This is a resource page developed by “Discussion in Infection Control” for the public to use to learn more about the risk of “superbug” infection associated with duodenoscopes (and “EUS” endoscopes).
Dr. Muscarella’s postings discussing duodenoscopes:
- Duodenoscopes (27)
U.S. Department of Justice:
— Olympus Medical Systems (2018):
- November 28, 2018: Plea agreement between the United States Department of Justice, and Olympus Medical Systems.
- December 10, 2018: “Olympus Medical Systems Corporation, Former Senior Executive Plead Guilty to Distributing Endoscopes After Failing to File FDA-Required Adverse Event Reports of Serious Infections.”
- December 10, 2018: “Olympus Issues Statement Regarding U.S. Department of Justice Settlement.“
— Pentax of America (2020):
- April 7, 2020: “Pentax Medical Company Agrees to Pay $43 Million to Resolve Criminal Investigation Concerning Misbranded Endoscopes.”
- April 2020: UNITED STATES OF AMERICA v. PENTAX OF AMERICA, INC., dba PENTAX MEDICAL COMPANY
- April 7, 2020: “HOYA/PENTAX Medical Issues Statement Regarding U.S. Department of Justice Settlement“
- April 2020: Copy of the Deferred Prosecution Agreement
Some FDA notices and guidance documents discussing duodenoscopes:
- Infections Associated with Reprocessed Duodenoscopes
- Information about Automated Endoscope Reprocessors (AERs) and FDA’s Evaluation.
- Reprocessing of Reusable Medical Devices: Information for Patients
Some FDA Correspondence to Duodenoscope Manufacturers:
- Warning Letter – Fujifilm Medical Systems U.S.A., Inc. 8/12/15
- Warning Letter – Hoya (Pentax) Corporation 8/12/15
- Warning Letter – Olympus Corporation of the Americas 8/12/15
- Fujifilm Medical Systems U.S.A., Inc., Wayne, NJ, 483 Issued 4-20-2015 (PDF – 535KB)
- Aizu Olympus Co. Ltd – Aizuwakamatsu-City, Fukushima, Japan – 483 Issued 04-17-2015 (PDF – 1.1MB)
- Fujifilm – Ashigarakami Gun, Japan – 483 Issued 05-01-2015 (PDF – 843KB)
- Fujifilm – Hitachiomiya City, Japan – 483 Issued 04-20-2015 (PDF – 362KB)
- FujiFilm Optics Co – Sano City, Tochigi, Japan – 483 Issued 04-22-2015 (PDF – 544KB)
- Hoya (Pentax) Life Care Division – Kurihara-shi, Miyagi, Japan – 483 Issued 04-24-2015 (PDF – 1.1MB)
- Hoya (Pentax) Corp – Akishima-shi, Japan – 483 Issued 04-21-2015 (PDF – 2.4MB)
- Olympus Medical Systems Corp – Hachioji-Shi, Japan – 483 Issued 04-24-2015 (PDF – 558KB)
- Fujifilm Corp 510k Status Letter – August 12, 2015 (PDF – 604KB)
- Hoya (Pentax) Corp 510k Status Letter – August 12, 2015 (PDF – 449KB)
- Olympus 510(k) status letter – March 18, 2014 (PDF – 391KB)
A congressional report that focused on the risk of duodenoscopes infecting patients with superbug:
- Sen. Patty Murray (D-WA): “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients” (January 2016)
- Lawrence F. Muscarella, PhD: “The Newly Cleared Olympus Duodenoscope Has Been Linked to a Superbug Cluster — An Update” (March 22, 2017)
- Sen. Patty Murray (D-WA) asks Olympus for the validation demonstrating that the newly cleared TJF-Q180V duodenoscope model can be effectively cleaned, disinfected. (April 3, 2017)
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Some FDA Communications on duodenoscopes:
- FUJIFILM Medical Systems, U.S.A., Inc. removes certain older duodenoscope models from clinical use: FDA Safety Communication (1/13/17)
- FDA clears Olympus TJF-Q180V duodenoscope with design modifications intended to reduce infection risk. FDA News Release. (1/15/2016)
- FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities: FDA News Release (10/5/15)
- Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication (8/4/15)
- Updated Information for Healthcare Providers Regarding Duodenoscopes (PDF – 219KB)
- Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication
- FDA Voice Blog: Bacterial Infections Associated with Duodenoscopes: FDA’s Actions to Better Understand the Problem and What Can be Done to Mitigate It
Some Updated Duodenoscope Reprocessing Instructions:
- UPDATE: Importance of Following Validated Reprocessing Instructions for PENTAX ED-3490TK Video Duodenoscopes: FDA Safety Communication (1/17/2017)
- Olympus Validates Reprocessing Instructions for Duodenoscope Models TJF-160F and TJF-160VF: FDA Safety Communication (3/15/2016)
- Olympus Customer Notification Letter to Olympus TJF-160F/VF duodenoscope customers. March 14, 2016.
