Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae

doi:10.1016/j.gie.2019.05.016

Gastrointestinal Endoscopy

Volume 90, Issue 5, November 2019, Pages 793-804

https://doi.org/10.1016/j.gie.2019.05.016 Get rights and content

Background and Aims

Worldwide, an increasing number of duodenoscope-associated outbreaks are reported. The high prevalence rate of contaminated duodenoscopes puts patients undergoing ERCP at risk of exogenous transmission of microorganisms. The contributing factors of the duodenoscope design to contamination are not well understood. This article reports on the investigation after the outbreak of a multidrug-resistant Klebsiella pneumoniae (MRKP) related to 2 Olympus TJF-Q180V duodenoscopes.

Methods

We conducted a contact patient screening and microbiologic laboratory database search. Reprocessing procedures were audited, and both duodenoscopes were fully dismantled to evaluate all potential contamination factors. Outcomes were reviewed by an experienced independent expert.

Results

In total, 102 patients who had undergone an ERCP procedure from January to August 2015 were invited for screening. Cultures were available of 81 patients, yielding 27 MRKP-infected or -colonized patients. Ten patients developed an MRKP-related active infection. The 2 duodenoscopes had attack rates (the number of infected or colonized cases/number of exposed persons) of 35% (17/49) and 29% (7/24), respectively. Identical MRKP isolates were cultured from channel flushes of both duodenoscopes. The review revealed 4 major abnormalities: miscommunication about reprocessing, undetected damaged parts, inadequate repair of duodenoscope damage, and duodenoscope design abnormalities, including the forceps elevator, elevator lever, and instrumentation port sealing.

Conclusions

Outbreaks are associated with a combination of factors, including duodenoscope design issues, repair issues, improper cleaning, and systemic monitoring of contamination. To eliminate future duodenoscope-associated infections, a multipronged approach is required, including clear communication by all parties involved, a reliable servicing market, stringent surveillance measures, and eventually new duodenoscope designs and reprocessing procedures with a larger margin of safety.

Section snippets

Setting

The University Medical Center Utrecht (UMCU) is a 1042-bed, tertiary academic center in The Netherlands performing 300 ERCP procedures yearly. At the time of the detection of the outbreak (July 2015), 2 Olympus TJF-Q180V (Zoeterwoude, The Netherlands) duodenoscopes (A and B) and 2 older Olympus TJF-160VR models (C and D) were being used. Maintenance and repairs were performed by a single independent service organization (ISO). Duodenoscope A (3.9 years; 571 procedures) had been repaired in May

Outbreak investigation

The outbreak investigation yielded culture results from 81 patients of the 102 contact patients. Eight patients refused to participate or did not respond to the request for screening, and 13 patients died in 2015 without any screening or clinical cultures available. An independent committee of medical experts reviewed the medical charts and considered their deaths not to be related to a possible colonization or infection with the outbreak strain. The epidemic curve is shown in Figure 1. In

Discussion

A rising number of reported outbreaks makes us question whether reprocessing of duodenoscopes is adequate enough to prevent infection of patients with exogenous microorganisms. In the outbreak described in this report, during 8 months, 2 duodenoscopes were persistently contaminated with identical MRKP isolates and infected ≥29% of all patients who underwent an ERCP procedure with 1 of the 2 duodenoscopes. In addition to standard outbreak investigations, this investigation included the full

Acknowledgments

We thank the reprocessing staff, medical devices experts, infection control practitioners, medical microbiologists, Bio Information Technology group, and gastroenterologists at the UMCU for their participation and effort in this outbreak investigation. The authors received no specific funding support for the research, authorship, and/or publication of this article.

