treatment for patients with severe hearing loss,” he said. “Today patients with these implants can speak clearly.”

Sounds of the Future

In 2013, three cochlear implant pioneers received the top U.S. honor in medical science, the Lasker-DeBakey Clinical Medical Research Award, for their respective contributions to the field. Graeme M. Clark, an emeritus professor at the University of Melbourne, Ingeborg Hochmair, co-founder of MED-EL in Innsbruck, and Blake S. Wilson of Duke University shared the award for their independent contributions to the device we know today.

Technologies recently introduced commercially or advancing through the development pipeline are focused on issues such as speech perception and sound localization. New rugged and waterproof external housings allow wearers to bathe, swim, or play active sports without harming their bionic ears. Work toward a 50-channel hi-fi implant with more strategically placed electrodes is under way to enrich the sound quality of music and speech.

FDA-led tests of hybrid implants that combine electronic stimulation and amplification are promising to make cochlear technology available to people with a wider range of hearing disorders. By using two different devices or sound processors to bring patients a broader spectrum of pitches, this technology could make cochlear implant technology an option for candidates with partial hearing loss. Other groups are working to make the already-discrete implant even less obtrusive, using a wirelessly rechargeable low-power signal processing chip and an internal microphone system to do away with the bulky external components.

The world may be moving toward thought-controlled limbs, total artificial hearts, and 3-D printed skin, but the cochlear implant is still the only practical mechanical device that replaces one of the five human senses. And unlike real ears that can diminish in performance as we age, cochlear implants just keep getting better

50 | May-June 2015 | Medical Device Asia

â&#x20AC;&#x153;As the number of mobile medical apps grows at a steady clip, companies are looking for innovative ways to streamline their products and personalize care. A new iOS device brings laboratory testing to the home, allowing individuals to test their vital levels with simple swabs of bodily fluids.â&#x20AC;?

Mobile medical app brings laboratory testing to the home

C

ue's eponymous product

sickness."

medical apps in September, saying

glucometers, and details from the

that it would cast a more critical eye

meeting were released earlier this

Cue is accepting preorders for its

toward apps that turned a

week.

cartridges that detect biomarkers

device and expects to ship its first

smartphone/tablet into a de facto

such as testosterone, inflammation,

units by the spring of 2015 but has

medical device.

vitamin D, and fertility. Users can

not yet won FDA approval for its

collect fluid on white test strips and

product. There are over 15,000

Cue also faces competition from

based on the manufacturer's

insert the strips into the microfluidic

health and fitness apps in Apple's

larger companies looking to cash in

intended use for the device," the

cartridges. Cue then analyzes the

app store, and only 120 or so have

on the mobile medical app market.

agency said in the meeting. "With

samples and displays the results

received FDA clearance, Wired

Leading app maker Apple ($AAPL)

regards to sensors, the presence of

through an iPhone app.

reports.

recently unveiled its mobile health

a particular sensor will not necessar-

and fitness platform, HealthKit, for

ily lend the device to FDA regulation.

The most challenging part of

According to the company's

iOS 8 and Mac.

Instead, FDA would be more likely

designing the device was creating

website, Cue is being presold under

an interface that anyone could use,

an Investigational Device Exemption,

The company sat down with FDA

sensor to use, if use of the software

product designer Scot Herbst told

a special regulatory loophole that

officials last December to discuss its

alters the device's use to be a

Wired. Unlike typical lab machines,

allows companies to bring their

new mobile products, sensors and

medical device."

Cue contains almost no buttons and

product to market and submit user

only displays a series of small LED

data for clearance.

consists of a small tabletop analyzer and color-coded

"Under the current regulatory scheme, FDA will review a device

to regulate the software that puts the

lights. The margin for user error is small, and the product's design

Meanwhile, the FDA continues to

makes it more approachable than

strengthen its oversight of mobile

larger testing devices.

medical apps, responding to a legion of complaints from Congress,

"Generally, medical products are

advocacy groups and the industry.

things that you hide, not display," Herbst said. "The idea is to change

Earlier this year, a bipartisan group of

this dynamic with health oriented

senators sent a letter to the agency

products that really plays into the

urging it to clarify its regulation of

philosophy that the product is

mobile apps. The FDA released its

about health and wellness, not

final rules for developing mobile

Medical Device Asia | May-June 2015 | 51

FDA allows marketing of the first test to assess risk of developing acute kidney injury Radiological Health at the FDA’s Center for Devices and Radiological Health. “The NephroCheck provides health care providers with a quick, validated method of assessing a patient’s AKI risk status which may inform patient management decisions.”

The FDA reviewed the data for NephroCheck through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

U

.S. Food and Drug Adminis tration allowed marketing of the NephroCheck test, a first-of-a-kind laboratory test to help determine if certain critically ill hospitalized patients are at risk of developing moderate to severe acute kidney injury (AKI) in the 12 hours following the administration of the test. Early knowledge that a patient is likely to develop AKI may prompt closer patient monitoring and help prevent permanent kidney damage or death.

The kidneys filter waste and extra water out of the blood and are important in controlling blood pressure and other essential body functions. When kidneys are not functioning properly, waste builds up in the body and can cause serious health problems. AKI is a

sudden decline in kidney function, often without early signs or symptoms, following an injury to the kidney caused by a co-existing disease, infection, or other condition. AKI can cause fluid to build up in the body, chest pain, muscle weakness, and permanent kidney damage or chronic kidney disease (the gradual loss of kidney function). Critically ill patients are the most at risk for AKI, particularly patients who meet certain factors such as advanced age, diabetes and high blood pressure.

detects the presence of insulin-like growth-factor binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases (TIMP-2) in the urine, which are associated with acute kidney injury. Within 20 minutes, the test provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed. No other tests currently on the market are FDA-approved or cleared to assess the risk of developing AKI in at-risk patients.

