Détails ressource biomédicale locale

Détails ressource biomédicale locale
Numéro 462
Titre Development of medical device policies
Rubrique Informations générales sur le don d'équipement
Auteur OMS
Résumé When used within the context of a robust health system, medical devices improve health outcomes. Through such a system, medical devices can be effectively allocated based on the needs of a particular population. A health system, however, is only as good as the polices, strategies, and action plans that constitute it. The World Health Organization (WHO) and its Member States recognized this in several World Health Assembly resolutions highlighting the importance of health technologies, particularly medical devices, to prevent, diagnose, treat illness, disease, and disability, and improve health and quality of life. Member States were urged to formulate appropriate national strategies and plans for assessment and management of medical devices; and WHO was requested to provide technical guidance to Member States in implementing policies on health technologies. Policies create a framework through which to direct valuable resources. A national health policy framework includes a vision, a situation analysis, policy directions, strategies to overcome challenges, a policy implementation plan, and the leadership and governance required to achieve sustainability. When embedded within a national health policy, health technologies policies can be linked to other health systems components - fi nancing, human resources, information, leadership and governance - that together address the needs of the target population and may result in better health outcomes. Effective health technology policies address inequity as well as accessibility, affordability and availability of innovative and core medical devices required to target the health needs, particularly those that address the Millennium Development Goals and noncommunicable diseases. To do this the four phases of medical devices - research and innovation, regulation for device safety, assessment for better decision making, and comprehensive management - must be considered and adapted to the priority public health conditions, resources and settings. Once the policies are compiled, organizational structures are required to implement the strategies and action plans contained therein. This includes a regulatory authority and regional and national institutions to optimally assess and manage health technology, with the support of specialized professionals in biomedical engineering and related areas. Monitoring and evaluation of the strategies, objectives or action plans and the use of indicators to trace effectiveness will increase accountability and provide feedback for improvement of the policy and its implementation process. The number of countries with existing health technology policies and with units to implement those policies, data available from WHO’s baseline country survey on medical devices, shows that there is forward movement in the development and implementation of health technology policies. However, because medical devices are complex to select, manage and use, it is important to ensure that new policies are developed appropriately and existing ones are modifi ed as necessary to make them as effective as possible. Proper integration of health technology policies and strategies within the framework of a national health plan has the potential to harness the political support to ensure improved access, quality and use of medical devices, enhance the best use of the resources in a framework of universal coverage, respond to the needs of the population, and ultimately achieve better health outcomes
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Lien site web http://apps.who.int/iris/bitstream/handle/10665/44600/9789241501637_eng.pdf?sequence=1&isAllowed=y
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