March 21, 2017 (9:58 pm ET) — A “corrected” duodenoscope design introduced last year by the manufacturer to replace a recalled device has been linked to a “superbug” cluster, I have learned.
The recalled duodenoscope had been a focus of the FDA in 2015, as well as of a 2016 U.S. congressional report, after being linked to several deadly CRE outbreaks in the U.S. and Europe.
Some of the more well-publicized, deadly outbreaks linked to this recalled duodenoscope included those at the Erasmus University Medical Center (the Netherlands), in 2012, and at UCLA’s Ronald Reagan Medical Center (Los Angeles, CA), in Dec. 2014, among others prominent hospitals using the TJF-Q180V device.
Last year on Jan. 15th, Olympus America wrote a letter informing customers that the company was voluntarily recalling the TJF-Q180V duodenoscope.
In the letter, Olympus (Center Valley, PA) instructed customers to return to the company the original TJF-Q180V duodenoscopes being used at the time — Olympus called these recalled devices “current” or “existing” models — for repair and replacement of a component of the endoscope, called the forceps elevator mechanism, with the newly corrected design cleared in Jan. 2016.
On the same day, the FDA issued a news release further announcing the clearance of Olympus’s newly designed duodenoscope model of the same name.
Olympus had previously acknowledged, in 2015, that it had been marketing the recalled TJF-Q180V since 2010, albeit without a legal clearance.
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A Timeline Update — April 5, 2017:
- March 21, 2017: This article was published two weeks ago, reporting (for the first time) that the “repaired” TJF-Q180V duodenoscope introduced in 2016 has been linked to a superbug cluster.
- March 22, 2017: The next day, the Los Angeles Times published the article: “Olympus’ redesigned scope linked to infection outbreak.”
- April 3, 2017: Two weeks later, U.S. Senator Patty Murray (D-WA) wrote a letter to Olympus informally entitled, “Following New Reports of Drug-Resistant Outbreak, Sen. Murray Calls on Olympus to Verify Medical Scopes are Safe for Use in U.S.”
- In this letter, the Senator asks Olympus “for more information” about this superbug cluster, including requesting the company’s validation data demonstrating that “repaired” Olympus TJF-Q180V duodenoscopes “can be reprocessed effectively.”
- April 4, 2017: The next day, the Los Angeles Times published an update that discussed Sen. Patty Murray’s letter to Olympus and her request to review the data showing that the redesigned, corrected TJF-Q180V models is safe.
New forceps elevator mechanism
This new forceps elevator mechanism design features “minor changes to the dimensional tolerance,” although these changes will not be visually apparent to the customer, according to information Olympus posted on its website.
Olympus estimated last year that the recalled forceps elevator mechanism on all of these existing TJF-Q180V models — approximately 4,400 devices — would be repaired by August 2016, according to the FDA’s Jan. 15, 2016, news release.
Olympus named both the original, recalled model and the newly-cleared, modified model the TJF-Q180V duodenoscope.
CRE is an acronym for carbapenem-resistant Enterobacteriaceae. As their name indicates, these life-threatening, nightmarish bacteria are resistant to carbapenems — the antibiotics of last resort for the treatment of certain serious infections.
This is the first published article to report that the TJF-Q180V’s new design that the FDA cleared in Jan. 2016 has been linked to a superbug cluster. (Being linked to an infection does not assure the device was the cause of the infection.)
The primary cause of this superbug cluster has not been independently determined.
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The superbug cluster
Last month, Olympus filed five regulatory reports notifying the FDA that five patients had tested “positive” for multidrug-resistant Klebsiella pneumoniae — a type of CRE — following ERCP performed less than two months earlier, between Dec. 6 and Dec. 26, using the TJF-Q180V duodenoscope.
In general, a patient testing “positive” for bacteria is infected or asymptomatically colonized. If the same strain of bacteria infects two or more patients, then this cluster would define an outbreak.
According to these reports (one of which may be read by clicking here-report #1), Olympus had replaced the TJF-Q180V device’s recalled forceps elevator mechanism, pursuant to the requirements Olympus described in its Jan. 15th customer letter, on Oct. 5, 2016, two months prior to performing ERCP on the five patients.
These reports suggest that the hospital’s duodenoscope linked to this cluster, possibly an outbreak, featured the TJF-Q180V’s newly cleared design, not the original, recalled design that had been the subject of federal warnings beginning in Feb. 2015.