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Cited by (46)

Borescope examination and microbial culture results of endoscopes in a tertiary care hospital led to changes in storage protocols to improve patient safety
2023, American Journal of Infection Control
Citation Excerpt :
A large number of steps in the procedure for reprocessing, inadequate training (which leads to missed steps), staffing, and time between procedures can all contribute to inadequate reprocessing.3 Endoscopes that are not reprocessed effectively pose a risk of transmission of pathogens to patients.5,6 Prior studies have demonstrated that internal channel damage in endoscopes has the potential to protect biofilms from high-level disinfection, further increasing the risk of patient-to-patient transmission of pathogens.
Flexible endoscopes are highly versatile and useful medical instruments, and their proper reprocessing is critical to patient health and safety. The value of routine visual inspections and surveillance of endoscopes in a tertiary care hospital was assessed by performing borescope examinations and microbial sampling on respiratory, gastro-intestinal (GI), and urological endoscopes.
A total of 42 endoscopes were cultured, and 36 endoscopes were examined with a borescope. The flush-brush-flush method was used to culture the endoscopes. Collected water was suctioned through a membrane filter device which was plated on a blood agar plate and incubated. A borescope was used to perform endoscope inspection in an antegrade and retrograde approach.
Positive microbial cultures were seen in 28% of respiratory, 22% of GI, and 30% of urological endoscopes. Borescope examinations revealed multiple abnormalities and damage including channel shredding, filamentous debris, water retention, discoloration, dents, and red particles.
Borescope examination and microbial culturing should be used routinely to assure endoscopic safety. Borescope examination enabled us to visualize structural damage, foreign material and moisture within endoscopes. The structural damages and the particles found in endoscopes resulted in timely repair and discontinuation of this type of distal end protectors in our facility.
Microbiological surveillance post-reprocessing of flexible endoscopes used in digestive endoscopy: a national study
2023, Journal of Hospital Infection
Microbiological surveillance of endoscopes is a safety measure for verifying the quality of reprocessing procedures and identifying contaminated devices, but duodenoscope-related outbreaks are still reported.
To assess the effectiveness of duodenoscope reprocessing procedures in Italy.
Between December 2019 and April 2020, data obtained from microbiological surveillance post-reprocessing in 15 Italian endoscopy units were collected. Sampling was carried out after reprocessing or during storage in a cabinet. In keeping with international guidelines and the Italian position paper, the micro-organisms were classified as high-concern organisms (HCOs) and low-concern organisms (LCOs).
In total, 144 samples were collected from 51 duodenoscopes. Of these, 36.81% were contaminated: 22.92% were contaminated with HCOs and 13.89% were contaminated with LCOs [2.08% with an LCO load of 11–100 colony-forming units (CFU)/device and 0.69% with an LCO load of >100 CFU/device]. The contamination rate was 27.5% in samples collected after reprocessing, 40% in samples collected during storage in a cabinet that was compliant with EN 16442:2015 (C-I), and 100% in samples collected during storage in a cabinet that was not compliant with EN 16442:2015 (NC-I). The respective HCO rates were 15.00%, 27.27% and 66.67%. Correlation between LCO contamination and storage time was demonstrated (Spearman's rho=0.3701; P=0.0026). The Olympus duodenoscope TJFQ180V demonstrated the lowest rate of contamination (29.82%), although the contamination rate was 100% for duodenoscopes stored in an NC-I cabinet.
Microbiological surveillance, along with strict adherence to reprocessing protocols, may help to detect endoscope contamination at an early stage, and reduce the risk of duodenoscope-associated infections.
The utility of lighted magnification and borescopes for visual inspection of flexible endoscopes
2023, American Journal of Infection Control
Infections have been linked to damaged or contaminated endoscopes with visible defects. Endoscope processing standards and guidelines state endoscopes should be visually inspected every time they are used. This study evaluated a new visual inspection program using magnification and borescopes in an endoscopy department that had not previously utilized these tools.
Site personnel were given visual inspection tools and training before systematically examining fully processed endoscopes twice during a 2-month period. A risk assessment protocol was used to determine whether endoscopes required recleaning, repair, or other action. Findings were documented using log sheets, photographs, and videotapes.
Visible damage and residue or debris were observed in 100% of 25 endoscopes at both assessments, and 76% required repair. Defects at baseline included scratches (88%); channel shredding or peeling (80%); adhesive band disintegration (80%); residual soil or debris (white 84%; black 68%; brown 40%; yellow/green 36%; and orange/red 8%); retained fluid (52%); and dents (40%). Findings were similar at follow-up.
