January 16, 2014 — The leading news source Fox News produced the insightful report: “Troubling outbreak of drug-resistant bacteria a growing threat” (January 15, 2014). [Click here to read it and to watch an informative, accompanying video.]
While this report by Fox News, which was aired during its “Sunday Housecall” news program, indisputably provides helpful advice, some of its statements, respectfully, are not entirely correct and could be confusing. A few of these statements, along with the corrected facts, are featured below.
1. Fox News’ “Housecall“: “With an outbreak of ‘nightmare bacteria’ in a Chicago suburb hospital that has infected 40 people in the last year, the threat of drug-resistant bacteria is growing.”
The Facts: Yes, it is true that the threat of becoming infected with a drug-resistant bacteria while receiving care in a hospital is growing, and that at least 40 people — actually, 38 patients of Advocate Lutheran General Hospital (Park Ridge, IL) — were exposed to the superbug known as carbapenem-resistant Enterobacteriaceae, or “CRE” for short, while receiving care at this hospital.
These 38 are members of a larger group of 243 patients, however, who officials of Advocate Lutheran General Hospital contacted in 2013 warning them of their risk of a superbug infection. These 243 patients were assessed to be at risk of infection because of their having undergone a certain type of upper gastrointestinal (GI) endoscopic procedure known as “endoscopic retrograde cholangiopancreatography,” or ERCP, between January and September, 2013, the confirmed time of the outbreak.
During ERCP performed at this hospital, each of these 243 patients were treated with a type of GI endoscope known, quite understandably, as an “ERCP endoscope,” which hospital officials and the Centers for Disease Control and Prevention (CDC) determined was a source of the hospital’s CRE outbreak. [Click here to read the CDC’s report about this outbreak.]
The CDC’s conclusion: The CDC concluded in its report that: “Previous studies have shown an association between ERCP endoscopes and transmission of multi-drug resistant bacteria; the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection.”
Of these 243 patients notified by letter or by telephone, only 114 have returned to Advocate Lutheran General Hospital, so far, for screening and further evaluation. Notably, 10 of these 114 patients were found to be infected with the outbreak’s strain of CRE, and 28 were found to be colonized with CRE (which means that each was determined to be a “carrier” of, but not to display symptoms of clinical infection with, CRE), totaling 38 (28 + 10) patients.
Six additional patients: The CDC identified 6 other infected patients, too, who were treated at a different Illinois medical facility, totaling 44 (38 + 6) patients in northeastern Illinois determined by officials to be either infected or colonized with the outbreak’s strain of CRE.
These findings confirm that more than 100 (243 minus 114) of Advocate Lutheran General Hospital’s 243 “at risk” patients (notified by hospital officials of the importance of being screened) have not yet returned for testing and evaluation, raising the possibility that several more people in the surrounding community of northeastern Illinois may be unknowingly infected, or at least colonized, with the strain of CRE that infected this hospital’s patients following ERCP.
That these more than 100 people could therefore unwittingly be transmitting this nightmarish bacteria within the community, through certain types of physical contacts (coupled with poor hand-washing and hygiene), is possible and has yet to be ruled out. The importance to public health of these remaining patients being screened is underscored.
2. Fox News’ “Housecall”: “In hospitals, the problem is a lack of quality cleaning and disinfecting. CRE in particular grows on respirators, cystoscopies and catheters, making it harder to detect it early.”
The Facts: Most notably, the CDC reports [click here] that CRE may also grow on and be insidiously transmitted by ERCP endoscopes, as Advocate Lutheran General Hospital’s outbreak of CRE following GI endoscopy in 2013 confirmed.
But consider this: What if the design or manufacturing of, or wear-and-tear to, Advocate Lutheran General Hospital’s implicated ERCP endoscopes precluded these complex instruments from being adequately cleaned and disinfected despite diligent efforts to reprocess them, resulting in the patient-to-patient transmission of this hospital’s strain of CRE?
Because of this reasonable possibility, it is not necessarily sound to advance the notion that “the problem is a lack of quality cleaning and disinfecting,” as if poor training or oversights by reprocessing staffer were this CRE outbreak’s primary cause — a conclusion that the CDC the facts do not entirely support.
