FIRSTS

A “New York Times” Shout-Out Discussing Dr. Muscarella’s “Firsts,” His Work:

• “The New York Times”: Lawrence Muscarella is “scours medical device reports submitted to the F.D.A. and has often been the first to identify infection risks.” (From: “Why Are These Medical Instruments So Tough to Sterilize?” (August 6, 2019).

This page lists of some of the safety risks and hazards associated with several different medical practices and types of medical devices that, having not been previously published or recognized, Dr. Muscarella brought to the public’s attention — for the first time. This list, which is incomplete, focuses on healthcare-associated infections and contaminated medical equipment:

1. DISPOSABLE DUODENOSCOPE ENDCAPS

• 2021 — First to warn the public about two types of adverse events associated with the use of new duodenoscope models featuring a removable distal endcap: the risk of these single-use endcaps: (1) tearing/lacerating mucosal tissue in the GI tract, and (2) becoming dislodged and falling off into the patient’s GI tract (e.g., stomach) or airway. Also see pp. 10-11 of this link.
  • 2022 — My concerns about these two specific types of adverse events were again discussed in 2022.
    • 2022 — My concerns are further expressed here in this article I wrote.
• 2023 (late February) — I discuss my concerns about these two adverse events, yet again, during this YouTube presentation.
  • 2023 (March)– FDA warned a manufacturer, in part, because of concerns about these two adverse events.

2. ENDOSCOPE CONTAMINATION, “SUPERBUG” INFECTION RISKS

• Infection Risk of Gastroscopes
  • 2022 (January): First to discuss publicly that the risk of gastroscopes transmitting multidrug-resistant organisms and related superbugs including “CRE” may be under-appreciated, and that:
    • the total number of FDA adverse event reports submitted to FDA between 2014 and 2021 describing actual or potential contamination of a flexible endoscope was greatest for gastroscopes (not duodenoscopes or bronchoscopes as might have been expected); and
    • the number of adverse event reports submitted to FDA in 2021 describing actual or potential contamination of a flexible endoscope, compared to seven years earlier in 2014, increased significantly for several types of flexible endoscopes — with gastroscopes displaying the most pronounced increase.
  • 2022 (January): First to recommend that federal officials consider publishing updated guidance to raise awareness and reduce the risk of a gastroscope remaining contaminated and exposing patients to potentially deadly CRE and related superbugs.
    • To improve the safety of gastroscopes, I suggested in 2022 that FDA and CDC consider modelling this guidance after the FDA’s safety communications previously published for reducing the risk of bronchoscopes, duodenoscopes and urological endoscopes transmitting infections.

• • 2016 (December): First to publicize the risk of gastroscopes infecting patients with CRE and other potentially deadly superbugs, despite being reprocessing according to their manufacturers’ instructions.

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  Duodenoscopes Posing a Risk of Life-Threatening “CRE” Infections

  • 2013 (December) — First to publicize that the U.S. appeared to be in the midst of an overlooked “epidemic” of outbreaks of superbugs, including CRE, linked to duodenoscopes.
  • 2014 (October) — First to warn the public (in a peer-reviewed article) that duodenoscopes might be posing an emerging risk of infecting patients with CRE, and that this risk was a global threat, not merely a local concern limited to one mid-western city.

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  Bronchoscopes Posing a Risk of Life-Threatening “CRE” Infections

  • 2015 (July) — First to warn the public that bronchoscopes had been linked to infections of CRE in the U.S. (Three years later, this risk was described in a peer-reviewed report.)
  • 2019 — By Drs. Mehta and Muscarella, the first peer-reviewed article:
    • to publicize comprehensively the potentially unrecognized risk of bronchoscopes transmitting “superbugs” including CRE; and
    • to suggest that the cleaning and high-level disinfection of bronchoscopes performed in accordance with manufacturer instructions may not always be sufficiently effective to eliminate contamination and prevent patient infections.

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  Colonoscopes Posing a Risk of Life-Threatening “CRE” Infections

  • 2019 (January) — First to advise the public of the risk of colonoscopes transmitting the “CRE” superbug.

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  Adhesive Deterioration of the Endoscope Due to Several Factors Including “Chemical Stress”

  • 2022 (January) — First to discuss publicly, in detail, safety concerns about the deterioration (e.g., a gap, crack or discontinuity) of the adhesive, sealant or glue at the distal end not only of duodenoscopes but also of ultrasonic gastroscopes (as well as bronchoscopes and cystoscopes too).
    • Deterioration of the endoscope’s adhesives can increase the risk of the endoscope’s contamination and patient infection due to ineffective reprocessing.
      • First to discuss publicly that the deterioration of these adhesives can be caused by, among other factors, the endoscope undergoing “chemical stress” or chemical damage due to incompatible chemical agents used to reprocess the endoscope as well as reprocessing over time.

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  “Supplemental Measures” Are Not Just for Duodenoscopes

  • 2018 (March) — First to advise U.S. hospitals to consider adopting an enhanced measure to improve safety and prevent bronchoscopes (and other types of flexible endoscopes) from infecting patients with CRE and related superbugs.
    • First to advise in this 2018 article that “supplemental measures,’ including sterilization, be considered not just for duodenoscopes but also for bronchoscopes, cystoscopes, echoendoscopes, gastroscopes and ureteroscopes.

