August 20, 2015 — A Pasadena hospital is investigating a potentially deadly ‘superbug’ outbreak that is reportedly related to the same type of medical endoscope federal officials have recently linked to several similar types of outbreaks across the U.S.
The endoscope, known as a duodenoscope, is used by medical specialists more than 650,000 times a year in the U.S. to perform endoscopic retrograde cholangiopancreatography, or ERCP.
According to Pasadena’s Huntington Memorial Hospital, at least three of its patients were infected with Pseudomonas bacteria following ERCP. While not yet confirmed by the hospital, this bacteria may be a potentially deadly strain that, like CRE, is resistant to carbapenems, the antibiotic of the “last resort.”
Since 2012, as many as a dozen U.S. hospitals have linked outbreaks of the deadly CRE — or, carbapenem-resistant Enterobacteriaceae — to contaminated duodenoscopes or ERCP.
While acknowledging that Olympus is the manufacturer of the duodenoscope the hospital uses to perform ERCP, officials of this Pasadena hospital are not naming the model.
If the hospital was using the TJF-Q180V model at the time of its outbreak, a significant wrinkle would be added to the circumstances surrounding these infections, as this Olympus model — despite being used by 85% of U.S. hospitals performing ERCP — lacks a legal clearance or FDA approval.
While also not naming the model, Los Angeles’ KNX NewsRadio reports that the endoscope linked by the hospital to the infections was not approved by the FDA, raising suspicions that it is the TJF-Q180V model.
The Los Angeles Times reported earlier this week that this Pasadena hospital’s outbreak first came to the attention of its physicians two months ago, in June.
Four months earlier, in February, the public learned of a deadly outbreak of CRE at UCLA’s Ronald Reagan Medical Center, in Los Angeles (CA) — which, like Huntington Memorial Hospital’s outbreak, was also was linked to ERCP.
Three of UCLA’s eight infected patients reportedly died. An outbreak of the same superbug was also confirmed in early 2015 at neighboring Cedars-Sinai Medical Center.
Officials have not announced whether any of Huntington Memorial Hospital’s infected patients have died.
In addition to duodenoscopes, bronchoscopes — which are used to examine and diagnose diseases of the lungs — have been linked in the U.S. to outbreaks of multidrug-resistant Pseudomonas and CRE. Refer to my recent article, “Contaminated Bronchoscopes Linked in 2014 to A Potential ‘Superbug’ Outbreak: An Under-recognized Risk?”
AERs
Additionally, if the hospital uses an automated endoscope reprocessor, or AER, which is likely, then the AER’s regulatory status, like the duodenoscope’s, could be in question.
Earlier this week, the FDA sent warning letters to Olympus and the other two manufacturers of duodenoscopes sold in the U.S. — Pentax and FujiFilm — citing each for a number of safety violations. Refer to my article, “FDA Warns Three Endoscope Manufacturers for Safety Violations Following Deadly ‘Superbug’ Outbreaks.”
The potential impact of these warning letters on the regulatory status of AERs is addressed in my related article, “A ‘Trickle-Down Effect’: The Potential Impact of the FDA’s Warning About Endoscope Safety on Automated Endoscope Reprocessors.”
Is enough being done to prevent these outbreaks?
Huntington Memorial Hospital’s Pseudomonas outbreak occurred despite the FDA’s issuance of a notice six months ago, in February (2015), that the physical complexity of duodenoscopes may hinder cleaning, posing an increased risk of infections during ERCP.
Since that February notice, the FDA has provided a number of additional recommendations to help hospitals prevent superbug outbreaks following ERCP, although the effectiveness of some of these recommendations has not been validated.
These recommendations include using ethylene oxide (EtO) gas to sterilize duodenoscopes.
Huntington Memorial Hospital’s Pseudomonas outbreak reported earlier this week raises questions about whether enough is being recommended, and practiced.
The Centers for Disease Control and Prevention (CDC) also recently published several recommendations for hospitals to consider. But neither has the effectiveness of some of these recommendations — for example, culturing the endoscope for bacterial contamination prior to its reuse, a process called the “test-and-hold” culturing method — been validated.
The Pasadena hospital’s public statement about the outbreak
Pasadena’s Huntington Memorial Hospital, which confirmed the association of this Pseudomonas outbreak with ERCP, released the following statement earlier this week:
“After discovering a potential link between bacterial growth in a small number of patients who had undergone an ERCP (Endoscopic Retrograde Cholangiopancreatography) procedure with endoscopes manufactured by Olympus, we moved quickly to notify public health authorities, quarantine suspected equipment and closely monitor potentially affected patients.