In short, poor reprocessing quality may have been less to blame for this hospital’s CRE outbreak than apparently the instrument’s complex physical design. As the CDC acknowledged, “… the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection.”
No matter how good the quality of the endoscope’s cleaning, it may not have been sufficient to overcome other contributing circumstances or hindrances. This distinction is important, because this superbug outbreak’s recurrence at other hospitals across the U.S. may only be prevented if every one of the factors that contributed to this strain of CRE’s transmission are correctly identified and then promptly remediated.
In general, unless a defect in the instrument’s design was determined by investigators to be at fault (refer to this blog’s article “Recall of Several Defective Bronchoscope Models in 2001: Recommendations to Stakeholders” — click here), a breach of one of the cleaning or disinfection/sterilization steps was found to be the cause of every instance of disease transmission in the past thirty years linked to a contaminated GI endoscope.
3. Fox News’ “Housecall”: “Once the problem is recognized, isolating the patient or minimizing his or her outside contact is key. By diminishing contact or having whoever comes into the room wear protective gowns, we can decrease the spread of bacteria.”
The Facts: This is good advice, but it does not address the ERCP endoscope’s potential contribution to this hospital’s CRE outbreak. (Again, the CDC concluded that: “… the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection.”)
Isolating infected or colonized patients and diminishing their contact with others are judicious and recommended measures to minimize the likelihood of this superbug’s patient-to-patient transmission in the healthcare setting, but these actions do little to address complex instrument design considerations and to prevent the superbug’s endoscope-to-patient transmission in Advocate Lutheran General Hospital’s GI endoscopy unit.
4. Fox News’ “Housecall”: “The good news is, this is only a “pocket” infection in Chicago and has not yet become a systemic problem across the nation. But other, more common bacteria are becoming problematic. E. coli is a kind of enterobacteriaceae that is made up of a family of 70 organisms that are becoming smarter and smarter.”
The Facts: I respectfully disagree. As readers of my article — “Investigation and Prevention of Bacterial Outbreaks following Endoscopic Retrograde Cholangiopancreatography, or ERCP” (click here to read it) — might attest (in addition to a number of superbug outbreaks that have not been publicly disclosed and remain confidential, and of which Fox News, like other news sources, could not be unaware), close to a dozen other outbreaks of CRE in hospitals both across the U.S. and in Europe have been confirmed following ERCP during the past few years, several during 2013 alone.
Citing (again) the CDC’s report about this CRE outbreak in Illinois: “Previous studies have shown an association between ERCP endoscopes and transmission of multi-drug resistant bacteria.”
In fact, suggesting that the “CRE” outbreak at Advocate Lutheran General Hospital, and its reported cause, is an instance of “deja vu,” Carbonne et al. (2010) — discussing an outbreak in France of the “superbug” KPC-producing Klebsiella pneumoniae type 2 following ERCP, too (click here to read their report) — write that this outbreak:
“… highlights the risk of transmitting multidrug-resistant bacteria through endoscopy, particularly through invasive procedures such as duodenoscopy, and by patient-to-patient transmission in hospital. Our analysis showed that seven of the 17 patients who underwent endoscopy with the same duodenoscope used for the source case were contaminated with the outbreak strain over a period of two months. Together with the indistinguishable PFGE pattern, this strongly suggests that this duodenoscope represented a persistent source of contamination. A review showed that endoscopy-associated outbreaks are related to inadequate endoscope cleaning, although the risk of exogenous infection from endoscopes that have been appropriately reprocessed is very low.“
Other similar examples of this outbreak in CHicago and in France have been recently published. If anything, therefore, Advocate Lutheran General Hospital’s superbug outbreak is not an isolated or a “pocket infection.”
The data suggest that, with significant public-health implications, transmission of CRE following ERCP is, right now, a systemic problem across the nation, and it is one that warrants immediate attention and action.
5. Fox News’ “Housecall”: “Sterilization is very important. Cidex is a common name for a variety of antimicrobial and disinfecting solutions that I use in my own practice and operating room. It’s used on some of our most invasive equipment – but the sanitization shouldn’t stop there. The more we sterilize, the more the patients will be protected.”
