Identification and Market Removal of Risky Medical Devices

JAMA Internal Medicine – Sept 28, 2020 – By Madris Tomes, Device Events Founder & CEO

Reporting of adverse events to the US Food and Drug Administration (FDA) has long been the primary mechanism of identifying safety issues with medical devices—ranging from nasal swabs to cardiac defibrillators to in vitro diagnostic test kits. Each day, approximately 3500 adverse event reports are collected in the agency’s Manufacturer and User Facility Device Experience (MAUDE) database. As anyone who has tried to use it will attest, the database provides a difficult-to-use interface to search these reports.

Read Full Article: JAMA 9-28-2020 Identification and Market Removal of RIsky Devices