Modern Healthcare – The U.S. Food and Drug Administration has released more than 20 years of reports detailing adverse events involving medical devices, ending a program that allowed some manufacturers to keep safety issues from the public.
The agency announced on Friday it has made publicly available approximately 6 million adverse event reports dating back to 1999 that were previously not included in the federal database Manufacturer and User Facility Device Experience, or MAUDE. Those reports previously were exempted under the FDA’s Alternative Summary Reporting program.
Established in 1997, the ASR program allowed exemptions for individual adverse events involving certain devices with “well-established risks.” Manufacturers were instead told to write quarterly summary reports of such events. This did not include events involving patient deaths and “unusual, unique or uncommon adverse events,” according to the agency.
In a statement, Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said the FDA also has informed 13 manufacturers that they’ve lost ASR exemptions for devices that included implantable cardiac defibrillators and pacemaker electrodes … Read more.