The How and Why of Medical Devices Standards

Abstract

The utilization of medical devices includes prevention, diagnosis and treatment of disease. Despite the many benefits, devices also pose potential adverse effects. As a result, standards have been implemented as a precluding determinant to protect the public against adverse effects and support approval for clinical use. Standards are formulated based on the following: 1. Safety, efficacy and protection of society 2. Need for helping patients 3. Scientific knowledge available at the time of device/drug approval 4. Level of risk that is acceptable, reasonable and can be acceptable by all stakeholders including patients, society, hospitals, healthcare providers and governments Valid, scientific evidence is required for reasonable assurance of the safety of a particular medical device. It is imperative that this evidence be measured using a dynamic set of standards formulated by all stakeholders.