February 18, 2014 — This article discusses the potential for healthcare-associated infections (HAIs) associated with the use of tap water, compared to sterile water, for irrigation (and/or cleansing the endoscope’s lens) during gastrointestinal (GI) endoscopic procedures, such as colonoscopy. A recommendation is provided to guide a GI endoscopy unit’s decision.
BACKGROUND and OVERVIEW
In early 2014 the American Society for Gastrointestinal Endoscopy (ASGE) issued its “Guidelines for safety in the gastrointestinal endoscopy unit” (click here to download a copy).
According to this guideline’s executive summary: “Historically, safety in the gastrointestinal (GI) endoscopy unit has focused on infection control, particularly around the reprocessing of endoscopes. Two highly publicized outbreaks in which the transmission of infectious agents were related to GI endoscopy have highlighted the need to address potential gaps along the endoscopy care continuum that could impact patient safety.”
At least one of these outbreaks was the transmission of the hepatitis C virus among patients undergoing GI endoscopy at an endoscopy clinic in Las Vegas, Nevada (USA). This viral outbreak has been attributed to the un-sterile administration of intravenous (IV) medications.
This guideline published by ASGE in 2014 also discusses notable infection control breaches associated with colonoscopy performed at two U.S. Department of Veterans Affairs medical centers (VAMCs) in Miami, Florida (USA), and Murfreesboro, Tennessee (USA).
These breaches posed an increased risk of disease transmission. Those confirmed at the former VAMC included the failure to reprocess tubing used for water irrigation after each GI endoscopic procedure as required, whereas those confirmed at the latter VAMC included the inadvertent fitting of this same type of reusable irrigation tubing with an improper “two-way” flow connector (see: Box A, below).
According to ASGE (ASGE, 2014), these incidents in Nevada, Florida, and Tennessee suggest that some opportunities remain for improved quality and safety in the GI endoscopic setting.
ASGE adds further in this 2014 guideline (ASGE, 2014) that: “the purpose of this (guideline) is to present recommendations for endoscopy units in implementing and prioritizing safety efforts and to provide an endoscopy-specific guideline by which to evaluate endoscopy units.”
Box A. A few infection control breaches confirmed at a number of Veterans Affairs medical centers (VAMCs) during the past few years.
The incidents at the two VAMCs in Miami (FL) and Murfreesboro (TN) discussed in the main article – along with a third incident at the VAMC in Augusta (GA) – are discussed in more detail in another of Dr. Muscarella’s articles: “Improper Use and Reprocessing of a Gastrointestinal Endoscope’s Auxiliary Water System” – click here.
The reader is also directed to other notable infection control breaches associated with colonoscopy and other flexible endoscopic procedures performed at the VAMC in San Juan, Puerto Rico – click here to download a front-page newspaper article discussing these breaches.
ASGE’s “safety” guideline (2014): A summary of its key strategies
Some of the key strategies that ASGE’s “Guidelines for safety in the gastrointestinal endoscopy unit” (ASGE, 2014) lists to maintain safety in the GI endoscopy unit include that the GI endoscopy unit:
- have a designated flow for the safe physical movement of dirty endoscopes and other equipment;
- have a terminal cleansing plan that includes methods and chemical agents for cleansing and disinfecting the procedural space at the end of the day; and
- implement a specific infection prevention plan that is directed by a qualified person.
Legal Reviews for Hospitals, Manufacturers, and Patients: Click here to read about Dr. Muscarella’s expertise and legal assessments of the causes of healthcare-associated infections, including “superbug” outbreaks linked to contaminated GI endoscopes and other reusable medical equipment.
While it addresses a number of important infection control issues, this “safety” guideline (published in 2014) defers, in part, to ASGE’s other guideline — previously published in 2011 — entitled “Multi-society guideline on reprocessing flexible gastrointestinal endoscopes: 2011″ (click here to download a copy).
This earlier, supplemental guideline from 2011 provides a more detailed guide for infection control and endoscope reprocessing in the GI endoscopic setting.
Although the risk of infections from endoscopic procedures, regardless of the setting, remains low, (there is) the need to address potential gaps along the endoscopy care continuum that may impact patient safety outcomes. — ASGE (2014).
