Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011

Petersen, Bret T.; Chennat, Jennifer; Cohen, Jonathan; Cotton, Peter B.; Greenwald, David A.; Kowalski, Thomas E.; Krinsky, Mary Lee; Park, Walter G.; Pike, Irving M.; Romagnuolo, Joseph; Rutala, William A.

doi:10.1016/j.gie.2011.03.1183

Cited by 171 publications

(125 citation statements)

References 86 publications

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“…Emergent species of CRE include: K. pneumoniae, 462 October 16, 2014|Volume 6|Issue 10| WJGE|www.wjgnet.com Table 3 Recommended practices for the effective reprocessing of gastrointestinal endoscopes 1 Reprocess the GI endoscope promptly after the endoscopic procedure in accordance with its manufacturer's step-by-step set of instructions (1) As required, supplement these instructions with the recommendations of published infection-control guidelines (2) Always reprocess the GI endoscope's air/water channels (Also, always reprocess the GI endoscope's suction and air/water valves and other accessories) (3) Before its reprocessing, visually examine the GI endoscope, especially its distal sheath, for excessive wear and tear, having it servicing when required (4) Practice Standard Precautions when reprocessing GI endoscopes (As required, also employ Contact Precautions to prevent CRE transmission) (5) Confirm that the high-level disinfectant is contacting all of the GI endoscope's potentially contaminated surfaces (6) The use of ethylene oxide (EtO) gas to sterilize ERCP endoscopes, in lieu of high-level disinfection, may be considered. (No matter, thorough cleaning of the endoscope is required) 2 Place emphasis on cleaning and brushing (prior to high-level disinfection) the area near, around and behind the ERCP endoscope's forceps elevator ( Figure 1B) (1) Ensure that, if it is exposed, the ERCP endoscope's elevator wire channel, which houses the cable that controls and angulates this forceps elevator, is thoroughly flushed with a detergent solution.…”

Section: Muscarella Lf Risk Of Cre Transmissions During Gi Endoscopymentioning

confidence: 99%

“…Common infection control strategies for the prevention of disease transmission during gastrointestinal (GI) endoscopy are routinely credited for the low reported rate of infections due to a contaminated GI endoscope [1][2][3][4][5] . Bacterial and viral outbreaks following GI endoscopy, with associated morbidity and mortality, have been reported (albeit infrequently) during the past 30 years, but the cause of virtually every one of these outbreaks was attributed to one or more infection control breaches -for example, to: (1) an endoscope reprocessing lapse, including the failure to clean the GI endoscope's instrument channel with a brush; or, the faulty reprocessing of the GI endoscope by an automated endoscope reprocessor, or AER, with a flawed internal design; (2) a damaged or improperly maintained or serviced GI endoscope; or (3) the unsterile administration of an intravenous (iv) medication [6][7][8][9][10][11][12][13][14] .…”

Section: Introductionmentioning

confidence: 99%

“…October 16, 2014|Volume 6|Issue 10| WJGE|www.wjgnet.com Table 2 Reasons why the recent emergence of carbapenem-resistant Enterobacteriaceae and their related superbugs is a serious public-health concern (1) While HAIs caused by CRE are relatively uncommon, their incidence both in the United States and globally is increasing, posing a growing public health threat [16,19,25,32] (2) Strains of Enterobacteriaceae that are responsible for HAIs are becoming CRE at an alarming rate (3) Infections of the bacterial strains that have emerged as CRE were once treatable with carbapenems, but are no longer, even though these antibiotics have been reserved by clinicians as a "last resort" or "last line" of defense for treating patients infected with multidrug-resistant bacteria (4) CRE's resistance to carbapenems significantly limits the number of available treatment options (5) Those very few antibiotics that remain effective for treating CRE infections are generally undesirable because, among some other limitations, they can be nephrotoxic (6) Some strains of CRE are pan-resistant (meaning they cannot be treated using any type of antibiotic) (7) The mortality rate of infections caused by CRE and related superbugs is relatively high (compared to carbapenem-susceptible Enterobacteriaceae), causing the death of as many as 50% of patients with a bloodstream infection of CRE (8) Not only are the number of patient deaths attributed to CRE infection (from all causes, not just bacteremia) significant, both in the United States and globally, but also the rate of death among patients with CRE infections (primarily of the bloodstream) has been reported to be as much as 2 times higher than that of patients infected with carbapenem-susceptible Enterobacteriaceae [35] (9) The genetic code that confers the antibiotic resistance of CRE and their related superbugs can be shared or exchanged with other bacteria of the same, or of even of a different, species (i.e., "gene swapping") (10) CRE and related superbugs are highly transmissible in the healthcare setting (and have the potential to spread in the community too) CRE: Carbapenem-resistant Enterobacteriaceae; HAIs: Healthcare-associated infections.…”

