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. 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.
2. First to publicize the potential for linear ultrasound “echo” gastroscopes to infect patients with Pseudomonas aeruginosa and Klebsiella pneumoniae, which can be deadly “superbugs.”
3. First to recommended (along with Sun et al., also to 2018) that healthcare facilities consider adopting one or more “supplemental measures” to reduce the risk of linear-array ultrasound gastroscopes — which, like duodenoscopes, feature an elevator mechanism — infecting patients with multidrug-resistant organisms.
4. 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.
5. First to publicize the risk of gastroscopes infecting patients with CRE and other potentially deadly superbugs, despite being reprocessing according to their manufacturers’ instructions.
6. First to recommend in 2016 and again in 2022 and 2023 that federal officials consider publishing a public safety notice to raise awareness and reduce the risk of a “reprocessed” gastroscope remaining persistently contaminated and infecting patients to potentially deadly CRE and related superbugs.
7. First to publicize that the risk of gastroscopes transmitting multidrug-resistant organisms and related superbugs including “CRE” appears to be under-recognized and under-reported.
8. First to warn the public that bronchoscopes had been linked to infections of CRE in the U.S.
9. First to publicize the warning that the  U.S. appeared to be in the midst of an overlooked “epidemic” of outbreaks of superbugs, including CRE, linked to duodenoscopes.
10. First to warn the public 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.
11. First to publicize, along with Dr. Atul Mehta, the potentially unrecognized risk of bronchoscopes transmitting “superbugs” including CRE; and the first two 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.
12. First to warn the publci about the risk of colonoscopes transmitting the “CRE” superbug.
13. First to discuss publicly, in detail, safety concerns about — and specifically, the increased risk of cross-infection associated with — 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).
14. First to advise 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.
15. First to advise that “supplemental measures,’ including sterilization, be considered not just for duodenoscopes but also for bronchoscopes, cystoscopes, echoendoscopes, gastroscopes and ureteroscopes.
16. First to warn the public of the potential association between patient exposure to a duodenoscope and the transmission of colistin-resistant bacteria. These bacteria can be untreatable and more dangerous than CRE.
17. First to advise the public of the potential for flexible intubation endoscopes to transmit multidrug-resistant bacteria.
18. First to publish 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.
19. First to clasify 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.
20. First to recommend that the water used to rinse flexible endoscopes after disinfection 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.”
21. 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.)
22. 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.
23. First to recommend that “irrespective of the claim of the liquid chemical sterilant or automated endoscope reprocess (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.” (CDC: “Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces.”)
24. First to recommend high-level disinfection of the rigid laryngoscope’s blade and handle. (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.”)