“Bringing trust and integrity back to public health, infection prevention, and endoscope reprocessing” — Dr. Lawrence F. Muscarella
Just in — Dr. Muscarella’s newest article: “Dr. Muscarella’s Responses, Proposals, and Recommendations to Medicare to Prevent Hospital-Acquired Infections.”
- Excerpt: This article “provides links to the proposals, rebuttals, and recommendations by Lawrence F. Muscarella, Ph.D. that were submitted to The Centers for Medicare and Medicaid Services (CMS) in response to ‘Proposed Rules’ the agency published in recent issues of the Federal Register. The primary goals of Dr. Muscarella’s comments are to prioritize infection prevention, incentivize improvements in patient care, and reduce the risk of hospital-associated infections (HAIs), while also reducing U.S. healthcare costs including for Medicare beneficiaries.”
“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 proposal — this is the first time such a proposal has been published — that federal agencies consider including endoscope-associated infections, or “EAIs,” as a reportable electronic clinical quality measure (“eCQM”) to incentivize quality improvements in health care, prioritize infection prevention, and prevent infections and related patient harms in hospitals.
Search: Click here to search “Discussions in Infection Control” and view a listing of the more than 200 hundred articles by Lawrence F Muscarella, PhD, uniquely featured in this public health blog.
Also new — 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.
- Dr. Muscarella's Responses, Proposals, and Recommendations to Medicare to Prevent Hospital-Acquired Infections
- 15 Patients Infected with Mycobacteria After Undergoing Cosmetic Surgery at a South Florida Clinic
- 17 U.S. Patients Were Exposed in December to a Colonoscope Contaminated with Salmonella Bacteria, FDA Reports Reveal
- In Support of Patient Safety, Healthcare Access, and Medicare Payment for a Single-Use Bronchoscope Model
- Guidance to Prevent Adverse Events, Including Mucosal Tissue Injuries, When Using Duodenoscopes with a Single-Use Endcap
- Gastroscopes Have Been Linked to a Cluster of Resistant E. coli Infections — Is the Risk Sufficiently Recognized?
- Assessment of the Effectiveness of Today's Endoscope Reprocessing Practices: An Abstract
- Flushing Endoscopes With 70% Alcohol to Facilitate Channel Drying
- Contamination of Flexible Endoscopes and Associated Infections
- Is A Less Robust Level of Disinfection Safe for Some 'Semi-Critical' Devices?
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:
- “The accuracy of death certificates has never been more important.” Los Angeles Times (October 22, 2020)
- “As COVID-19 spread, the feds relaxed rules, and hospitals tried to contain the outbreak. Other infections may have risen.” USA Today (August 5, 2020)
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:
- 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.
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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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.
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.”
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:
http://www.medivators.com/sites/default/files/minntech/documents/50098-028%20REV%20A%20Channel%20Monitoring.pdf
http://www.medivators.com/sites/default/files/minntech/documents/50097-186%20Rev%20D.pdf
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
Good discussion about infection control.It is an essential, though often under recognized and under supported, part of the infrastructure of health care.