FDA advisory panel votes against approval of DMD drugRecently the U.S. Food and Drug Administration (FDA) publicly exposed a dozen hospitals for failing to report—or failing to report in a timely manner—patient injuries or deaths. The facilities in violation include the Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center in Los Angeles.

Federal regulations require hospitals to report patient injuries linked to use of medical devices to the device manufacturer within 10 days; further, if the injury results in death, the FDA must be notified as well. When device manufacturers learn of a device-related injury or death, they must file a report with the FDA within 30 days.

A total of 17 hospitals were reviewed for reporting compliancy. The FDA said that six failed to properly report both requisite injuries and deaths within the 10-day window. Five others failed to report injuries within the required timeframe. The inspection occurring at NewYork-Presbyterian centered around a single fatality.

NewYork-Presbyterian, however, said it filed reports “in accordance with FDA regulations” and pointed out that none of the agency’s determinations involved patient safety or patient care.

Are hospital staff uniformly trained in reporting stipulations?

Dr. Jeffrey Shuren is the director of the FDA’s Center for Devices and Radiological Health. He sees a broader problem than what a focus on only the 12 in-violation hospitals would indicate.

“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 writes in a recent agency blog post. “Hospital staff often were not aware of, nor trained to comply with, all of the FDA’s medical device reporting requirements.”

Shuren says that the agency does not have plans for punitive action against the facilities in question, beyond the public announcement of the violations. Rather, he stresses the importance of hospital-agency collaboration with the goal of strengthened device monitoring.

“We feel certain there is a better way to work with hospitals to get the real-world information we need, and we should work with the hospital community to find that right path,” he writes.

While useful in part, the redacted inspection reports can’t give as complete a picture as some may like (for example, regarding the specific device involved in every case). Still, the reports demonstrate that some hospitals filed required reports tardily, and others failed to report them altogether.

Certain medical tools coming under fire for risk of injury or infection

A duodenoscope is a long, flexible instrument placed down the throat. The FDA investigation revealed that a patient at Huntington Memorial Hospital in Pasadena contracted a drug-resistant infection and suffered cardiac arrest after a procedure involving the device; the patient ultimately died.

According to the FDA, the hospital was in possession of test results that showed that the patient’s infection was potentially linked to over a dozen infections resulting from contaminated duodenoscopes. “However, this death was not reported to the FDA and the manufacturer by your facility,” a December 2015 agency report notes.

“We have taken steps to ensure rigorous compliance going forward,” Eileen Neuwirth, a Huntington Memorial Hospital spokesperson stated.

Shuren notes that the FDA didn’t choose the 17 hospitals it investigated at random. Rather, they were selected because prior safety issues involving certain devices had occurred there, especially duodenoscopes or morcellators (a tool employed during hysterectomies to cut up benign growths called fibroids; the FDA has issued a warning about the potential for the device to spread cancerous tissue).

Arguably, the public and the industry have had a heightened awareness of the issue of contaminated duodenoscopes since a U.S. Senate report at the beginning of the year exposed manufacturer errors and reporting failures by medical facilities that allegedly added to “superbug” outbreaks across the country. Also criticized in the report? The FDA’s “spotty” medical device oversight.

The agency reports that between 2010 and 2015, 350 patients at more than 40 medical facilities on a global level have been exposed to contaminated duodenoscopes, some of those exposures resulting in infection.


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