Duodenoscope Post-Market Oversight

December 10, 2018 — Statements and articles about duodenoscopes, medical device reporting and other federal regulations, and a plea agreement finalized with the U.S. Department of Justice. Some quotes from these statements and articles are provided.

Olympus: “Olympus Issues Statement Regarding U.S. Department of Justice Settlement

U.S. Justice Department:  “Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections

Reuters: “Olympus unit pleads guilty to resolve U.S. duodenoscope probe

Wall Street Journal: “Olympus Unit Settles Criminal Probe Over Device Linked to ‘Superbug’ Infections

Allentown Morning Call: “Olympus failed to properly notify the FDA of 3 incidents involving its scopes in Europe. Now, it must pay $85 million.”

Medscape:Higher Than Expected Contamination Rates Found With Duodenoscopes After Reprocessing, FDA Warns.”


Quality, Safety and Reviews:  Click here to read about Dr. Muscarella’s quality and safety services designed to help clients reduce the risk of healthcare-associated infections, including superbug outbreaks linked to contaminated duodenoscopes and other types of reusable medical equipment.

Manufacturers’ post-market duodenoscope surveillance data:


  • February 26, 2018: FDA, Centers for Disease Control and Prevention (CDC), and American Society for Microbiology (ASM), together with other endoscope culturing experts, released voluntary standardized protocols for duodenoscope surveillance sampling and culturing. See: “Duodenoscope Surveillance Sampling and Culturing: Reducing the Risks of Infection.”
    • These protocols 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.
    • For health care facilities that choose to implement duodenoscope surveillance sampling and culturing, these protocols can be used to help monitor the quality of a facility’s endoscope reprocessing procedures. Adequate monitoring may reduce the risk of infection.

Some related articles (by Lawrence F Muscarella, PhD):

Also read:


(New information, statements and news reports will be added as warranted.)