FDA releases millions of adverse event reports on medical devices

FDA releases millions of adverse event reports on medical devices


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.

“We believe these steps will improve our ability to identify and address device safety signals and provide patients and healthcare professionals with important information they can use to make better informed health care decisions,” Shuren wrote on Friday.

The FDA first announced it was ending the ASR program in May. At that time the agency announced it was ending all adverse event summary reporting for breast implants in response to concerns over related anaplastic large cell lymphoma, which forms in the scar tissue around a breast implant.

Shuren said the FDA has been working on sunsetting the ASR program since 2017 as it developed the recently-unveiled Voluntary Malfunction Summary Reporting Program where devicemakers report events in a quarterly summary that’s made publicly available through MAUDE.

In addition, Shuren said the FDA will make the MAUDE database more user-friendly over the next few years.

“Our goal is to make MDR (medical-device reporting) data more usable and easier to find, furthering our efforts to increase transparency in medical-device reporting,” Shuren wrote.

2 Responses

  1. My Father, took his life about 10 years ago after over 55 years of earning his own way through life.AFTER being convinced that an electrical implant would resolve his health issues from specific neuropathy issues. He was “old fashioned” and used as little opiate medication as he could. He was vey “hyped” and excited about the implant which he was soooo hopeful that it would help his incredible continuous pain which turned out to be so disastrous that he could not get help resolving the implant issue he took his own life. Sad, very sad with zero recourse against lying physicians!

  2. There are still CPPs responding with optimism about the pump or simulator or injection or rhizotomy they are going to get. So scared for these.

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