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.” On this episode of Transmission Control, 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, based solely on his work, and became the standard of care through the state. Our guest on this episode is Christian Berling of Germany’s HEINE Optotechnik, who discusses how his company redesigned the reusable rigid laryngoscope to comply with Dr. Muscarella’s stringent guideline and recommendation, like California.
- This episode, and each of the other more than a dozen “Transmission Control” podcasts taped in 2021, can be heard here on Apple Podcast.
Endoscope recall, FDA clearances
- December 10, 2021
- Manufacturer recalls the TJF-Q180V duodenoscope because use of this device “with adhesive deterioration or other damages may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion; contaminated endoscope can present an infection risk to patients.”
- February 4, 2016
- Manufacturer recalls the TJF-Q180V duodenoscope to replace the forceps elevator mechanism with a new forceps elevator design consistent with the design specification described in the recently cleared TJF-Q180V 510(k) clearance (below).
- January 15, 2016
- FDA clears the TJF-Q180V duodenoscope “with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections.”
- September 22, 2015
- Manufacturer recalls the TJF-Q180V duodenoscope: New and validated reprocessing procedures were issued for the TJF-Q180V duodenoscope consisting of revised manual cleaning and high level disinfection procedures.
- “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 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”]
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
Inquiries: Submit your confidential inquiry by clicking here.
Dr. Muscarella’s expert guidance provided 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 | 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 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
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.