Medical Device ASIA, May-June 2015

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

MEDICAL FAIR THAILAND 2015

Healthcare Event - tHIS

THE WORLDS LARGEST

Show Report!

of Indias Healthcare!

Future

Hi-Tech logistics service

Medical Device ASIA | May-June 2015 | 3

Published, Printed and owned by: World-Wide Publications, D-182, PR House, Anand Vihar, New Delhi-110092, India and printed at Technical Press Inc. D-182, PR House, Anand Vihar, New Delhi 110092 - India. The publisher does not necessarily agree with the views expressed by the contributors, in this issue, nor do accept any responsibility for any errors or interpretation in the publication.

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

Medical Devices & Equipment | Healthcare | Pharmaceutical Journal

Editorial Advisory BoardAlex & Lilly - [email protected] McCourt - Australia

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For advertising, subscribing or to submit a press release, write to :D-182, PR House, Anand Vihar, New Delhi - India. Tel : +91 11 22141542 / 4309 4482 Fax: +91 11 22160635Email: [email protected]

Managing Editor Sarvjit

Associate Editor & Public Relations Director

Reny

Joint EditorsVishwapreet

Amrita

ProductionRakesh

Marketing & CommunicationsLovleen

Web EditorRavindar

CirculationSurekha

Secretary & Legal AdvisorSurinder

China CorrespondentsYing Wei / Adrian Liu

h i g h l i g h t s

e d i t o r i a l

In addition to the US, the Asia-Pacific region represents a promising avenue for volume growth in the viscosupplementation sector, says analystViscosupplementation 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 companys 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 non-surgical osteoarthritis treatment.

According to Linda Tian, MSc, GlobalDatas 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,

Viscosupplementation market value will increase from approximately $1.76 billion in 2014 to a little under $2.64 billion by 2021

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 Chinas 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.

4 Utilization of major surgery in South India 6 MEDICAL FAIR THAILAND 2015 10 A Big Success : The Worlds Largest Healthcare Event -

tHIS 14 Rhenus Logistics India launches Hi-Tech logistics

service 15 SOLED15F Focusable LED lamp for examination and

minor surgery 18 Future of Indias Healthcare Tied To Homecare 22 Xenex Germ-Zapping Robots Enhanced Cleaning

Process 26 FDA approves spinal cord stimulation system 31 Adhesives and Material Technologies for Medical

Applications 34 Custom Cable, Tubing and Catheter Products 41 Prolonged stress leads to multiple inner health

problems 45 Microneedles for Easy Delivery of Drugs into Eye 47 Virtual Reality Hand Training with Haptic Technology 48 Genteel Lancing Device for Pain-Free Glucose Testing

Anywhere on Body 51 Mobile medical app brings laboratory testing to the

home 53 FDA Encourages Medical Device Data System

Innovation 54 Ahead 100 device for detecting traumatic brain injury

In 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.

Cardiovascular surgeries (8%) alone accounted for 21% of cost. Annual per capita cost of surgical claims was US$149[95% CI: 132-165].

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 doesnt 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 Kings Centre for Global Health, Kings College London, and one of the commissions lead authors.Scale-up of levels of access to surgery will need investment, the commissions authors said. Although the scale-up costs are large, the costs of inaction are higher and will accumulate progressively with delay, the commissions lead author, John Meara, Kletjian Professor in Global Surgery at Harvard Medical School and Associate Professor of Surgery at Boston Childrens 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.

Utilization of major surgery in South IndiaA retrospective audit of hospital claim data from a large community health insurance program

4 | May-June 2015 | Medical Device ASIA

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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 Dsseldorf 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

MEDICAL FAIR THAILAND 2015 The Biggest And Most Influential Show Yet

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

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 regions flourishing medical and healthcare industry.

Aside from live product & technical demonstrations, MEDICAL FAIR THAILANDs 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 years edition with a focus on A New World in Rehabilitative Care.

Visitors are encouraged to pre-register, 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 pre-registration, please visit www.medicalfair-thailand.com v

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HOW AGED WILL SOUTH EAST ASIA LOOK IN 2030?

SINGAPORE

MALAYSIA

THAILAND

PHILIPPINES

INDONESIA

Over 14 million (~11% of its population) will be 60 and above

Over 13 million (~19% of its population) will be 65 and above

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50% of the Worlds Population Live in Rural Areas, but Fewer than 38% of Nurses and 25% of Doctors Work There

UN World Health Organization

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 Hospitals 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 Healths 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)

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

Myanmar: In rural areas where 70% of the countrys 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.

Will become an ageing population country, with 4.9 million (~15% of its population) 60 and above

SHORTAGE OF HOSPITAL BEDS AND LONG WAIT TIMES IS A GLOBAL ISSUE

LOW ACCESSIBILITY TO CARE IN RURAL AREAS

6.4 working citizens will support one elderly. (2010: 13 workers to every older person)

Expanding the Care Continuum through SMART Homes and Intermediate and Long-Term Care (ILTC) Services

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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 Chinas 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

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 events 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

A Big Success : The Worlds Largest Healthcare Event - tHIS


here, there lies the explosive popularity of the event.

