Abstract

The U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) is responsible for ensuring patient safety and continued surveillance of more than 500,000 medical device models on the U.S. market. Currently, the CDRH Office of Surveillance and Biometrics (OSB) does not have standardized procedures in place for monitoring device problems, but rather rely on individual analysts’ experience and observations for problem detection. Furthermore, the increase of medical device reporting (MDR) makes timely review by analysts evermore difficult. These difficulties may lead to delayed awareness of potentially harmful and life-threatening design flaws, and hinder timely enforcement actions. An ongoing project aims to build a framework for an effective detection system by focusing on existing patterns in the MDR database and from analyst experiences, as well as on previous Class I device recall (the most serious) cases. This presentation will provide a snapshot of U.S. FDA ’s current postmarket surveillance process for medical devices and use past device recalls to demonstrate both quantitative and qualitative methods that will help improve the system of ensuring patient safety.