How The US Food And Drug Administration Is Improving The Safety Of Medical Devices

Poor quality medical devices are highly dangerous to patient safety – and as the problem has worsened during the last decade, it’s resulted in more frequent recalls in the United States.

The Food and Drug Administration (FDA) has reported a total of 29 medical device recalls so far this year, of which seven were reported in July.

A recent Kaiser Health News investigation revealed that the FDA granted device makers numerous “exemptions” from the standard rules of publicly reporting harm related to devices through the Alternative Summary Reporting (ASR).

This was done rather than filing an individual report on each issue to the publicly-available Manufacturer and User Facility Device Experience (MAUDE) database, meaning it would not visible to doctors, medical researchers or the public.

But this year, the FDA has ended the ASR programme and is now making more than 600,000 reports received under ASR exemptions from 1999 to 2019 available to the public.

FDA director Dr Jeffrey Shuren said: “We have formally ended the ASR programme and issued revocation letters to the remaining 13 manufacturers with ASR exemptions, which covered three kinds of devices – dental implants, implantable cardiac defibrillators and pacemaker electrodes.

“While ASR reports were submitted to the FDA for review, in an effort to increase transparency we modified the conditions of the ASR programme in 2017 to require manufacturers to also submit a “companion” medical device report so that some information collected through it would be visible publicly in our MAUDE database.” – NS Medical Devices