Tap water vs. sterile water for irrigation during GI endoscopy: Spurring the debate
One updated, if not also controversial, infection control practice that ASGE’s “safety” guideline in 2014 recommends is the use of tap water, instead of sterile water, during GI endoscopy (Deas and Sinsel, 2014).
Under its section heading “Recommendations for safe medication administration practices,” ASGE’s 2014 guideline states (ASGE, 2014) that: “Although the multiple-society guideline (2011) recommends using sterile water in the irrigation bottle, it is acceptable to use tap water because this has been shown to be safe.”
As a general principle, requirements for safety ought to be rooted in evidence that demonstrates a benefit in outcomes. When data are absent, these requirements may be derived from experts with experience in the safe delivery of care in the GI endoscopy setting. — ASGE (2014)
In this 2014 guideline ASGE provides the following rationale, in large part, for now recommending tap water’s use during GI endoscopy (ASGE, 2014):
“The rates of bacterial cultures are no different with the use of tap water versus sterile water, and neither has been associated with clinical infections” (see: this 2014 guideline’s ‘recommendation No. 14‘). This same recommendation and rationale are provided by Deas and Sinsel (2014).
Additionally, ASGE’s 2014 “safety” guideline advises that “consideration should be given to the promotion of efficient care and cost containment, with avoidance of requirements unsupported by evidence that then contribute to rising healthcare costs.”
Over the past two years, surveyors have called into question accepted practices at many accredited endoscopy units seeking reaccreditation. … ASGE recognized a need to develop nationally-recognized guidelines for endoscopy units. … These endoscopy-specific guidelines will also serve as an important resource for surveyors tasked with evaluating endoscopy units. — Audrey H. Calderwood, MD (ASGE)
A shift in position
ASGE’s recommendation in its 2014 guideline (and in the article by Deas and Sinsel ) of the use of tap water during the GI endoscopic procedure is a notable shift in its position.
Three years earlier in the aforementioned “multi-society” guideline ASGE recommended that “sterile water should be used to fill the water bottle” as well as, at least daily, to “high-level disinfect or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure) and its connecting tube (ASGE, 2011).
Click here to visit a webpage reserved solely for irrigation during GI endoscopy.
These same two instructions appear identically in this multi-society guideline’s predecessor, which — published by ASGE eight years earlier in 2003 — is similarly entitled “Multi-society guideline for reprocessing flexible gastrointestinal endoscopes” (ASGE, 2003; click here for a copy).
Sterile water should be used to fill the water bottle (used for cleaning the lens and irrigation during the procedure). — ASGE (2003, 2011; see: ‘recommendation No. 22‘ and ‘recommendation No. 25,’ respectively).
The reader is directed to Table 1, near the bottom of article, for a comparison of ASGE’s guidelines published in 2003, 2011 and 2014.
A “YouTube” video by ASGE
A well-produced YouTube video discussing ASGE’s endorsement of the use of tap water, compared to sterile water, for irrigation during GI endoscopy is provided by clicking here.
This video by ASGE features the perspectives of the renowned GI endoscopist and colleague Deepak Agrawal, MD (with whom, for full disclosure, Dr. Muscarella co-authored the article “Delayed reprocessing of endoscopes” in the April, 2011, issue of Gastrointestinal Endoscopy).
Other organizations’ recommendations: Use sterile water
Summarized in Table 1 (below), although ASGE’s guideline in 2014 approves of the use of tap water during GI endoscopy (ASGE, 2014), ASGE’s two earlier “multi-society” guidelines, published in 2003 and 2011, both “strongly recommend” the use of sterile water (in the water bottle used for irrigation and lens cleaning during GI endoscopy), stating that this practice is “supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale” (ASGE, 2003, 2011).
Like ASGE’s guidelines published in 2003 and again in 2011 (but in contrast to its “safety” guideline published in 2014) several other organizations have published instructions that also enjoin the use of sterile water during upper and lower GI endoscopy.
