April 21, 2014 — Advocate Lutheran General Hospital (Park Ridge, IL) in 2013 linked multiple patient infections and colonizations of carbapenem-resistant Enterobacteriaceae, or “CRE,” to contaminated gastrointestinal (GI) endoscopes.

This is the largest outbreak of this “superbug” bacteria — so named, along with the moniker “nightmarish bacteria,” primarily because of its resistance to most antibiotics, including carbapenems — ever recorded in the U.S.

The details of this hospital’s CRE outbreak are provided in a number of articles written by Lawrence F Muscarella, PhD, and published in his blog (“Discussions in Infection Control“) including in his well-read article: “Overlooked Outbreaks of “CRE” Following GI Endoscopy: A “Superbug” Epidemic in Our Midst?” — click here.

This superbug outbreak is also discussed in an article by the Centers for Disease Control and Prevention (CDC) entitled: “New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013” -> Click here.

Briefly, in 2013, Advocate Lutheran General Hospital notified 243 “at risk” patients, who underwent a certain type of GI endoscopic procedure known as endoscopic retrograde cholangiopancreatography, or “ERCP,” between January, 2013, and September, 2013, of their potential exposure to reusable instrumentation, known as ERCP endoscopes, contaminated with CRE.

But, this hospital’s CRE outbreak may be as distinguished for the number of infected (or colonized) patients as for the watershed moment it presents.

Specifically, this hospital’s outbreak of CRE appears to be the first documented instance of a hospital notifying affected patients of their need to be screened for bacterial infections (and for colonizations, meaning that the patients are asymptomatic carriers, but do not currently display clinical symptoms of infection) as a result of their potential exposure to improperly reprocessed GI endoscopes contaminated with a superbug.

Attention Patients, Healthcare Facilities: Contact Dr. Muscarella in strict confidence – click here – if you have any questions about a possible outbreak of bacteria linked to a contaminated endoscope.

For background, whenever a healthcare facility determines that a breach in the cleaning, disinfection or sterilization of a reusable instrument may have contributed to disease transmission — like Advocate Lutheran General Hospital’s publicized CRE outbreak — patients determined to be “at risk” are often notified, albeit (rightly or wrongly) of the singular risk of their being infected with a blood-borne virus, such as HIV and the hepatitis B and C viruses.

In general, these “at risk” patients are not informed additionally of the potential for the infection-control breach to have also resulted in their infection or colonization with a resistant bacterium, such as CRE.

Facilities should consider surveillance cultures from patients with epidemiological links to CRE case-patients. The goal fo these cultures is to identify additional unrecognized CRE-colonized patients who are a potential source for transmission. — CDC

An exception

With the exception of Advocate Lutheran General Hospital’s notification of these 243 “at risk” patients of the importance of their returning to the hospital to be promptly screened and tested for CRE infection or colonization, no other similar instance of a cohort of patients being notified of the risk of improperly reprocessed GI endoscopes being contaminated with and possibly transmitting a superbug bacteria has been recorded in the U.S.

This hospital’s unique, if unparallelled, actions are commendable and raise for discussion whether a new and notable precedent has now been established.

It may be that a confirmed endoscope-reprocessing breach now warrants that “at risk” patients be notified and screened, not only for viral infections (as has been the norm), but also for infections or colonizations with a superbug, such as CRE. This possibility warrants further discussion.— Lawrence F Muscarella PhD

A new precedent?

More specifically, Advocate Lutheran General Hospital’s notification of these 243 patients of their risk of infection with CRE might have established a new precedent, or waterline, whereby, possibly, as a direct consequence, the FDA, CDC and Veterans Health Administration (VHA), among other organizations and agencies, might consider revising their respective patient-notification standards to require that:

  • all “at risk” patients notified henceforth of the potential for an endoscope-reprocessing breach to result in infection with a blood-borne virus (e.g., HIV) be informed, additionally, of their potential to be infected or colonized with a superbug such as CRE.

Attention Healthcare Facilities: Could your GI endoscopy unit be harboring CRE?  Click here to read about an safety/auditing program specifically designed by Dr. Muscarella – this article’s author – to prevent infection-control breaches and disease transmission during ERCP and other GI endoscopic procedures.

