The Food and Drug Administration admitted that recent superbug infections sped up its efforts to update four-year-old recommendations for improving the complex devices linked to the outbreak.
The FDA released the recommendations on Thursday that demonstrate how manufacturers can design better medical instruments that aren’t so difficult to clean. The agency told the Washington Examiner it would now review cleaning instruction data for duodenoscopes, a complex instrument that may have infected hundreds of people in California with drug-resistant superbugs.
The California outbreak “accelerated the push to finish the final guidance but it was already under development,” FDA spokeswoman Jennifer Dooren told the Examiner. The draft version of the recommendations was released in 2011.
Since the outbreak generated headlines last month, the FDA has faced criticism over the issue. The agency admitted it didn’t clear the scope in question made by Olympus and did not review data that affirmed the cleaning instructions were adequate.
Some lawmakers were furious about the lapses.
“FDA was supposed to be regulating these scopes,” said Sen. Patty Murray, D-Wash., during a hearing with outgoing FDA Commissioner Margaret Hamburg on Tuesday.
A letter from 11 lawmakers asked the FDA when it learned of the sterilization problems of the scopes and what it has done to combat superbugs.
Dooren said there was a good reason it took the agency nearly four years to finalize the recommendations. The agency received more than 500 comments from manufacturers, healthcare workers and other stakeholders. The agency also held several public meetings in 2011 on the issue.
“The scientific deliberations and resulting points of disagreement around these issues take time to resolve,” Dooren said.
The recommendations apply to other complex instruments such as endoscopes, bronchoscopes and other reusable devices.
The agency emphasized that the risk of “acquiring an infection from a reprocessed medical device is low,” said William Maisel, chief scientist at the FDA’s medical device center.
A duodenoscope is a long and narrow tube that is used instead of invasive medical procedures to get tissue samples or deliver a drug to an area of the body. It can be used to examine bile ducts in the pancreas.
It is used in more than half a million medical procedures a year, the FDA said.
In addition to the recommendations, the FDA will take a larger role in overseeing cleaning instructions.
The agency normally only reviews on a case-by-case basis data from a duodenoscope manufacturer that shows the cleaning instructions can be followed and actually work. Now the agency will review all that data when a new duodenoscope applies for regulatory approval, Dooren said.
The FDA first heard of infections linked to duodenoscopes in fall 2013, Dooren said. The agency then reached out to manufacturers about their cleaning and sterilization protocols.
Officials also collected information from hospitals where the infections occurred and asked the Environmental Protection Agency to test the disinfectants used on the scopes to make sure they were effective, Dooren said.
The first superbug outbreak hit Ronald Reagan University of California-Los Angeles Medical Center. The outbreak from a duodenoscope procedure infected seven people and two peopled died.
The hospital is reaching out to more than 100 patients to determine if they were infected.
Cedars-Sinai in Los Angeles reported that four people were infected due to the same procedure using a duodenoscope. It is reaching out to more than 60 patients to see if they were infected.
