This article by Lawrence F Muscarella, PhD, discusses the Veterans Health Administration’s (VHA) assessment in 2009 that the risk of healthcare-acquired infections associated with several instrument-reprocessing breaches recently identified within the VA Caribbean Healthcare System (located in San Juan, Puerto Rico) is “negligible.”
BACKGROUND
For the second time in as many years, the Veterans Affairs Office of Inspector General (VAOIG) issued a report in March (2010) documenting the improper cleaning and disinfecting of reusable medical equipment, including flexible endoscopes and transvaginal ultrasound transducers, by medical facilities within the Veterans Health Administration (VHA).[1,2]
Click here to read a front-page newspaper article “Infection Control Breaches Unveiled at Veterans Medical Center” (June, 2009) that discusses these adverse events identified in the Caribbean.
Specifically, this report by the VAOIG details the findings of its Office of Healthcare Inspections, which—based on a complaint alleging adverse events that posed a risk of patient-to-patient disease transmission—inspected, during the summer of 2009, a number of medical facilities within the VHA’s VA Caribbean Healthcare System.
This healthcare system includes a Veterans Affairs medical center (VAMC) located in San Juan, Puerto Rico, and outpatient clinics located in the surrounding municipalities, including Ponce and Mayaguez, and in St. Thomas and St. Croix (both of the U.S. Virgin Islands).[1]
Described in its report, the VAOIG confirmed during the inspections of these facilities several infection-control breaches, including the:
- failure to high-level disinfect trans-vaginal ultrasound transducers;
- improper cleaning of flexible laryngoscopes;
- failure to leak-test colonoscopes and flexible laryngoscopes; and
- the (routine) use of both a damaged flexible laryngoscope and a misbranded flexible laryngoscope. Also described in this report is the VHA’s assessment of the risk of infection associated with these several breaches.
Deja vu?
These confirmed instrument reprocessing breaches—which are summarized in a front-page newspaper article, which can be read by clicking here—do not appear to be isolated or necessarily rare events.
As if a case of déjà vu, these breaches are markedly similar in type and detail to those substantiated, and discussed in meticulous detail, in another report the VAOIG published just one year earlier, in June, 2009.[2]
The infection-control breaches confirmed by the VAOIG within the VA Caribbean Healthcare System do not appear to be isolated or necessarily rare. — Lawrence F Muscarella, PhD
Documented in this earlier report, the VAOIG determined that, during 2008 and 2009, three other medical facilities within the VHA—namely, VAMCs located in Murfreesboro (TN), Augusta (GA), and Miami (FL)—had similarly failed to reprocess flexible endoscopes and other reusable medical equipment, as required.[2]
These infection-control breaches—which were the focus of several national news reports and congressional hearings—are discussed in more detail in Dr. Muscarella’s related articles:
- “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” — click here; and
- “Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices” World J Clin Infect Dis 2012 April 25; 2(2): 13-27 — click here.
“Fundamental defects”
The VAOIG published in this earlier report that the instrument-reprocessing breaches it substantiated at these three VAMCs (in Murfreesboro, Augusta, and Miami) were a consequence of “fundamental defects” within the structure of the VHA that posed “a risk of infectious disease to veterans.”[2]
The VHA’s policies of patient disclosure laudably emphasize a “presumptive obligation” to inform patients of potentially harmful adverse events. — Lawrence F Muscarella, PhD
The VHA, therefore, notified more than 10,000 patients of the risk of their exposure to infectious agents, including HIV and the hepatitis B (HBV) and C (HCV) viruses,[2] as prescribed by its policies of patient disclosure.[1,3]
Demonstrating “respect for the patient, professionalism, and a commitment to improving care,” the VHA’s policies of patient disclosure emphasize its “ethical,” “legal” and “presumptive obligation” to inform patients of “harmful or potentially harmful” adverse events, even those that “may not be obvious or severe.”[3]
Confidential Quality and Safety Healthcare Services, Risk Assessments, and Legal Reviews for Hospitals, Manufacturers and the Public: 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.
A “negligible” risk of infection
Although markedly similar to those that the VAOIG substantiated one year earlier at these three VAMCs (in Murfreesboro, Augusta, and Miami) and that the VHA concluded posed a significant risk of infection,[2] the VHA, in contrast, concluded that the instrument-reprocessing breaches confirmed by the VAOIG within the VA Caribbean Healthcare System posed a “negligible”1 risk of infection (and, therefore, did not warrant patient disclosure).[1]
For reference, the reader s directed to Table 1 of Dr. Muscarella’s related article “A Tale of Two Assessments of the Risk of Disease Transmission” — click here.