(The other four regulatory reports that Olympus filed documenting this outbreak may be read by clicking here-report#2, here-report#3, here-report#4, and here-report#5.)
Update — Sen. Patty Murray responds to this superbug cluster (April 5, 2017): U.S. Senator Patty Murray (D-WA) wrote a letter on Monday to Olympus informally entitled, “Following New Reports of Drug-Resistant Outbreak, Sen. Murray Calls on Olympus to Verify Medical Scopes are Safe for Use in U.S.“
These five regulatory reports appear to document — possibly for the first time — the association between a cluster of CRE-positive patients and a “corrected” TJF-Q180V duodenoscope featuring the new forceps elevator mechanism, which the FDA cleared in Jan. 2016.
The FDA had announced in its Jan. 15, 2016, news release that this newly cleared TJF-Q180V duodenoscope design is “intended to help reduce the risk of bacterial infections.”
No other public documents or records reviewed for this article — other than these five regulatory reports — describe an association between a potential superbug outbreak and this modified, newly cleared TJF-Q180V duodenoscope.
The mortality rate of patients infected with CRE or a related multidrug-resistant bacteria can be as high as 50%.
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The cluster’s cause
The cause of this superbug cluster has not been determined yet, according to the regulatory reports Olympus filed last month.
One of these five patients died, but Olympus’s filed reports conclude that a “pre-existing pathology,” not the infection, was the cause of death.
The hospital’s implicated duodenoscope, which the regulatory reports identify by the code “04953170229503,” had not been returned to Olympus for closer examination, these reports state.
Whether this code is the implicated TJF-Q180V device’s serial number is unclear. The regulatory reports Olympus filed state that the device was manufactured on September 4, 2015.
Last year, on Jan. 15, the FDA updated an earlier safety communication informing the public that Olympus had validated the new reprocessing instructions for the TJF-Q180V duodenoscope model.
A year earlier, in March 2015, the FDA had published a guidance document recommending that the 510(k) applications submitted for certain “greater risk” devices — such as duodenoscopes and automated endoscope reprocessors, or AERs, among other devices — include “protocols and complete test reports” demonstrating the validation of their cleaning, disinfection or sterilization instructions.
This recommendation would seem to suggest that Olympus may have provided the FDA with the validation data demonstrating the effectiveness of the cleaning and disinfection instructions for the corrected TJF-Q180V — these are the validation data Sen. Murray is now requesting from the company — when the company submitted the premarket 510(k) application to the FDA requesting to market this corrected device, which the agency cleared last year.
Olympus had begun mailing these updated cleaning instructions to customers last year on Feb. 8th, 2016, according to the company’s Jan 15th letter.
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More about the forceps elevator mechanism and ERCP
Endoscopic retrograde cholangiopancreatography, or ERCP, is commonly performed to diagnose and treat certain disorders and diseases of the biliary and pancreatic ductal systems in the upper gastrointestinal tract.
An enclosed wire connects a manually controlled lever on the duodenoscope’s control section to the forceps elevator mechanism located at the tip of the duodenoscope. This mechanism is used to control the direction of endoscopic accessories threaded through the duodenoscope’s working channel during ERCP.
Both the recalled and the newly cleared TJF-Q180V duodenoscopes encase this wire in a “sealed” channel — called the elevator wire channel, which cannot be cleaned or disinfected. In certain older Olympus duodenoscope models, however, this channel was “open” requiring reprocessing to prevent infections.
Meticulous cleaning of the newly cleared TJF-Q180V’s forceps elevator mechanism remains a requirement.
ERCP is performed more than 500,000 times annually in the U.S. using a duodenoscope, like the TJF-Q180V, according to the FDA. Along with Olympus, Pentax Medical (Montvale, NJ) and FujiFilm Medical Systems (Wayne, NJ) manufacture the ED-3490TK and ED-530XT duodenoscope models, respectively.
According to a report issued by a senate committee on Jan. 13, 2016, two days before the TJF-Q180V’s recall, Olympus manufactures 85% of these duodenoscopes, with the lion’s share being the TJF-Q180V model.
In Feb. 2015, the FDA warned that the moving parts of the (recalled) TJF-Q180V’s forceps elevator mechanism contain microscopic crevices that may impede effective cleaning using a brush. Consequently, “residual body fluids and organic debris may remain in these crevices after cleaning and disinfection,” posing a risk of infection the FDA further cautioned.