‘Ex post facto’ notification

But Advocate Lutheran General Hospital’s superbug outbreak may not only bear influences on the future; it may also have consequences for the past.

Whether these new considerations might cause the FDA, CDC and/or VHA similarly to urge that:

  • all “at risk” patients who had been previously notified, within the past year or two, of their increased risk of blood-borne viral infections due to an endoscope-reprocessing breach (unrelated to and separate from Advocate Lutheran General Hospital’s outbreak) — at least those patients treated with GI endoscopes of the same type or model as the ones Advocate Lutheran General Hospital linked to its CRE outbreak following ERCP — now be notified, too, ex post facto, of the additional potential for their infection or colonization with a superbug, such as CRE, is unclear, although  could be warranted.

The implications of Advocate Lutheran General Hospital’s patient-notification actions are far-reaching; may be be prophylactically and wisely intended, in part, to prevent person-to-person transmission of this outbreak’s strain of CRE in the community; and are not limited to public health, but would also bring into focus the FDA’s regulation of GI endoscopes and other types of medical devices.

An ‘ex post facto’ candidate?

The reasons for healthcare facilities and administrations having previously informed “at risk” patients of the risk of viral transmissions, but not of bacterial infections too, due to a confirmed endoscope-reprocessing breach are complex.

Consider this example: The Veterans Affairs Office of Inspector General (VA-OIG) published a report in 2009 about 10,000 patients/veterans who were notified of their potential exposure to blood-borne viruses, such as HIV, due to several confirmed instances in Murfreesboro (TN), Augusta (GA), and Miami (FL) of the faulty cleaning and disinfection of reusable GI endoscopic equipment.

This VA-OIG’s report — which is entitled “Use and Reprocessing of Flexible Fiberoptic Endoscopes at VA Medical Facilities” and may be read by clicking here — states that its Clinical Risk Assessment Advisory Board, or CRAAB, limited its consideration of the type of infectious agents that might have been transmitted to patients as a result of these reprocessing missteps solely “to viral illnesses that resulted from cross contamination, and even more specifically, hepatitis B, C and HIV.”

Attention Medical Device Manufacturers:  Could your reusable medical device be harboring CRE?  Click here to read about a quality program designed by this article’s author – Dr. Muscarella – to improve the design of reusable medical instruments and to minimize the likelihood of their association with CRE transmission.

The VA-OIG’s report added that this advisory board “noted that it would take a prolonged time period, e.g., months to years for such infection (due to these reprocessing errors) to become apparent. In contrast, (this advisory  board) noted, bacterial cross contamination would result in illness within days of the endoscopy.”

In short, the VHA decided not to inform any of these 10,000 “at risk” patients of the potential for the faulty cleaning and disinfection of reusable GI endoscopic equipment to expose and possibly infect them with bacteria primarily because of the short time it would take for related instances of bacterial cross contamination to be conspicuous and cause illness.

As a result, none of these patients were told to return to a VA facility to be tested and screened for bacterial infections and colonizations, as Advocate Lutheran General Hospital’s superbug outbreak and consequential actions might suggest is now a necessary action. (If found to be colonized, affected patients would presumably be treated with antibiotics to which the bacteria are not resistant.)

Box: A Fungal Outbreak at a Children’s Hospital: A sign of the times?

One children’s hospital recently acknowledged that it disclosed the cause of a fungal outbreak responsible for five infant deaths almost five years after both the federal Centers for Disease Control and Prevention (CDC) and the state’s health department had investigated the deadly outbreak back in 2008-2009.

This deadly outbreak was linked to infectious fungus that resided in contaminated bed linens. Parents and families found out about it in 2014 through the news media.

Click here to read about this outbreak in a news report (dated: April, 2014), which raises a question:  If all infections in the U.S., such as this children’s hospital’s fungal outbreak, are not publicly reported, even those like this hospital’s that the CDC investigated, then how does the CDC know, as is often publicized in the press — including in this report (click here) in The New York Times in 2014 — that infections rates in the U.S. are dropping?

Without true quality including full disclosure, employed corrective actions to prevent disease transmissions may be flawed and publicized claims about decreases in the infection rates of hospitals in the U.S. may be inaccurate and incomplete.

