“Medical Devices_ Managing the Mismatch”

7/22/2014 COMMENTS ON THE REPORT OF THE WORLD HEALTH ORGANIZATION, “MEDICAL DEVICES: MANAGING THE MISMATCH” » GMTA - Glo…

http://www.globalmedicaltechnologyalliance.org/comments-on-the-report-of-the-world-health-organization-medical-devices-managing-the-mismatch.html 1/24

Subscribe to RSS feed

Search Search

Home

News

Position papers

About GMTA

Members only

COMMENTS ON THE REPORT OF THE WORLD HEALTHORGANIZATION, “MEDICAL DEVICES: MANAGING THEMISMATCH”

The Global Medical Technology Alliance (GMTA) represents medical technology associations whose members supply nearly

85 percent of the medical devices and diagnostics purchased annually around the world. These members produce the medical

devices, diagnostic products and health information systems that are transforming health care through earlier disease

detection, less invasive procedures and more effective treatments and range in size from the largest to the smallest medical

technology innovators. They bring medical technology to patients around the world in every setting.

The GMTA is eager to play a constructive role in helping to resolve the world’s healthcare problems. We believe that the

medical technology industry is actively developing innovative solutions, supporting health system capacity-building, and

training health care providers to address many of the recognized problems of health care in the developing world

The GMTA would like to put forward a specific suggestion for consideration for the medical technology industry and World

Health Organization (WHO) to work together to address the aligned 15 public health needs identified in this report. We

recommend the establishment of an expert advisory group that would include industry to work with a WHO group on the

identified public health needs and develop solutions to address specific situations, on the ground, in a country. It is very

possible that there may be companies already working and innovating in these countries to address these issues, and we could

help identify work underway and best practices.

When addressing use of technology for more advanced treatments, there are inputs that must be considered, such as

improving human resource training, expertise, spare parts for equipment, maintenance, reliable power supply, clean water, etc

which would require local government support. Involvement by the local government would be very important to the success

of such an effort. An expert advisory group could also be used to explore how local manufacturing could be encouraged for

local conditions. Another suggestion would be to break the issues into substantive groups and provide room for more than

one working group to consider the range of issues and make recommendations on solutions.

We look forward to working constructively with the WHO to help address the concerns identified in the Report.

General Comments

http://www.globalmedicaltechnologyalliance.org/feed

http://www.globalmedicaltechnologyalliance.org/


http://www.globalmedicaltechnologyalliance.org/category/news

http://www.globalmedicaltechnologyalliance.org/category/positionpapers

http://www.globalmedicaltechnologyalliance.org/about

http://www.globalmedicaltechnologyalliance.org/members

http://www.globalmedicaltechnologyalliance.org/comments-on-the-report-of-the-world-health-organization-medical-devices-managing-the-mismatch.html



The GMTA welcomes the opportunity to comment on the WHO’s report Medical Devices: Managing the Mismatch (the

Mismatch report). This report helps to elevate a much needed discussion on the importance of medical devices as part of a

sustainable healthcare infrastructure. We appreciate the Mismatch report’s recognition of the development of increasingly

innovative medical technology by the private sector during the past 50 years. The Mismatch report also highlights the

diversity and complexity of the 10,000 major categories of medical devices and diagnostics. In addition, this report makes an

important contribution by distinguishing medical devices from pharmaceuticals, especially in the need for training in the use of

medical technology. We strongly endorse the role medical devices can play in improving patient lives, as documented by the

Mismatch report.

We are concerned that the Mismatch report does not consistently address a number of key factors including the importance of

incremental innovation, the need to consider healthcare needs in their overall setting, and the role of market forces in

rewarding, or punishing, companies that manufacture medical technology. Some chapters of the report recognize these forces,

but in other sections, these factors are ignored.

The mismatch in this report appears to be based on the false assumption that “public health needs” can first be identified by

some external agent and then industry can be directed to manufacture medical technology on the basis of those needs. That is,

somehow the “right” medical products would have been developed – and not the vast array of marvelous technologies on the

market – if only the mismatch had been identified in advance. We take issue with the statement, that “research is often not

based on public health needs.” While we recognize that the full array of devices appropriate for every setting on the face of the

globe and for every disease may not be available today, our contribution to improving global public health is nothing short of

remarkable.

We believe an important element missing from the Report’s discussion of the “wider context of the complete health-care

package necessary to address public health needs” is recognition of infrastructure needs such as access to electricity and

clean water and the role of government in providing that infrastructure. The Mismatch report seems to focus on requiring

medical devices to conform to the overall healthcare setting, instead of promoting a more integrated approach appropriate to

the needs of each country. The Mismatch recommendations also do not appear to be placed in the context of overall resource

allocation for healthcare in low resource countries. In preparing the “Priority Medical Device” project, which appears to be the

foundation for the Mismatch report, the major recommendations relate to ensuring countries purchase the correct relative mix of

medical technologies. This is an important issue. However, for low resources countries, the larger question in terms of priorities

is whether scarce resources would be better allocated to tackling other problems. For example, the UN estimates that 884 million

people lack access to safe drinking water and 39 percent of the world’s population lacks adequate sanitation. Solving these

severe problems would not only be major triumphs in themselves but also substantially improve the performance of some

medical devices and diagnostics in “low resource” countries.

The report does not acknowledge the global spread and interrelationship of major diseases and the resulting concerted effort

needed to resolve them. For example, WHO predicts that 700 million adults will be obese by 2015. Obesity causes a range of

health ailments including diabetes. WHO predicts that countries with the most cases of diabetes in 2030 will be China and India

– both rapidly growing emerging markets, not “low resource” countries. And, both countries have expanding medical

technology industries that are developing medical technologies to address their countries’ healthcare needs. Thus, the “10/90”

concept, which was developed in 1990, is out of date in terms of both the location and nature of the problems and the efforts

underway to resolve them.

As Dr. Nancy E. Oriol, Dean for students at Harvard Medical School, explains, “The same factors that determine today’s health

will determine tomorrow’s health: access to clean water, safe air, adequate food and society’s determination to practice healthy

lifestyles.” And, as the UK’s Chief Executive of NICE, Sir Andrew Dillon, stressed, given that “there is a limit to how much can



be spent…on healthcare…a system should focus on things that make the most difference.”

When placed in this broader context, attention should be devoted to determining how countries can best use limited healthcare

resources, including the purchase of medical technology. The medical technology industry is actively engaged in addressing

global health system disparities. We too are searching to find solutions to the “4 As” highlighted in the report: Availability,

Accessibility, Appropriateness and Affordability. Indeed, the market forces that brought forth the current medical technology

marvels are at work on new generations of products. Some of these medical technologies are already being manufactured for a

variety of economic and environmental settings, with the prospect of many more in the future. These advances are being made

not only in companies that are viewed as current market leaders – such as those listed in the Mismatch report – but are also

coming from rapidly emerging markets, such as China, India and Brazil. Companies in emerging markets are creating “frugal”

technologies for their own people and plan to export such medical devices to others in the future.

Comments on the Body of the Report

Medical Devices

There is some discussion in the report on the differences between pharmaceuticals and medical devices. A key difference

between the two is rapid innovation – this combined with the high number of competitors in the field, leads to a downward

pricing trend for new technology. The report reflects a misunderstanding of how innovation works as pointed out in section

2.2.2. Future Trends, second paragraph: “the lure of technology is strong, but the cost-effectiveness, real need, and likely

usefulness of many innovative technologies are questionable. For example, ultrahigh-field strength MRIs, robotic assisted

surgical systems, and proton radiation therapy have uncertain benefits and high financial costs”.

A good example of technology that had “uncertain benefits and high financial costs” is cellular telephones. In the 1980s, this

was a very new technology that was very expensive, difficult to use, and available only in the developed world. Given rapid

innovation, the design improved and the prices dropped dramatically. Now, in 2010, it is a technology that is common place and

has become extremely important in the developing world, including for healthcare. The same will hold true for those

technologies above.

In Annex I to our response, please find a matrix describing some of the key ways and differences in how medical devices

innovate.

Within the Public Health Needs section, there is a criticism of physicians’ preference. While training and information is needed

to be able to make an informed decision, we believe that the appraisal and decision of using a specific device should rest with

the healthcare professional. We would like to emphasize the positive role of industry to develop training programs for

physicians and health care works.

