2015-03-17 15:37:57 UTC

CDC, FDA Release New Guidance to Prevent Scope Infections

March 13, 2015

In light of the recent reports of patient-to-patient infections of CRE bacteria linked to ERCP procedures, CDC has issued an interim protocol for health-care facilities regarding duodenoscope reprocessing and surveillance, while FDA has issued final guidance for device manufacturers.

Through the AGA Center for GI Innovation and Technology, AGA is committed to outlining a path forward with zero device-associated infections. On Saturday, March 21, we will be convening key stakeholders from FDA, CDC and device manufacturers to take a critical look at this issue and develop both short- and long-term solutions to address the proper cleansing of duodenoscopes. AGA leadership will also participate in a public meeting of the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee, convened by FDA, on May 14 and 15.

AGA is taking the lead on addressing this issue and will continue to work closely with FDA, CDC and device manufacturers to ensure safe patient care with no preventable infections.

CDC Guidance: Interim Duodenoscope Surveillance Protocol

The CDC interim protocol is intended to supplement, and not replace or modify, manufacturer-recommended reprocessing procedures. The measures outlined in the interim protocol may change as new information becomes available. Please read the entire guidance for complete information, but some considerations include:

Duodenoscope Reprocessing: Facilities should ensure strict adherence to manufacturer’s instructions, paying particular attention to how the elevator mechanism, located at the distal tip of the duodenoscope, is cleaned. Facilities must also ensure that the channels of the duodenoscope and elevator mechanism are thoroughly dried prior to storage.

Use of Duodenoscope Culturing: Although routine culturing of endoscopes is not part of current U.S. guidelines, recent outbreaks have led some facilities to consider regular monitoring to assess the adequacy of duodenoscope reprocessing. Post-reprocessing cultures of duodenoscopes should be assessed for two types of microbial growth: high- and low-concern organisms. Any duodenoscope found to be contaminated with any high-concern organisms or unacceptable amounts of low-concern organisms should be reprocessed again and taken out of use until repeat post-reprocessing cultures can be obtained.

FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling

The new final guidance from FDA outlines steps device manufacturers can take to ensure the safety of reusable medical devices and to address the possible spread of infectious agents. Specifically, the guidance focuses on manufacturer’s reprocessing instructions and outlines steps manufacturers should take to ensure these directions are clear and effective.

More on ERCP

AGA Supports New Government Scope Safety Protocols

Feb. 28, 2018

While voluntary, AGA encourages GIs to review and consider adopting sampling and culturing of reprocessed duodenoscopes.

Attend the AGA Postgraduate Course for Practical, Take Home Information

Feb. 12, 2018

Join us on June 2-3 in Washington, D.C. This course is held in conjunction with Digestive Disease Week® (DDW) 2018.

Voluntary Recall of Pentax ED-3490TK Duodenoscopes

Feb. 8, 2018

Recall designed to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.