Current laboratory tests can only assess whether a patient may already have AKI; often, the patient has progressed to moderate to severe AKI before the test results confirm the clinical diagnosis. NephroCheck

“Early assessment and timely treatment for AKI can help prevent kidney damage and potential associated complications,” said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and

52 | May-June 2015 | Medical Device Asia

The FDA’s review included two clinical studies evaluating the test’s safety and effectiveness. The two studies compared the clinical diagnoses of more than 500 critically ill subjects at 23 hospitals to NephroCheck test results.

NephroCheck accurately detected 92 percent of AKI patients in one study and 76 percent in the other. In both studies, NephroCheck incorrectly gave a positive result in about half of patients without AKI. The NephroCheck Test System is manufactured by Astute Medical based in San Diego, California. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. FDA also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA Encourages Medical Device Data System Innovation By: Bakul Patel

T

hanks to advances in digital health, doctors and their patients are more frequently using computer systems to collect medical data that can provide useful information on a patient’s health.

Bakul PatelSome of these systems, referred to as “medical device data systems,” are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices.

Medical device data systems can collect and store data from a variety of other medical devices, including glucose meters, blood pressure cuffs, and weight scales. This data can be used at home to track certain information or it can be stored for a doctor to review at a later time.

and has determined that these devices pose a low risk to the public.

Today, given the low level of patient risk, we are proposing a compliance policy under which medical device data systems should see their burdens reduced.

Why would we do that?

Since our 2011 action, we’ve been working with two other federal agencies that oversee health IT – The Office of the National Coordinator for Health IT (ONC) and the Department of Health and Human Services, and the Federal Communications Commission (FCC) on a proposed risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. In the course of our work on the proposed framework, we sought extensive public

feedback. And we listened.

In light of those discussions, we believe that medical device data system products pose little risk.

While every medical device and procedure carries a certain level of risk, the health IT report proposes a risk-based framework – where we use our regulatory tools, resources, and expertise where they are most needed – and that’s with devices that carry greater levels of risk.

This allows developers of medical device data systems to focus on making these products better able to operate amongst various devices and technology systems – resulting in stronger products.

Today’s proposed guidance for manufacturers of medical device data systems is thus consistent with the health IT report we issued earlier this year with ONC and FCC on the proposed framework. That report

placed health IT products in three categories according to their risk to patients. FDA’s regulatory oversight of health IT products is focused on the devices that pose higher risk to patients.

Medical device data systems are critical to the success of digital health because they transfer, store, convert, and display a variety of information from medical devices critical to understanding an individual’s health.

These systems are the foundation for intercommunication and interoperability among devices and between medical devices and other health IT. xBecause they pose such a low risk, FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems. FDA believes that this will encourage greater innovation in the development and maturation of these systems.

Medical device data systems can be used in hospitals to collect information and data from other medical devices including bedside monitors and infusion pumps. This information can then be stored in a patient’s electronic health record for a more complete review of a patient’s total health.

In 2011, FDA issued a regulation down-classifying medical device data systems. Since that time, FDA has gained additional experience with these types of technologies,

Medical Device Asia | May-June 2015 | 53

BrainScope wins U.S. regulatory clearance for its Ahead 100 device for detecting traumatic brain injury

B

rainScope wins FDA approval for Ahead 100 brain-injury scanner.

BrainScope said it won 510(k) clearance from the FDA for its Ahead 100 device, designed to detect traumatic brain injury.

The Ahead 100 uses a patient's EEG readings to help determine the structural condition of the brain. The handheld device is intended to help evaluate whether a patient should receive a CT scan, but should not be used in place of a scan, BrainScope said.

The Ahead 100 is cleared for use in patients aged 18 to 80 who have sustained a head injury in the last 24 hours, according to a press release.

"Each year there are approximately 2

million patients in the U.S. alone who sustain head injuries and go to emergency departments for evaluation," Dr. J. Stephen Huff of the University of Virginia School of Medicine said in prepared remarks.

"Many of these patients present with very mild symptoms, yet may have life-threatening bleeds in the brain.

An objective, accurate capability that can rapidly help identify and categorize patients with even the mildest forms of brain injury could help save lives, reduce radiation exposure, and decrease costs to the healthcare system."

In September, BrainScope won nearly $16 million in contracts from the U.S. Defense Dept. to further develop its concussion-detection technology. The company said that it's won more than $27 million in DoD research grants over the years.

54 | May-June 2015 | Medical Device Asia

BrainScope is also testing the technology for sports-related head trauma under a grant from the National Football League's Head Health Challenge I initiative.

"Over the last 2 years, we have focused on improving this technology, including adapting it for use on ubiquitous hardware platforms such as smartphones and tablets," CEO Michael Singer said in a statement."We will direct all of our commercialization efforts for the Ahead product family using these hardware platforms both for assessment of structural brain injury in urgent care settings, and for assessment of concussion on the battlefield and the sports field. We also have an eye to the future with our technology showing promise in other neurological indications, such as stroke and cognitive decline."

Government of India, Registrar of Newspapers of India (RNI)#: DELENG/2009/30008