FDA Updates Protocols to Reduce Duodenoscope-Associated Infection Risk

By on 6:28 AM

The U.S. Food & Drug Administration (FDA) has announced new voluntary, standardized protocols for duodenoscope surveillance sampling and culturing.

They outline steps healthcare facilities can follow to help improve infection prevention and increase the safety of the medical devices. These steps are meant to be followed in addition to manufacturer-reprocessing instructions.

The protocols were developed by FDA, Centers for Disease Control and Prevention (CDC) and American Society for Microbiology (ASM), along with duodenoscope manufacturers and other experts. They are intended to address the concerns regarding validation of duodenoscope culturing protocols raised in ASM's policy statement on culturing of duodenoscopes published in 2015 and represent an update to the "Interim Duodenoscope Surveillance Protocol" released by CDC in March 2015.

The new protocols' overview includes the following introduction: 

"Microbiological sampling and culturing of duodenoscopes involves sampling duodenoscope channels and the distal end of the duodenoscope, followed by culturing those samples with the goal of detecting bacterial contamination that may be present on the duodenoscope after reprocessing. … Current U.S. guidelines for endoscope reprocessing and infection control do not recommend endoscope surveillance sampling and culturing; however, some U.S. healthcare facilities have successfully implemented routine or periodic surveillance sampling and culturing of reprocessed duodenoscopes to provide an early notice of potential problems. This document provides recommendations for those healthcare facilities that choose to implement duodenoscope microbiological surveillance sampling and culturing."

Download the protocols by clicking here. Learn more about the risks associated with cleaning and disinfection of devices such as duodenoscopes in an ICCS special report on reprocessing procedures for reusable medical devices.

Free Webinar

To learn more about the protocols, register for a Thursday, March 22, webinar featuring representatives of FDA, CDC, ASM and other endoscope culturing experts. The program is scheduled for 1:00–2:30 PM EST.

Call (800) 369-1735 (conference number PWXW7014509, passcode 7001903) to hear the presentation and ask questions. Register to view the slide presentation during the webinar by clicking here.

Phenelle Segal, RN, CIC, FAPIC

Phenelle Segal, RN, CIC, FAPIC, is the founder and president of Infection Control Consulting Services LLC (ICCS). Phenelle has more than 30 years' experience providing customized comprehensive infection control and prevention services to healthcare facilities nationwide. Her services focus on assisting hospitals, ambulatory surgery centers, dental office and oral surgery practices, doctor's offices, nursing homes and other organizations with implementing and maintaining an infection control program that: complies with The Joint Commission, AAAHC, Centers for Medicaid and Medicare Services (CMS) and other regulatory agencies; respond to situations of noncompliance; and improve the processes for reducing risk.