Medical Device Companies Hide Reports of Injuries and Malfunctions, Leaving Doctors in the Dark.
For over 15 years, medical device manufacturers exploited a self-reporting system known as the Alternative Summary Reporting program. Rather than disclosing Adverse Events on the FDA’s MAUDE database, which is accessible to the medical community and the public, they concealed significant device issues in the ASR. This allowed them to evade scrutiny and profit from devices that were causing harm to the very patients they were meant to assist. An exposé in Kaiser Health News ultimately exposed these deceitful practices, shedding light on the situation.
Dr. Douglas Kwazneski was assisting a surgeon in Pittsburgh in removing an appendix when something concerning occurred. The surgical stapler, which was supposed to cut and seal the tissue around the appendix, suddenly malfunctioned.
Later on, Kwazneski consulted the Food and Drug Administration’s public database, which keeps track of medical device failures. To his surprise, there was no record of this particular incident. However, when he conducted a survey among leading surgeons, he discovered that more than two-thirds of them had encountered a stapler malfunction or knew someone who had. These failures can have fatal consequences.
What Kwazneski didn’t know was that the FDA had quietly granted surgical stapler manufacturers a special “exemption.” This allowed them to file reports of malfunctions in a hidden database, inaccessible to doctors and the general public.
“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.
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The FDA has created and expanded a large, but unknown, repository of reports on injuries and malfunctions related to medical devices, as uncovered by a Kaiser Health News investigation. Since 2016, over 1.1 million incidents have been included in the internal “alternative summary reporting” repository, rather than being individually described in the widely reviewed public database called MAUDE. Medical experts heavily rely on MAUDE to identify issues that could endanger patients.
Although deaths are still required to be reported in MAUDE, the hidden database has contained reports of serious injuries and malfunctions for approximately 100 medical devices, including those implanted in patients or used in numerous surgical procedures. These devices have included surgical staplers, balloon pumps for enhanced circulation, and mechanical breathing machines.
According to an FDA official, this program is designed for issues that are already “well-known and well-documented with the FDA”. In 2017, the program underwent reforms and a new voluntary summary reporting program was established, encompassing up to 5,600 devices.
However, the program, in all its iterations, has been so obscure that many doctors and engineers dedicated to improving device safety remain unaware of it. Even a former FDA commissioner admitted to having no knowledge of the program.
KHN extensively examined public records for indirect mentions of reporting exemptions. After months of questioning the FDA, the agency confirmed the existence of reporting-exemption programs and thousands of instances of malfunctions or harm that had never been acknowledged before.
During the information blackout concerning device risks, patients have suffered injuries in numerous cases, as lawsuits and FDA records indicate.
“The public has a right to know,” stated Dr. S. Lori Brown, a former FDA official who accessed the data for her research. She emphasized that relying solely on public reports, without awareness of potential omissions, can lead doctors to erroneous conclusions regarding the safety records of specific devices.
The FDA has also established additional, albeit less known, channels for device makers to report a plethora of injuries brought to light by lawsuits or even deaths present in private registries utilized by medical societies to monitor patients. These exemptions pertain to high-risk and controversial products, such as pelvic mesh and cardiac implants.
Deborah Kotz, an FDA spokeswoman, verified that the “registry exemption” was implemented without public notice or regulations. “Any device manufacturer can request an exemption from its reporting requirements,” she clarified via email.
KHN’s “Hidden Harm” series on the FDA’s secret database of malfunctioning medical devices was honored on Oct. 2, 2019, with the prestigious Barlett & Steele Award for Investigative Journalism. The series prompted the FDA to publish its entire hidden database online, revealing 5.7 million device-related injuries or malfunctions.
If you or your loved ones have possibly been impacted by a medical device malfunction, please feel free to reach out. One of our caring team members will assist you in navigating the situation.