In Annex II, please find a list of examples of industry working in low resource settings to help develop sustainable, local

healthcare infrastructures around the world.

The description of the Priority Medical Devices Project encourages the questions: is there confirmation and validation of the

data? It appears that the data are frequently misaligned and contradictory. There is a marked difference in the list of 15 diseases

(table 4.1) and the list of priorities as produced by the survey of 4 countries. In table 4.5, for example, cancer and cardiovascular

diseases in general are raised as top priority in the country survey while not appearing in the top 15 from the WHO. An aligned

priority list from countries and WHO would be very useful in targeting efforts and identifying resources to address these needs

and disease states.



Medical Devices: Problems and Possible Solutions

HTA

While we recognize the potential value of using Health Technology Assessment (HTA) for the allocation of resources to

healthcare products and services, its application to medical devices must recognize their special and unique characteristics and

avoid the pitfalls of using the criteria traditionally developed for pharmaceuticals and medical services. HTA is difficult to adapt

to local situations which vary and is difficult to maintain current in the face continuous modification of devices and technology

leaps. These, and other complexities, were raised during the HTA sessions at the First Global Forum on Medical Devices in

Bangkok.

From a methodological standpoint, it is imperative that HTA for medical devices allow for the fact that the benefits of medical

devices are realized over an extended period of time that goes beyond the typical time horizon used for HTA (usually a year or

less) whereas most of costs are accrued upfront. For many medical devices, benefits of devices are realized over several years

(e.g. orthopedic hips, joints, and also cardiovascular products like stents, pacemakers). This introduces a potential asymmetry

between benefits and costs as calculated in standard HTA processes and biases the results against devices. For drugs, each

unit’s benefit and costs are almost contemporaneous. In addition, due to the “operator effect” present in devices, any (context)

independent measurement of benefits as done for pharmaceutical in HTA is nearly impossible. This must be accounted for.

From a process standpoint, as we look to different models of HTA around the world (NICE, etc) it is important that we adopt a

broad approach to the type of HTA mechanism that may be used. A key element is the inclusion of stakeholder input and

transparency of decision-making by HTA bodies. This is often overlooked or excluded in any one-shot and unilateral decision-

making process to the detriment of the soundness of the ultimate decision-making as it can preclude the use of evidence and

data best known to and understood by the supplier of the technology.

Post Market Surveillance

There is a mention in the report of the failure of existing Post Market Surveillance systems, but there are no data to support

these claims. That being said, it is likely that there may be under reporting due to lack of personnel and training to do such

surveillance. Member states should focus their effort on adverse events as it has been proven to be the most efficient way to

monitor a market in a dynamic innovation climate. Industry can play a role in training on how to gather data on use of devices,

and set up registries. The National Competent Authority Report program of the Global Harmonization Task Force (GHTF) is a

platform that could be further developed by including third world countries with WHO support and possibly financing.

Clinical Guidance

Industry supports clinical guidance provided they are elaborated with the adequate experts, from a technology standpoint

(Industry) and from a use standpoint (Users). Local priorities, skills and use differ from one country to another and bundling all

developing countries under blanket guidance may create another gap by giving an artificial big picture not supported by local

use data.

Dealing with Corruption

The report correctly states that corruption is an issue that should be addressed to improve patient access to needed medical

technology. Industry supports establishment of ethical and sales codes of conduct. The root cause for corruption may in most



cases lie with the user/purchaser. Industry values the development of mechanisms for good procurement practices that may be

enforced locally. The GMTA members are working to establish harmonized codes of ethics for their corporate members and

work on this issue is on-going within the Asia-Pacific Economic Cooperation organization as well as in other forums.

Please find a list of the websites for these codes in Annex III.

Developing a Single Nomenclature

The purpose of a medical device nomenclature system is to facilitate identifying, processing, filing, storing, retrieving,

transferring, and communicating data about medical devices, particularly for the identification of devices involved in adverse

incident reports. There is a need for a common nomenclature and harmonization between existing regulatory systems.

There are two major nomenclature systems – Universal Medical Device Nomenclature (UMDN) and Global Medical Device

Nomenclature (GMDN). Nomenclature is used to exchange data in the healthcare community by describing medical devices

with similar features, characteristics and intended use. GMDN forms the basis of medical device regulations in many

jurisdictions. UMDN is mainly used by health institutions. GMDN’s structure is based on risk, so it is not only used in

purchasing; it is also used between regulatory bodies for market surveillance and adverse incidents reporting.

We offer the following current status of nomenclature efforts in various countries:

USA: UMDNS is adopted for healthcare purposes, while CDRH nomenclature is used for regulatory purposes. FDA has two

people constantly working with the GMDN Agency. In its draft UDI regulation and pilot program, FDA includes GMDN.

Canada: Currently Canada is not requiring GMDN for registration, but captures GMDN codes if they are provided.

Japan: JMDN is a translation of an early version of GMDN. It is used for regulatory purposes to define all classes of devices

and was established in 2005. There are currently no ongoing contacts with the maintenance agency and the new terms

developed by it. Coherence on the international level and the creation of new terms are therefore an issue. However, there is

currently no plan to join an international effort. The Ministerial Notification #298 (July 20, 2004) lists JMDN and their

classification.

Australia: The GMDN is mandatory within the TGA system and is detailed in the legal framework.

EU: The European Commission has undertaken the translation of all current terms into the 20 official languages of the EU. This

will remove the barrier for the implementation of the EU post-market vigilance system (EUDAMED).

GHTF: GMDN is accepted by GHTF as the definitive nomenclature to be used for generic identification. The GMDN Agency

has recently reformed its governance structure to ensure it is sustainable, accessible and transparent to address the increasing

interest of regulators and industry. It is currently working on funding models to make the nomenclature freely available.

Asian Harmonization Working Party (AHWP): has two nominees on the board of trustees of the GMDN Agency and five

nominees on policy advisory group.

We believe WHO has a role to support GHTF efforts in working with the GMDN Agency and making GMDN a single and

globally accessible nomenclature. WHO’s support would add considerable weight for a global acceptance of the GMDN

nomenclature



Barriers to using medical devices

The report states that “lack of training is not the only cause of use errors, mistakes often results from a combination of factors

such as poor equipment design, poorly written labels and failures to read equipment manuals”.

GHTF was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of

medical devices, the lack of which is a source of the problems identified. The purpose of the GHTF is to encourage

convergence in regulatory practices related to ensuring the safety, effectiveness/performance and quality of medical devices,

promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished

is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents provide a

model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities.

The GHTF guidance document on” Essential Principles of Safety and Performance of Medical Devices” GHTF/SG1/N41R9:2005

provides a comprehensive list of design and manufacturing requirements of safety and performance, some of which are relevant

to each medical device. These are grouped as:

Chemical, physical and biological properties.Infection and microbial contamination.Manufacturing and environmental properties.Devices with a diagnostic or measuring function.Protection against radiation.Requirements for medical devices connected to or equipped with an energy source.Protection against mechanical risks.Protection against the risks posed to the patient by supplied energy or substances.Protection against the risks posed to the patient for devices for self-testing or self-administration.Information supplied by the manufacturer.Performance evaluation including, where appropriate, clinical evaluation.

The manufacturer selects which of the design and manufacturing requirements are relevant to a particular medical device,

documenting the reasons for excluding the others. The Regulatory Authority and/or Conformity Assessment Body should

verify this decision during the conformity assessment process.

The guidance document on labeling: “Labeling for Medical Devices” GHTF/SG1/N43:2005, requires labeling to serve to

communicate safety and performance related information to users of medical devices and/or patients as well as to identify

individual devices – “ …In particular, instructions for use should be written in terms readily understood by the intended user

and, where appropriate, supplemented with drawings and diagrams. Some devices may require separate information for the

healthcare professional and the lay user”.

Regarding translation, ideally training manuals would be available in all languages in a way that would convey the same

meaning in all languages. However the industry does not yet have them in all languages in developed countries due to the

huge cost and safety issues associated with translation and complying with standards. One option may be to explore the

increased use of symbols in accordance with international standards.