Meanwhile, anticipating a huge turnout and with a focus on APIs and formulations, Chinas 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 worlds leading event organizer Reed Exhibitions and Chinas leading state-owned pharmaceutical group Sinopharm, used their combined strength of international networks and industry connectivity to write a new chapter for Chinas healthcare industry, as it transforms from localized industry developments into a maturing market with global reach.

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

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, [email protected]; Sophie Zhang, [email protected]


Indias definitive exhibition & conference on products & services that aid the inclusion of differently abled

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

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Eminent speakers at 2 day Asia Rehab Summit

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Training sessions for the differently abled and their families

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For more details, contact :Japesh Thakur +91 [email protected]

The 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 sellers 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

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 governments 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

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 high-tech 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

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


SOLED15F 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 4.500K

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

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for its entire life duration.

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

increasable up to 77.000 lux (small

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

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

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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

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SOLED15F Focusable LED lamp for examination and minor surgery


In 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 m. 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

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


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 innovation-driven 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.

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, Jrgen 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

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 Dsseldorf Group abroad. The growing success is also fuelled by the close cooperation with the Dsseldorf-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


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 countrys future healthcare burden, writes Dr Gaurav Thukral, Head Medical Services, HealthCare at Home.

Attending to the healthcare needs of the 1.2 billion-population 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

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 patient-centric, 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.

Future of Indias Healthcare Tied To Homecare


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 Organizations 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.


Headaches are one of the most common health problems we experience in our daily lives. Given the high paced, stress-driven, 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 lenss 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

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.

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

Recurrent Headaches: When to See a Neurologist?Dr. A K Sahani, Sr. Consultant, Neurology, Indian Spinal Injuries Centre

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.


Peripheral 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

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.

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

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.

References:1. Bali Medical Journal (Bali Med. J.) 2014, Volume 3, Number 3: 112-115\P-ISSN.2089-1180, E-ISSN.2302-2914www.balimedicaljournal.org or www.ojs. unud.ac.id 112 HEMATOPOIETIC PROGENITOR CELLS AS A PREDICTIVE OF CD34+ ENUMERATION PRIOR TO PERIPHERAL BLOOD STEM CELLSHARVESTING1Zefarina Zulkafli, 2Rapiaah Mustaffa, and 2Shafini Mohammed Yusoff2. Hemopoietic Progenitor Cell (HPC)Enumeration: A Comparitive Study betweenFlowCytometry and Sysmex XE-2100Hematology Analyzer-Salem H. Khalil, Barbara GengJournal of Appplied Hematol-ogy 20103. http://www.bloodjournal.org/content/122/21/2032November 15, 2013; Blood: 122 (21)4. December 27, 2013, in the Inter-national Journal of Laboratory Hematology.

Hematopoietic Progenitor Cells (HPC)Novel Parameter in Hematology Analyzer

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

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


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 patients intestines is aided

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.

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.

MedStar Franklin Square Medical Center Reduces C.diff Infections by 29% Xenex Germ-Zapping Robots Enhanced Cleaning Process


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 DAgostino, BSME, LSSBB, Senior Operational Excellence Specialist at MedStar Health. C.diff is a global problem and its 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.

MedStars 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 patients 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 facilitys 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 Xenexs 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.

With this bundled approach to infection control, MedStar Franklin Square was able to reduce its C.diff infection rate by 29 percent facility-wide 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 toenhance patient safety and stop these unnecessary C.diff infections.

Uniquely designed for ease of use and portability, a hospitals 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

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.

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

Xenexs 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.


Today, 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

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 multi-disciplinary 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.

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

Acute Kidney InjuryAcute 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.


The U.S. Food and Drug Administration announced the filing of a consent decree against Medtronic, Inc., and two of the companys officersS. 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 companys 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

Synchromed II Implantable Infusion Pump System is medically necessary for a patients 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 companys compliance. In addition to these audits, the FDA will monitor the companys 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 Medtronics 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 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 FDAs 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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

FDA enters consent decree with Medtronic, Inc.


Recently, 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 sensationcalled paresthesiain patients, said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at FDAs Center for Devices and Radiological Health. Since some patients dont 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 patients reporting of symptoms,

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 patients back. The lead is connected to a rechargeable, implantable pulse generator that is implanted in the patients 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.

FDAs 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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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


The 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, ring-shaped 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 powerbut 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 FDAs 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

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

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 devices 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 nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


SCHURTER 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

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

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

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

successful cooperation with all partners.

FUSES AND FUSE-HOLDERSThis 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.

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

CONNECTORS, POWER ENTRY MODULES AND EMC LINE FILTERThe 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 electro-magnetical 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 EQUIPMENTThe 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

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


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

VANDAL PROOF OR CUSTOMIZED INPUT SYSTEMSThe 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 PRODUCTSThe 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 SERVICESThousands 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.

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

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 Medicals 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.


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

Prototype testing of orthopedic implantsOur 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.

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:

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 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 ha

Medical Device ASIA, May-June 2015

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Transcript of Medical Device ASIA, May-June 2015