Dive Brief:
- Many reports of medical device adverse events are sent to the Food and Drug Administration later than the 30-day requirement, according to a study published last week in the BMJ.
- Just 71% of adverse events were reported on time, while 4.5% were reported between 31 days and 180 days, and 9.1% were reported after 180 days, the study found. Many reports (15.5%) had missing or invalid date data. Researchers analyzed about 4.4 million reports of malfunctions, injuries and deaths between September 2019 and December 2022.
- More active FDA enforcement could deter late reporting, the authors recommended, noting that just three manufacturers and 13 devices accounted for more than half of the late reports.
Dive Insight:
The top manufacturers with the highest number of late reports included BD, Medtronic, Dentsply, Abbott and Boston Scientific, according to the BMJ study.
The top devices included BD’s infusion pumps, Abbott’s glucose monitors, Medtronic’s insulin pumps and Dexcom’s glucose monitors.
BD spokesperson Troy Kirkpatrick wrote in an email that the adverse event reports referred to in the study were based on observations from a March 2020 inspection where the company retrospectively reviewed 2 million service records dating back to 2018. The reports were not delayed reports from customer complaints, but instead were from records BD found in its retrospective analysis.
Since then, BD has made improvements to its IT and quality management systems, Kirkpatrick added.
The study highlighted the challenges of the adverse event reporting system for medical devices.
The vast majority of adverse events are reported by medical device manufacturers, which are required to submit them within 30 days of becoming aware of events. Importers and certain health facilities must also submit adverse events, while the reports are voluntary for clinicians and patients.
When action is needed to “prevent an unreasonable risk of substantial harm to public health,” manufacturers must submit adverse event reports within five working days, although the FDA’s database does not indicate which reports fall under this requirement.
Many details are also omitted from the reports, and patient deaths are often miscategorized as injuries or malfunctions, according to the BMJ article.
Delays in reporting can prevent regulators, physicians and patients from learning about emerging safety issues, the study’s authors wrote. In one of the largest recent medical device recalls, Philips pulled more than 15 million sleep apnea machines and ventilators in 2021 due to the breakdown of sound abatement foam used in the devices. An investigation by the Pittsburgh Post-Gazette and ProPublica found that Philips had accumulated thousands of adverse event reports before notifying the FDA. Lawmakers called for a review of the FDA’s medical device oversight, citing the Philips recall.
To address the problem, the study authors recommended the FDA send warning letters and conduct follow-up enforcement actions, adding that the study results suggest on-time reporting is feasible.
“Insufficient enforcement may give manufacturers the impression that late reporting will be tolerated and result in ultimately harming patients by delaying access to important safety information,” the authors wrote.
They recommended the FDA require manufacturer notification dates on electronic submissions of adverse event reports. The FDA could also publish a list of manufacturers or devices with several late reports.
The findings point to the challenges of passive postmarket surveillance systems, which are used by the U.S. and many other countries. The authors said the results demonstrate a need to develop more active postmarket surveillance mechanisms.