Federal regulators Monday ordered makers of some duodenoscopes to conduct post-market research on how disinfecting those devices works in medical settings.
The move is in response to several recent outbreaks of antibiotic-resistant infections due to the scopes.
Duodenoscope manufacturers Olympus America, Fujifilm Medical Systems, USA and Hoya, parent company of Pentax Medical, were asked to conduct surveillance and evaluate how well healthcare personnel follow cleaning instructions to disinfect the devices between uses.
The companies have 30 days to submit their plans to the Food and Drug Administration.
Specifically, product makers are required to answer whether the cleaning instructions they include with the devices are sufficient to ensure adherence, what percentage of endoscopes remain contaminated even after manufacturer instructions are followed, and what factors contribute to contamination after conducting disinfection procedures.
“This is a significant step in the effort to combat infections spread through duodenoscopes,” Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, said in a released statement.
Duodenoscopes have been linked to separate outbreaks of carbapenem-resistant enterobacteriaceae, or CRE, that occurred at Ronald Reagan Medical Center at the University of California at Los Angeles and Cedars-Sinai Medical Center between August 2014 and January 2015.
As many as 250 people were potentially exposed to the drug-resistant bacteria as a result of contaminated duodenoscopes at UCLA and Cedars-Sinai, resulting in 11 infected cases and two deaths.
Hospital officials said at the time that the manufacturers had provided insufficient instructions on how to disinfect the scopes in order to be reused and reduce the risk of infection.
The outbreak prompted hospital officials to take additional steps such as analyzing culture samples to monitor for potential bacteria at Cedars, and the use of ethylene oxide gas sterilization at UCLA.
The devices, which are used in more than 500,000 endoscopic retrograde cholangiopancreatography procedures annually in the U.S., provide minimally invasive ways to drain fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones or other conditions.
The FDA has maintained the benefits of ERCP outweigh the potential risk of contamination from the endoscopes, issuing an advisory to health providers in March (PDF) recommending that they do not begin canceling endoscopic procedures.
But the agency has acknowledged that the design of the duodenoscope may make it difficult to ensure disinfection.
“Although the complex design of duodenoscopes improves the efficiency and effectiveness of ERCP, it causes challenges for cleaning and high-level disinfection,” the agency stated in an ">alert
All three devicemakers were cited in August for failures in the production of the devices and in their internal processes for handling reports of adverse events.
The FDA said it has received 75 adverse medical-device reports from January 2013 through December 2014 about possible transmission of microbial pathogens to as many as 135 patients from duodenoscopes.
An FDA advisory committee review in May found the agency had received as many as 146 reports of incidents dating to 1997 of patient infections, exposures or device contaminations associated with the use of duodenoscopes with the majority of cases occurring over the past five years.
