- Medical devices range from simple thermometers to sophisticated and costly diagnostic imaging equipment.
- There are an estimated 1.5 million different medical devices, in over more than 10 000 types of generic device groups available worldwide.
- Medical devices are indispensable for effective prevention, diagnosis, treatment and rehabilitation of illness and disease.
- The majority of the world's population is denied adequate access to safe and appropriate medical devices within their health systems.
- Almost 2/3 of all low-income countries do not have a national health technology policy which could ensure the effective use of resources through proper planning, assessment, acquisition and management of medical devices.
Global situation and challenges
Medical devices ranging from simple thermometers to sophisticated and costly diagnostic imaging equipment are needed to serve global health care needs. Medical devices can be used by health care workers, patients and individuals in a variety of settings including hospitals, clinics and even at home for prevention, diagnosis, treatment and rehabilitation of illness and disease.
Medical devices help to save and prolong life. For example, surgical instruments and anaesthetic equipment are needed for surgery procedures. Cancer is treated by radiotherapy units. Premature babies can be warmed with incubators. Medical devices also improve quality of life. Vision is improved with eyeglasses. The loss of a limb can be compensated by a prosthetic device. Haemodialysis machines replace kidney function.
Despite the variety and quantity of medical devices worldwide, availability in low-income countries is still limited. For example, access to computer tomography (CT), was found to be one per 64 900 people in high-income countries on average and one per 3.5 million people in low-income countries on average.
Major gaps exist between what is available in countries and what is needed. Even devices such as pulse oximeters or simple x-rays systems for primary health interventions are often lacking. Progress is further inhibited by a lack of information on the types of medical devices needed for prevailing diseases and public health priorities.
Access to safe medical devices depends upon systems for ensuring that medical devices work properly and are safe. However, 40% of low-income countries do not have an authority responsible for implementing and enforcing medical device regulations which ensures the safety of the device for the practitioner and the patient.
Many medical devices designed for high-income countries do not respond to low- and lower- middle-income country needs. Devices which are complicated to use, for example, are not appropriate in settings where there is a shortage of trained staff. In order to be effective, the device must be suitable for the context in which it will be used. This requires taking into account the available infrastructure, human and financial resources and local requirements.
The vast number of medical devices available complicates prioritization, selection and procurement. National guidelines, policies or recommendations on the procurement of medical devices are not used in a majority of countries either because they are not available or because there is no one recognized to implement them. Approximately a third of all countries lack a designated unit responsible for managing medical devices.
This creates challenges to establish priorities in the selection of medical devices on the basis of their impact on the burden of disease.
Areas where more work is needed
Almost two thirds of all low-income countries do not have a national health technology policy in the national health programme to guide the planning, assessment, acquisition and management of medical devices. Lack of a policy may lead to investments of inappropriate medical devices that do not meet priority needs of the population or are incompatible with the existing infrastructure and services, or too costly to maintain. This wastefulness can undermine the health system as a whole by draining funds needed for other essential services.
Better policy in countries will lead to an increase in the quality, effectiveness and coverage of health care with regards to medical devices. Advocacy is needed to mobilize stakeholders to action. Governments, academia, NGOs, donors, industry, UN and professional organizations will need to collaborate to share knowledge, explore challenges and determine required actions.
Health technology assessment, regulation and management of health training in countries will lead to better organization of health technologies and a more efficient use of resources. Adequate assessment of country needs for medical devices, including prevailing diseases and public health priorities is required. WHO tools and guidelines on the subject need to be further disseminated. National and regional workshops for healthcare planners, programme managers, and other non-technical personnel on the proper selection and prioritization of medical devices should be ongoing as new technologies for global health concerns are being available.
Staff managing, using and maintaining medical devices need appropriate professional training and a better retention of the trained staff must be achieved. In addition, the recognition of the role of the biomedical engineer as responsible for medical devices is necessary to improve countries' ability to properly manage medical devices.
Identification of innovative health technology solutions
Improved awareness of the need for medical device innovation and the identification of safe and appropriate solutions are needed to meet health care needs and improve the performance of health systems in countries.
Priority medical devices for specific purposes
High burden diseases and maternal and neonatal health need to be addressed through the development of recommendations of medical devices to be used by healthcare professionals for prevention, diagnosis, treatment and rehabilitation. Identifying countries' needs and communicating these needs to researchers and industry is essential. Tools and guidelines ought to be promoted at different healthcare delivery levels and in different settings and regional and national partnerships should be established.
- Provide country access to guidelines and tools required for the regulation, assessment, selection, procurement, management, training and use of medical devices, in line with resolution WHA60.29 on health technologies.
- Identify innovative technologies, in particular medical devices, which address global health concerns and which are appropriate and affordable for use in resource-limited settings.
- Make available a web site to make health technology documentation available to the public (www.who.int/medical_devices).
- Identify and establish an online community of health technology nominated focal points within ministries of health for exchange of best practices and information and compiling the information of countries' health technology policies, management, assessment and regulations through the first Baseline country survey on medical devices.
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