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    Foto: Ary Rogerio Silva, OPS/OMS
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Medical Devices

Medical Devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way.

The steps that involve Medical Devices manufacturing, regulation, planning, assessment, acquisition, and management are complex but essential to guarantee their quality, safety and compatibility with the settings in which they are used.

Key facts
  • Medical devices, in particular, are crucial in the prevention, diagnosis, and treatment of illness and disease, as well as patient rehabilitation
  • A health technology is “any intervention that may be used to promote health, to prevent, diagnose or treat disease or for rehabilitation or long-term care”
  • Appropriate HTA strategies enable developing and emerging countries to contextualize global knowledge, support transparent and accountable decisionmaking, and promote health equity.
PAHO Response

The Pan American Health Organization (PAHO), through the Medicines and Health Technologies area, supports countries of the Americas Region with Medical Device Regulation, Health Technology Management and Health Technology Assessment (HTA).

PAHO undertakes several activities in order to build capacity in Member States through Regional meetings and workshops, technical cooperation, information sharing, and training through online courses.

The objective of PAHO is to collaborate with the Member States in the creation and strengthening of Regulatory Capacity on Medical Devices in the Americas Region in order to guarantee the quality, safety and efficacy of products used by the population.

PAHO has promoted the harmonization of the regulatory requirements of several countries through annual Regional meetings, information exchange, joint projects, training and the recent designation of CECMED as a PAHO/WHO Collaborating Centre for the Regulation of Health Technologies.

In 2014, PAHO was designated as an Affiliate Organization of the International Medical Devices Regulators Forum (IMDRF)

 

List of priority medical devices for the first level of care

 

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Medical Devices are considered a fundamental component of Health Systems; the benefits they can provide continue to increase as they're essential to prevent, diagnose, treat and rehabilitate illnesses and diseases in a safe and effective way. The steps that involve Medical Devices manufacturing, regulation, planning, assessment, acquisition, and management are complex but essential to guarantee their quality, safety, and compatibility with the settings in which they are used.

 

The Medical Device market has grown fast; following technological trends in healthcare to improve people's welfare, there are currently more than 10, 000 different kinds of medical devices around the world. The countries of the Americas Region are an important market for medical devices; indeed, in several countries this sector has witnessed a rapid annual growth rate. With few exceptions, the countries import more than 80% of their medical devices. Nevertheless, patient safety and access to high quality, safe and effective medical devices remains the top priority for countries.

Health Authorities face an overwhelming variety of options with regard to increasingly sophisticated, technologically complex and new medical devices. In addition to having more options, authorities must also consider the technological complexity of the devices; more global and competitive markets; increases in the marketing of used and refurbished equipment; donation of devices; reuse of single-use devices; ever-increasing use of devices in physician's offices and at the household level; patients with greater access to information; weak post-sale technical support services; need to establish a post-marketing surveillance program as well as the challenge of delivering good quality services and beneficial treatments as a function of cost-effective Medical Devices.

To ensure public health benefit and the safety of patients, healthcare workers and the community, it is necessary to guarantee access to high quality, safe and effective medical devices and to restrict those products that are unsafe or have limited clinical use through regulatory processes.

The resolution CD42.R10 on Medical Devices, approved during the 42nd Directing Council, urged the Member States to develop and strengthen their programs for the regulation of Medical Devices. Later, the World Health Assembly resolution WHA60.29 urged the Member States to strengthen national regulatory systems, to engage in global, regional and subregional networks of national regulatory authorities, and to promote international cooperation, as appropriate; it also requested the General Director to prioritize support for establishing and strengthening regional and subregional networks of Regulatory Authorities, as appropriate, including strengthening areas of regulation of health products that are the least developed, such as regulation of Medical Devices and to support the building-up of effective national and regional regulatory bodies and networks. More recently, the World Health Assembly approved the resolution WHA60.27 on Regulatory system strengthening for medical products.

Niño con dispositivo médico

In 2012, PAHO held the "1st Regional Meeting of the Regulatory Authorities for the Strengthening of Regulatory Capacity on Medical Devices in the Americas Region" in La Habana, Cuba; it was joined by representatives of the National Regulatory Authorities (NRAs) of several Member States. During the meeting, a Regional Working Group was established and is currently comprised of 16 NRAs; countries join the Working Group voluntarily, with the commitment to work in solidarity to advance towards achieving the set objectives.

The Regional Working Group on Medical Device Regulation aims to strengthen the Regulatory Capacity on Medical Devices through Regional exchange of information in PRAIS, joint projects and training strategies towards the harmonization of regulatory requirements.

 

Management of Medical Equipment

The successful delivery of health care depends largely upon medical devices; therefore, the Management of Medical Equipment (MME) is one of the most important areas within Health Systems. This area requires the active participation of staff from different disciplines such as: technical, clinical, financial, administrative, among others.

In developed countries, the MME includes designating a unit of professionals trained in the proper handling and management of medical equipment. MME promotes a better use of technology, and greater efficiency and effectiveness in hospitals. The MME issue has yet to gain momentum in Latin America; because of the lack of trained personnel, equipment is underutilized, broken, or abandoned.

 

PAHO's role in Management of Medical Equipment

PAHO, through the Medicines and Health Technologies Unit, promotes and facilitates the adoption of proper Management of Medical Equipment in the Americas Region through technical assistance, online training, regional cooperation, dissemination of documents, among others and the designation of CENETEC as a PAHO/WHO Collaborating Centre in Health Technology; also recognizes the significant impact of the Units of Biomedical / Clinical Engineering in the quality of health care services and therefore promotes its incorporation into the local health care.

PAHO/WHO Collaborating Centres in Medical Devices

PAHO/WHO Collaborating Centre for the Regulation of Health Technologies

Country: Cuba

Date of designation: 14/Jul/2014

Terms of Reference:

  1. Assisting PAHO/WHO in the strengthening of the Health Authorities Network for the regulation of medical devices, ensuring effective and timely exchange of regulatory information between countries in the region.
  2. In collaboration with PAHO/WHO, to improve the capacity in the region on regulation of medical devices.
  3. Assisting PAHO/WHO in the development and dissemination of documents regarding medical devices regulatory issues
  4. To provide technical assistance in assuring the quality, safety and efficacy of medical devices at the global, regional and national levels.
  5. To participate in collaborative studies and to conduct regulatory research according to WHO priorities.

 

Learn about the Regional Base of Health Technology Assessment Reports in the Americas - BRISA (in Spanish)

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