Visual inspection with magnification and borescopes identified actionable defects that could interfere with processing effectiveness in 100% of endoscopes. Infection preventionists have a critical role to play in supporting processing personnel now that standards, guidelines, and manufacturer instructions recommend enhanced visual inspection of every endoscope, every time.
Healthcare worker feedback on duodenoscope reprocessing workflow and ergonomics
2022, American Journal of Infection Control
The objectives of this survey study were to assess duodenoscope precleaning and manual cleaning times, identify human factors issues in duodenoscope reprocessing workflow or ergonomics, and ascertain any best practices in duodenoscope reprocessing.
Researchers developed the confidential, qualitative, online Duodenoscope Reprocessing Workflow and Ergonomic Design Human Factors Survey with an intended audience of healthcare workers (HCWs) who routinely perform duodenoscope precleaning or manual cleaning. The unrestricted survey link was distributed to target HCW email addresses in December 2020; the survey closed in January 2021.
Three hundred and forty-one individuals completed the survey. Most respondents complete duodenoscope precleaning in 10 minutes or less and manual cleaning in 16-to-30 minutes. Most respondents’ facilities use fixed distal endcap duodenoscopes. Most respondents experience pressure to work faster when cleaning duodenoscopes and reported that cleaning duodenoscopes caused fatigue or discomfort in at least one body part. Mentoring HCWs and retaining experienced staff were 2 primary duodenoscope reprocessing best practices identified by respondents.
To enhance duodenoscope cleaning, facilities should provide ample reprocessing work spaces with incorporated height-adjustable work surfaces, train HCWs on validated duodenoscope reprocessing instructions, provide step-by-step instructions for HCWs when duodenoscope cleaning is performed, mentor reprocessing HCWs, and retain experienced staff.
Assessment of postmanual cleaning adenosine triphosphate tests to prevent the use of contaminated duodenoscopes and linear echoendoscopes: the DETECT study
2022, Gastrointestinal Endoscopy
We investigated whether the use of postmanual cleaning adenosine triphosphate (ATP) tests lowers the number of duodenoscopes and linear echoendoscopes (DLEs) contaminated with gut flora.
In this single-center before-and-after study, DLEs were ATP tested after cleaning. During the control period, participants were blinded to ATP results: ATP-positive DLEs were not recleaned. During the intervention period, ATP-positive DLEs were recleaned. DLEs underwent microbiologic sampling after high-level disinfection (HLD) with participants blinded to culture results.
Using 15 endoscopes of 5 different DLE types, we included 909 procedures (52% duodenoscopes, 48% linear echoendoscopes). During the intervention period, the absolute rate of contamination with gut flora was higher (16% vs 21%). The main analysis showed that contamination was less likely to occur in the intervention period (odds ratio, .32; 95% credible interval [CI], .12-.85). A secondary analysis showed that this effect was based on 1 particular duodenoscope type (estimated probability, 39% [95% CI, 18%-64%] vs 9% [95% CI, 2%-21%]), whereas no effect was seen in the other 4 DLE types. In detail, of the 4 duodenoscopes of this type, 2 had lower contamination rates (69% vs 39% and 36% vs 10%). During the control period, both these duodenoscopes had multiple episodes with ongoing contamination with the same microorganism that ended weeks before the start of the intervention period (ie, they were not terminated by ATP testing).
Postmanual cleaning ATP tests do not reduce post-HLD gut flora contamination rates of DLEs. Hence, postcleaning ATP tests are not suited as a means for quality control of endoscope reprocessing.
Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial
2022, Gastrointestinal Endoscopy
Disposable gastroscopes have recently been developed to eliminate the risk of infection transmission from contaminated reusable gastroscopes. We compared the performance of disposable and reusable gastroscopes in patients undergoing gastroscopy.
Patients requiring gastroscopy were randomized to either the disposable or reusable digital gastroscope group. The primary endpoint was the success rate of photographing customary anatomic sites, with a noninferiority margin of –8%. Secondary endpoints were technical performance factors such as gastroscope imaging quality, maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, and safety. Data were analyzed using the Newcombe-Wilson score method and Fisher exact 2-tailed t test.
Of 110 patients, 55 were treated using disposable gastroscopes and 55 using reusable gastroscopes. The success rate for capturing images of customary anatomic sites was 100% in both groups. The average imaging quality score was significantly lower (37.02 ± 3.09 vs 39.47 ± 1.92, P < .001) and the operating time significantly longer (P < .001) in the disposable gastroscope group. No significant differences in maneuverability, gastroscopy completion rate, device failure/defect rate, operating time, or safety were found between the 2 groups.
Given the overall safety profile and similar technical performance, disposable gastroscopes represent an alternative to reusable gastroscopes for routine examination, bedside first aid, and some certain circumstances.