Barriers to Innovation

Medical device regulation

Medical device regulation regimens are established in over 70 countries in the world. Medical device regulation should ensure

safety and performance of medical devices as well as timely access to these devices. Two major reasons for the lack of

regulatory systems are the lack resources and capability, and ignorance of the medical device sector and the work that has

been done by GHTF.

In 1993, WHO published its guiding principle for medical device regulation. In this guidance, it clearly indicates the following:

Implementing a full regulatory programme can be very expensive and demanding on resources. The work of the GHTF and the

trend to use international standards are, in effect, tackling this problem by steering manufacturers more and more toward

producing medical devices with uniform standards. The methods and procedures relating to governmental regulations are also

converging. These developments create opportunities for countries to establish low-cost programmes that promote the safety

and performance of medical devices by taking full advantage of what others have already done in this field. Local adoption of

harmonized recommendations will facilitate international exports of medical devices manufactured locally.

Pre-market approval is one of the most important aspects of any comprehensive policy. The difficulty of establishing a local

pre-market review team is not just financial but also depends on whether specialized scientific and clinical expertise is available

in the country. However, with the work of the GHTF and the ability to look at approval decisions in other countries, it is now

feasible for many countries to avoid the expense of a local premarket review team. Most medical devices today are

manufactured in developed countries which have comprehensive regulatory systems in place that follow the “Essential

Principles of Safety and Performance of Medical Devices” recommended by the GHTF.

As an alternative to a local pre-market review team, a government can adopt a policy of accepting devices that are

manufactured in compliance with the regulations of another country with a sound regulatory system. The choices include, for

example, devices with an Australian, Canadian or Japanese license, devices with a European “CE” mark, or devices that have

been granted marketing clearance by the US-FDA. In this way the citizens of the importing country will be assured of the same

risk exposure as the citizens of the exporting countries. The government can require that local manufacturers make submissions

for compliance acceptance to a country that has an accepted pre-market review team. In fact, this is what the manufacturers

have to do anyway if they want to sell internationally. The convergence of national regulatory systems can facilitate the

exportation of these products to international markets as well. In avoiding the expense and effort of a pre-market review team, a

government can concentrate on implementing vendor and device registration and surveillance programmes for devices in use.

Overcoming cost barriers

The report states, “…in low resource setting, the origin of this barrier is lack of local research infrastructure and capacity to

develop promising ideas – in other words, new ideas originate from those outside the context in which a device will be used”.

We would again point to Annex II to the list of examples of industry working with and for the improved healthcare

infrastructure in low resource settings around the world.

The role of technology transfer from developed countries to developing countries is one possible way to overcome cost

barriers to innovation. It is imperative that the products resulting from any technology transfer are proven to be clinically safe

and effective, and that design and manufacturing processes are well established. Technology transfer can help reduce the cost



due to mass manufacturing, localizing materials and labor. The cost may be reduced if the local system is efficient and safe and

this would also help develop local manufacturing infrastructure and capability in developing countries. National policy should

support and encourage the necessary infrastructure development to allow successful and sustainable technology transfer.

The role of multinational companies

Multinational companies play an important role in reducing cost through local sourcing, local establishment of R&D centers,

partnering with local suppliers and research institutes. Especially in recent years, multinational companies are increasing their

investment in developing countries as they seek to provide appropriate products for the customers in those countries.

Through their investment both financial and in talent, partnerships with local universities, institutes and companies,

infrastructure and local capability, this helps to build capability and infrastructure in developing countries.

Towards Appropriate Medical Devices: Options for Future Research

The report states that a “universal lack of standardization in the medical device arena (such as the lack of standardized

laboratory equipment and consumables) has great impact on diagnostic tools and negatively affects their effective use.

Solutions to allow for greater standardization would be most beneficial and help to encourage universal use of “generic”

diagnostic tools”. We would like to point out that international standards exist for most medical equipment.

The report states: “the provided examples highlight that although cutting-edge technologies to develop new medical devices

has its place, research in developing current medical device to make them appropriate to specific contexts, particularly for low-

income settings, is also urgently needed”.

We urge WHO to encourage public/private partnerships to address healthcare systems gaps. Individual patients, clinicians,

governments, and health care systems, no matter how poorly resourced, benefit from many medical technologies through

programs supported by the medical technology industry. The medical technology industry works directly, and in partnership,

with leading non-governmental organizations (NGOs), academic/medical institutions, and governments.

In Conclusion

The GMTA applauds WHO for the work that went into developing this report and for allowing us the opportunity to provide

our views. As a variety of stakeholders, including industry, search to find solutions to the “4 As” highlighted in the report:

Availability, Accessibility, Appropriateness and Affordability, it would be very useful to find ways to combine our resources

and work together.

There are improvements that the medical device industry can make, and we strive to do so, but in order to achieve real success

in addressing healthcare needs, the industry must have the opportunity to work collaboratively with stakeholders. This is the

best way to develop and produce technology that addresses the needs of patients and healthcare providers in local settings.

Medical technology plays a complementary role in improving and saving lives and contributing to societal and broad economic

goals. Local governments and non-governmental groups also have their roles and must seek to fulfill them.

A suggestion we have put forward in our response is the establishment of an expert advisory group that would include

industry to work with WHO on the identified public health needs and develop solutions to address specific situations, on the

ground, in a country. The medical technology industry has a long history of working to develop sustainable solutions to

improve healthcare infrastructures around the world – and these efforts are increasing. We look forward to identifying ways



with WHO to find solutions to these critical health issues.

December 6, 2010

ANNEX

Annex I Matrix of innovation differences for medical technology

Annex II Examples of industry capacity building efforts for local healthcare workers in low resource settings

Annex III Links to Codes of Ethics for the Medical Technology Industry

Annex 1 Description of How Medical Devices Innovate and How it Differs from Pharmaceutical Innovation

Medical Devices Pharmaceuticals

Industry Composition Over 80% small and medium-sized

companies Very large multinationals dominate

Active Components Generally based on mechanical,

electrical, and materials engineeringBased on pharmacology and chemistry; now encompassing

biotechnology, genetic engineering, etc.

Most act through physical interaction with the body or

body part.

Products are administered by mouth, skin, eyes, inhalation, or

injection and are biologically active; effective when absorbed

into the human body. Often act systemically on the entire body.

Product Development Wide variety of products and

applications – from thermometers and bandages to

pacemakers to x-rays

Products are usually in the form of pills, solutions, aerosols, or

ointments

Designed to perform specific functions and approved on

the basis of safety and performance

Product development by discovery, trial, and approved on basis

of safety and efficacy

Products developed by engineers, in many cases together

with doctors or nurses in a clinical setting.

Products developed in laboratories by chemists and

pharmacologists.

Intellectual Property Concerns Continuous innovation and

iterative improvements based on new science, new

technology, and new materials

Extensive research and development of a specific compound or

molecule; takes several years for a new drug to enter the product

pipeline



Short product life cycle and investment recovery period

(typically 18 months on market). Little patent linkage

possible. Data exclusivity is important.

Intensive patent protection, including data exclusivity and patent

linkage, needed due to extensive product life cycle and long

investment recovery period.

Majority of new products bring added functions and clinical

value based on incremental improvements

Usually large step innovation

Support Provided Large investment in manufacturing,

distribution, and user training/education; plus need to

provide service and maintenance (for many high tech

devices)

In most cases, no service or maintenance.

Annex II

EXAMPLES OF MEDICAL TECHNOLOGY INDUSTRY CONTRIBUTIONS TO HEALTH SYSTEM CAPACITY BUILDING

IN DEVELOPING COUNTRIES

The medical technology industry is actively engaged in addressing global health system disparities. It is proactively

developing innovative solutions, supporting health system capacity-building, and training health care providers to address

many of the recognized problems of health care in the developing world.

The following examples demonstrate how individual patients, clinicians, governments, and health care systems, no matter how

poorly resourced, benefit from many medical technologies through programs supported by the medical technology industry.

The medical technology industry works directly, and in partnership, with leading nongovernmental organizations (NGOs),

academic/medical institutions, and governments.

