Gut Check | Monday, March 12, 2018
Stay In the Know: Updated Protocols for Duodenoscope Surveillance Culturing
In late February 2018, the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with other endoscope culturing experts released an update to the Interim Duodenoscope Surveillance Protocol released by the CDC in March 2015.
The new, voluntary protocols are meant to help health care professionals take additional steps to further reduce the risk of infection and ultimately increase patient safety. These protocols address concerns that were raised in April of 2015, around ASM’s Policy Statement on Culturing Duodenoscopes regarding validation of duodenoscope culturing protocols. SGNA members were among those who provided commentary on the draft document last year.
The newly released document from the FDA, CDC and ASM is divided into three parts. First is an overview of the sampling and culturing protocols. Second is a section on the materials and methods for duodenoscope sampling, to be conducted by personnel such as endoscopy or reprocessing staff. The third section shares four different methods for culturing samples from duodenoscopes, to be conducted by appropriate microbiology laboratory staff, as well as suggested initial limits for microbiological cut-offs, based on expert opinion.
More than 500,000 endoscopic retrograde cholangiopancreatography (ECRP) procedures are performed in the United States each year, which means duodenoscopes are being reprocessed between patient use at least that many times. GI nurses and associates, more than anyone else, understand the importance of keeping pace with the latest protocols to ensure patient safety. One of the many goals of these new protocols is to minimize staff workload while maximizing potential for detecting organisms that could cause infection or outbreak.
To better help healthcare professionals understand what these new protocols entail, the FDA, CDC and ASM will host a free webinar on March 22, from 1-2:30 p.m. ET. No registration is required to join and participants are welcome to ask questions. More information can be found below.
The Bottom Line
If you or your team has been following the CDC’s interim protocols, they have been superseded by the FDA’s “Duodenoscope Surveillance Sampling & Culturing; Reducing the risks of Infection,” as of February 2018. A free webinar is available to learn more about the new protocols.
Free Webinar
March 22, 2018
1-2:30 PM ET
U.S. Callers Dial: 800-369-1735
CONFERENCE NUMBER: PWXW7014509; PASSCODE 7001903
International Callers Dial: 1-603-395-0143
CONFERENCE NUMBER: PWXW7014509; PASSCODE 7001903
To view the slide presentation during the webinar:
https://www.mymeetings.com/nc/join.php?i=PWXW7014509&p=7001903&t=c
Following the conference, a transcript, audio recording and slides will be available at:
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm411063.htm