According to the FDA’s Jan. 15, 2016 news release, “Olympus modified its design of the elevator channel sealing mechanism to create a tighter seal,” adding that this new mechanism is designed to “reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.”
More about the duodenoscope recall
The TJF-Q180V’s 2016 clearance features an updated operator’s manual and reprocessing instructions to require, among other changes, that this model’s forceps elevator mechanism be inspected annually by Olympus service personnel.
Olympus “plans to conduct annual inspections of each scope in use by facilities to identify any wear and tear on the elevator channel sealing mechanism or the presence of attached debris at the scope’s tip, which would require replacement of the potentially contaminated parts,” the FDA further elaborated in its Jan. 15 news release.
The TJF-Q180V model’s new instructions also provide updated parameters for using ethylene oxide gas to sterilize the duodenoscope, as well as requiring that the device be manually cleaned “even when using an Automated Endoscope Reprocessor (AER)” (that may be labeled to eliminate such cleaning).
The serial number of TJF-Q180V duodenoscopes manufactured with the newly cleared forceps elevator mechanism design uses “1″ as its third digit, distinguishing these devices from the original model whose design was recalled and repaired.
(Existing duodenoscopes that were repaired per the terms of, and manufactured prior to, the TJF-Q180V’s Jan. 2016 clearance would feature their original serial number.)
Device, design corrections
Olympus and the FDA have, at times, called the replacement of the TJF-Q180V duodenoscope’s recalled forceps elevator mechanism with the newly cleared design a “device removal,” a “repair,” a “corrective action,” and/or “a recall.”
In most other cases, such “corrections” of medical devices currently in use by hospitals are performed on devices that the FDA had previously cleared.
Whether the FDA has concluded that Olympus’s repair and replacement of this recalled forceps elevator mechanism on existing TJF-Q180V devices (manufactured prior to the model’s Jan. 2016 clearance) with the new design, in effect, renders these existing, corrected TJF-Q180V devices FDA-cleared, too, is unclear, though possible.
If so, then it would seem that Olympus recalled and repaired the original design of the TJF-Q180V’s forceps elevator mechanism, receiving a new clearance for this modified design — not per se for the device itself.
The FDA defines a “recall” as a company’s removal or correction of a marketed product that the FDA considers to be “in violation of the laws it administers and against which the agency would initiate legal action.”
OXA-48-producing Kl. pneumoniae
The regulatory reports Olympus filed last month appear to be the first, at least in the FDA’s medical device database, to associate a superbug cluster with a TJF-Q180V duodenoscope featuring the newly designed and “corrected” forceps elevator mechanism.
According to these regulatory reports, five patients tested positive for OXA-48-producing Klebsiella pneumoniae following ERCP performed in December using a TJF-Q180V duodenoscope (whose forceps elevator mechanism, according to the reports, had been corrected two months earlier in October).
The hospital reprocessed the duodenoscope using an AER sold by Soluscope, according to the regulatory reports. Certain findings in these reports suggest this cluster may have occurred in Europe, possibly France, although this could not be confirmed.
OXA-48-producing Kl. pneumoniae is a type of superbug that carries the blaOXA-48 gene, which encodes for an enzyme that can hydrolyze (dismantle) carbapenems, generally rendering these antibiotics ineffective for the treatment of serious bacterial infections.
It would therefore appear that the OXA-48-producing Kl. pneumoniae strain discussed in the five regulatory reports Olympus filed confers carbapenem resistance — and, therefore, is CRE.
Like these five regulatory reports, a German report published in 2015 linked an outbreak of carbapenem-resistant OXA-48–producing Klebsiella pneumoniae to ERCP.
Another study published two years earlier in 2013 reported an outbreak of OXA-48-producing Kl. pneumoniae in a German hospital, but these infections were linked to contaminated bronchoscopes, not duodenoscopes.
Soluscope (Aubagne, France) does not currently market an AER model sold in the U.S.
Not all multidrug-resistant superbugs linked to a contaminated duodenoscope are bona fide CRE, however.
For example, although these superbugs can be just as deadly, the 2012 outbreak at the Erasmus University Medical Center, for instance, was linked to contamination of the (recalled) TJF-Q180V duodenoscope with multidrug-resistant Pseudomonas aeruginosa. While these bacteria were resistant to carbapenems, they are not CRE, because P. aeruginosa is of the Pseudomonadaceae — not the Enterobacteriaceae — family.
