Manufacturers must disclose safety event details within 30 days, and the FDA relies on these disclosures to decide whether to communicate safety concerns or pursue other regulatory actions. Image credit: Fox_Ana / Shutterstock.
Almost a third of medical device adverse events (AEs) were reported by manufacturers later than the US Food and Drug Administration’s (FDA) required 30-day window across a three-year period, a new cross-sectional study has found.
Published in the BMJ, the study analysed more than four million reports submitted to the FDA’s centralised Manufacturer and User Facility Device Experience (MAUDE) database between September 2019 and December 2022. The agency relies on such disclosures to inform decision-making over whether to communicate safety concerns or pursue other regulatory actions.
The study researchers found that 4.5% of AEs were reported between 31 and 180 days and 9.1% after 180 days later than the FDA’s required window while 15.5% of reports had missing or invalid data provided by the manufacturer. In addition, 71% of AEs throughout the assessed period were reported within the required window.
Late AE reports were determined to be concentrated among a few manufacturers, with three manufacturers contributing towards 54.8% of late reports, with a mean late reporting rate at the manufacturer level of 23.4%.
The top manufacturers with the highest level of late reports included Becton Dickinson, Medtronic, Abbott, and Boston Scientific.
Similarly, 13 devices attributed to 50.4% of late reports. Researchers found that the top ten devices ranked by total late reports included Becton Dickinson’s infusion pumps, Abbott’s glucose monitors, and Medtronic’s insulin pumps.
Out of all reports filed to the MAUDE database across the period, 13,587 were deaths, around 1.5 million were injuries, and almost three million malfunctions, with the figures originating from 3,028 unique manufacturers and 88,448 unique medical devices. However, it was out of the scope of the study to determine the impact that the percentage of reports filed late may have had on onward action taken by the FDA.
In an editorial accompanying the BMJ publication, Harvard Medical School-affiliated researchers W B Feldman and Aaron Kesselheim said that such delays and information gaps can “hinder regulatory action, undermine trust in the MAUDE system, and harm patients” if problems with sensitive diagnostic equipment or life-saving treatments are not swiftly addressed.
The research group stated that while an effective tool, MAUDE has known limitations, including a reliance on external individuals and organisations to report AEs, rather than systematically and prospectively collecting safety and outcome data.
To bolster its ability to improve corrective actions being taken over certain medical device recalls, the FDA’s Center for Devices and Radiological Health (CDRH) initiated a pilot last year that centred on improving the timeliness of communications to the public around corrective actions being taken by companies with devices believed to be high-risk recalls.
The FDA recently issued an early alert over a ‘potentially high-risk’ issue with certain Baxter Sigma Spectrum and Spectrum IQ infusion pumps and tagged a recall of breathing circuits manufactured by Sentec/Percussionaire as Class I.
Email newsletter icon
Sign up for our daily news round-up!
Give your business an edge with our leading industry insights.