FIRSTS

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

• “The New York Times”: Lawrence Muscarella “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. 1st to warn the public — prior to FDA, CMS, and the CDC — about the risk of duodenoscopes remaining contaminated and transmitting deadly “superbug” diseases.
2. 1st to warn the public about two (2) adverse event types associated with the use of new duodenoscope models featuring a removable distal endcap: the risk of these single-use endcaps: (1) tearing/lacerating the GI tract’s mucosal tissue, and (2) becoming dislodged and falling off inside the patient’s GI tract or airway.  To date, FDA, CDC and CMS have not advised the public of this safety concern.
3. 1st to warn the public — before the FDA — that bronchoscopes had been linked to “superbug” infections.
4. 1st to warn the public about the risk of colonoscopes remaining contaminated despite cleaning and exposing patients to life-threatening multidrug-resistant organisms. To date, FDA, CDC and CMS have not advised the public of this safety concern.
5. 1st to warn the public about the under-reported risk of gastroscopes remaining contaminated and infecting patients with superbugs, despite being reprocessed according to manufacturers’ instructions. To date, FDA, CDC and CMS have not advised the public of this safety concern.
6. 1st to propose that CMS include “endoscope-associated infections’ as a reportable Medicare measure to incentivize improvements in patient safety.
7. 1st to classify — prior to FDA, CMS, the CDC and AAMI et al. — flexible endoscopes into three (3) groups — high, intermediate and low — based on the risk of patient infection, particularly of their risk of 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. Note: Listen to Dr. Muscarella’s lecture on this topic: “Disinfection or Sterilization of Flexible Endoscopes? A Newly Proposed Classification Scheme.”
8. 1st to identify and publicize the potential for the adhesives or glues at the distal end of certain reusable flexible endoscope models to deteriorate, become chipped, peel, and/or to form “gaps” that prevent effective cleaning, posing an increased risk of device contamination, retained bioburden, and transmission to patients of life-threatening ressitant infections.
9. 1st to advise accreditating agencies and the public that use of immediate use steam sterilization — or IUSS, also known as “flash” sterilization — to process an instrument, and particularly an implant, be recorded in the patient’s chart and documented as part of the patient’s permanent medical record (e.g., patient disclosure) to improve quality and patient safety.
10. 1st to propose that FDA consider using alternative, clearer language in manufacturer warning letters that conclude a regulated device is “misbranded” (or “adulterated”). The purpose of this proposal is to avoid confusion and a potential clinical disclosure predicament.
11. 1st to warn the public that the identified association between contaminated heater-cooler devices and mycobacterial (NTM) infections among open-chest surgery patients was a national (and global) concern and not limited to only one or two U.S. hospitals.
12. 1st to publicize the potential for linear ultrasound “echo” gastroscopes to infect patients with antibiotic-resistant bacteria.
13. 1st to recommended (like 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.
14. 1st 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. 1st 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. 1st to advise the public about the risk for flexible intubation endoscopes to transmit multidrug-resistant bacteria.
18. 1st to recommend in 2002 years prior to AAMI and others — 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. (Note: Dr. Muscarella wrote in this 2002 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.”)
19. 1st to identify and notify the public — before the FDA, AAMI and others —  that tap water filtered through a 0.1 or 0.2 micron bacterial filter does not produce “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.)
20. 1st to advise the public 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.
21. 1st to recommend — prior to FDA, CMS, the CDC and AAMI et al. — 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.”)
22. 1st to advise the public to high-level disinfect (if not sterilize) 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.”)