The importance of the medical equipment trade and the role of the WHO
Economic aspects of medical devices
Tracking and explaining the growth in health spending in all national systems has been a prominent concern in governmental, academic and industrial research in both developing and developed countries. Many studies have shown that technological changes in health care, especially medical devices are among the key drivers of growth in health expenditure growth. In Europe, 6.2% of the total health expenditure goes on procurement and maintenance of medical devices, while both the United States of America and Japan spend some 5.1% of total health expenditure on medical devices. Owing to serious gaps in knowledge, figures for the Eastern Mediterranean Region cannot be confirmed. However, crude estimates indicate that Member States spend even more.
There is a need to strike a balance between the largely supply -driven regional market and the actual needs of the health sector based on population size and health problems. The health sector and the individual citizen both need to be protected against unnecessary expenditures. To conserve the already meagre financial resources, countries need very clear evidence-based information on how to a) conduct proper needs assessment; b) assess cost-effectiveness of purchase versus hire of equipment, including donated and second-hand equipment; c) develop policies on rational procurement and use; and d) regulate purchasing decisions in both the public and private sectors. In an effort to rationalize health spending and curb health care inflation, many countries require health planners to evaluate community needs and institute a Certificate of Need review program, particularly for heavy medical technology. Although Certificate of Need programs were intended to control health care spending by limiting service expansion, many studies indicate that they have not lived up to expectations. The pursuit of rational use of medical devices requires more than government regulations and Certificate of Need programs. It requires strong collaboration between private industry and governments; solid information on impact, supply trends and use of different technologies; databases on health technology expenditures for different interventions; institutionalization of health technology assessment (HTA) for new and existing health technologies; and innovative, integrated and efficient methods of determining the appropriate technology for any health care delivery level.
WHO role and position
WHO working strategies
WHO is working on new ISO standards and performance indicators, promoting the concept of a list of model essential medical devices, and collaborating with international bodies such as the Global Harmonization Task Force4 in order to establish internationally accepted guidelines and standards, WHO is pursuing four strategy c directions aimed at assisting national health authorities in the selection, procurement, use, maintenance and disposal of high quality medical devices that meet their particular needs . National policies and regulations Governments need to put in place policies that will address all elements related to medical devices, from their outset, through the manufacturing process, advertising, sale and use, to the disposal of the device. However, policies will be unsuccessful unless they are translated into national regulations that are enforced by laws. Access to essential medical devices Access to medical devices is not only about adequate resources. It is about managing the supply chain from selection and procurement to local distribution and rational use. To achieve equitable access and cost-effectiveness, there is a need to develop technology transfer networks among countries. Centers of excellence can be helpful in training and encouraging countries to address and/or deal with many medical device-related problems. To ensure appropriate access, a list of essential devices is required. Quality and safety issues Medical devices need to be of adequate quality and safety to bring public health benefits without harming patients, health care workers or the community. Thus, regulations should mandate that all devices, whether imported or locally produced, meet international norms and standards. In addition, countries should participate in global and local vigilance networks to ensure the effective management of adverse events. Management, maintenance and use of medical devices National management programs need to be established in order to ensure that trained personnel, facilities and standard operating procedures are in place, together with systems for maintenance and repair of equipment. WHO is developing products and tools, such as policy and procurement guidelines, rapid assessment tools and training programs.
Concept of “Essential medical devices” One of the key initiatives in WHO is the development of lists of essential medical devices. A medical device should be considered essential only when its use meets the basic needs of health services, has been proven to be cost-effective, and is evidence-based (i.e. follows well defined specifications and is validated through controlled clinical studies or widely accepted consensus by experts). Medical devices should be selected with respect to their public health relevance based on need, efficiency, safety and cost-effectiveness. A static list of medical devices is neither feasible nor useful. Nevertheless, evidence shows that a template list of essential medical devices can assist countries to plan and manage their needs . Global Alliance for Healthcare Technology the Global Alliance for Healthcare Technology is an initiative of WHO and the World Bank to propose concrete solutions to major problems facing developing countries regarding health technology. The project aims at streamlining health care technology investments so that they match the economic strength of any country. In finding the appropriate match, countries can learn from each other by looking at what has actually been established in other countries of comparable economic status. Thus, rather than mimicking the design of health services of high income countries, countries of similar economic strength could benefit from each other’s experience . Accordingly, WHO will Indicate how a country is doing in terms of health technologies vis-à-vis other countries with similar economic strength; generate a set of benchmarking indicators which allow comparison between countries; Estimate performance indicators, which include coverage and utilization; and Formulate recommendations on strengthening the use of technologies. The project will be implemented in conjunction with Fudan University in China, where initial tests and data collection protocols are being investigated. As soon as these initial tests are completed, pilot studies will take place including countries from the Eastern Mediterranean Region.
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