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: DISCLOSURE: The following authors disclosed financial relationships relevant to this publication: F. P. Vleggaar: Consultant for and research grant recipient from Boston Scientific. M. J. Bruno: Consultant for 3M, Boston Scientific, and Cook Medical; speaker for Boston Scientific and Cook Medical; grant recipient from 3M, Boston Scientific, Cook Medical, and Pentax Medical. M. C. Vos: Grant recipient from 3M, Pentax Medical, and IMS Innovations. All other authors disclosed no financial relationships relevant to this publication.

: If you would like to chat with an author of this article, you may contact Dr Monkelbaan at [email protected].

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Original articleClinical endoscopyIndependent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae

Background and Aims

Methods

Results

Conclusions

Section snippets

Setting

Outbreak investigation

Discussion

Acknowledgments

Lancet Gastroenterol Hepatol

Gastroenterology

Gastrointest Endosc

Gastroenterology

Gastrointest Endosc

Am J Infect Control

Am J Infect Control

Am J Infect Control

Gastrointest Endosc

Am J Infect Control

Gastrointest Endosc

Gastrointest Endosc

Am J Infect Control

Gastrointest Endosc

J Hosp Infect

Am J Infect Control

Gastrointest Endosc

Am J Infect Control

Preventable tragedies: superbugs and how ineffective monitoring of medical device safety fails patients

Transmission of infection by flexible gastrointestinal endoscopy and bronchoscopy

Clin Microbiol Rev

Risk of infection following colonoscopy and sigmoidoscopy in symptomatic patients

Endoscopy

Rates of infection after colonoscopy and osophagogastroduodenoscopy in ambulatory surgery centres in the USA

Gut

Statement from Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health, on updated safety communication about rates of duodenoscope contamination from preliminary postmarket data 2018 [updated 10-12-2018]

High-quality endoscope reprocessing decreases endoscope contamination

Clin Microbiol Infect

Surveillance of guideline practices for duodenoscope and linear echoendoscope reprocessing in a large healthcare system

Gastrointest Endosc

A survey of reprocessing methods, residual viable bioburden, and soil levels in patient-ready endoscopic retrograde choliangiopancreatography duodenoscopes used in Canadian centers

Infect Control Hosp Epidemiol

Measures to improve microbial quality surveillance of gastrointestinal endoscopes

Endoscopy

High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study

Gut

Original article
Clinical endoscopy
Independent root-cause analysis of contributing factors, including dismantling of 2 duodenoscopes, to investigate an outbreak of multidrug-resistant Klebsiella pneumoniae