Read Dr. Muscarella’s article “Dear CDC,” which both is supported by such report’s as this children’s hospital’s and suggests that the infection rate in U.S. hospitals may not be dropping as much as the CDC claims.

Was the VHA wrong to inform the affected patients only of the risk of viral transmissions?   This question is important to ask, but its answer is not clear. Arguing for these patients possibly to be notified of the the risk of bacterial transmissions, too, Advocate Lutheran General Hospital’s actions resulted in 114 returning to the hospital, so far, for screening and further evaluation — 10 and 28 of whom were found to be infected and colonized, respectively, with the outbreak’s strain of CRE.

These findings confirm that dozens of this hospital’s original 243 affected patients could unknowingly be infected, or at least colonized, with the outbreak’s strain of CRE. Possibly calling into question the VHA’s rationale not to inform patients of their potential exposure to infectious bacteria, if colonized with a superbug (as opposed to being infected), these patients would not display symptoms of infections, so they may not know they were carriers.

According to the medical director of a Canadian health group that confirmed that 41 of its patients were either infected or colonized with the superbug CRE (unrelated to endoscopy) between last summer and the end of 2013:  “We are still finding people who are colonized (with CRE) fairly regularly. …  We will continue to have patients who are colonized with this. And the more we screen, the more we are likely to find.” — click here to read this report, dated January 23, 2014.

Whether these patients could be colonized for months with a superbug without becoming infected, and, therefore, could unwittingly transmit this nightmarish bacteria within the community, through certain types of physical contacts (coupled with poor hand-washing and hygiene), seems plausible but certainly has not been confirmed.

Recommended reading: Dr. Muscarella’s article “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” — click here.

In summary, whether the VHA in 2009 should have additionally informed these 10,000 patients of their potential to be colonized (or infected) with a bacterium, not necessarily CRE or another superbug, as a result of the endoscope-reprocessing breaches confirmed by the VA-OIG in its 2009 report is unclear, but debatable.

Is is also unclear whether there is sufficient data and evidence today to suggest that it might now be appropriate for the VHA to contact these 10,000 veterans, ex post facto, and recommend that they be screened for infection or colonization with CRE.

It would be interesting to learn, if these 10,000 affected veterans were called back and screened for an antibiotic-resistant bacterium, whether, compared to a randomized control group, they are associated with a significantly higher incidence of infection or colonization with a superbug.

Note: The CDC has published that medical facilities should consider surveillance cultures from patients with epidemiological links to CRE case-patients (Gupta et al., 2011*).  Which raises a question about a possible response (the goal of which would be to identify unrecognized CRE-colonized patients who are a potential source for transmission):

Does the CDC then, too, recommend that people in the community with “epidemiological links” to those of the 243 “at risk” patients that Advocate Lutheran General Hospital contacted for prompt screening and were found to be infected or colonized with CRE also be screened and tested for colonization or infection with CRE?

Closing remarks

Remaining unknowingly colonized with CRE for months, people can unwittingly be “microbial time bombs,” with the colonizing strain of CRE posing an increased risk of infection if they were to enter certain body sites. A mortality rate of as high as 50% is associated with CRE’s entrance into the bloodstream.

And, if proper hygiene is not exercised (i.e., proper hand washing), then CRE, which may be found in stool, could be unwittingly transmitted from colonized people to others in the community through direct and indirect contact.

Therefore, this article concludes that it is important that patients possibly exposed to CRE while having previously received treatment in a healthcare facility be notified, ex post facto, of the potential for their exposure.

Otherwise, having no reason to return to the facility for evaluation, these colonized patients, despite harboring CRE, could spread CRE in the community, instead of their being in a medical facility, under Contact Precautions, receiving critical care.

The importance, therefore, to public health of all of Advocate Lutheran General Hospital’s 243 patients returning and being screened for CRE infection is underscored.

Article by: Lawrence F Muscarella, PhD, of the think-tank quality company “LFM Healthcare Solutions, LLC” — click here for a list of its services. Posted 1/21/2014, Rev A; updated 4/21/2014, Rev A.

*  Gupta N, et al. Carbapenem-resistant Enterobacteriaceae: Epidemiology and prevention. CID 2011;53(1):606-7.

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