More than 1.2 million medical device adverse event reports—nearly one-third of all submissions—were not demonstrably reported to the U.S. Food and Drug Administration within the required 30-day timeframe, with over 400,000 reports delayed by more than 6 months, according to a recent study. 

Researchers conducted a cross-sectional study analyzing the timeliness of adverse event reporting by medical device manufacturers to the U.S. Food and Drug Administration (FDA) via the Manufacturer and User Facility Device Experience database. They evaluated reports submitted between September 1, 2019, and December 31, 2022, to assess compliance with the FDA-mandated 30-day reporting requirement. Their findings were published in The BMJ.

The analysis included 4,432,548 initial reports submitted by 3,028 unique manufacturers for 88,448 medical devices. Of these, 13,587 reports involved deaths; 1,552,268 involved injuries; and 2,866,693 described device malfunctions. Researchers led by Alexander O. Everhart, PhD, of the Division of General Medical Sciences in the John T. Milliken Department of Medicine at Washington University School of Medicine in St. Louis, examined the time elapsed between manufacturer awareness of an event and FDA receipt of the report, categorizing submissions as timely (≤ 30 days), moderately late (31–180 days), and significantly late (> 180 days).

Results indicated that 71.0% (n = 3,146,957) of reports were submitted on time, while 4.5% (n = 197,606) were submitted between 31 and 180 days, and 9.1% (n = 402,891) were submitted after 180 days. Additionally, 15.5% (n = 685,094) of reports contained missing or invalid dates. Late reporting was concentrated among a small number of manufacturers, with 3 manufacturers and 13 devices accounting for 54.8% of all late reports.

Higher-risk devices exhibited greater delays. Among reports with valid dates, 22.4% of Class III (high-risk) device reports were late, compared with 13.8% of Class II (moderate-risk) and 6.9% of Class I (low-risk) device reports (Q < .001). Breakthrough-designated devices demonstrated an overall lower late reporting rate (2.6% vs. 16.0% for non-breakthrough devices, Q < .001), yet breakthrough device death reports were more frequently late (18.9% vs. 7.4%, Q < .001).

Additionally, recalled devices had a lower overall late reporting rate (15.7% vs. 16.4% for non-recalled devices, Q < .001), but reports involving deaths and injuries were more likely to be delayed for recalled devices. Late reports were often submitted in large batches rather than distributed consistently over time.

In conclusion, researchers found that nearly one-third of medical device adverse event reports were submitted late, with most delayed by more than 6 months. They emphasized that stricter compliance measures and greater transparency could potentially improve postmarket surveillance.

Full disclosures can be found in the published study.