Hospitals have a responsibility to report any adverse event related to medical devices to the U.S. Food and Drug Administration (FDA), but a recent investigation found many hospitals are unaware of the reporting requirements.
The FDA spent the last year investigating claims certain hospitals were not reporting patient injuries potentially caused by medical devices. The FDA inspected 17 hospitals across the country, including UMass Memorial Medical Center. The FDA found UMass Memorial failed to report patient infections possibly related to a medical device called a duodenoscope.
These devices contain a small camera that can be inserted through the mouth and travel down to the colon, where doctors can take a closer look at the small intestine. Unfortunately, it was discovered this past August that these devices have an increased infection risk. The devices have a design defect that makes it difficult to completely sterilize them between uses.
UMass Memorial was cited for failing to report 14 separate infections possibly caused by defective duodenoscopes. Three of the infected patients later died of complications and two suffered further health issues. The hospital stated it didn’t believe it had to report the incidents because it couldn’t definitively link the infections to the duodenoscopes.
However, federal law requires all hospitals to report any information that reasonably suggests a medical device has caused or contributed to the death or injury of a patient directly to the FDA and the manufacturer.
According to Jeffrey Shuren, M.D., J.D., Director of the FDA’s Center for Devices and Radiological Health, the FDA’s investigation of the hospitals revealed many hospital staff members are unaware of the FDA’s reporting requirements for medical devices.
Hospitals are crucial in helping the FDA identify potentially defective medical devices as quickly as possible, and underreporting puts patients at serious risk. The FDA pledged to partner with more hospitals to help them understand reporting requirements, but in the meantime, patients should be extra vigilant during hospital visits.