The Need for Greater Reporting of Medical Device Incidents

Abstract

Post-market monitoring of medical devices by manufacturers and regulatory agencies aids the identification of novel hazards or increasing trends in the risks associated with devices. This narrative review estimates the rates of under-reporting of medical device adverse events and explores the reasons and possible solutions. Incident reports may be presented to the manufacturer or the regulatory agency spontaneously by consumers, patients, clinicians, or distributors of medical devices. However, it is evident that reporting does not occur to a great extent, with the rate of reporting estimated to be as low as 0.5% of all occurrences. The programmes and processes to increase and support the reporting of adverse events need to be reviewed, with consideration given to the cost-benefit of increased reporting in relation to the regulator, regulated entities, healthcare facilities, and professionals, as well as the public.