GLOBAL

Global Health Scholars Program More than 60 medical residents, teaching faculty and career physicians take part in the

Johnson & Johnson Global Health Scholars Program., which selects the most promising candidates from major American

institutions, and sends them for six weeks or longer to one of six overburdened health care sites in places such as Eritrea,

Indonesia, Liberia, South Africa, Uganda and Central America. The program gives visiting physicians and students an

opportunity to learn how to diagnose and treat complex diseases, and gives patients access to more doctors who can

contribute to better diagnoses and treatments. Working in remote and/or overburdened healthcare communities challenges

most visiting scholars to think innovatively and resourcefully given the limited amount of medications and medical equipment,

the long-processing times for basic tests, and the inability of patients to pay for expensive healthcare treatments. It is a highly

beneficial and rewarding experience for both scholars and patients.

Improving Clinical and Laboratory Services (focus: HIV/AIDS and TB) Limited access to clinical and laboratory health services

is one of the largest constraints to battling disease in developing countries. Through collaboration with over 20 health

agencies, universities, NGO’s and international agencies, Becton Dickinson (BD) has conducted over 270 Good Laboratory

Practice (GLP) workshops in more than 50 developing countries, providing hands-on training to more than 2200 laboratory

workers. This training is focused on implementation of Standard Operating Procedures (SOP’s) for immune system monitoring

of HIV/AIDS patients (CD4 testing). It also teaches fundamental laboratory practices such as quality control and blood



sampling, and is presently being expanded to cover TB testing procedures.

Associated with this GLP workshop initiative, BD has established eight training centers in locations around the world including

Africa, Asia, Eastern Europe and South America. For example, BD has collaborated with Stellenbosch University in South

Africa and the Kenyan Medical Research Institute (KEMRI) in Kenya to open training centers in these countries. These

centers have fully outfitted laboratories with equipment donated by BD, and when not in use for training purposes, the

laboratories are available for actual patient monitoring and HIV/AIDS research.

In 2000, BD, together with the Program for Appropriate Technology in Healthcare (PATH) developed a training manual entitled

“Giving Safe Injections: Using Auto-Disable Syringes for Immunization.” This manual was created for healthcare workers who

inject vaccine and includes information on how to administer a vaccination without harming the recipient or the healthcare

worker. BD healthcare professionals continue to engage with local Ministries of Health, national organizations and

international agencies to train thousands of healthcare workers each year. Since 2000, BD has conducted over 250

Immunization Injection Safety Trainings in 49 countries throughout Asia, Africa, Eastern Europe, Middle East and Latin

America.

BD is an HIV/AIDS collaborating partner of the Millennium Village Project. This commitment includes funding for the project’s

global HIV/AIDS coordinator and in-country health coordinators, as well as collaboration on diagnostic and clinical

infrastructure and core competency needs.

BD and the US Global AIDS Coordinators Office (responsible for coordinating the

U.S. President’s Emergency Plan for AIDS Relief or PEPFAR) started a pilot project in Mbarara University, Uganda for

laboratory and clinical practice training. Through the PEPFAR agreement, BD has provided laboratory strengthening and

training in Africa and established tuberculosis (TB) reference labs. In October 2007, BD and PEPFAR announced an expanded

collaboration to include a five- year public-private partnership aimed at improving laboratory practices in African countries

severely affected by HIV/AIDS and TB.

Advanced Medical and Community Health Information Centers

The Medtronic Foundation is a long-time partner of WiRED International. WiRED’s mission is to provide medical and

healthcare information in developing and war-affected regions. Begun 10 years ago, WiRED has installed more than 100

Medical Information Centers and Community Health Information Centers on four continents (Latin America, Africa, the Balkans

and the Middle East). Among a range of programs, WiRED’s Medical Information Centers deliver the latest technical

information to professional health care providers, medical school faculty and students. These centers offer on-board medical

libraries, and where Internet connectivity is available, access to on-line resources including the WHO’s HINARI database. This

rich source of medical information (more than 1,200 biomedical journal titles and thousands of texts) offers physicians and

healthcare workers in disadvantaged regions access to world-class medical libraries.

WiRED’s Community Health Information Centers present healthcare information to patients, primary care givers, the general

public and the media. WiRED also supports disease prevention programs for young people. Local groups run these Centers

and WiRED provides the equipment and program material, the training and ongoing support.

WiRED recently added a telemedicine program that provides medical educators and practitioners access to outside training

programs, seminars, workshops and clinical assessment opportunities. WiRED’s technicians install the high-end, video

conferencing equipment. Educational material and patient consultations are provided through professional U.S. medical

associations & partnerships with organizations such as the University of California, San Francisco Medical School, and

Massachusetts General Hospital. WiRED is working to extend its telemedicine program to India, using a new design which it



will test with Calicut Medical College (CMC) and field hospitals in Calicut in the southern Indian state of Kerala. Although

many large urban medical schools in India have access to the latest medical information, other less developed areas lack

opportunities for physicians & other medical professionals to stay current. CMC has no program now through which Indian

doctors and medical experts outside engage in routine educational exchanges. WiRED will test the “relay approach” to

Continuing Medical Education (CME), involving a consortium of American medical institutions and Calicut Medical College

(CMC). Following each teleconference with American medical educators, the CMC will add observations and comments and

then retransmit the digital recordings to seven regional hospitals throughout the Calicut state network. The content of this

program will include lectures, grand rounds, patient assessments, video conferencing and satellite communications equipment,

and other material as needed for the CMC.

Occupational Injury Surveillance

In collaboration with the University of Virginia, BD works to deploy the EPINet™ occupational injury surveillance system at no

charge to health care facilities. This system, already in use in 27 countries, protects clinicians through precise tracking of the

sources of sharps injury and other blood exposures, facilitating data collection and planning of appropriate exposure

prevention policies.

Primary Care Physician Training and Education

Welch Allyn has supported partnership projects between NGO’s and Universities in which deliver equipment and educational

programs to advance the skills of primary care physicians in emerging countries (Central Asia, Vietnam, Kosovo and South

Africa). These programs improve the physicians’ ability to assess, diagnose, treat and manage chronic conditions such as

hypertension which leads to cardiovascular disease. The Physicians with Heart Program, a collaborative effort of Heart to Heart

International and the American Academy of Family Physicians, has trained hundreds of physicians in the Central Asian

Republics since its inception in the 1990’s, using a train the trainer model to empower sustainable change. Welch Allyn has

supported similar educational partnerships in Kosovo with AmeriCares and Dartmouth Medical College, and has equipped

training centers in medical universities in Vietnam and South Africa to support professional medical education programs. These

efforts promote primary care skills aimed at keeping patients with chronic conditions healthier and more productive longer, and

address the shortage if skilled healthcare professionals in these countries.

Development of Advanced Pediatric Cardiac Care

The Medtronic Foundation is a long-time partner of Children’s HeartLink (CHL). This NGO works in partnership with health

care centers in developing countries to promote sustainable cardiac care for children with congenital or acquired heart disease.

Founded in 1969, CHL’s goal is to empower local experts to prevent, treat and cure pediatric heart disease in their own

populations. Last year, CHL provided 844 training opportunities, reaching over 40,000 children at their partner sites. CHL has 11

partner sites in China, India, Malaysia, Kenya, S. Africa, Ukraine, Costa Rica and Ecuador.

CHL supports its partner sites in a variety of ways—including sending hospital personnel from underserved countries to the

U.S. and other world medical centers for training; bringing surgical teams from the U.S. & Europe to work side by side to train

colleagues in developing countries; donating medical equipment/supplies; providing financial support to perform surgeries on

impoverished children; working to develop and strengthen education campaigns about the prevention of heart disease

acquired through rheumatic fever and Chagas disease; helping to create regional networks of support in which more advanced

hospitals assist their lesser developed counterparts; assisting in the training and retention of cardiac team members, and

helping hospitals start charitable foundations to fund care for needy children. CHL medical volunteers come from prestigious

pediatric cardiac programs such as the Mayo Clinic & the Lucile Packard Children’s Hospital of Stanford University (U.S.), &

Birmingham Children’s Hospital (U.K.).

Developing Specially-Designed Products



To help prevent inappropriate reuse of disposable syringes and needles, BD developed several auto-disable products in close

collaboration with the World Health Organization (WHO) and several other international agencies. These devices include

products such as the BD SoloShot™ range of injection devices and BD Uniject™ pre-filled injection device. To date, BD has

shipped over four billion auto-disable syringes to 90 countries in Asia, Africa, Middle East, Eastern Europe and South Latin

America.