It is acknowledged that some practices essential to prevent infections in the operating room setting are not necessarily required of a GI endoscopy department. Of course, one example is the “sterile field,” whose preparation and maintenance are ordinarily exclusive to the operating room. — Lawrence F Muscarella PhD
These organizations include: The Society for Healthcare Epidemiology (SHEA); American College of Gastroenterology (ACG); American Gastroenterological Association (AGA); Association of periOperative Registered Nurses (AORN); Association of Professionals in Infection Control and Epidemiology (APIC); The Joint Commission; and the Society of Gastroenterology Nurses and Associates (SGNA).
Sterile water should be used to fill the water bottle used during all GI endoscopic procedures. — ACG, AGA, AORN, APIC, Joint Commission, SHEA, and SGNA.
The recommended used of sterile water is not limited to the U.S. The Public Health Agency of Canada (in its “Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy”) similarly recommends that:
“sterile water only should be used to fill the (water) bottles” (click here to download a copy of this guideline).
This Canadian guideline adds that “each ERCP procedure requires a fresh sterile bottle filled with sterile water.”
So, what’s a GI endoscopy unit to use in the water bottle during all types of GI endoscopic procedures (e.g., colonoscopy, ERCP): sterile or tap water?
Consistent with the current guidelines of SGNA and others, this article recommends the use of sterile water to fill the water bottle used during GI endoscopy (particularly during ERCP) as a “best practice” and precautionary, preventive measure.
This article’s recommendation to use sterile water during GI endoscopy is based on a number of considerations that focus primarily on quality and patient safety.
Although rarely harmful to the general public, tap water is not sterile and may, and almost always does, contain permissible levels of bacteria.
Indeed, patient colonization, infection, morbidity and mortality due to “opportunistic” bacteria found in drinkable (potable) tap water — and on other moist or wet environmental surfaces, including hand-washing sinks (Hota et al., 2009; click here) — have been reported in the healthcare setting (Muscarella, 2004, 2006).
These findings highlight the importance of using sterile water for many types of medical procedures.
Read Dr. Muscarella’s related articles:
- The Environment as a Source of Antibiotic-Resistant Pseudomonas aeruginosa Linked to Hospital Infections” (click here).
- “Prevention of Legionnaires’ Disease in Healthcare Settings” (click here).
An argument for the safety of using tap water
It is true that reports of bacterial outbreaks due to the tap water used for irrigation during colonoscopy are very few, and arguments for the safety of using tap water for this purpose were recently published (Deas and Sinsel, 2014; Agrawal and Rockey, 2013 – click here).
But, first, validated clinical data, especially those collected using randomized controlled studies, assuredly demonstrating the safety of tap water, compared to sterile water, for irrigation and/or lens cleaning during all types of GI endoscopic procedures are lacking.
And, second, to be sure, scant clinical data directly linking tap water in the water bottle used during GI endoscopy to disease transmission and healthcare-associated infections (HAIs) does not validate this practice’s safety, ASGE’s countenancing of the use of tap water during GI endoscopy in its guideline published in 2014 notwithstanding.
The rationale for ASGE’s “safety” guideline in 2014 to recommend the use of tap water for irrigation during colonoscopy — and, by clear implication, during all other GI endoscopic procedures, including ERCP — is based primarily on only two studies, and they were published almost 20 years ago (Wilcox et al., 1996; Puterbaugh et al., 1997).
One view: While reports confirming the infection risk associated with using tap water for irrigation during colonoscopy are admittedly few, the lack of data demonstrating the potential harm of this practice does not validate its safety. — Lawrence F Muscarella, PhD
Whether a change in a long-standing practice — namely, ASGE’s newly published guideline in 2014 now permitting (if not recommending) the use of tap water, instead of sterile water, during GI endoscopy (ASGE, 2014) — might require more than the absence of data confirming the contrary — is presented for the reader’s own assessment.
Another view: In the absence of clinical data to support the benefit or increased safety of using sterile water for endoscopy irrigation, the added costs … of using sterile water does not justify its use. — Deas and Sinsel, 2014
Argumentum e silentio
The recommendation to use tap water for irrigation during all types of GI endoscopic procedures, including ERCP, based primarily on an absence of clinical data demonstrating the enhanced safety of (more expensive) sterile water warrants circumspection, however.
