Just in — FDA issues a warning letter to a manufacturer of duodenoscopes featuring a disposable endcap. Click here to read this warning letter dated March 15, 2023.
Two of the concerns detailed in this warning letter I had begun publicizing — possibly for the first time — as early as 2021.
The following timeline lists some of my guidance and quotes, beginning in 2021, discussing two new adverse events that these new duodenoscope designs — which FDA began in 2019 recommending hospitals transition to — can introduce:
2021 — First to warn the public about two types of adverse events associated with the use of new duodenoscope models featuring a removable distal endcap: the risk of these single-use endcaps:
- tearing/lacerating mucosal tissue in the GI tract, and
- becoming dislodged and falling off into the patient’s GI tract (e.g., stomach) or airway. Also see pp. 10-11 of this link.
2022 (April) — I discuss these two specific adverse events again in 2022.
- 2022 (September) — My concerns are further expressed here in this article I wrote.
2023 (late February) — Again, I discuss my concerns about these two adverse events, during this YouTube presentation.
- 2023 (March)– FDA warned a manufacturer, in part, because of concerns about these two adverse events.
Recalls: In 2021, two recalls were associated with these two new adverse events:
“Firsts”: Other Dr. Muscarella firsts involving publicizing unsafe medical devices or practices can be read by clicking here.
News: Dr. Muscarella’s most recent article:
- “Resistant Infections Linked to Gastroscopes — Is the Concern Sufficiently Recognized?” (January 2023)
Posts: A list of Dr. Muscarella’s articles published in Discussions in Infection Control may be read here.
Services: Some of Dr. Muscarella’s safety healthcare services, including case and forensic reviews, may be read here.
Also just In: Dr. Muscarella’s Research Discussed In the News —
- Single-Use Endoscopy: “Comprehensive Review of FDA Adverse Event Reports Involving Flexible Endoscopes Investigates Reprocessing Effectiveness” (August 23, 2022)
- Medtech Insight: “Study: FDA Data Shows Endoscope-Related Adverse Events Continue To Rise.” (Apr. 28, 2022)
- Infection Control Today: “Despite Safety Alerts, Contaminated Flexible Endoscopes Continue to Put Patients at Risk.” (Apr. 7, 2022)
- Press release: “Comprehensive Endoscope Study Reveals More Patients Are Potentially Being Exposed to Pathogens.” (Mar. 22, 2022)
Dr. Muscarella original research discussed in each of these three reports can be read here:
- “Contamination of Flexible Endoscopes and Associated Infections: A Comprehensive Review and Analysis of FDA Adverse Event Reports.” Discussions in Infection Control (January 28, 2022)
Dr. Muscarella’s study aims to be the most comprehensive review and analysis to date of FDA adverse event reports involving a flexible endoscope, specifically device contaminations with and without associated infection.
Recent FDA alerts involving a flexible endoscope —
- April 5, 2022: “Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication.”
- April 4, 2022: “UPDATE: Change in Reprocessing Methods with Certain Karl Storz Urological Endoscopes – Letter to Health Care Providers.”
About endoscope drying, recently published:
- Read Dr. Muscarella’s latest article: “Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying: Does this Measure Reduce the Contamination Risk?” This article provides a review of published data to clarify the contribution of a 70% alcohol rinse, prior to forced-air drying, to a reduction in the risk of endoscope contamination.
The “Transmission Control” Podcast: A newly released public health podcast co-hosted by Beyond Clean’s Justin Poulin and Lawrence F Muscarella, PhD.
- Episode 15 (Dec. 6, 2021) — “Medical Devices: Design Evolution & Variations in Standards of Care.” We discuss improvements to the design of medical devices to prevent patient infections. We focus on how our co-host — Lawrence F. Muscarella, PhD — published a unique recommendation circa 2006 about decontamination of rigid laryngoscopes that California adopted and that became the standard of care through the state. Our guest on this episode is Christian Berling of Germany’s HEINE Optotechnik, a manufacturer of reusable rigid laryngoscopes.