BD also developed an innovative, unique new injection device for the Stop TB program of the Global Drug Facility to safely

inject streptomycin for TB patients in developing countries, most of whom are HIV-positive. The BD Chek™ HIV Multi-Test,

launched in Africa in March of 2006, provides rapid results in just 10 minutes for detection of antibodies to HIV-1, HIV-1

Subtype O, and HIV-2. In 2007, BD launched the BD Vacutainer® CD4 Stabilization Blood Collection Tube in Africa. The tube

stabilizes CD4 cells for longer time periods and at higher temperatures, enabling more samples to be taken in remote areas and

transported to central labs for HIV/AIDS testing.

Operation Smile

Stryker Corporation assists in Operation Smile, headquartered in Norfolk, Virginia, is a worldwide children’s medical charity that

helps children with surgery to correct cleft lips and other issues. Operation Smile currently supports international and local, in-

country medical missions to 26 countries and its partner countries include: Bolivia, Brazil, Cambodia, China, Colombia, Ecuador,

Egypt, Ethiopia, Gaza Strip/West Bank, Haiti, Honduras, India, Jordan, Kenya, Mexico, Morocco, Nicaragua, Panama, Paraguay,

Peru, Philippines, Russia, South Africa, Thailand, Venezuela, and Vietnam. Since 1982, more than 115,000 children and young

adults have been treated by thousands of volunteers worldwide and thousands of healthcare professionals have been trained

globally.

Operation Smile integrates its partnerships with leading medical teaching institutions into its in-country medical education

programs. Our partners in education include Yale University, Chang Gung Hospital and University (Taiwan), Duke University

and the University of Southern California. Thousands of students in more than 500 Operation Smile Student Associations in

the United States and around the world build awareness, raise funds and educate students about values of commitment,

leadership and volunteerism. The annual Operation Smile Physicians’ Training Program (PTP) brings doctors and nurses from

around the world to the United States for advanced training in their specialized skills. Since 1987, more than 700 health care

professionals have attended the program, held at our headquarters in Norfolk, Virginia.

Establishing Neurosurgical Residency Programs

Integra LifeSciences Holdings Corporation provided an in-kind donation in 2007 of over $4 million worth of neurosurgical

medical devices to the Foundation for International Education in Neurological Surgery (FIENS). “We are very grateful for

Integra’s generous donation, which furthers the foundation’s mission to establish permanent neurosurgical residency

programs at our sites in Central America, South America, Africa and Asia,” said Merwyn Bagan, MD, MPH, FACS and Chair of

the FIENS Executive Committee. Founded in 1969, the foundation’s mission is to address the critical lack of trained

neurosurgeons in the developing world. Its volunteers provide on-site training and education to neurosurgeons around the

world, teach their techniques to local neurosurgeons, and set up neurosurgery residency programs. FIENS volunteers also

provide critical assistance in the operating room.

Addressing Health & the Environment

Johnson & Johnson has partnered with local groups in Africa and in Asia to address health and environmental issues. In

Kenya, it helped to open dispensaries beginning in 2006. Before the dispensaries were available, families had to travel 6 to 8

hours to get to a health care facility. Most children were not immunized. Mortality rates for women and babies were high. In

addition, prior to the partnership, education about how to purify water, prevent disease and practice good hygiene was

nonexistent.



The water wells were open, which exposed available water to contamination from the environment. Through the partnership,

wells were covered and pumps were installed to keep the water clean.

In Nepal, Johnson & Johnson focused on protecting forests and improving air quality. Traditionally, villagers have relied on

woodburning stoves and the forest’s trees to fuel them. Today, villagers are learning about the harmful emissions from wood-

burning stoves and how to use biogas units instead, which are fueled by cattle manure. A healthy environment is necessary for

people to be healthy.

AFRICA

Improving Clinical and Laboratory Services

BD and the International Council of Nurses (ICN) recently announced a multi-year initiative to provide health and wellness

services to healthcare providers working on the front lines in four African nations. This collaboration will help address the risk

to health workers in sub-Saharan Africa associated with the very high levels of disease prevalence in their healthcare

environment.

HIV/AIDS Programs in South Africa:

Siemens has been a pioneer in the establishment of an HIV/AIDS Workplace program in South Africa. Key features of the

program include its non-discriminatory nature, a commitment to the confidentiality of information, the continuation of benefits

for employees who are shown to be HIV positive and the management of employment termination due to ill health. In 2004,

Siemens South Africa received the Global Business Coalition on HIV/AIDS Award for “Business Excellence in the Workplace.”

Siemens has signed an agreement with a church association (Community of Sant’Egidio) to invest ca. one million Euros to

lower the costs of laboratory testing by 35 percent to combat HIV resistance to drug therapies. The agreement was signed at

the fifth international conference of the Drug Resource Enhancement against AIDS and Malnutrition (DREAM) Project.

According to Mario Marazziti, spokesman for the Community of Sant’Egidio, in order for AIDS therapies to be effective, the

distribution of medicine must go hand in hand with the constant monitoring of how these drugs react in the human body. Lab

tests are now considered necessary to establish whether HIV patients are becoming resistant to drug therapies.

Siemens has donated two Siemens Sonoline ultrasound units to Chris Hani Baragwanath and Tshepong Hospitals in Cape

Town, South Africa. These donations support efforts to combat HIV/AIDS by assisting the hospitals’ research into the

disease. The Siemens donation saved the hospitals some R80,000 – funds that are now being used for laboratory

investigations.

Rebuilding the Ranks of Healthcare Professionals In Somalia

Two decades of civil wars have resulted in a rapid decline in qualified health care professionals in Somalia. The Hermann

Gmeiner School of Nursing was established in 2002 to train healthcare professionals from the local population with the support

of Johnson & Johnson. Students attending the school complete a three-and-a-half-year program that includes a WHO-

approved curriculum. In 2009, 16 individuals graduated from the school. And they did so in the midst of frequent mortar attacks

and terrorist raids that often displaced them from their classrooms.

Healthcare Training and Infrastructure Development

BD collaborates with the Academic Alliance Foundation and the Infectious Disease Institute at Makerere University in Uganda

to develop training programs on clinical, public health, and laboratory practices for clinicians and researchers from throughout

sub-Saharan Africa.

Through the BD Volunteer Program, BD sends teams of its associates to remote health facilities to help build local health



capacity through training, construction, health services and laboratory strengthening. In 2005, BD collaborated with the

Catholic Medical Mission Board (CMMB) to send teams of BD associates to five health centers in Zambia to help expand the

country’s capacity to diagnose and treat infectious diseases such as HIV/AIDS. Recognizing the need for follow up, BD

associates returned to Zambia in 2006 to continue their work at the same health centers. In 2007, BD collaborated with Direct

Relief International to send BD associates to two health centers in Ghana. BD employees trained local health care providers,

constructed a new health facility, upgraded existing laboratory capabilities and incorporated clean water solutions at existing

facilities, bolstering the clinics’ abilities to provide vitally needed services to their patients.

Prevention of Rheumatic Heart Disease

To help prevent rheumatic heart disease (RHD), the most common cause of heart disease and of heart failure in patients under

age 30, the Medtronic Foundation has supported the World Heart Federation’s RHDnet, a tool to share knowledge globally,

and to encourage more countries to address the problem. The Foundation also supported the establishment of an Africa RHD

Registry, which is particularly important for effective delivery of the antibiotic prophylaxis that can prevent rheumatic fever

from progressing to being a debilitating disease. It also enables researchers to get the epidemiological data which is needed

both to better understand the disease, to effectively plan interventions, and to advocate for health resource allocation.

Medtronic employees have also been active in raising funds to prevent RHD.

In addition, the Medtronic Foundation has partnered with the University of Cape Town in South Africa on the development of

the A.S.A.P. program to raise awareness of the public and healthcare workers about RHD, determine the incidence of RHD

through surveillance, advocate for improved public policy to prevent and treat RHD, and work towards the establishment of

primary & secondary prevention programs of RHD at the community level in South Africa. The University is working with the

Pan African Society of Cardiology (PASCAR) to encourage development of similar programs in several other African countries.

HIV/AIDS Training and Education

BD provided philanthropic support to Save the Children for the establishment of clinics for HIV-positive children in Ethiopia.

