U.S. FDA seeks to improve hospital reporting of device injuries

Many injuries and deaths associated with medical devices uncovered at 17 hospitals should have been reported and were not, U.S. regulator says.

Move follows high-profile safety scandals in U.S.

Thomson Reuters Posted: Oct 25, 2016 11:28 AM EDT | Last Updated: October 25, 2016

Hospitals are uniquely positioned to help identify new safety problems with medical devices, the FDA says. (Jason Reed/Reuters)

The U.S. Food and Drug Administration isseeking to improve hospital reporting of injuries and deathsassociated with medical devices after inspections at 17hospitals revealed widespread under-reporting of such events.

The FDA initiated the inspections following high-profilesafety scandals involving power morcellators and contaminatedduodenoscopes.

Morcellators are used to remove uterine fibroids but canspread unsuspected cancerous tissue beyond the uterus.

Duodenoscopes are threaded through the mouth and throat to treatproblems in the pancreas and bile ducts.

Contaminated scopes cancarry infections from one patient to another.

In a blog posted on the FDA's website on Monday, Dr. JeffreyShuren, head of the agency's device division, said many eventsuncovered at the 17 hospitals should have been reported and werenot, in violation of the agency's reportingrequirements. TheFDA believes such under-reporting is a nationwide problem in the U.S.

"We believe that these hospitals are not unique in thatthere is limited to no reporting to FDA or to themanufacturers," he said.

In some cases, hospital staff were neither aware of, nortrained to comply with, the agency's medical device reportingrequirements.

Shuren said the agency wanted to "work with all hospitals toaddress these issues."

On Dec. 5, the FDA will hold a public workshop seeking inputon improving hospital surveillance systems and how hospitals canbetter evaluate how well devices work in the clinical setting.

Last year, the FDA sent warning letters to manufacturers ofduodenoscopes, saying they skirted a host of testing,manufacturing and reporting requirements. The biggest makers ofthe products are Olympus Corp, Pentax Medical and FujifilmHoldings Corp.

The FDA first warned of their potential to transmitantibiotic-resistant germs in 2009. Since then they have beenimplicated in superbug outbreaks at multiple U.S. hospitals.

In 2014, the FDA warned that morcellators couldinadvertently spread uterine cancer. It recommended that the useof these instruments be restricted and that the label includes aboxed warning, the most severe possible.

Morcellators are used to slice fibroid and uterine tissueinto small pieces inside the body, allowing it to be removedthrough a small opening.

The FDA estimates that 1 in 350 women who have fibroidsurgery have an unsuspected uterine cancer.

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FDA is working with hospitals to modernize data collection about medical devices

U.S. FDA seeks to improve hospital reporting of device injuries

Move follows high-profile safety scandals in U.S.

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