PURPOSE and METHODOLOGY
The medical literature and these two reports issued by the VAOIG one year apart (in June, 2009,[2] and March, 2010[1]) were reviewed:
- first, to evaluate the correctness of the VHA’s assessment that the instrument-reprocessing breaches confirmed within the VA Caribbean Healthcare System posed a negligible risk of infection; and
- second, to provide recommendations to prevent disease transmission vis-à-vis these specific breaches (because the VAOIG’s report[1] did not include any such recommendations) — these recommendations may be read by clicking here.
RESULTS
At odds with the VHA’s assessment of a negligible risk of infection,[1] this review identified studies that suggest that the several breaches confirmed within the VA Caribbean Healthcare System would pose an increased risk of disease transmission warranting patient notification.
DISCUSSION
This conclusion notably contrasts with—and calls into question the soundness of—the VHA’s assessment, advanced by the VAOIG,[1] that the risk of infection associated with the infection-control breaches confirmed within the VA Caribbean Healthcare System is negligible (not warranting patient disclosure).[1]
Moreover, the similarities between the instrument reprocessing breaches confirmed within the VA Caribbean Healthcare System and those substantiated one year earlier at the three VAMCs in Murfreesboro, Augusta and Miami—in one instance, the same breach was identified: the improper reprocessing of flexible laryngoscopes—suggest
- that important lessons within the VHA are not being adequately taught and/or learned;
- the aforementioned “fundamental defects” identified by the VHA within its own structure remain intact; and,
- that the VHA’s commitment to quality assurance, to complying with its own policies vis-à-vis patient disclosure,[3] and to public health would appear lacking.
As this review confirmed, trans-vaginal ultrasound transducers, colonoscopes, and flexible laryngoscopes are semi-critical instruments that pose an increased risk of infections if not properly cleaned and high-level disinfected (or sterilized) after each use.[1,2,4-15]
Moreover, the leak testing† of flexible endoscopes is a reprocessing step that is necessary to detect damage that could result in the contamination of the endoscope’s internal structures and disease transmission.[1,8-12]
Calling into question the VHA’s assessment, this review suggests that the breaches confirmed by the VAOIG within the VA Caribbean Healthcare System posed an increased—not negligible—risk of patient infection. — Lawrence F Muscarella, PhD
[† During leak testing, equipment is used to pressurize with air the flexible endoscope’s internal structures. This equipment, which may be little more than a manometer, typically features a gauge to display the air’s pressure. A drop in air pressure generally indicates a leaking and damaged endoscope.]
A. Failure to high-level disinfect trans-vaginal ultrasound transducers or probes.
Acknowledging that at least one of the medical facilities within the VA Caribbean Healthcare System (i.e., the outpatient clinic in Mayaguez) failed to high-level disinfect (or sterilize) trans-vaginal ultrasound transducers after each use, the VAOIG states in its report that staff covered these transducers with a sheath, presumably to minimize the risk of contamination and disease transmission.[1]
But, a study by Kac et al. (2010) reports that trans-vaginal (and trans-rectal) ultrasound transducers, including those covered with a sheath, were contaminated after use with potentially infectious agents, including Klebsiella spp., Pseudomonas spp. and the human papilloma virus (HPV)—the latter of which has been linked to cervical and anogenital cancers.[5]
And, according to the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC), because sheaths can have a high rate of perforations and failure, at least high-level disinfection of these transducers, therefore, is necessary, whether or not a sheath is used to cover them.[13,14,16,17]
In agreement with the FDA,[13] Kac et al. (2010) write that “micro-perforations” may form within the sheath before or during the procedure, permitting blood and other potentially infectious materials to contaminate the “covered” transducer via the sheath’s “open rim.”[5]
Click here to read Dr. Muscarella’s related article “The Reprocessing of Sheathed “ENT” Endoscopes and Cystoscopes.”