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confidence: 99%

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Risk of transmission of carbapenem-resistantEnterobacteriaceaeand related “superbugs” during gastrointestinal endoscopy

Muscarella¹

2014

WJGE

120

112

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To evaluate the risk of transmission of carbapenemresistant Enterobacteriaceae (CRE) and their related superbugs during gastrointestinal (GI) endoscopy. Reports of outbreaks linked to GI endoscopes contaminated with different types of infectious agents, including CRE and their related superbugs, were reviewed. Published during the past 30 years, both prior to and since CRE's emergence, these reports were obtained by searching the peer-reviewed medical literature (via the United States National Library of Medicine's "MEDLINE" database); the Food and Drug Administration's Manufacturer and User Facility Device Experience database, or "MAUDE"; and the Internet (via Google's search engine). This review focused on an outbreak of CRE in 2013 following the GI endoscopic procedure known as endoscopic retrograde cholangiopancreatography, or ERCP, performed at "Hospital X" located in the suburbs of Chicago (IL; United States). Part of the largest outbreak of CRE in United States history, the infection and colonization of 10 and 28 of this hospital's patients, respectively, received considerable media attention and was also investigated by the Centers for Disease Control and Prevention (CDC), which published a report about this outbreak in Morbidity and Mortality Weekly Report (MMWR), in 2014. This report, along with the results of an independent inspection of Hospital X's infection control practices following this CRE outbreak, were also reviewed. While this article focuses primarily on the prevention of transmissions of CRE and their related superbugs in the GI endoscopic setting, some of its discussion and recommendations may also apply to other healthcare settings, to other types of flexible endoscopes, and to other types of transmissible infectious agents. This review found that GI endoscopy is an important risk factor for the transmission of CRE and their related superbugs, having been recently associated with patient morbidity and mortality following ERCP. The CDC reported in MMWR that the type of GI endoscope, known as an ERCP endoscope, that Hospital X used to perform ERCP in 2013 on the 38 patients who became infected or colonized with CRE might be particularly challenging to clean and disinfect, because of the complexity of its physical design. If performed in strict accordance with the endoscope manufacturer's labeling, supplemented as needed with professional organizations' published guidelines, however, current practices for reprocessing GI endoscopes, which include high-level disinfection, are reportedly adequate for the prevention of transmission of CRE and their related superbugs. Several recommendations are provided to prevent CRE transmissions in the healthcare setting. CRE transmissions are not limited to contaminated GI endoscopes and also have been linked to other reusable flexible endoscopic instrumentation, including bronchoscopes and cystoscopes. In conclusion, contaminated GI endoscopes, particularly those used during ERCP, have been causally linked to outbreaks of CRE and their related su...

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Section: Muscarella Lf Risk Of Cre Transmissions During Gi Endoscopymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

mentioning

confidence: 99%

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Risk of transmission of carbapenem-resistantEnterobacteriaceaeand related “superbugs” during gastrointestinal endoscopy

Muscarella¹

2014

WJGE

120

112

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“…In principle, manufacturers do not have to follow such recommendations as found in FDA guidances because they are not binding. However, the consequences of not following an FDA guidance can be problematic and more burdensome than just following the guidance [252].…”

Section: Devices That Must Validate Their Reprocessing Methodsmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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“…202 For this reason multiple endoscopic and infection-control societies have issued newer recommendations regarding the handling and reprocessing of duodenoscopes. [203][204][205] …”

Section: Cholangitis/infectionmentioning

confidence: 99%

Endoscopic retrograde cholangiopancreatography complications: Techniques to reduce risk and management strategies

Tarnasky

Kedia

2017

Int J Gastrointest Interv

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Adverse events after endoscopic retrograde cholangiopancreatography (ERCP) are not uncommon and can be associated with tragic outcomes. Bleeding, perforation, and post-ERCP pancreatitis are the most common complications. Some events are unavoidable; others are associated with well described risk factors so that they can be either anticipated and/or measures can be taken for prevention or at least risk reduction. This review will focus on the more common complications after ERCP, their risk factors, and potential strategies for risk reduction. Additionally, recommendations for management of ERCP complications will be presented.

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Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011

Cited by 171 publications

References 86 publications

Risk of transmission of carbapenem-resistantEnterobacteriaceaeand related “superbugs” during gastrointestinal endoscopy

Risk of transmission of carbapenem-resistantEnterobacteriaceaeand related “superbugs” during gastrointestinal endoscopy

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Endoscopic retrograde cholangiopancreatography complications: Techniques to reduce risk and management strategies

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