Factors influencing reporting of medical device related incidents in the Maltese healthcare system

Abstract

Ranging from simple tongue depressors to heart valves and robotic surgery systems, medical devices are essential in healthcare sector providing numerous benefits to the patients. The use of medical devices (MD) is associated with adverse incidents which may lead to serious health implications. Voluntary reporting by users and operators is a means of data sharing, adverse event trends and overall performance. In Europe, MD manufactures are obliged to report serious adverse to regulatory authorities. Voluntary reporting, although encouraged by regulators, is not a requirement for healthcare professionals, users and facilities but should be done based on moral obligations in the interest of promoting public heath. Reporting of MD-related incidents by healthcare professional (HCPs) is essential for successful post-market surveillance systems.