Abbott Fund and the Government of Tanzania have partnered to develop one of Africa’s most comprehensive initiatives to

strengthen a country’s health care system and train staff to meet the needs of people with HIV and other life-long diseases.

This partnership has expanded testing and treatment at more than 80 health centers throughout Tanzania, bringing HIV

services into some remote regions for the first time. In Dar es Salaam, Tanzania’s largest city, the program is building state-of-

theart clinical diagnostic laboratories and a three-story outpatient center at the country’s leading reference hospital, training

more than 10,500 health care workers and providing voluntary HIV counseling and testing for more than 130,000 people.

The Johnson & Johnson/UCLA Management Development Institute(MDI) was created in 2006 as an intensive one-week

program designed to enhance the management skills of health care leaders of East African organizations devoted to the care,

treatment and support of people and their families living with HIV/AIDS. Johnson & Johnson, its Tibotec subsidiary and the

African Medical Research Foundation help the Ugandan NGO Sikiliza Leo to provide HIV testing, counseling, treatment and

care in rural Uganda. Since March 2003, HIV testing and counseling have been offered to 3,586 community members, of whom

559 have tested positive for HIV. A total of 272 persons receive Home Based Care and a first group of 20 are now receiving

ARV therapy. The program has also established two day-care facilities that support some 250 orphans and vulnerable children

in Mulanda and Lwala parishes. Psychosocial development, education, nutrition and care are offered to children from 3 to 8

years of age. The program has been recognized by the American Embassy, and a grant has been provided to improve facilities

and food.

Imaging Training and Infrastructure Development

Philips Medical Systems assisted the Government of Tanzania in rehabilitating the diagnostic services and operating theaters

of district and regional hospitals spread over an area of 945,000 km2. The project furnished 98 hospitals with diagnostic



equipment, such as X-ray, ultrasound scanners and laboratory photometers, and equipment for surgical and dental treatment.

Buildings were rehabilitated, and water treatment units and power generators were installed to ensure availability of clean water

and electricity. Training was provided for hospital staff and service engineers.

Nurse Training and Education and Retention

The Medtronic Foundation is supporting Children’s HeartLink to develop a model program that addresses the problem of

critical care nurse retention, and provides nurse training. Many developed countries have growing nursing shortages (which

will only increase with aging populations), and they look to developing countries to solve their recruiting needs. As a result,

some hospitals in South Africa are known to have an 80% annual turnover in critical care nurses. This affects the quality of

care for patients. This pilot project engages nursing staff, educators, cardiac service professionals & hospital administrators in

South Africa and abroad to develop programs for nurse retention & professional development through one model project

which, if successful, could be replicated in other sites.

The Medtronic Foundation is also supporting the University of Witswatersrand to help South Africa cope with emerging forms

of heart disease and the resulting massive increase in patients with acute coronary syndromes using cardiac clinic services at

Baragwanath Hospital. This hospital, which serves Soweto and the region around Johannesburg, is the largest hospital in the

southern hemisphere, with 3,500 beds. Many medical professionals have little knowledge of heart disease and are ill-equipped

to deal with it. Soweto has only 12 primary care clinics for its 1 million inhabitants. Primary care clinics are regularly staffed only

with nurses, not doctors. Few of the nurses know the symptoms of heart disease or chronic heart failure (CHF). There are no

CHF treatment protocols or management plans. For patients treated for heart failure in hospital, there is often no follow-up at

their community clinic after discharge. The goal of this program is to improve the local capacity of selected community-based

nurses in the primary care clinics in Soweto to recognize and manage heart disease and heart failure, and to liaise with

Baragwanath Hospital so they can provide expert medical care across the whole continuum of the health care system. Once the

nurses are trained, they can refer patients directly to Baragwanath hospital, without the need for a referring doctor. If

successful, this model can be extended to include all 12 primary care clinics in Soweto.

World Cup pool donated to charitable organization “Mercy Ships”

Siemens’ “Learning Campus @ Med” group donated some 10,000 Euros to Mercy Ships. Since July 2006, a Mercy Ship hospital

ship has been anchored in the harbor of Tema, Ghana where physicians on board have performed more than 1,000 eye

operations — primarily on people with cataracts.

Training and Education on Diabetes

The Medtronic Foundation supports Kids & Care South Africa to develop & publish books and films for children about living

with diabetes. These materials are distributed to diabetic children & their families, and to schools in South Africa. This initiative

is part of a nationwide diabetes education program.

ASIA

India

Medical Education Padyatra:

“Transforming Standard of Patient Care” Johnson and Johnson in India launched a new Professional Education-initiative, the

“Medical Education Padyatra” in line with their philosophy of ‘Transforming Standard of Care’. Planned for approximately 300

cities across India over a period of seventeen month period, the padyatra will meet surgeons and learn about their practice,

share best practices and effectively usher in change. The faculties will conduct workshops on ‘Advances in Hernia’ and ‘Best

Practices for Surgical Site Infections’. These two areas are of great significance with almost 2 % of the adult population in India



suffering from Hernia and Surgical Site Infection constituting almost 20% of all hospital acquired infections. Customized

curriculum, tong insights and focus, top faculties and great team organizing and engaging back to back programs and creating

an environment for adoption to best practices. The MedEd Padyatra started from Gujarat in the month of April 2009 has now

achieved a national foot print and covered 15 states. From East to West and from North to South in the last six months Med Ed

Padyatra has touched 5200 Health Care Professionals in 202 cities. These doctors will now benefit thousands of patients with

the new learning/best practices.

For the cause of patient care, eminent faculties are joining the Padyatra to perpetuate and share best practices. Medical

Education Padyatra seeks to raise the bar with respect to standard of care.

Nurture: Nursing magazine for nurses

In ever challenging healthcare environment, the need for keeping abreast with best practices and personal enrichment of

knowledge and skill is very critical for nursing professionals for superior support to the surgical team. Understanding this need

Johnson & Johnson launched ‘Nurture’ magazine, which features current best practices in nursing world, nursing etiquettes,

well illustrated surgical procedure and many more inspiring nursing articles. Launched throughout all of India on May 12th 2009

‘International Nurses Day’ reaching 21000 nurses across all nursing homes and top hospital. By now four issues have been

circulated in India. The success encouraged them to launch the same in Bangladesh in the Bangla language. Nuture is

committed to enhancing knowledge of nurses.

Improving Chronic Care In India, Baxter’s International Foundation partnered with Charities Aid Foundation in New Delhi,

India, in 2006 to establish a chronic care initiative to increase awareness and improve access and availability of treatment

options for conditions such as heart disease, diabetes and obesity among high-risk populations.

Training and Education on HIV/AIDS

BD partners with Hindustan Latex, Ltd. to help prevent the reuse of syringes in India through the introduction of auto-disable

syringes, education and training of healthcare workers, and the implementation of advocacy programs with the Government of

India. According to a WHO report, unsafe injections are the second leading cause of HIV spread in India.


The Medtronic Foundation has partnered with the India Diabetes Research Foundation for an initiative in 10 Indian states to

train 960 doctors, 600 health educators/dieticians, and 4,000 paramedical field staff in diabetes over five years. India has the

world’s largest diabetes population, estimated at 40 million, but many health professionals have little knowledge of the disease.

IDRF will encourage participants to join in the establishment of a network of Diabetes Prevention & Control Centers, and will

raise awareness of all stakeholders including policymakers, health managers, high-risk groups and the general population on

prevention of diabetes and its complications.

The Medtronic Foundation has also supported the Madras Diabetes Research Foundation in a program to train doctors and

allied specialists in diabetes and related complications. MDRF will train physicians, ophthalmologists, diabetes educators,

nurses and technicians.

China

Hospital Equipment in Rural China

In April 2007, Siemens together with the Clinton Global Initiative kicked off a 5-year rural healthcare project in China with a total

investment volume of US $10 million. The project, which is supported by China’s Ministry of Health, will help improve

healthcare in rural areas of China. Luochuan County in Yan’an, Shaanxi province, was the site of the first project



implementation. Siemens has equipped the local county hospital in Luochuan County with a full range of diagnostic imaging

equipment including ultrasound, X-ray and CT scanners. Since appropriate knowledge is crucial to the healthcare delivery

process, Siemens is also providing medical and application training to support physician education at the hospital. Siemens is

also installing water treatment equipment to prevent health threats to the environment from the hospital’s wastewater.

