“Discussions in Infection Control” Welcome to Dr. Muscarella's popular blog

BREAKING —  Heater-cooler devices are in the news, again: Open-heart surgery patients contacted about infection riskKCCI-8 TV (Des Monies, IL)

Dr. Muscarella: “This risk is national and affects dozens of U.S. hospitals. I wrote about this risk being a national concern two years ago, in 2014. Read my article: ‘Deadly Infections at a South Carolina Hospital in 2014: Was A Heater-Cooler Device To Blame?‘”



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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)




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  • Click here to read about Dr. Muscarella’s quality and safety services committed to educating and helping hospitals (and manufacturers and patients) reduce the risk of healthcare-associated infections, including those linked to contaminated GI endoscopes and heater-cooler devices, among other types of reusable devices.


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Olympus recalls the “sealed” TJF-Q180V duodenoscope

FDA clears a modified TJF-Q180V duodenoscope

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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)

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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.

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  • 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

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