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

A Prospective Multicenter Study Evaluating Learning Curves and Competence in Endoscopic Ultrasound and Endoscopic Retrograde Cholangiopancreatography Among Advanced Endoscopy Trainees: The Rapid Assessment of Trainee Endoscopy Skills Study

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These results demonstrate the feasibility of establishing a centralized database to report individualized learning curves and confirm the substantial variability in time to achieve competence among AETs in EUS and ERCP.

Device Recall: Fujifilm ED-530XT Duodenoscopes

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If you use this device, Fujifilm will be in touch by October 2017 with next steps for replacing your device(s).

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May 6, 2017

Digestive Disease Week® (DDW) is the premier meeting for the GI professional. Every year it attracts approximately 15,000 physicians, researchers and academics from around the world who desire to stay up-to-date in the field.