Townships are also included in the project scope, as they play an important role in the delivery of first-line healthcare services

in rural China. A total of six township health centers surrounding the county hospital will receive X-ray and ultrasound

equipment from Siemens. Once the equipment upgrades are complete, Siemens will ensure this rural healthcare network has the

appropriate technical infrastructure to provide quality services to the local population. On-site research activities will also

evaluate and monitor the efficiency and effectiveness of healthcare delivery at the project sites to drive a process of

continuous improvement.


In China, BD in partnership with Project HOPE, an international health education and humanitarian assistance organization, has

renewed its 1998 commitment to the China Diabetes Education Program (CDEP). CDEP provides comprehensive diabetes

training to local medical and healthcare providers, also known as Trained Trainers. To date, outreach efforts by Trained

Trainers across 800 local hospitals and community care centers have successfully trained nearly 37,000 medical professionals

and about 170,000 patients with diabetes. The program’s efforts have won strong support from China’s Ministry of Health and

government offices at various levels. More than 30 million Chinese citizens are currently estimated to have diabetes, a figure

forecast to rise to as many as 100 million by 2010. Due to patient education and training issues, however, many affected people

are unaware of healthcare measures that can alleviate and postpone associated complications.

Developing Advanced Orthopedic Care

In China, Stryker has outreach programs focusing on its orthopedic expertise – to replace knees and hips in individuals in

underserved areas around the globe, in a partnership with Operation Walk, a not-for-profit, volunteer medical services

organization. Operation Walk provides free surgical treatment for patients in developing countries and the United States that

have no access to therapies for arthritis or other debilitating bone and joint conditions. It also educates in-country orthopedic

surgeons, nurses, physical therapists and other health care professionals. Stryker’s first partnership with Operation Walk was

with its Chicago branch on a trip to China in 2005. The teams performed 56 total joint replacements at Huaxi Hospital in

Chengdu, China, during a one-week period. A year later, Operation Walk Chicago and Stryker traveled to two locations in

China, Chengdu and the Zhejiang Traditional Hospital in Hangzhou. There medical teams performed more than 80 total joint

replacements. For both trips, Stryker donated more than 130 implants, necessary instrumentation and manpower from both the

U.S. and Stryker China.

Training and Education of Senior Chinese Government Health Officials

The Medtronic Foundation has supported the Harvard School of Public Health program to educate senior government health

officials, mostly policy makers, as well as hospital administrators, to improve the quality of patient care in China. The objective

is to help China produce a critical mass of well-informed and highly responsible leaders and executives who can develop and

implement sound policies while dealing with local issues. Specific objectives are (1) to develop participants’ comprehensive

understanding of the major global, national, and regional health developments and health system reform issues; (2) to sharpen

participants’ problem-solving, analytic, strategic planning, and leadership skills; (3) to equip participants with a spectrum of

international working models of health development and policy practice against which they may judge and weigh local issues

and options; and (4) to analyze the particular functional challenges shaping modern China’s health policy environment and

healthcare marketplace.

Training Healthcare Workers in China



With the understanding that health education is essential in making healthcare accessible to medically underserved

communities, in partnership with the Chinese Red Cross Foundation, Philips launched the Rural Healthcare Program in 2006.

This three-year initiative will educate 300 village doctors in Beijing, Shanghai and Guangzhou and includes sponsoring a train-

the-trainer program for those who will work with rural doctors. The program will also establish 10 Philips clinics and hospitals.

Philippines, Taiwan, Vietnam, Singapore

Caring, Rebuilding Storm-Ravaged Lives and Communities

Severe storms and floodwaters struck Taiwan, the Philippines and Vietnam in 2009. Johnson & Johnson helped many of the

displaced and wounded in these countries by donating disaster relief packages that included consumer products,

pharmaceuticals, trauma care kits and medical devices.

In the Philippines, typhoons affected 2.5 million people. Johnson & Johnson partnered with AmeriCares, the Asian

American Institute, Direct Relief International (DRI), Heart to Heart International, HOPE Worldwide, Medical Teams

International, Save the Children and others to provide relief. Employees from Johnson & Johnson Philippines

volunteered in soup kitchens, helped package and distribute supplies, and raised funds for organizations like World

Vision and the Corporate Network for Disaster Response.

In Vietnam, storms affected more than 200,000 people. Johnson & Johnson partnered with Direct Relief International,

Save the Children and the Kim Long Charity Clinic to provide relief. Johnson & Johnson Consumer Companies Inc. and

McNeil Consumer Healthcare gave products to AmeriCares and DRI. In addition, Janssen-Cilag Vietnam donated and

distributed food to 100 households in Quang Nam.

In October 2009, towering waves slammed into Samoa, American Samoa and Tonga, destroying villages and lives.

Johnson & Johnson partner with Direct Relief International and local health centers to provide antibiotics and wound

care supplies. Several operating companies in the region provided products and monetary support to help those

affected by the tsunami.

Training Midwives and Expanding Healthcare Education into Rural Communities

Johnson & Johnson Philippines created the Midwives Leadership Development Program (MLDP) in cooperation with the

Integrated Midwives Association of the Philippines (IMAP), Inc. to train and strengthen the leadership and health care skills of

midwives. The program gives midwives an opportunity to take part in an intensive training program that aims to enhance their

knowledge and leadership skills and develop them to become more effective health professionals. Since 2004, the MLDP has

trained more than 100 midwives across the country. In the Philippines, midwives are valued for the important role they play in

the health of the Filipino people, especially in the country’s far-flung communities. The job often goes well beyond caring for

expecting mothers and attending to the birth of babies, providing educational information about renal disease, tuberculosis and

sexually transmitted infections.

Imaging Training and Infrastructure Development

Philips Medical Systems is assisting the Department of Health in the Philippines to upgrade medical equipment for diagnosing

and treating chronic diseases of the heart, lungs and kidney in national and regional hospitals throughout the country as part

of their The project furnished sophisticated medical equipment to improve five specialist heart-lung-kidney centers in the

Philippines. Equipment for noninvasive procedures, diagnostic imaging, operating theaters, recovery and patient monitoring

areas, as well as items for hemodialysis and bronchoscopy were included. Buildings were rehabilitated and training for hospital

staff and service engineers was provided. Equipment will be supported with long-term comprehensive warranty and

maintenance contracts. Period: 2005 – 2011



Advanced Hospital Management

Johnson & Johnson, in cooperation with the Singapore Management University, runs a Regional Hospital Management

Program. The program helps hospitals in the Asia-Pacific region improve their management and operations so they can deliver

better health care services. Professors from renowned institutions in Singapore and the

U.S. review modern hospital management principles and techniques with 50 senior hospital administrators from different Asian

countries during this five-day seminar. Since its inception in 1997, 368 hospital administrators from 305 different health care

institutions have participated in the program, increasing the interaction among administrators in the Asia-Pacific region and

strengthening the leadership capabilities of hospital managers.

CENTRAL & EASTERN EUROPE

Advanced Cardiology Training and Education

The Medtronic Foundation is a long-time partner of the American Austrian Foundation which provides in cardiology for

doctors from Russia and Central & Eastern Europe. Since 1994, AAF has operated a program based in Austria called the Open

Medical Institute, offering postgraduate educational programs in medicine. Over 7,000 physicians from 30 countries have

participated. There are 3 programs: Seminars – physicians attend for one week in their medical specialty, taught by faculty from

prestigious U.S. universities (Cornell, Columbia, Duke); Internships – providing postgraduate training at Austrian hospitals for

one month in Cardiology, Neurology and Internal Medicine; and Satellite symposia – to reach more doctors and see conditions

in the target countries, seminar faculty travel to the region just before or after a seminar to conduct two-day satellite symposia.

The symposia consist of six state of the art lectures, a panel discussion with experts from the region, case presentations, &

visits to local hospitals.

Development of Advanced Pediatric Cardiac Care

The Medtronic Foundation supports the Heart to Heart organization to enable it to develop pediatric cardiac centers of

excellence in Russia. Medical teams from prestigious U.S. hospitals work side by side with colleagues in Russia to train them in

cardiac surgery & catheter lab interventions for newborns and very young children. In Russia, there are only four cardiac

centers where a newborn can get access to cardiac surgery. About 20,000 children are born in Russia each year that will be

“waiting” for heart surgery. Heart to Heart plans to set up six new regional self-sustaining pediatric cardiac centers of

excellence, so that all regions of Russia can offer excellent cardiac care to children.