Another regulatory report involving the TJF-Q180V
Last August, seven months after Olympus voluntarily recalled the TJF-Q180V duodenoscope on Jan. 15, 2016, a different hospital filed an unrelated regulatory report with the FDA describing contamination of the Olympus TJF-Q180V duodenoscope.
The report, which the FDA received on August 1, 2016, states that, “Through our routine microbiological surveillance cultures of duodenoscopes, we have identified an olympus duodenoscope {TEXT REDACTED} that has cultured {TEXT REDACTED; possibly the word “positive” was used} for {TEXT REDACTED — whether the redacted word is “CRE” is possible but unknown} on 2 occasions despite several rounds of high level disinfection and sterilization.”
This regulatory report also states that, “Once after our routine repeat high level disinfection process (2x hld) and then through the {TEXT REDACTED; the state or county’s name is crossed-out} department of public health that the {TEXT REDACTED} isolates only differed by three bands and are probably related.”
Adding to this previous sentence, the report adds that, “This despite 2 cycles of hld and one subsequent cycle of eo {added: which most likely refers to ‘ethylene oxide gas’ sterilization, with the sentence adding that} replacement of the elevator mechanism with the new parts per the fda recall.”
This report suggests the Olympus TJF-Q180V duodenoscope remained contaminated despite the hospital high-level disinfecting it twice and then sterilizing it (which the FDA recommended in August 2015 as a supplemental measure to mitigate the infection risk).
(According to this hospital’s regulatory report, which presents the hospital’s understanding of the facts, and not the manufacturer’s, this duodenoscope was not linked to any patient infections.)
This hospital’s regulatory report demonstrates how the redaction (i.e., removal) of important information — including the type of bacteria that was cultured from the duodenoscope after reprocessing — can interfere with an understanding of the incident and its significance, as well as hindering the implementation by hospitals of important proactive measures that might otherwise improve safety.
Nonetheless, this August 1st regulatory report — the forceps elevator mechanism of most if not all (approximately 4,400) TJF-Q180V duodenoscopes in the U.S. would likely already have been corrected by this date, according to the FDA — raises additional questions about this duodenoscope model’s repair, and whether this device can remain contaminated despite disinfection and sterilization.
Beginning in earnest in 2013, similar concerns about infection were voiced about the original TJF-Q180V design, which Olympus recalled in early 2016.
As Sen. Murray discussed in a report she issued in January 2016, duodenoscopes “could remain contaminated even after the manufacturer’s reprocessing instructions were followed.” The recall of Olympus’s TJF-Q180V model in 2016 was intended to mitigate the original model’s infection risk.
Concerns about the forceps elevator mechanism of other duodenoscope models
The Olympus TJF-Q180V is not the only duodenoscope model whose forceps elevator mechanism design is difficult to clean.
On Jan. 17, 2017, the FDA issued a safety communication warning users about a potential concern with the design and manufacturing of the PENTAX ED-3490TK duodenoscope.
This safety communication states that: “cracks and gaps in the adhesive that seals the (this duodenoscope model’s) distal cap to its distal tip can occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.”
PENTAX, a competitor of Olympus, manufactures the ED-3490TK duodenoscope in the U.S. for performing ERCP.
The previous day, on Jan. 16th, PENTAX issued a field correction informing users of this concern and requiring users to meticulously clean the ED-3490TK’s elevator recesses.
According to this field correction, “PENTAX is working closely with the FDA to further evaluate and mitigate the potential risk of infection associated with leakage, if leakage were to occur, into or out of the distal cap area.”
To mitigate the infection risk, both PENTAX and the FDA stress the importance of health care facilities meticulously following the ED-3490TK’s updated manual reprocessing instructions.
The validation of these updated instructions was the subject of an earlier safety communication the FDA published in Feb. 2016. These updated instructions replaced those provided in this model’s original device labeling.
The FDA’s safety communication also recommended that users “closely inspect” the distal cap area of the ED-3490TK model, with PENTAX advising users to immediately stop using the ED-3490TK duodenoscope if it shows visible signs of wear or physical damage.
PENTAX will provide annual inspection and servicing to all customers with ED-3490TK duodenoscopes, according to the company’s field correction.
The company also warned in this field correction that “continuing to use devices with integrity issues (i.e. holes, cracks, kinks and scratches) can contribute to persistent device contamination and subsequent patient infection.”