The link between this bacteria, Pseudomonas, which is a community acquired bacteria found prevalently outside the hospital setting, has not yet been traced to a scope. We are still investigating the potential link and have engaged two nationally renowned medical research facilities for assistance. Even though the link between the scope and bacteria is not confirmed, we alerted the affected patients about a possible link as well as reported the bacterial growth to health officials.
We care deeply for every patient and believe our track record of providing high-quality, patient-centered care reflects this. As with any medical procedure, the risk and benefit was carefully weighed. As a large hospital that provides leading-edge procedures, we take very seriously the responsibility of informed consent before any procedure. The patients who experienced the bacterial growth were very ill before they underwent the scope procedure, and the risk of the procedure was explained to each patient and family.
This is a problem facing every hospital and we will be part of the solution. Guidelines in place for disinfecting and monitoring scopes for bacterial growth are in line with FDA and manufacturer standards. We cannot deprive appropriate care to patients whose health issues can be relieved or addressed through the use of these scopes, but we are proceeding with an abundance of caution in our disinfecting and monitoring protocols to ensure patient safety.” — Paula Verrette, MD, of Huntington Memorial Hospital.
Quality and Safety Services for Hospitals, Manufacturers, Patients: Click here to read about Dr. Muscarella’s quality and safety services committed to reducing the risk of healthcare-associated infections, including CRE outbreaks linked to contaminated endoscopes and other reusable medical equipment.
A discussion about the ERCP informed patient consent process
This Pasadena hospital’s Pseudomonas outbreak, like many other previously reported CRE outbreaks linked to contaminated duodenoscopes, presents a myriad of medical complications for the infected patients.
It also places Huntington Memorial Hospital, like other U.S. hospitals performing ERCP, in a potentially awkward predicament, one that is testing several boundaries — including those that surround the ERCP informed consent process.
The Pasadena hospital’s statement, above, that “We take very seriously the responsibility of informed consent before any procedure,” all but implies that the hospital’s infected patients were notified, prior to undergoing the procedure, of ERCP’s now recognized increased risk of potentially untreatable superbug infections.
This hospital’s statement is one of the first to introduce the topic of informed consent into these discussions about superbug outbreaks following ERCP. Its statement also raises questions about what hospitals do, and do not, have a legal (and ethical) responsibility to tell patients who are scheduled to undergo ERCP, especially if the duodenoscope used to perform the procedure is “misbranded.”
These superbug outbreaks are also awkwardly challenging the relationship between the patient, the physician and the physician’s employer: the hospital. In these instances, the line that distinguishes the patient’s interests from those of the hospital’s can become blurred.
Notably, in its Interim Duodenoscope Surveillance document published earlier this year, the CDC states, under the heading “Patient Information and Notification”:
“Patients undergoing procedures using duodenoscopes should be informed during the consenting process that there is a risk of patient-to-patient bacterial transmission associated with the procedure, including uncommon transmission of a multidrug-resistant organism.”
Both the CDC’s recommendation and Huntington Memorial Hospital’s implied statement notwithstanding, anecdotal reports suggest that, indeed, patients are generally told during the ERCP informed consent process (prior to the procedure) of the risk of infection, but not of the recently identified increased risk of transmission of CRE or another potentially untreatable superbug during ERCP.
Examples of three ERCP informed consent forms that were arbitrarily retrieved by Google during an internet search include healthcare facilities in Arizona, California, and Virginia.
These anecdotal reports also suggest that neither are patients told prior to undergoing ERCP that a duodenoscope model may be used to perform the procedure that lacks a legal clearance or FDA approval, such as the Olympus TJF-Q180V model.
Whether Huntington Memorial Hospital’s ERCP informed consent form informed its three Pseudomonas-infected patients, prior to their undergoing ERCP, as the hospital’s statement, above, implies, of the increased risk of a superbug infection, as well as of the possibility that the hospital might use a duodenoscope model that lacks a legal approval, or both, has not been publicly disclosed.
Published reports suggest that by disclosing to patients the specific risks of superbug infections associated with ERCP, hospitals can reduce its potential liability while enhancing the patient’s understanding of the procedure.*
As this hospital’s statement (above) stresses, “this is a problem facing every hospital.”
The topic of the ERCP informed consent process warrants further discussion.
My related articles
Readers may refer to the following four related articles I recently published in “Discussions in Infection Control” (a blog) about the risk and impact of superbug outbreaks following ERCP:
- “FDA Warns Three Endoscope Manufacturers for Safety Violations Following Deadly ‘Superbug’ Outbreaks“
Article by: Lawrence F Muscarella, PhD. Posted 8/20/2015; updated 8/27/2015, Rev B.
E: Larry@LFM-HCS.com. Twitter: @MuskiePhD
References
* O’Sullivan S, et al. Are patients informed when they consent to ERCP? Can J Gastroenterol 2002.