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

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  • 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.


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


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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 NEWS, UPDATES — THE REPAIRED TJF-Q180V DUODENOSCOPE: A Timeline of the news

Other relevant dates — January 15, 2016


JUST IN — HEATER-COOLER DEVICES IN THE NEWS …


BREAKING — EDUCATION:

  • 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.

JUST IN — GI ENDOSCOPES IN THE NEWS …


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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


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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


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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.


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3 comments

  • 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

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