Tuesday, October 25, 2016
The U.S. Food and Drug Administration is seeking to improve hospital reporting of injuries and deaths associated with medical devices after inspections at 17 hospitals revealed widespread under-reporting of such events.
The FDA initiated the inspections following high-profile safety scandals involving power morcellators and contaminated duodenoscopes.
Morcellators are used to remove uterine fibroids but can spread unsuspected cancerous tissue beyond the uterus. Duodenoscopes are threaded through the mouth and throat to treat problems in the pancreas and bile ducts. Contaminated scopes can carry infections from one patient to another.
In a blog posted on the FDA's website on Monday, Dr. Jeffrey Shuren, head of the agency's device division, said many events uncovered at the 17 hospitals should have been reported and were not, in violation of the agency's reporting requirements. The FDA believes such under-reporting is a nationwide problem.
"We believe that these hospitals are not unique in that there is limited to no reporting to FDA or to the manufacturers," he said.
In some cases, hospital staff were neither aware of, nor trained to comply with, the agency's medical device reporting requirements.
Shuren said the agency wanted to "work with all hospitals to address these issues."
On Dec. 5, the FDA will hold a public workshop seeking input on improving hospital surveillance systems and how hospitals can better evaluate how well devices work in the clinical setting.
Last year, the FDA sent warning letters to manufacturers of duodenoscopes, saying they skirted a host of testing, manufacturing and reporting requirements. The biggest makers of the products are Olympus Corp, Pentax Medical and Fujifilm Holdings Corp.
The FDA first warned of their potential to transmit antibiotic-resistant germs in 2009. Since then they have been implicated in superbug outbreaks at multiple U.S. hospitals.
In 2014, the FDA warned that morcellators could inadvertently spread uterine cancer. It recommended that the use of these instruments be restricted and that the label includes a boxed warning, the most severe possible.
Morcellators are used to slice fibroid and uterine tissue into small pieces inside the body, allowing it to be removed through a small opening.
The FDA estimates that 1 in 350 women who have fibroid surgery have an unsuspected uterine cancer.
Source : reuters.com
