Just in — Dr. Muscarella’s “Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap.”

The following timeline lists some of my guidance and quotes, beginning in 2021, discussing two new adverse events that the new duodenoscope designs with disposable components can introduce:

2021First 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:

  1. tearing/lacerating mucosal tissue in the GI tract, and
  2. 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.

2023 (late February) — Again, I discuss my concerns about these two adverse events, during this YouTube presentation.

“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:

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 —

Dr. Muscarella original research discussed in each of these three reports can be read here:

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 —

About endoscope drying, recently published:

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.

Other News

More News

Most recent blog posting

Recently published

Endoscope recalls, removals in the news:

As quoted in the “Los Angeles Times”:

As quoted in “USA Today”:

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.

Some of Dr. Muscarella’s most recent peer-reviewed articles:

  1. Muscarella LF. Use of ethylene-oxide gas sterilisation to terminate multidrug-resistant bacterial outbreaks linked to duodenoscopes. BMJ Open Gastro August 2019.
  2. Mehta AC, Muscarella LF. Bronchoscope-Related “Superbug” Infections. CHEST August 2019.
  3. 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:

  1. Dr. Muscarella as seen on CBS News


    Gastroenterology & Endoscopy News: “Which Flexible Scopes Really Need Sterilization?” (Oct. 23, 2019)

  2. 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:

  1. 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.
  2. Muscarella LF. The study of a contaminated colonoscope. Clin Gastroenterol Hepatol 2010 Jul;8(7):577-80.e1.
  3. 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.
  4. Muscarella LF. Other Possible Causes of a Well-Publicized Outbreak of Pseudomonas aeruginosa Following Arthroscopy in TexasAdvances in Infectious Diseases 2013;3(2):134-145.
  5. Muscarella LF. Inconsistencies in endoscope-reprocessing and infection-control guidelines. The importance of endoscope drying. Am J Gastroenterol 2006 Sep; 101(9):2147-54.
  6. Click here for a listing of more of Dr. Muscarella’s peer-reviewed articles

Inquiries: Submit your confidential inquiry by clicking here.

Contact: Contact Dr. Muscarella for a prompt response:  Call | Email | Text | Skype

Dr. Muscarella’s expert guidance provided on the following TV news programs: CNN | NBC’s The Today Show | NBC’s Nightly News with Lester HoltABC World News Tonight | CBS Evening News with Scott Pelley | Wall Street Journal Live | WWL-TV News (New Orleans, LA) | CNC-TV News (NBC, Charlotte, NC)

Some of Dr. Muscarella’s radio interviews and quotes in the press: USA TODAY | New York Times | CNN | The Washington Post | Wall Street JournalCBS News Radio (Los Angeles, CA) | Philadelphia Inquirer | Los Angeles Times | Bloomberg BusinessNPR Radio (Los Angeles) | The Los Angeles Times | Scientific AmericaThe Seattle Times | Reuters | Highlands TodayThe Palm Beach PostMassLive! | Los Angeles Times | Bloomberg Business Newsweek | Al Jazeera America | KNX-1070 NewsRadio | CBS News 3 | CBS News 2 | ABC6 On-Your-Side | The Associated Press | The San Francisco Chronicle | WSOC-TV Eyewitness News | Reuters | The Los Angeles Times | USA TODAY | The Seattle Times | The Iowa City Gazette | | The Philadelphia Inquirer | Winston-Salem Journal | Wall Street Journal | San Juan Weekly

Paid memberships: This site is subscription-based and requires a membership. Each newly posted article may be read, free-of-charge, within the first week of its publication. Thereafter, a paid membership is required. 

Search postings: Click here to search within this blog for a posting about a specific topic.

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.

Blog: By LFM Healthcare Solutions, LLC, which owns, publishes, and is solely responsible for the content of “Discussions in Infection Control.” © Copyright 2013-2021. All Rights Reserved.


3 thoughts on “NEWS”
  1. 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.
    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.”

  2. Hi Lawrence,

    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.

    Sally Bainbridge

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