UMass Memorial cited for failure to report device injuries

UMass Memorial Health Care was cited by the FDA for failing to report injuries that may have been related to medical devices.

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By Laura Finaldi

UMass Memorial Medical Center was one of three Massachusetts hospitals cited by the U.S. Food and Drug Administration for failing to properly report patient injuries possibly caused by medical devices.

The Worcester hospital was inspected last year by the FDA when the government agency followed up on reports of infections associated with contaminated medical devices used in the small intestine and events related to the spread of uterine cancer from the use of a surgical instrument. The FDA initiated inspections at 17 U.S. hospitals, including Brigham & Women’s Hospital and Massachusetts General Hospital in Boston, which were also cited for infractions.

In its report released in October, the FDA citations against UMass Memorial included failure to report patient infections possibly associated with a duodenoscope, which goes into the small intestine. According to the FDA, three of those patients later died, but two had complicated illnesses.

According to UMass Memorial, 14 patients developed infections. The hospital couldn’t definitively link the duodenoscope to the infections, even after an investigation, said hospital spokesman Anthony Berry. The hospital notified the Massachusetts Department of Public Health and the manufacturer, but didn’t think it had to tell the FDA because there wasn't a definitive link to the device, said Berry.

In its investigation of the 17 hospitals, the FDA found that hospitals often were not aware of FDA medical device reporting requirements, according to a blog post on the FDA website from Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health.

“Based on the number of user facilities in the United States and the number of reports we receive, we believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers at some hospitals,” Shuren wrote. “We want to work with all hospitals to address these issues.”