Development of Advanced HIV/AIDS care

BD provided philanthropic support to Save the Children for the establishment of clinics for HIV-positive children in Eastern

Europe.

Mending the Hearts of Children in the Ukraine

Siemens loaned an ACUSON Cypress system to Children’s HeartLink for a mission trip to the Clinical Regional Hospital in

Lviv, Ukraine. In one week, the team of volunteer doctors and nurses treated 27 critically ill children, including 12 surgeries and

15 interventional catheterization procedures.

LATIN AMERICA

Diabetes Training and Education

Abbott partners in Bolivia with Direct Relief International, a leading international relief organization, to support outreach

activities of El Centro Vivir Con Diabetes, a group dedicated to the education, care and counseling of low-income adults and

children with diabetes. The Abbott Fund’s grant supports diabetes education, expands public outreach campaigns, trains



health care personnel in diabetes management and develops a core group of diabetes educators. Donated glucose screening

and monitoring equipment has helped screen approximately 8,000 people for the disease and monitors the condition of

thousands more.

HIV/AIDS Training and Education

Johnson & Johnson works with The Associacao Saude da Familia (ASF) to mobilize community support in poor favelas in

Sao Paulo, Brazil, to protect young people from unwanted pregnancies and sexually transmitted diseases. This includes raising

awareness and spreading information about HIV/AIDS. In these teeming slums, where drugs and violent crime are a constant

reminder of the fragility of civil societies, ASF works with local community leaders, and municipal and state governments, to

implement its programs to encourage safer and healthier behavior. In its newest program, ASF trains laypersons in poor

communities to become outreach workers. They make door-to-door visits providing HIV prevention education and offer

voluntary testing and counseling services. With a grant from Johnson & Johnson, ASF was able to expand the scope of this

program, and to help local health care units to provide diagnosis, prevention, treatment and care for people living with

HIV/AIDS.

Johnson & Johnson supports an educational program in Mexico with the Instituto Mexicano de Investigación de Familia y

Población (IMIFAP), for youth that utilizes the existing national network of middle schools to teach students about HIV

prevention before they become sexually active, increasing the likelihood that these adolescents will practice safe sex in the

future. IMIFAP engages all levels of the community from the Ministries of Health and Education, to the school administrators

and local politicians, to the teachers and students. The program includes teacher training, a software program, and Web site

support. The 10,400 schools in Mexico with Internet access bring this program to more than 300,000 students. For those

schools without Internet access, IMIFAP trains teachers and students to run the program, and has partnered with UNETE, a

member of The Resource Fund, to raise educational levels using technology to distribute the program in more rural and remote

areas.

New Mission Hospital in Peru

In September 2007, Siemens donated a CT scanner to a new mission hospital in Peru. Some 750,000 people live within a three

hour radius (by car) of Curahuasi – the lost city of the Incas. Until recently, the region did not have a hospital. The new

hospital is equipped with 50 beds, four operating rooms, an intensive care unit, a lab and X-ray facilities.


The Medtronic Foundation has funded the Juvenile Diabetes Association (ADJ) of Brazil for a “train the trainer” program,

educating 40 public and private health professionals (physicians, nurses, psychologists, and nutritionists) in diabetes. These

health professionals will in turn train 1,200 others during the first year. The course will cover diabetes types 1 and 2: how to

treat the disease in coordination with a specialist, the emotional support needed by patients, and how to teach the patients

their own role in managing the disease. The course requires that the health professionals develop a plan for introducing

diabetes educational programs in their area.

Mexico Diabetes Program

Johnson & Johnson, in cooperation with Project Hope, developed in 2005 a “5 Steps for Self Care” course for healthcare

providers and their patients dealing with diabetes. Over 150 healthcare workers in 25 clinics were trained in the course. By 2009,

over 2,500 patients were counseled and it is estimated that over 75,000 community members were reached. The program has

shown proven results in decreasing risk of complications associated with diabetes and has won several awards.

KEY FEATURES OF THE MEDICAL TECHNOLOGY INDUSTRY



Industry

Relatively young, very diverse industry made up of a few large companies and a large number (~80% of industry) of

small- and medium-sized enterprises (SMEs) – over 10,000 worldwide.

Products/Innovation

Very large number (tens of thousands) and broad variety of products ranging from syringes, hospital beds andbandages to implantable pacemakers/defibrillators, prostheses and pumps and human tissue products.Products traditionally based on mechanical, electrical and materials engineering and often designed in cooperationwith doctors and nurses.Continuous innovation and iterative improvements based on new science, advances in diagnostic and therapeuticand related technologies and available materials.Very short product life cycles and investment recovery periods — approximately 18-24 months on the market.

Essential Support Services

High and ongoing distribution and training costs, often underpinned by a requirement to provide services andmaintenance (especially for high tech devices).Often integral part of medical procedures, so user training and education are essential for safe and effective use ofproducts.

Annex III

The Global Medical Technology Alliance (GMTA) represents medical technology industry associations from several regions –

Asia, Europe and North America – which account for over 90 percent of the medical technology used around the world. We

want to assure the WHO that we are committed to the highest ethical standards.

Scientific research as well as practical experience applied to the design, development and refinement of medical technology is

the essence of our industry. We work closely with physicians and health care providers to ensure that they are properly trained

to utilize our technology and to continually refine our technology, all for the greater benefit of patients.

GMTA is composed of both national and regional associations, all which have adopted written commitments to the highest

ethical standards. Our members have worked for several years to develop, adopt and implement strict ethics codes to ensure



that our member companies understand and adhere to these standards. The variations in countries’ legal and regulatory

systems are reflected in the different versions of industry compliance codes, but the underlying principles of the codes are

being harmonized internationally. Our member organizations continually refine and update these codes to guarantee that they

remain both relevant and comprehensive. The codes ensure that a health care practitioner’s treatment and technology selection

is based on the best interests of the patient.

Here are links to the codes:

MTAA and MTANZ

This is a shared code:

http://mtaa.org.au/pages/images/5th%20Edition%20and%20guidance%20material%20cl

ean%20copy%2027%20Oct%2009.doc.pdf

EUCOMED

http://www.eucomed.org/~/media/680287A3BCD745D9AEE1FF70B9705C85.ashx

http://www.eucomed.org/~/media/7B93DCC3E60946E699D032B567C3F88F.ashx

MEDEC

http://www.medec.org/en/code

AdvaMed

http://www.advamed.org/MemberPortal/About/code/; http://www.advamed.org/NR/rdonlyres/61D30455-F7E9-4081-

B21912D6CE347585/0/AdvaMedCodeofEthicsRevisedandRestatedEffective20090701.pdf

GMTA

GMTA is the Global Medical Technology Alliance. Its members are national or regional medical technologyassociations, which represent innovative companies that currently develop and manufacture 85 percent of theworld’s medical devices, diagnostics and equipment. It provides a forum for the development and advocacy ofpolicies that support innovation in medical technology to address patients’ healthcare needs. Medical

technologies save, support, and improve lives every day around the world. Please go to “About GMTA” formembership criteria and process, and for the governance rules.

Contact GMTA

You can contact GMTA at: [email protected]

Documents

NewsPosition papers

mailto:[email protected]?subject=Email%20for%20GMTA%20Secretariat

http://www.globalmedicaltechnologyalliance.org/category/news

http://www.globalmedicaltechnologyalliance.org/category/positionpapers



Except where otherwise noted, content on this site is licensed under a Creative Commons Licence.

Valid XHTML 1.0 Strict Valid CSS Level 2.1

GMTA - Global Medical Technology Alliance uses Graphene theme by Syahir Hakim.

http://creativecommons.org/licenses/by-nc-nd/3.0/

http://validator.w3.org/check?uri=referer

http://jigsaw.w3.org/css-validator/check/referer/


http://www.khairul-syahir.com/wordpress-dev/graphene-theme

Date post:	11-Jan-2016
Category:	Documents
Upload:	shilpi-khattri
View:	231 times
Download:	0 times