Under federal law, hospitals must report adverse events related to medical devices to the U.S. Food and Drug Administration (FDA). Doing so will help the FDA identify potentially defective medical devices much earlier, and hopefully prevent more patients from suffering injuries or death. However, the FDA’s recent inspection of 17 hospitals revealed the hospitals were largely under-reporting the number of adverse events related to defective medical devices.
The FDA began investigations earlier this year after widespread concern over two medical devices, power morcellators and duodenoscopes, caused serious injuries and even deaths. The FDA selected 17 hospitals reporting adverse event from these devices, but without a corresponding report in the FDA’s reporting database.
Power morcellators are used to remove uterine fibroids, but the devices can accidentally spread cancerous tissue beyond the uterus and throughout the body. Duodenoscopes are used to treat problems in the pancreas and bile ducts; however, the devices are difficult to sanitize and can inadvertently spread infections.
The FDA’s inspections revealed hospitals are not adequately training staff on FDA regulations and compliance, contributing to under-reporting of adverse events. The agency believes these 17 hospitals are not unique, and that the problem of under-reporting extends to all hospitals nationwide. The agency suspects many hospitals are not reporting medical device adverse events at all.
Not all hospitals have processes and procedures in place for reporting device-related injuries or deaths, and the FDA has pledged to work with hospitals and industry specialists to develop the most efficient and accurate method of reporting. In the case of morcellators and duodenoscopes, under-reporting or nonexistent reporting caused the dangerous devices to fly under the FDA’s radar and continue to harm more patients.
But the FDA isn’t the only one trying to make adverse event reporting more efficient. Legislation introduced into Congress by Rep. Mike Fitzpatrick would require doctors, not just hospitals, to report adverse events associated with medical devices to the FDA.