SHORT-SIGHTED ON SCOPES Could duodenoscope-related outbreaks have been prevented?

A lack of action by manufacturers, the FDA and hospitals allowed duodenoscope-related patient infections to spread worldwide, according to an investigation by the U.S. Senate.

The Senate report links 25 outbreaks of antibiotic-resistant infections in the United States and Europe between 2012 and 2015 to cross-contamination by improperly cleaned duodenoscopes. These outbreaks sickened, sometimes fatally, at least 250 patients, says the report, which notes that many more incidents may have gone unreported. And it places the blame squarely on those who failed to sound an alarm: scope makers who failed to alert users to design flaws, the government's ineffective medical device regulators and hospitals that didn't report infection incidents.

The report, issued on Dec. 13, "documents a systemic and unacceptably slow response to growing evidence that duodenoscopes could not be reliably decontaminated between patient use, and makes clear that FDA's current system to monitor medical device safety is unable to effectively identify device problems when they occur, which poses an unacceptable risk to patients," says Sen. Patty Murray (D-Wash.), whose Health, Education, Labor, and Pensions Committee conducted the yearlong investigation.

"Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented," she says.

The report singles out manufacturer Olympus, which provides 85% of the duodenoscopes used in American hospitals, for its insufficient oversight of its scopes' safety and failure to warn users once their flaws became apparent in 2012.

"The faith that patients, doctors, hospitals and public health officials placed in Olympus to thoroughly test their cleaning instructions before putting devices in the marketplace was clearly misplaced," it said, adding that manufacturers Pentax and Fujifilm also "failed at every level" to address the scopes' cross-contamination hazards.

The report urges the FDA to consider mandatory repairs and recalls for the scope, and suggests strengthening their hand in the supervision of manufacturers' product modifications.

David Bernard