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  Duodenoscopes and Colistin-Resistant Bacteria 

  • 2017 (September) — First to warn the public of the potential association between duodenoscopes and the transmission of colistin-resistant bacteria. These bacteria can be untreatable and more dangerous than CRE. (A year later, this risk was acknowledged and publicized in a peer-reviewed study.)

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  Flexible intubation endoscopes and multidrug-resistant bacteria

  • 2018 (November) — First to advise the public of the potential for flexible intubation endoscopes to transmit multidrug-resistant bacteria.

3. A TIERED ENDOSCOPE SCHEME BASED ON THE RESPECTIVE INFECTION RISK

• Classifying Certain Flexible Endoscope Based on Their Respective Infection Risk
  • 2018 — First to recommend that certain flexible endoscopes — including bronchoscopes, linear array echoendoscopes and ureteroscopes — pose a higher risk of remaining contaminated after reprocessing and transmitting multidrug-resistant organisms compared to other endoscope types (e.g., colonoscopes), warranting special reprocessing attention including sterilization “when deemed appropriate, feasible and warranted.”
    • Citation: Muscarella LF. Risk of Flexible Endoscopes, Including Gastroscopes and Echoendoscopes, Transmitting “Superbug” Infections: An Important Update. The Ruhof Corp: Mineola, NY. 2018.
  • 2019 — First to classify flexible endoscopes into three groups — high, intermediate and low — based on the risk of patient infection, particularly of their transmitting multidrug-resistant organisms.
    • Citation: Muscarella LF. Selection of Low-Temperature Sterilization for the Prevention of Multidrug-Resistant Bacterial Infections During Flexible Endoscopy. Ambu: Columbia, MD. 2019
  • Also click here and click here for more information about Dr. Muscarella’s 2019 classification scheme.

4. MONITORING WATER QUALITY IN THE HEALTHCARE SETTING

• Monitoring the Microbial Quality of the Water Used to Rinse Flexible Endoscopes
  • 2000 — First to suggest that the water used to rinse flexible endoscopes after chemical disinfection (along with the endoscope itself) be microbiologically sampled to confirm its safety and lack of bacterial contaminants that could pose an infection risk.
  • 2002 — First to recommend that the water used to rinse flexible endoscopes be microbiologically monitored for bacterial contamination to prevent transmitting infectious waterborne bacteria, such as Pseudomonas spp., to patients.
    • Dr. Muscarella wrote in this article that “the CDC, AAMI and other endoscopy and infection (control) organizations are encouraged to adopt this article’s recommendation to sample the rinse water used during endoscope reprocessing.”
  • 2004 — Also read Dr. Muscarella’s article: “The importance of bronchoscope reprocessing guidelines: raising the standard of care,” which further discusses Dr. Muscarella’s recommendation to periodically monitor the rinse water.

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  Contamination of Tap Water with Antibiotic-Resistant Pseudomonas aeruginosa

  • 2004 — First to discuss publicly that the environment (e.g., tap water) can be a potential source of antibiotic-resistant Pseudomonas aeruginosa colonizations and infections following flexible endoscopic procedures, such as bronchoscopy.

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  “Sterile” Filtered Rinse Water

  • 2000 — First to identify an FDA oversight and report that tap water filtered through a 0.1 or 0.2 micron bacterial filter cannot yield “sterile” water in the healthcare setting, although under ideal conditions the process can produce “bacteria-free” water.
    • Almost a decade later, FDA agreed with Dr. Muscarella.

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  “Wet Bronchoscopes and other Types of Flexible Endoscopes

  • 2004 — First to recommend that “irrespective of the claim of the LCS or AER (i.e., “high-level disinfection” or “liquid sterilization”), or the quality of the water used for rinsing (eg, tap water, “bacteria-free” water, or water labeled as “sterile”), the endoscope be dried after reprocessing both between patient procedures and prior to storage.” (LCS = liquid chemical sterilant; AER = automated endoscope reprocessor)
    • Otherwise, if the endoscope is not dried after water rinsing and reused again on a patient, clinicians could introduce an bronchoscope wet with rinse water into a patient’s lungs.
      • A basic principle of sterile technique and infection prevention states that a wet or moist instrument is a potentially contaminated instrument requiring, therefore, disinfection or sterilization be performed again prior to he instrument’s clinical use.
        • CDC: “Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces.”

5. HEATER-COOLER DEVICES

• Heater-Cooler Devices and Infections of Nontuberculous Mycobacteria (NTM)
  • 2014 (June) — First to warn the public about the association between contaminated heater-cooler devices and mycobacterial (NTM) infections among open-chest surgery patients, and that this risk was not local, but likely a national (if not global) concern.

6. RIGID ENDOSCOPES

• Rigid Laryngoscope Blades and Handles

• • 2004 — First to recommend (in the peer-reviewed literature) high-level disinfection of the rigid laryngoscope’s blade and handle
  • 2007 — Again, Dr. Muscarella recommend (in the peer-reviewed literature) high-level disinfection of the rigid laryngoscope’s blade and handle.
    • 2007 — The State of California adapted Muscarella’s first-of-its-kind recommendations for cleaning and disinfecting laryngoscope blades and handles. As the state wrote in 2007: “To our knowledge (Dr. Muscarella’s) are the only published guidelines specific to reprocessing rigid laryngoscopes.”
    • 2008 — Also click here for more information about Dr. Muscarella’s recommendation.
  • 2012 — Read Dr. Muscarella’s related article, “The Joint Commission’s Recommendation for Reprocessing Rigid Laryngoscopes: Is it Valid?”