FDA still allowing devicemakers to shield medical device safety flaws from the public

The FDA has allowed several devicemakers to file secretive reports on device-related harm and malfunctions, despite the agency saying it wants more transparency on device safety, according to the Star Tribune

One devicemaker, Boston Scientific, was reportedly allowed by the FDA to file secretive reports about four deaths involving its permanent heart implants.

Last week, the FDA declined the Star Tribune's request to release any information regarding the four deaths caused by Boston Scientific's Watchman left-atrial appendage closure device, which is a heart implant used to reduce stroke risk in patients with atrial fibrillation. 

The FDA allowed Boston Scientific to file a non-public adverse event report that summarized the four deaths in a few lines of text and keep secret the name of the study that discovered the deaths. 

Earlier this year, the FDA ended alternative summary reporting, which allowed devicemakers to avoid publicly filing adverse event reports about specific devices that the agency felt were "well-understood," according to the Star Tribune.

Former FDA Commissioner Scott Gottlieb, MD, tweeted that the agency ended the program because it was "imperative that all safety information be available to the public." 

However, in October, JAMA Internal Medicine published a research letter that said an FDA database was still accepting reports from Edwards Lifesciences and Abbott Laboratories that the authors claim misclassified patient injuries and deaths. The letter raised concerns over the accuracy of adverse event reports from devicemakers, despite the agency saying it wanted to improve transparency around medical device safety.

The FDA told the Star Tribune the adverse event report for Boston Scientific's Watchman device was part of a different summary reporting system that the agency still operates, though it is aware that it shields device safety data from the public. 

"We take all patient safety and any potential product-related complications seriously, and are transparent and comprehensive with our reporting of events per established criteria set by the FDA. Boston Scientific has a robust complaint reporting system and we report all relevant complaint information we receive in compliance with all FDA regulations. We do not withhold or keep in secret any relevant complaint information," Boston Scientific told the Star Tribune.

Read the full article here.


Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.