Discussions in Infection Control An independent educational site for hospitals, manufacturers and the public.



  • March 9, 2018: FDA warns the three duodenoscope manufacturers for failing to comply with an FDA order issued in October 2015 instructing the companies to conduct postmarket surveillance studies designed to assess the effectiveness of cleaning and disinfection.


  • WWLTV – New Orleans (LA) (Sept. 12, 2017): “Expert says he warned of machine used in Children’s Hospital heart surgeries.”
    • “In 2014, I suggested and published that this would turn out to be probably a national concern, and possibly a national calamity if proper mitigations were not developed and immediately implemented,” said Bioengineer Dr. Lawrence F. Muscarella,  President and Owner of LFM Healthcare Solutions, LLC in Montgomeryville, Pennsylvania.
    • “Dr. Muscarella says it took the CDC a couple of years to confirm the suspicions that he was raising, that the heater-cooler machines could be a source of spreading different types of infections (including M. abscessus, not only M. chimaera), even when cleaned following the manufacturers recommendations.”

  • More news to follow …

Dr. Lawrence Muscarella provide independent research about hospital infections and medical devices, as discussed by Consumer Reports, CNN, NBC’s The Today Show, Wall Street Journal, ABC World News Tonight, CBS Evening News,  The Los Angeles Times, The Philadelphia Inquirer, The New York Times, The Washington Post, Newsweek, USA Today, Bloomberg Business, and NPR Radio, among other sources.

MORE NEWS —  Duodenoscopes and Other Endoscope Types in the News:


Contact me (using your smart phone):  Call me (via Skype) | Email me | Text me

NEW! MEDICAL DEVICE RESOURCES —  New comprehensive pages that discuss: Heater-Cooler Devices || Duodenoscopes (and Echo-Endoscopes) || Automated Endoscope Reprocessors (or AERs) || (More pages to follow soon.)


Other relevant dates — January 15, 2016



  • Heater-Cooler Devices: SHEA experts from the University of Iowa Hospitals and Clinics: On January 24, 2017, experts presented an educational webinar on the infection risk associated with contaminated heater-cooler devices. Click here to download this webinar’s slides.


ALSO BREAKING — Consumer Reports:

Confidential Safety Services, Research, Reviews Performed for Hospitals, Device Manufacturers and the Consumer: 

  • Click here for a brochure.
  • Click here to read more about Dr. Muscarella’s confidential quality and safety services designed to help hospitals (and manufacturers and patients) better understand — and prevent — healthcare-associated infections, including those linked to contaminated GI endoscopes and heater-cooler devices, among other types of contaminated medical devices.


Unless an expired, infected patient’s medical records include clinical data to the contrary, a hospital-associated infection ordinarily cannot reasonably be excluded as a contributor to death. — Lawrence F Muscarella PhD

Dr. Muscarella’s 5 most recently posted articles:

Contaminated medical equipment, such as a duodenoscope or heater-cooler device, should not ordinarily or reasonably be ruled out as a potential reservoir or cause of an infection or outbreak without irrefutable data to the contrary. — Lawrence F Muscarella PhD


Dr. Muscarella, As always, THANK YOU for your efforts and expertise chronicling infection control, transmission, investigations, revelations and insight into solutions. Your site and efforts have single-handedly provided a “One-Stop Go-To” resource allowing medical practitioners, patients, regulators, researchers, stakeholders, attorneys, etc., a most valuable and time-saving reference. You are deserving of the highest award in public service.” — LR, responding to one of Dr. Muscarella’s recent postings. (More testimonials)

PAID MEMBERSHIP — This blog 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 Click here to search within this blog for a posting about a specific topic.


A sample of Dr. Muscarella’s Live (and taped) TV-news broadcasts include:

CNN | NBC’s The Today Show | NBC’s Nightly News with Lester HoltABC 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

A sample of Dr. Muscarella’s radio interviews and comments in newspaper articles include:

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 | NJ.com | The Philadelphia Inquirer | Winston-Salem Journal | Wall Street Journal | San Juan Weekly

These outbreaks at UCLA and other hospitals could collectively be the most significant instance of disease transmission ever linked to a contaminated reusable medical instrument. — Lawrence F Muscarella, PhD, a hospital-safety consultant in Montgomeryville, Pennsylvania as quoted in The LA Times (February 18, 2015)

SERVICE:  For a listing of Dr. Muscarella’s quality healthcare services, including audits, click here.

CONTACTClick here to contact Dr. Muscarella.

FOLLOW: Follow Dr. Muscarella on Twitter at @MuskiePhD


Lawrence F Muscarella PhD is the owner of LFM Healthcare Solutions, LLC, a Pennsylvania-based quality improvement and consulting company that provides safety services for hospitals, manufacturers and the publicEmail Dr. Muscarella for more details.

Disclaimer: LFM Healthcare Solutions, LLC, owns, publishes, and is solely responsible for the content of “Discussions in Infection Control.” © Copyright 2013-2016. All Rights Reserved.

[Top of page]


  • 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:

    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

Leave a Reply

Verify *