Signals from Device Events
Signals is a quarterly medical device adverse events newsletter.
FDA Releases 5.8 MILLION Alternative Summary Reports (ASRs)
On May 2, 2019, the FDA quietly announced the shut down of the ASR program after it was highly criticized in early 2019, following a Kaiser Health News report that described it as "so obscure that is unknown to many of the doctors and engineers dedicated to improving health safety". In June 2019, the FDA also made public the database of over 5.8 million ASRs submitted over the past 20 years, although they provided no reporting capability.
Device Events - Ready to Report on ASRs
Device Events is the only reporting service that provides support to search, extract and report on the 5.8 million ASRs. Preliminary results of our findings are shown below and highlight ASR Report Type, Top Manufacturers Submitting ASRs and Top Devices Submitted via ASR.
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IN THE NEWS
The follow articles were in the news and document some of the activity and outcomes resulting from the exposure of ASRs to the public.
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Hidden FDA Reports Detail Harm Caused By Scores Of Medical Devices
March 8, 2018 - Kaiser Health News - The Food and Drug Administration has let medical device companies file reports of injuries and malfunctions outside a widely scrutinized public database, which leave doctors and medical sleuths in the dark.
Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up. Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences.
Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski, who practiced in Pasco County, Fla., from 2016 through earlier this year. Read More...
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FDA Chief Call for Release of All Data Tracking Problems with Medical Devices
March 27, 2019 – Kaiser Health News – FDA Commissioner Scott Gottlieb announced in a tweet Wednesday that the agency plans to release hundreds of thousands, if not millions, of previously unpublished injury and malfunction reports tied to about 100 medical devices. “We’re now prioritizing making ALL of this data available,” Gottlieb tweeted.
A recent Kaiser Health News investigation revealed the scope of a hidden reporting pathway for device makers, with the agency accepting more than 1.1 million such reports since the start of 2016. Device makers for nearly 20 years were able to quietly seek an “exemption” from standard, public harm-reporting rules. Devices with such exemptions have included surgical staplers and balloon pumps used in the vessels of heart-surgery patients. Read More…
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Breast Implant Injuries Kept Hidden As New Health Threats Surface
November 26, 2018 - International Consortium of Investigative Journalist - Manufacturers fought to get implants back on the market. Regulators gave in. Now thousands of patients are paying the price.
- Breast implant safety problems persist around the world
- U.S. and European authorities allowed manufacturers to keep breast implant injury reports hidden from the public
- A rare form of cancer is linked to textured breast implants, most regulators have not acted
- Growing evidence suggests that breast implants may be associated with autoimmune disorders
More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.
The U.S. Food and Drug Administration’s decision to restore silicone implants to the market in 2006 followed an earlier decision to approve the less-commonly-used saline-filled implants. It came after a furious lobbying campaign by leading manufacturers Allergan and Mentor, which convinced regulators that frequent ruptures and leaks, and an array of other ailments reported by breast implant patients, were concerns of the past. Read More...
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FDA Closes Alternative Summary Reporting Program
June 26, 2019 - AAMI - In a move intended to increase transparency in medical device adverse event reporting, the Food and Drug Administration (FDA) has shuttered its Alternative Summary Reporting (ASR) Program, a program that for two decades has allowed some medical device manufacturers to provide the agency with quarterly summary reports of medical device adverse events.
The ASR program drew public criticism earlier this year following a Kaiser Health News report that described it as “so obscure that it is unknown to many of the doctors and engineers dedicated to improving device safety” including former FDA commissioner Robert Califf, according to the report. Most of the reports filed under the program were not available to the public, despite some describing “serious injury and malfunctions.” Read More...
NOTE: The Medical Device Adverse Event data described in this newsletter was extracted from the FDA MAUDE and or Alternative Summary databases using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA.