Lawrence F Muscarella, PhD, is an internationally known biomedical engineer with more than 25 years of experience. He is the president of LFM Healthcare Solutions, LLC, which he founded in 2013. Dr. Muscarella's expert services and solutions focus on medical...
- New York Times (Aug. 6, 2019): “Why Are These Medical Instruments So Tough to Sterilize?”
- “Duodenoscopes have sickened hundreds of patients in hospital outbreaks. Now some experts are demanding the devices be redesigned or taken off the market.”
- Quote: “As long as organisms were susceptible to antibiotics, there really wasn’t a problem, because even if the scopes were transmitting bacteria, you give patients antibiotics prophylactically before and after procedures, and you take care of it,” said Larry Muscarella, a health care consultant who scours medical device reports submitted to the F.D.A. and has often been the first to identify infection risks.
- SGNA: SGNA’s response to this NY Times article – click here.
Just published (May 30, 2019) — “New Guidance for Transitioning to the Sterilization of Flexible Endoscopes” (Discussions in Infection Control)
- May 9th, 2019: Sen. Patty Murray (D-WA) writes a letter to each of the three manufacturers about the higher-than-expected rates of microbial contamination in certain duodenoscope models following reprocessing (e.g., cleaning and disinfection) performed according to the respective manufacturer’s IFUs: FujiFilm Medical Systems U.S.A., Olympus Corporation of the Americas and Pentax Medical.
- Related — April 12, 2019: “FDA Continues to Remind Facilities of the Importance of Following Duodenoscope Reprocessing Instructions: FDA Safety Communication“
- Related — March 9, 2018: FDA writes a letter to each of these three manufacturers concluding that certain duodenoscope models are “current misbranded under section 502(t)(3) of the (Federal Food, Drug and Cosmetic Act)”: FujiFilm Medical System U.S.A., Olympus Corporation of the Americas, and Pentax Medical,
- “A Colonoscope is Linked to Two Infections of the Nightmarish ‘CRE’ Superbug“
- Dr. Muscarella’s peer-reviewed article: “The study of a contaminated colonoscope” (Clin Gastroenterol Hepatol 2010 Jul;8(7):577-580)
- Also read the peer-reviewed article, “Delayed reprocessing of endoscopes” by Drs. Agrawal and Muscarella (Gastrointest Endosc 2011 Apr;73(4):853-4)
Dr. Muscarella’s 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; New York State health officials. Recommendations for preventing hepatitis C virus infection: analysis of a Brooklyn endoscopy clinic’s outbreak. Infect Control Hosp Epidemiol 2001 Nov;22(11):669.
Consulting Services — LFM-Healthcare Solutions, LLC provides medical expertise and solutions for hospitals, manufacturers, and the public, specializing in healthcare-associated infections linked to medical equipment. Services include litigation support. Years of experience. Reasonable rates.
Significant “Firsts” — Click here for a list of some of the salient infection risks and identified adverse events reported “first” by Discussions in Infection Control.
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Dr. Muscarella’s 7 most recent postings —
- New Guidance for Transitioning to 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.
- Are Enzymatic Detergents the Primary Cause of The Inflammatory Eye Reaction Called TASS? A recently published article investigates risk factors for TASS.
- New Guidance to Prevent Other Types of Flexible Endoscopes From Transmitting Superbugs. A new practice is provided to prevent contaminated gastroscopes, echo-endoscopes and other types of flexible endoscopes from infecting patients with multidrug-resistant bacteria
- FDA Warns Duodenoscope Manufacturers for Not Completing Ordered Surveillance Studies
- A Duodenoscope Has Been Linked to ‘Probable Transmission’ of a Colistin-Resistant Superbug. In January, the FDA had issued a safety alert reporting a "design issue" with the endoscope "that could increase the risk of patient infection."
Dr. Muscarella has provided expert guidance on the following TV news programs — CNN | NBC’s The Today Show | NBC’s Nightly News with Lester Holt | ABC World News Tonight | CBS Evening News with Scott Pelley | CBS News 3 (Philadelphia, PA) | WFMZ’s 69News (Allentown, PA) | Huffington Post Live | Wall Street Journal Live | CBS Los Angeles | WSOC-TV (NC) | Al Jazeera America | WWL-TV News (New Orleans, LA)
Some of Dr. Muscarella’s radio interviews and quotes in the press include — USA TODAY | New York Times | CNN | The Washington Post | Wall Street Journal | CBS News Radio (Los Angeles, CA) | Philadelphia Inquirer | Los Angeles Times | Bloomberg Business | NPR Radio (Los Angeles) | The Los Angeles Times | Scientific America | The Seattle Times | Reuters | Highlands Today | The Palm Beach Post | MassLive! | 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 | NJ.com | The Philadelphia Inquirer | Winston-Salem Journal | Wall Street Journal | San Juan Weekly
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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.
LFM Healthcare Solutions, LLC, owns, publishes, and is solely responsible for the content of “Discussions in Infection Control.” © Copyright 2013-2019. All Rights Reserved.