- PENTAX Validates Reprocessing Instructions for ED-3490TK Video Duodenoscopes: FDA Safety Communication, February 19, 2016
- PENTAX Customer Notification Letter to ED-3490TK Customers, February 19, 2016
- FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes: FDA Safety Communication
- Fuji Customer Notification Letter to ED-530XT duodenoscope customers. December 23, 2015.
- Fuji Customer Notification Letter to 250 and 450 duodenoscope customers. December 23, 2015.
- Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication
- Letter dated March 26, 2015 to health care facilities and other users of the TJF-Q180V Duodenoscope
Advisory Committee Meeting Information:
Some publications in the peer-reviewed medical literature discussing duodenoscopes (and “EUS” echo-endoscopes):
- Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy. World J Gastrointest Endosc 2014 Oct 16;6(10):457-74. [This article has been viewed almost 3,000 times.]
- Verfaillie CJ, et al. Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing Pseudomonas aeruginosa. Endoscopy 2015 Jun;47(6):493-502.
- Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography. Endoscopy 2010 Nov;42(11):957-9.
- Chapman CG, et al. Risk of infection transmission in curvilinear array echoendoscopes: results of a prospective reprocessing and culture registry.Gastrointest Endosc 2017 Feb;85(2):390-397.
- Wendorf KA, et al. Endoscopic retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak. Infect Control Hosp Epidemiol 2015 Jun;36(6):634-42.
- Naryzhny I, et al. Impact of ethylene oxide gas sterilization of duodenoscopes after a carbapenem-resistant Enterobacteriaceae outbreak.Gastrointest Endosc 2016 Aug;84(2):259-62.
- Ross AS, et al. A quarantine process for the resolution of duodenoscope-associated transmission of multidrug-resistant Escherichia coli. Gastrointest Endosc 2015 Sep;82(3):477-83.
- Epstein L, et al. New Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli associated with exposure to duodenoscopes. JAMA 2014 Oct 8;312(14):1447-55.
- Tokar JL, et al. Getting to Zero: Reducing the Risk for Duodenoscope-Related Infections. Ann Intern Med. 2015 Dec 1;163(11):873-4.
- Nelson DB, Muscarella LF. Current issues in endoscope reprocessing and infection control during gastrointestinal endoscopy.World J Gastroenterol 2006 Jul 7;12(25):3953-64.
Dr. Muscarella’s 5 most recently posted articles on a number of topics:
- Do Bronchoscopes Pose a Risk of Transmitting ‘Superbugs’?
- Sterilization of Duodenoscopes Found to Terminate ‘Superbug’ Outbreaks Other effective measures include returning the endoscope to the manufacturer for servicing.
- New Guidance for Hospitals Considering the Sterilization of Flexible Endoscopes A newly developed 3-tiered classification scheme based on the infection risk is discussed.
- A Colonoscope is Linked to Two Infections of the Nightmarish ‘CRE’ Superbug. Colonoscopy could now also be a risk factor for infection, in addition to ERCP and bronchoscopy.
- A Bronchoscope is Linked Again in the U.S. to an Outbreak of the Feared ‘CRE’ Superbug Safety Notice: Is enough being done to improve the safety of bronchoscopes? And, several bronchoscope models are recalled.