The Food and Drug Administration doesn’t plan to issue new regulations for complex medical instruments that caused several deadly superbug outbreaks, but will offer more guidance to healthcare officials.
The agency took heat from lawmakers for not clearing an instrument called a duodenoscope that may have infected more than 100 people in California. Outgoing FDA Commissioner Margaret Hamburg was chided about the outbreak during a Senate hearing Tuesday.
“One of the large outbreaks was in my state of Washington. There were 32 patients infected,” said Sen. Patty Murray, D-Wash., referring to an outbreak that killed 11 people between 2013 and this year. “FDA was supposed to be regulating these scopes.”
Hamburg, who steps down at the end of this month, told Murray the agency is taking the problem very seriously.
“We are increasing our efforts to really understand what has happened in the context of these recent outbreaks,” she said.The agency received reports of several isolated infections due to the scopes, but it wasn’t until late 2013 it learned the scopes were behind drug-resistant superbug infections, Hamburg said.
The FDA is speaking with manufacturers about the design of the scopes and plans to give manufacturers guidance and create resources on how healthcare professionals can adequately sterilize the instruments.
However, Hamburg told the Washington Examiner after the hearing there is no plan for issuing new regulations over the scopes at this time.
The agency approved the scope linked to the infections, but then the manufacturer, Olympus, made modifications to the device. The agency previously told the Examiner that those changes needed new regulatory approval, which is still pending, but didn’t pull the device from shelves because of demand.
FDA also did not approve the cleaning instructions for the scope. That may not seem important, but it may have contributed to the outbreak.
A duodenoscope is a long, narrow tube with a camera and other apparatus on one end that is inserted into the body through the mouth and enables doctors to look for diseases. The scope can also take tissue samples for testing and deliver a drug to a certain area of the body.
Nearly half a million procedures use the scope each year on patients instead of more invasive surgeries.
However, the reusable scopes are extremely difficult to clean. The scope has a mechanism that enables the delivery of treatments, but it can also easily trap fluids such as blood.
One step in the cleaning process is to brush the scope, but that can miss the fluids, the FDA said. The cleaned scope is then used again and can infect the next patient.
The California hospitals have changed how they clean the scopes, opting for a gas instead of manual brushing.
