“Bringing trust and integrity back to public health, infection prevention, and endoscope reprocessing” — Dr. Lawrence F. Muscarella

Search:  Click here to search this website and view a listing of the few hundred articles by Lawrence F Muscarella, PhD, uniquely featured in this public health blog and that are available (at no charge) for downloading and reading.

“Firsts”: Click here to review public health risks, adverse safety events, and infection concerns that Dr. Muscarella identified and publicized for the first time.

Just in — Dr. Muscarella’s “In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model”

  • Excerpt:This article discusses a rebuttal, by Lawrence F. Muscarella, Ph.D., to initial conclusions by The Centers for Medicare & Medicaid Services (CMS), published in July (2023), that assess the risk of contaminated bronchoscopes infecting patients with potentially life-threatening diseases including multidrug-resistant organisms.”
  • Excerpt: “Two months after receiving his rebuttal in support of a company’s application requesting a new device category for what’s called transitional pass-through (“TPT”) payment status, CMS reassessed its July decision and, in November, approved the application for a single-use bronchoscope model.”

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

  • Excerpt:While novel duodenoscopes with disposable components may reduce the risk of infection for patients, these innovative devices are not failsafe, and can introduce two previously unfamiliar adverse events, FDA acknowledged in a letter earlier in 2023.”
  • Excerpt:This article provides updated guidance — possibly the most replete list of recommendations — to reduce the risk of both events: (1) mucosal injuries in the upper GI tract, and (2) dislodgement of the single-use endcap inside the patient when using a duodenoscope with a single-use endcap. This guidance includes proper training and confirming the single-use endcap is correctly attached to the duodenoscope prior to the procedure, and not using a single-use endcap that has a crack, pinhole or otherwise appears damaged.”

“Firsts”: Dr. Muscarella was the first to bring to the public’s attention a number of adverse events involving medical devices or practices —  click here to read the list.

Recent Posts:  The following is a list of Dr. Muscarella’s 5 most recently published posts. To view his articles written about a specific topic, click this website’s “Category” page.

Services: Some of Dr. Muscarella’s safety healthcare services, including case and forensic reviews, may be read here.

Dr. Muscarella’s recent quotes in the news:

Dr. Muscarella’s expertise mentioned by U.S. Congressman Ted Lieu (California’s 33rd District):

Forensic Care Reviews, Expert Guidance, Quality Reviews focusing on healthcare-associated infections due to an error or preventable advrse event:  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.

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

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 2013-2024. 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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