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Why the FDA's Failure to Track Data Hinders Medical Device Safety

The U.S. Food and Drug Administration (FDA) could be doing more to improve medical device safety. As highlighted in a new report, the agency’s post-approval monitoring program fails to capture valuable data.

FDA’s Post-Approval Monitoring

As we have previously discussed on this San Diego Injury Blog, the FDA conducts post-market surveillance of approved drug and medical devices to verify they are safe once released to a wider group of patients. To track safety issues, manufacturers and hospitals must submit timely adverse event reports. In addition, healthcare providers and patients are encouraged to voluntarily report complications and other adverse events via the FDA MedWatch system.

In 2016, a report by the Government Accountability Office (GAO) found there were serious gaps in the FDA’s procedures for tracking drug safety issues. "FDA's data on post-market safety issues and studies were found to be incomplete, outdated, to contain inaccuracies, and to be stored in a manner that made routine, systematic analysis difficult," the report stated.

Specific issues noted in the report include the FDA’s failure to complete a timely review of more than half of the 1,400 follow-up studies it had requested or required between 2008 and fall of 2013. The reports could contain valuable information about potential side-effects and other safety risks that arose once the drug was administered to a larger group of patients.

Overlooking Data Regarding Adverse Events

A recent report by researchers at the University of Michigan agrees that the FDA and the medical industry are failing to tap into the wealth of data generated by medical devices. “Warning signs of unsafe or low-value care are detectable within existing data but often are overlooked,” the scholars write in a study published in the Journal of the American Medical Association. “Rather than duplicate efforts and collect[ing] more data, healthcare leaders should renew their focus on making better use of available data. An example in which this is readily apparent involves the monitoring of medical devices.”

In support of their position, the authors cite the declining use of laparoscopic gastric bands to treat morbid obesity. Although the medical device is disfavored by doctors due to the high risk of reoperation, the FDA recently expanded its indications. In concluding that gastric bands are effective and safe, the agency relied on a small trial involving 149 patients. “With that evidence, the FDA expanded indications for use of the gastric band,” the authors write. “Had existing administrative data been used to evaluate the device, however, it is possible that the decision may have been different.”

As the authors further note, the FDA lacked the data it needed to accurately assess the safety of the gastric band because there is currently no system to effectively track medical devices. “The majority of medical devices used in practice today cannot be identified within existing administrative data because they lack device-specific ICD-9-CM or Current Procedural Terminology codes,” the scholars explain.

The authors highlight the establishment of a national medical device surveillance system

as a potential solution. The proposed plan would require that all medical devices contain unique device identifiers, and that the information be included in standardized medical claims data. “Legislation that would require all FDA-approved devices to be trackable within data that are already collected could be a useful strategy to help ensure that, unlike the gastric band, the warning signs of other widely adopted devices are not missed.”

As San Diego injury lawyers, we remain concerned that lax FDA oversight could expose patients to medical devices associated with a high risk of complications and other safety-related issues. We will continue to closely monitor the situation.

Don’t hesitate to contact a San Diego medical product lawyer at the Law Offices of Robert Vaage for a free consultation. We are here to help you seek maximum compensation for your pain and suffering.