May 16, 2015

New Database Allows Consumers to Track Medical Device Safety/Effectiveness


Last week, the Food and Drug Administration (FDA) and the National Library of Medicine of the National Institutes of Health launched a beta version of a website, AccessGUDID, which will make it possible for health care providers and consumers to track medical devices from manufacture to distribution to patient use. GUDID (pronounced "good ID") stands for Global Unique Device Identification Database. Right now data are available on only the highest risk medical devices, such as pacemakers and heart valves. But the unique device identifier (UDI) system, to be phased in over several years, eventually will require manufacturers to submit key product information, including safety data, on all medical devices. By September 24, 2015, the labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. It is hoped that the UDI system ultimately may serve to reduce medical errors and facilitate device recalls. The FDA is encouraging stakeholders to submit feedback on the new site. More information is available at http://accessgudid.nlm.nih.gov/. You can sign up for email updates on GUDID here.