FDA Relies Too Heavily On Post-Marketing Adverse Event Reports To Identify Drug, Medical Device Problems: Study

The findings of a new report suggest U.S. regulators may be relying too much on adverse event data to discover potential risks and problems with medical devices already on the market.

Israeli researchers published a study this week in the medical journal JAMA Internal Medicine, which indicates the FDA primarily uses postmarketing reports by doctors and patients to determine if a medical device has a problem that may require new warnings or a recall. However, the report indicates these problems should be detected before the devices are even allowed onto the market.

Researchers sought to determine what data sources have the most influence on leading the FDA to issue a Medical Device Safety Communication {MDSC), and how those sources influence the agency’s subsequent actions and if certain sources tend to favor certain types of safety issues.

From their findings, the researchers called for the FDA to be more proactive in identifying issues with medical devices before they are made available to the public.

The cross-sectional study looked at all medical device safety communications published on the FDA’s website from January 1, 2011 through December 31, 2019, finding a total of 93 MDSCs during that time period. The median time between device approval until a safety communication was issued was 10 years.

The most common sources which triggered safety communications were adverse events directly reported to the Medical Device Reporting program. Such reports accounted for 44 of the safety communication announcements, according to the findings.

Patient injury was the most common safety issue, accounting for 27% of communications. That was followed by warnings of potential wrong diagnoses, which accounted for 20% of safety communications, and risk of death, which accounted for 19% of MDSCs.

The researchers note there is a “statistically significant correlation” between adverse event reports and a risk of death as a safety issue, meaning the FDA was more likely to find out a medical device was deadly when someone else told them there was a problem, as opposed to discovering the problem on their own.

“In this cross-sectional study, the most common source of initial safety signals that triggered MDSCs was direct reports of real-world adverse events to the FDA through the MDR program,” the researchers concluded. “The delayed detection of postmarketing adverse events highlights the importance of proactive identification of emerging device-related safety issues.”

The findings appear to support conclusions of a February 2017 study which called for the FDA to conduct more active surveillance of medical devices. According to that study, using active surveillance instead of adverse event reports resulted in health risks being discovered within the first 12 months of monitoring, researchers in that study found.

Concerns Over Reporting of Medical Device Adverse Events

In recent years, the FDA has faced criticism over its approval of medical devices before health risks are known, and its inability to quickly inform the public about emerging risks once they are discovered. However, the FDA is hindered by reporting of such incidents.

Adverse events are generally first reported by either a medical professional who witnesses a problem occurring with a patient, or by the patients themselves. Often, these are reported to the manufacturers, who then are legally obligated to pass along that information to the FDA in a timely manner. However, a number of recalls and medical device adverse events have revealed that manufacturers do not always meet their reporting requirements.

Additionally, reporting of adverse events is voluntary, and it is estimated that only about 10% of adverse events are actually reported to the FDA by consumers or medical providers.