The Facts: This statement raises many question, only one of which I will not focus: How does Fox News propose that a hospital’s ERCP endoscopes be sterilized? Is it certain that disinfection — not, for example, a complex instrument design or service flaw — contributed to this outbreak’s true cause and that sterilization would solve the problem and prevent additional cases of CRE infection? Is Fox News recommending that every ERCP endoscope used in U.S. hospitals today be sterilized to prevent more outbreaks?
Cidex: Cidex is the brand name of a high-level disinfect used to reprocess semi-critical instruments, such as GI endoscopes and cystoscopes. Its active ingredient is 2% (alkaline) glutaraldehyde. As used by hospitals in the U.S. to reprocess endoscopes after each clinical use, Cidex does not achieve sterilization.
In truth, there are no validation data whatsoever showing that a GI endoscope, let alone an ERCP endoscope, can be consistently and reliability sterilized using any available method cleared by the FDA.
Further, no sterilizer that uses ethylene oxide (EtO) gas (or another type of low-temperature sterilizing agent) — the CDC states in its report that:
“In September 2013, as a result of the investigation, (the hospital) changed ERCP endoscope reprocessing from automated high-level disinfection to gas sterilization with ethylene oxide; no new cases with exposure to a gas-sterilized ERCP endoscope have been identified — has been cleared by the FDA for being effective for the sterilization ERCP endoscopes.”
In short, the data supporting the effectiveness of EtO gas for reprocessing GI endoscopes have not been validated. Indeed, the employment of a sterilization method may help to reduce the risk of CRE transmission following GI endoscopy.
Yet, disinfectants can continue to be the method of choice and are effective (and many have been cleared by the FDA specifically for reprocessing GI endoscopes) provided the endoscope’s design cooperates and permits contact of the disinfectant with all of the instrument’s potentially contaminated surfaces.
Update: A news report dated February 3, 2015, states that:
“Swedish Medical Center, which performs about 1,000 of the procedures each year, has detected no cases of CRE infection associated with the scopes, said Dr. John H. Vassall, chief medical officer. The hospital uses high-level disinfection practices recommended by the CDC, the FDA and the manufacturer of the scopes, he added, and has not changed practices in response to the Virginia Mason outbreak.”
This finding may support the conclusion that contact of the disinfectant with all of the GI endoscope’s potentially contaminated surfaces likely prevents superbug transmissions.
6. Fox News’ “Housecall“: “Be vigilant during your next appointment with your doctor or dentist. Make sure that all sterilized packages are opened in front of you. If you see a physician using unsterile practices, don’t be afraid to say something. Being aware of these situations and making sanitization a priority, will keep the people around us healthy and the spread of bacteria to a minimum.”
The Facts: Along with its conclusion about a cause of the development of antibiotic-resistant bacteria — “Housecall”: “The overuse of antibiotics is a major contributing factor. Because we often use antibiotics when they are not necessary, bacteria are able to evolve and even become stronger. It’s important that doctors and other health care workers take every precaution when prescribing antibiotics to make sure they are absolutely necessary.”
Fox News could not be more correct about its advice that patients ask questions, be vigilant, and take health matters into their own hands.
In closing, much about this Fox News report is correct and well-taken. Correction or the clarification of a few of its other comments, however, would minimize confusion and advance its pubic-health contribution.
Recommended reading: The following articles and quotes by Dr. Muscarella, this article’s author, discussing Lutheran General Hospital’s CRE outbreak are recommended reading:
- “GI Endoscopy: Pushed Beyond its Reprocessing Limits?” Click here.
- “Largest Outbreak of Dangerous Bacteria in U.S. Tied to GI Endoscopy at a Hospital in Park Ridge, Illinois.” Click here.
- “Overlooked Outbreaks of the Superbug ‘CRE’ Following Gastrointestinal Endoscopy: An Epidemic in Our Midst?” Click here.
- “Investigation and Prevention of Bacterial Outbreaks during Endoscopic Retrograde Cholangiopancreatography (ERCP).” Click here.
- “CDC Confirms Superbug Transmission via Endoscopy – Medscape.” Click here. (Registration is free.)
Article by: Lawrence F Muscarella, PhD, president and owner of the think-tank quality and safety company “LFM Healthcare Solutions” — click here for a list of its services. Posted 1/16/2014. 0001