World Health Organization (WHO) has asked member countries to ensure implementation of essential principles of safety and performance regulations in purchase of medical devices to use in the hospitals.

According to WHO Global Model Regulatory Framework for Medical Devices, growing interest in medical devices in the global health community and the lack of regulatory systems for medical devices in many countries, WHO decided to develop this document.

It said many WHO member states have yet to develop and implement regulatory controls relating to medical devices, as well as to jurisdictions that are continuing to improve their regulatory frameworks to ensure the quality and safety of medical devices available in their countries.

It said that many countries have neither the financial resources nor the technical expertise to transition successfully from an unregulated market to a comprehensive medical devices law in a single programme.

Instead, the WHO model recommends a progressive, or stepwise, approach to regulating the quality, safety and performance of medical devices as it provides guidance for a staged development of the regulatory system.

This starts from the publication of the law and resourcing the regulatory authority to undertake enforcement actions then progresses to expanded-level controls such as inspection of registered establishments and oversight of clinical investigations.
It said that today there are an estimated two million different kinds of medical devices on the world market, categorized into more than 22,000 generic devices groups.

It said that the processes for the design and production should ensure that a medical device when used according to the intended purpose.

It said that it should be ensured that the device meets the conditions of technical knowledge and training of the user is safe and does not compromise the clinical condition of the patient or the health of the user.

It said that the manufacturers must be able to demonstrate to the regulatory authority that their product complies with the essential principles and has been designed and manufactured to be safe and perform as intended during its lifetime.

The WHO said that medical devices contribute to the attainment of the highest standards of health for individuals. Without medical devices, common medical procedures from bandaging a sprained ankle, to diagnosing HIV/AIDS, implanting an artificial limb or any surgical intervention would not be possible.

It said that medical devices are used in many diverse settings, for example, by laypersons at home, by paramedical staff and clinicians in remote clinics, by opticians and dentists and by health-care professionals in advanced medical facilities, for prevention and screening and in palliative care.

Such health technologies are used to diagnose illness, to monitor treatments, to assist disabled people and to intervene and treat illnesses, both acute and chronic, it added.