- This episode, and each of the other more than a dozen “Transmission Control” podcasts taped in 2021, can be heard here on Apple Podcast.
- “FDA Investigating Reports of Infections Associated with Reprocessed Urological Endoscopes” (Endoscopy Insights; September 20, 2021) Time: 13:37 minutes
- “Best Practices in Endoscope Reprocessing” (Endoscopy Insights; September 20, 2021) Time: 19:51 minutes
- “Superbug Fungus in Two Collin County Hospitals Killed Four, Officials Say” (5NBC; July 23, 2021) — Dr. Muscarella provides his perspectives and advice for patients seeking care in today’s emerging world of the deadly superbug Candida auris.
Most recent blog posting
- Dr. Muscarella’s “Is A Less Robust Level of Disinfection Safe for Some ‘Semi-Critical’ Devices?” (Discussions in Infection Control, July 7, 2021)
- “A Bronchoscope Recalled in 2018 is Now Being Removed From Use, Worldwide” (Discussions in Infection Control; January 26, 2021)
- “Multisociety guideline on reprocessing flexible GI endoscopes and accessories.” (January, 2021)
Endoscope recalls, removals in the news:
- Urgent Field Safety Notice (Overseas). RE: Handling and use of duodenovideoscopes TJF-Q170V | TJF-Q190V | TJF-Q290V | Single use distal cover MAJ-2315. February 2021
- “How to use the single-use distal cover” MAJ-2315 for the TJF-Q190V (refer to page 7 of 7)
- A regulatory report regarding the single use distal cover (11/25/2020): The manufacturer “was informed from the user that the 3 instances of unexpected healthy mucosa shearing/tearing off by the single use distal cover.”
- Ultrasound endoscopes recalled — November 27, 2020
- A bronchoscope model removal — August 31, 2020
- Bronchoscope models recalled — September 29, 2018
- “A Bronchoscope Recalled in 2018 is Now Being Removed From Use, Worldwide” — January 27, 2021
As quoted in the “Los Angeles Times”:
- “The accuracy of death certificates has never been more important.” October 22, 2020.
As quoted in “USA Today”:
“As COVID-19 spread, the feds relaxed rules, and hospitals tried to contain the outbreak. Other infections may have risen” (August 5, 2020)
As discussed by U.S. Congressman Ted Lieu (California’s 33rd District):
- As discussed in a letter by Mr. Lieu (March 23, 2015)
- As appears on Mr. Lieu’s webpage (June 13, 2016): “While it is unclear if the infection was a factor in the deaths — many of the patients had serious illnesses including cancer — the findings of the ongoing investigation show that, in general, the number of patients infected by dirty medical scopes is underreported, Lawrence Muscarella, a medical safety consultant in Montgomeryville, Pa., told The Los Angeles Times. ‘This shows a total failure of the system, from top to bottom,’ Muscarella told the newspaper.”
Dr. Muscarella’s 7 most recent postings:
[catlist numberposts=7 author_posts=”muskiephd”]
“Firsts”: Some of the significant infection risks and identified adverse events reported “first” by Discussions in Infection Control — click here.
Expert Consulting, Quality Reviews, Forensic Services: LFM-Healthcare Solutions, LLC provides medical expertise and solutions for healthcare facilities, device manufacturers and patients, specializing in the causes and prevention of healthcare-associated infections (HAIs) linked to contaminated medical equipment. Years of experience, reasonably priced services. Click here.
- Muscarella LF. Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ Open Gastro August 2019.
- Mehta AC, Muscarella LF. Bronchoscope-Related “Superbug” Infections. CHEST August 2019.
- Muscarella LF. Risk of transmission of carbapenem-resistant Enterobacteriaceae and related “superbugs” during gastrointestinal endoscopy. World J Gastrointest Endosc October 2014.
