Duodenoscope Sampling and Culturing Protocol

Standardized Protocols to Reduce Risk of Duodenoscope-Associated Infections

FDA, along with CDC, representatives from the American Society for Microbiology (ASM) and other endoscope culturing experts, has developed voluntary standardized protocols for duodenoscope surveillance sampling and culturing.

The protocols outline steps hospitals and healthcare facilities can take to reduce the risk of infection and increase the safety of these medical devices. These steps are in addition to meticulously following manufacturer-reprocessing instructions.

They are an update to the Interim Duodenoscope Surveillance Protocol released by CDC in March 2015, and address the concerns regarding validation of duodenoscope culturing protocols raised in ASM's April 2015 Policy Statement on Culturing of Duodenoscopes.

Learn more on Thursday, March 22, during a webinar with FDA, CDC, ASM and other endoscope culturing experts.

PDF

Webinar Details:
March 22, 2018 1:00 – 2:30 PM EST.
To ensure you are connected, please dial in 15 minutes prior to the start of the webinar.
NOTE: You must dial in to hear the presentation and ask questions:

  • U.S. Callers Dial: 800-369-1735
    • CONFERENCE NUMBER: PWXW7014509; PASSCODE 7001903
  • International Callers Dial: 1-603-395-0143
    • CONFERENCE NUMBER: PWXW7014509; PASSCODE 7001903

Register 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

 

Update: February 26, 2018

12:00 pm Web Updates (FDA web content updated, post protocol, webinar announcement uploaded)
(CDC web content updated)
(ASM web content updated)

12:30 pm FDA OL and OCA – Outreach to Hill

1:00 pm Emails sent:
FDA:

  • All registered and listed duodenoscope manufacturers (procode FDT) – Paul Boccadoro
  • CDRH Medical Device Safety and Recalls lists – Paul Boccadoro
  • American Gastroenterological Association (AGA) - Shannon Thor
  • Association of periOperative Registered Nurses (AORN) - Shannon Thor
  • Association for Professionals in Infection Control and Epidemiology (APIC) - Shannon Thor
  • American Society for Gastrointestinal Endoscopy (ASGE) - Shannon Thor
  • International Association of Healthcare Central Service Materiel Management (IAHCSMM) - Shannon Thor
  • Infectious Diseases Society of America (IDSA) - Shannon Thor
  • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) - Shannon Thor
  • Society of Gastroenterology Nurses and Associates (SGNA) - Shannon Thor
  • Society for Healthcare Epidemiology of America (SHEA) - Shannon Thor
  • Media Outlets – Deb Kotz

ASM:

  • Clinical Microbiology Portal
  • ASM listserv

2:00 pm CDC will issue a GovD announcing the protocols and information for the Webinar

  • CDC will send out a partner communication email to a targeted group of stakeholders announcing the protocols and webinar.

2:30 pm Social Media

  • FDA Tweet from @CDRHIndustry

"To help mitigate the risk associated with the transmission of infections by duodenoscopes, the FDA, CDC and ASM are providing recommendations for health care facilities that choose to implement surveillance and culturing."

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