FDA Updates

The following lists most of the FDA’s recently issued updates, safety communications and alerts discussing the manual and automated cleaning and disinfection of side-viewing duodenoscopes (or, ERCP endoscopes).

Recommendations provided by the CDC and Olympus America, among others, are also listed below.

FDA (Food and Drug Administration)

  • November 13, 2015: “FDA orders recall under consent decree for all Custom Ultrasonics automated endoscope reprocessors.”
  • October 5, 2015: “FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities.”
  • September 17, 2015: “Infections Associated with Reprocessed Flexible Bronchoscopes: FDA Safety Communication.”
  • August 4, 2015: “Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication.
  • March 26, 2015: “Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes Safety Communication.”
  • March 4, 2015: “Updated Information for Healthcare Providers Regarding Duodenoscopes”
  • February 19, 2015: “Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning Safety Communication.”

Olympus America

  • March 26, 2015: “Urgent Safety Notification: Important updated labeling information: New reprocessing instructions for the Olympus TJF-Q180V duodenoscope”

Centers for Disease Control and Prevention (CDC)

  • September 11, 2015: “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices.”
  • March 11, 2015: “CDC: Interim Protocol for Healthcare Facilities Regarding Surveillance for Bacterial Contamination of Duodenoscopes after Reprocessing.”
  • October 8, 2014: Epstein L, Hunter JC, Arwady MA, et al. New Delhi Metallo-β-Lactamase–Producing Carbapenem-Resistant Escherichia coli Associated With Exposure to Duodenoscopes.” JAMA Oct 8, 2014;312(14).
  • January 3, 2014: “Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013.” Morbidity and Mortality Weekly Report January 3, 2014;62(51):1051-1051.



Infection Control & Hospital Epidemiology, Endoscopy

The April, 2015, issue of the journal Infection Control & Hospital Epidemiology includes this article, which discusses the CRE outbreak at Virginia Mason Medical Center (Seattle, WA) between 2012 and 2014:

  • Wendorf KA, Kay M, Baliga C, et al. Endoscopic Retrograde Cholangiopancreatography-Associated AmpC Escherichia coli Outbreak. Infect Control Hosp Epidemiol 2015 Jun;36(6):634-42 — abstract.
  • Verfaillie CJ, Bruno MJ, F Voor in ‘t Holt A, et al. Withdrawal of a Novel-Design Duodenoscope Ends Outbreak of a VIM-2-Producing Pseudomonas aeruginosa. Endoscopy 2015 Jun;47(6):493-502 — abstract.

Case Reviews for Hospitals, Manufacturers, Patients:  Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.


AGA (American Gastroenterological Association)

By: Lawrence F Muscarella PhD; posted: 4/8/2015; updated: 12/1/2015.

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