FDA Medical Device Reports May Significantly Undercount Patient Deaths: Study
While adverse event reports involving medical devices are often crucial in identifying products containing serious and potentially life threatening defects, a new study suggests nearly a quarter of all deaths linked to certain medical devices may not be reported accurately to federal regulators.
In a research letter published earlier this month in the medical journal JAMA Internal Medicine, researchers from the University of California San Francisco warn many patient deaths linked to medical devices appear to go unreported in the FDA’s adverse event database.
In the study, researchers looked at data on several medical devices involved in reports filed with the FDA’s Manufacturer and User Facility Device Experience (MAUDE) database. They used software to collate adverse event reports on two transcatheter valve devices, including the Sapien 3 and the MitraClip.
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The researchers found numerous reports where patients were listed as “expired” or “passed away” but were misclassified as injuries or malfunction events. According to the findings, 217 of 1,238 patient deaths linked to Sapien 3, or 17.5%, were misclassified. The study also found that 97 of 392, or 24.7%, of patient deaths linked to the MitraClip were misclassified.
“We found a substantial misclassification of patient deaths in the FDA’s MAUDE database for the Sapien 3 and MitraClip devices, which resulted in the underreporting of deaths,” the researchers said. “Our findings raise concerns about the accuracy of adverse-event reports for high-risk devices. The results complement recent news reports that the FDA allowed device manufacturers to file reports of malfunctions in a hidden database, known as alternative summary reporting.”
The researchers said improving the clarity and accuracy of such reports should be a high priority for both the FDA and the medical device industry.
In June, the FDA announced it was releasing more than 6 million adverse event reports not previously seen by the public, which were part of a program known as the Alternative Summary Reporting (ASR) Program.
The announcement came following an investigative report by Kaiser Health News in May 2019, which revealed that the ASR program had allowed medical device manufacturers to file reports of medical device malfunctions and patient injuries to the ASR for years, instead of providing the information to the agency’s Manufacturer and User Facility Device Experience (MAUDE) database, which is publicly accessible.
This means that those reports, which are required by law and often involve high-risk devices that could experience repeated reports of similar problems, were effectively hidden from public view.
The program granted exemptions to certain manufacturers for devices with well-known adverse events, allowing them to file those reports with the ASR on a quarterly basis. However, critics say that the program allowed many manufacturers to hide the scope of such problems by making it appear there were fewer incidents than there really were.
SherryOctober 28, 2019 at 12:11 am
The Zimmer Biomet mom Hip Device (Larger Ball and Cup) put in me in 2007 caused me SERIOUS,DEADLY BIO-LOGICAL AND DEFORMING ISSUES EVER SINCE! Not only has, early on, my spine been compromised by the onset of slight,Spinal Stenosis then deforming SCOLIOSIS but also, the pseudotumer denied by my Orthopedic Surgeon for 2 years, then needing a revision, NOT EVEN to be warned of DEADLY IONS THAT WOUL[Show More]The Zimmer Biomet mom Hip Device (Larger Ball and Cup) put in me in 2007 caused me SERIOUS,DEADLY BIO-LOGICAL AND DEFORMING ISSUES EVER SINCE! Not only has, early on, my spine been compromised by the onset of slight,Spinal Stenosis then deforming SCOLIOSIS but also, the pseudotumer denied by my Orthopedic Surgeon for 2 years, then needing a revision, NOT EVEN to be warned of DEADLY IONS THAT WOULD EXIST IN MY BLOOD STREAM FOR UP TO 4YEARS. I had rashes on and off the time I had the MOM Hip. Rashes on my knuckles and fingers, NEVER RECOGNIZED as an adverse complication with metals in my body. NEVER WARNED BY ZIMMER BIOMET OF THESE ISSUES TO LOOK FOR, let alone my HAIR FALLING OUT IN CLUMPS AND EURUPTIONS ON MY SCALP AND rashes on my skin surrounding my hip device, hip. The Revision was in sept 2012. I needed SPINAL SURGERY TO ADDRESS THE SCOLIOSIS NEVER WARNED OF THE DEADLY IONS STILL FLOWING THRU MY MAJOR ORGANS VIA MY BLOOD STREAM FOR AT LEAST 4 YEARS, THE SPINAL SURGERY INVOLVING MORE METAL, RE-ACTIVATED THE SEVERE HYPERSENSITIVITIES TO THESE METALS AND NOW I AM A DEFORMED CRIPPLE WITH DEADLY DERMATOMYOSITIS WITH AN OVERLAPPING OF DIFFUSE SCLERODERMA INVOLVING ALL OF MY MAJOR ORGANS. FDA HAS WARNED PATIENTS OF LATER ONSET ISSUES FROM MOM HIP DEVICES. WELL, I NOW SUFFER AS WELL FROM HYPOTHYROIDISM,SERIOUS DEPRESSION, I TAKE 380 MG OF BLOOD PRESSURE MEDS/DAY 100MG OF "CYTOXAN" (CHEMO) /DAY AS WELL AS 3 DAY INFUSIONS/MONTH OF IMMUNO-GLOBULIN. i HAVE LITTLE TO NO CIRCULATION IN MY HANDS,ARMS AND FEET, SO ANY BLOOD WORK OR INFUSIONS MUST BE THRU A PORT IN MY CHEST! ZIMMER BIOMET AND THEIR TEAMS OF LAWYERS TRY TO INTIMIDATE THEIR WAY OUT OF THIS. RULINGS(PREMATURE AND ELEMENTARY) BY A JUDGE MILLER SEEM CONSPICUOUS AND MOST UNFAIR TO ALL VICTIMS OF THIS MURDEROUS HIP DEVICE. I FIND IT ALSO PECULIAR FOR THE FDA TO APPROVE A DEVICE THAT WAS EARLY ON, RECALLED(YEARS AGO) LOOPHOLES, PAYOFFS? I AM STILL A VICTIM AND NEED ANSWERS AND PERHAPS THE SUPREME COURT TO HELP ME, POSSIBLY OTHERS WHO HAVE NOT YET SUCCUMBED TO ZIMMER BIOMETS REDICULOUS PAYOFFS AND SETTLEMENTS.
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