FDA updates sampling, culturing protocols to improve duodenoscope safety

The FDA announced that it has released new voluntary protocols for surveillance sampling and culturing of duodenoscopes to further reduce the risk for infection associated with these devices.

The FDA worked with the CDC, the American Society for Microbiology (ASM), and endoscope surveillance culturing experts to develop the protocols. When paired with strict adherence to manufacturer reprocessing instructions, these added steps can help health care facilities improve the safety of duodenoscope use.

“This document was developed to provide validated methods for surveillance sampling and culturing of duodenoscopes that would address some of the concerns that have been previously raised about duodenoscope sampling and culturing,” Shani Haugen, PhD, of the FDA’s Center for Devices and Radiological Health said during a conference call. “This type of surveillance is the only way to monitor, with testing, the quality of start-to-finish endoscope procedure in a clinical environment.”

Following the discovery of a potential link between multi-drug resistant bacteria and the use of duodenoscopes in 2013, the FDA issued an interim protocol that addressed sampling and culturing of duodenoscopes in 2015. Immediately after, the FDA established a working group to develop a validated sampling and culturing protocol.

The 2018 protocol differs from the interim protocol in a few ways. First, it suggests the collection of a combined sample from three locations on the scope — the instrument channel, the elevator recess and the distal cap seem. The 2015 protocol did not include sampling at the distal cap, and sample combination was optional. It also suggests the addition of a neutralizer, such as a Dey-Engley broth, to the sample to limit false-negatives. Additionally, it suggests a 72-hour incubation period rather than the 48-hour period suggested in the interim protocol.

The FDA and the members of the working group said the guide has a few options built in to give each facility a choice of which culturing method they will use and what kind of action plan they will develop.

Judith Noble-Wang, PhD, of the CDC’s Division of Healthcare Quality Promotion, stressed the importance of the new protocol, saying that while the interim protocol served a key purpose, it was always meant to be replaced.

“At the time the interim protocol was released in 2015, there was a pressing need for a standardized sampling and culturing protocol,” she said during the conference call. “It was always intended as a place holder until appropriate testing could be conducted to validate a certain sampling and culturing protocol. Without a validation, the performance of the interim sampling and culturing methods was unknown.” – by Alex Young

Reference:

https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm598194.htm

Disclosures: Haugen is employed by the FDA. Noble-Wang is employed by the CDC.