These authors conclude:
- that sheaths may fail and are “inefficient at preventing contamination”;[5]
- like flexible laryngoscopes, these transducers may become contaminated during handling, or when the sheath is placed onto, or removed from, them;[13,14] and
- improper reprocessing of these transducers may result in “HPV cross-transmission.”[5]
Inconsistent with the VHA’s assessment of a “negligible” risk of infection,[1] published reports suggest that the improper reprocessing of trans-vaginal ultrasound transducers within the VA Caribbean Healthcare System would pose an increased risk of infection, warranting the disclosure of this potentially adverse event to patients.[3,5,13-19] — Lawrence F Muscarella, PhD
B. Improper reprocessing of larynogoscopes
Like Kac et al.’s (2010) study discussing trans-vaginal ultrasound transducers, several studies similarly indicate that flexible (and rigid) laryngoscopes may become contaminated with and transmit blood and other potentially infectious materials.[5,16,17]
Similarly inconsistent with the VHA’s assessment of a negligible risk of infection,[1] these published studies suggest that the improper reprocessing of flexible laryngoscopes within the VA Caribbean Healthcare System would pose an increased risk of infection warranting patient notification.[3,16-19]
The VHA’s assessment of a negligible risk of infection notwithstanding,[1] these studies discussing the contamination of flexible laryngoscopes are consistent with another of the VHA’s risk assessments, which, published by the VAOIG one year earlier, concluded that the infection-control breaches identified at the three VAMCs in Murfreesboro, Augusta and Miami posed a significant risk of infection.[2]
A re-assessment by the VHA of the risk of infection associated with the breaches confirmed within the VA Caribbean Healthcare System is recommended. — Lawrence F Muscarella PhD
These published studies also corroborate the conclusions presented by the VAOIG in June, 2009, when, testifying about the breaches substantiated at these three VAMCs, it stated that:
“the impact of improper high level disinfection of reusable endoscopes places veterans at risk of infection,” adding that viruses, including HBV and HCV, “have been transmitted through endoscopes.”[18,19]
That the VHA provided two such incongruous assessments of risk for the same breach—namely, the improper reprocessing of flexible laryngoscopes at a VAMC in San Juan (PR) (a negligible risk[1]) and at one in Augusta (GA) (a significant risk[2]) identified a year apart—would also suggest, not only that one of these two assessments is necessarily unsound, but also that there are deficiencies in the process by which the VHA evaluates the risk of infection associated with infection-control breaches.
Also notable, the VAOIG’s report discussing the infection-control breaches within the VA Caribbean Healthcare System failed to disclose a most critical consideration: that one of this healthcare system’s outpatient clinics (in Ponce, PR) was using on patients a misbranded flexible laryngoscope.[20] According to the FDA, the safety and effectiveness of such a device cannot be assured.[21,22]
C. Failure to leak test flexible endoscopes
DiazGranados et al. (2009) causally linked the use of a damaged flexible endoscope (a bronchoscope) to an outbreak (or pseudo-outbreak) of P. aeruginosa.[10]
Similarly, Ramsey et al. (2002) reported the patient-to-patient transmission of respiratory tuberculosis due to the use of a damaged flexible endoscope (also a bronchoscope).[11]
Routine leak testing of the endoscope—a crucial reprocessing step that Ramsey et al. (2002) acknowledged might have preemptively detected this damage and the accumulation within the endoscope of inaccessible infectious materials—was not performed.
Similarly inconsistent with the VHA’s assessment of a negligible risk of infection,[1] these studies by DiazGranados et al. (2009) and Ramsey et al. (2002) suggest that, like the use of a misbranded flexible laryngoscope, the VA Caribbean Healthcare System’s both failure to perform leak testing and (routine) use of a damaged flexible laryngoscope would pose an increased risk of infection warranting the disclosure to patients of this potentially adverse event.[10,11,18,19]
CONCLUSION
Suggesting that the VHA’s assessment advanced by the VAOIG in its report—namely, that the risk of infection associated with the several instrument-reprocessing breaches confirmed within the VA Caribbean Healthcare System was negligible[1]—is in error, the findings of this review conclude that these breaches would pose an increased risk of disease transmission[4-8,10-22] warranting patient notification as prescribed by the VHA’s own policies.[3]
A re-assessment by the VHA of the risk of infection associated with these breaches, therefore, would appear necessary—lest healthcare staff erroneously (though understandably) interpret the VAOIG’s report to be perilously suggesting that, if, as the VHA claims, their improper reprocessing posed a negligible risk of infection,[1] then the proper reprocessing of reusable medical equipment is superfluous and unnecessary.[15,16]
The references to this blog may be read by clicking here.
Article by: Lawrence F. Muscarella PhD posted on 1-10-2013; updated: 8/5/2014.
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, manufacturer and the public. Email Dr. Muscarella for more details.