(Also in Jan., FujiFILM, the third manufacturer of duodenoscopes sold in the U.S., informed the FDA that it would begin replacing legacy 250/450 duodenoscope models, due to their limited use, with the ED-530XT duodenoscope at no cost to customers.
FujiFILM advises customers to continue using the revised, validated manual instructions the company issued in December 2015 for reprocessing the ED-530XT duodenoscope. These instructions replaced those provided in the device’s original labeling.
Other endoscope types featuring a forceps elevator mechanism
Duodenoscopes are not the only type of gastrointestinal (GI) endoscope that features a forceps elevator mechanism.
Last month Olympus filed a regulatory report documenting the contamination of a type of GI endoscope called a linear echo, or “EUS,” endoscope. These types of endoscopes uses high-frequency sound waves to produces images of the GI tract.
Like the duodenoscope, the EUS endoscope features a forceps elevator mechanism at its distal tip to control and manipulate accessories, such as a cannula or needle, which are passed through the endoscope’s working channel.
However, unlike the TJF-Q180V model, the elevator channel in EUS endoscopes is exposed requiring reprocessing.
Moreover, whereas duodenoscopes are used to examine the GI tract to identify diseases of the liver, bile ducts, and pancreas, EUS endoscopes are used to examine the lining and walls of the upper and lower GI tract during a procedure known as endoscopic ultrasonography (EUS).
According to Olympus’s filed report, an organism {the name is REDACTED in the report} was cultured from the forceps elevator mechanism of an Olympus (GF-UCT140-AL5) ultrasound gastroscope.
While it states that no patients potentially exposed to this endoscope were infected, this regulatory report raises the question whether the forceps elevator mechanism used on this EUS endoscope model is similar in design to that which Olympus recalled and replaced in the corrected TJF-Q180V duodenoscope model, and whether this ultrasound endoscope can remain contaminated with bacteria despite cleaning and disinfection.
More than two years ago, I wrote an article entitled, “Risk of ‘Superbug’ Outbreaks Linked to Two Types of Gastrointestinal Endoscopes: Pittsburgh (PA), 2012,” which discussed an abstract published by a Pennsylvania medical center entitled “High Level Disinfection (HLD) Failure in Gastrointestinal Scopes with Elevator Channels: Is it Time to Switch to Ethylene Oxide (ETO) Sterilization?”
This abstract published the findings of a study designed to determine the effectiveness of an automated reprocessing for preventing duodenoscopes and EUS endoscopes from infecting patients with CRE.
According to this abstract’s findings, high-level disinfection was not effective “in eradicating bacteria from” either Olympus duodenoscopes or EUS endoscopes.
As a safety measure, the abstract’s authors reported that the medical center began using ethylene oxide gas (EtO) gas to sterilize all endoscope models featuring a forceps elevator mechanism — namely, both duodenoscopes and linear EUS endoscopes.
This abstract’s findings are echoed by those of Chapman et al. (2017), who reported last month that (curvilinear array) echo-endoscopes (which feature an elevator forceps mechanism) were cultured and tested positive for “high-concern organisms” after high-level disinfection.
As a result, Chapman et al. (2017) concluded that, “recommendations regarding infection risk should take into consideration elevator-containing echoendoscopes in addition to duodenoscopes to ensure patient safety and endoscope reprocessing efficacy.”
Closing remark
In August 2015 the FDA recommended hospitals adopt at least one of four “supplemental measures” to mitigate the risk of duodenoscopes transmitting resistant bacteria.
Updated last November, the FDA posted a webpage listing the models of automated endoscope reprocessors (or AERs) that (according to the agency) have been validated for reprocessing duodenoscopes.
This webpage does not discuss EUS endoscopes, however, even though these complex GI endoscopes also feature a forceps elevator mechanism.
Whether hospitals should apply one or more of the FDA’s four supplemental mitigations to EUS endoscopes too, and whether the FDA’s webpage listing AER models validated for reprocessing duodenoscopes should be updated to include EUS endoscopes, warrants further investigation and discussion.
Article by: Lawrence F Muscarella, PhD. Posted: March 21, 2017. LFM Healthcare Solutions, LLC Copyright 2017. LFM Healthcare Solutions, LLC. All rights reserved.
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, manufacturers and the public. Email Dr. Muscarella for more details.