Dr. Muscarella’s proposed paradigm for disinfecting or sterilizing flexible endoscopes:
Gastroenterology & Endoscopy News: “Which Flexible Scopes Really Need Sterilization?” (Oct. 23, 2019)
- Running Out of Runway — A Podcast: Dr. Lawrence Muscarella’s talks about “Building a Case for a Paradigm Shift in Endoscope Reprocessing” (Produced by Beyond Clean; Oct. 28, 2019)
Some of Dr. Muscarella’s other relevant peer-reviewed articles:
- Muscarella LF. Infection control and its application to the administration of intravenous medications during gastrointestinal endoscopy. Am J Infect Control 2004 Aug;32(5):282-6.
- Muscarella LF. The study of a contaminated colonoscope. Clin Gastroenterol Hepatol 2010 Jul;8(7):577-80.e1.
- 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.
- Muscarella LF. Other Possible Causes of a Well-Publicized Outbreak of Pseudomonas aeruginosa Following Arthroscopy in Texas. Advances in Infectious Diseases 2013;3(2):134-145.
- Muscarella LF. Inconsistencies in endoscope-reprocessing and infection-control guidelines. The importance of endoscope drying. Am J Gastroenterol 2006 Sep; 101(9):2147-54.
- Click here for a listing of more of Dr. Muscarella’s peer-reviewed articles
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Disclaimer: Lawrence F Muscarella PhD is the owner of LFM Healthcare Solutions, LLC, a Pennsylvania-based quality improvement and consulting company that has provides safety services for hospitals, manufacturers and the public since 2013.
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3 thoughts on “NEWS”
Lawrence F Muscarella PhD, writing here along with award winning Health Journalists’ Chad Terhune and Melody Petersen, in LA Times shed light on this tragic problem.
Olympus knew, concealed, had proof, in excess of 15+ years, that many of their scopes, as designed, could not be cleaned. Where was FDA who failed to grant their usual ‘rubberstamp’ of more recent scope designs? Facilities knew when outbreaks occurred yet did nothing, leaving uninformed patients at risk of dying.
The Senate report is critically important. It defines the problem and presents solutions. http://www.help.senate.gov/imo/media/doc/Duodenoscope%20Investigation%20FINAL%20Report.pdf
The simple conclusion:
“A passive device surveillance system is ineffective even when manufacturers and hospitals self report information about device safety to FDA”
“Even when” misleads when the report clearly acknowledges both manufacturer and facility reporting are severely lacking.
Charting device serial numbers, scanning barcoded device entries to insurance documentation as is now required for pharmaceutical and blood products should be required by law. Inspections to ensure compliance? YES. Ignoring the problem will not make it disappear. Healthcare facilities, of all entities, should be spearheading compliance to lessen overall escalating infections, reducing healthcare costs, saving lives.
“First do no harm.”
Thank you for your great blog and endoscope reprocessing resources offered.
I am a nurse researching various options for new AERs as our current machines are due for replacement this year. One of the machines we were considering is the Medivators Advantage however I have found some product bulletins which are raising alarm bells, see below:
This sentence in particular is very concerning:
“In these instances MEDIVATORS has removed the ability to monitor the specific channels from the software parameter set to eliminate false alarms related to disconnection and blockage anomalies. Users reprocessing these endoscopes should check for blockages in the pertinent channels during the manual cleaning process. Then during reprocessing in the ADVANTAGE, any channel that is found disconnected at the completion of the reprocessing cycle should be reconnected and the entire endoscope reprocessed again”
I am aware of at least two models listed which are in regular use at our hospital.
Lawrence, what is your advice concerning the lack of complete channel monitoring/alarming offered by the Medivators Advantage endoscope reprocessor? What are the dangers of manually checking for blockages and how can we prevent human error?
Thanks in advance.
Good discussion about infection control.It is an essential, though often under recognized and under supported, part of the infrastructure of health care.