WHO for implementing essential safety principles of medical devices


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

According to the WHO global model regulatory framework for medical devices, the growing interest in medical devices in the global health community and the lack of regulatory systems for medical devices in many countries was why WHO decided to develop this document.

The organization said that 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 program.

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 with the publication of the law and resourcing the regulatory authority to undertake enforcement actions which 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 device groups; the processes for the design and production should ensure that a medical device is used according to the intended purpose.

It also said that it should be ensured that the device meets the conditions of technical knowledge and training of the user, the device is safe and does not compromise the clinical condition of the patient or the health of the user and 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 stated 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, diagnosing HIV/AIDS, implanting an artificial limb, to any surgical intervention would not be possible.

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

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