A type of fallacious argument known as “argumentum e silentio” asserts that a practice is safe based not on collected data confirming this conclusion to be valid, but rather on the absence of data demonstrating the conclusion to be false (i.e., a lack of clinical data confirming that the practice harms patients).
Whether this type of argument is possibly being applied to the assertion that tap water is as safe to use as sterile water for irrigation during GI endoscopy is presented for the reader’s own assessment.
Much published data show that medical errors, in general, and HAIs, in particular, including those linked to GI endoscopy, are often under-reported.
Which is why the lack of reported HAIs being the primary basis for revising an accepted standard (i.e., the use of sterile water) and now sanctioning the use of tap water for irrigation during GI is particularly salient (ASGE, 2014).
For example, according to the Joint Commission, “numerous high profile media reports of incidences of patient death resulting from hospital-acquired infection indicate that such cases are seriously under-reported” (Consumer Reports, 2009).
Under-reporting of ‘reportable diseases’ — diseases required to be reported to state and federal health authorities (including Legionnaires’ disease caused by a waterborne bacterium) — is a big problem with a lot of hospitals. — Dr. Mary McIntyre, assistant state health officer (Alabama) (click here).
Similarly, California Watch reported in 2012 that “California public health authorities who reviewed 100 hospitals found that the facilities failed to report as many as a third of the infections they should have reported in 2011 under the state’s public reporting law” (California Watch, 2012).
An investigative team reports that “national studies have found under-reporting is a widespread problem. One study, published May (2011) in Health Affairs, estimated that the system used in Connecticut and other states—voluntary reporting, based on federal patient-safety indicators—missed 90 percent of all adverse events” (Chedekel, 2012).
Reports suggest, too, that HAIs specifically linked to GI endoscopy are under-reported (Dirlam Langlay et al., 2013). Gastmeier and Vonberg (2014) report that it is “very likely” that many outbreaks of Klebsiella spp. (a type of Enterobacteriaceae that can be resistant to antibiotics) following GI endoscopy have been “missed” and not reported.
The findings of these reports beget the necessary question:
If HAIs are often, if not routinely, missed or under-reported, one organization’s assertion of the safety of using tap water during GI endoscopy, based on a paucity of reported HAIs associated with this practice, may, most respectfully, not be a complete assessment of this practice’s true risk of disease transmission.
Waterborne infections following GI endoscopy
During the past quarter century many published reports document disease transmission due to opportunistic bacteria found in tap water, including Pseudomonas aeruginosa, during GI endoscopy (and other flexible endoscopic procedures, including bronchoscopy) (Moayyedi et al., 1994; Muscarella, 2004, 2006).
Legionella spp. is an example of an insidious bacterium that resides in tap water and is often linked to HAIs. — Lawrence F Muscarella, PhD
Several of these reports describe patient infection, morbidity and mortality following ERCP due to these exogenous bacteria residing in the water used to rinse the GI endoscope during either manual or automated endoscope reprocessing (Allen et al., 1987; Alvarado et al., Cryan et al., 1984; Streulens et al., 1993; Muscarella, 2010).
So, too, have patient morbidity and mortality been associated with bacterial contamination not only of the GI endoscope’s air/water channels (Cryan et al., 1984) — this air/water system is used by the GI endoscope, along with the water stored in the water bottle, to cleanse the lens located at the GI endoscope’s distal tip — but also of the water bottle used during GI endoscopy (Bass et al., 1990; O’Connor and Axon, 1983; Classen et al., 1988; Welch et al., 2009).
Ribeiro and de Oliveria (2012) similarly report that the air/water channels of both colonoscopes and gastroscopes pose a risk of contamination and transmission during GI endoscopy, possibly due to the inadequate reprocessing. More specifically, these authors found the air/water channels of 5.7% and 10.7% examined gastroscopes and colonoscopes, respectively, to be contaminated with K. pneumoniae.
The storing of contaminated rinse water, along with its faulty design, were the primary reasons for one automated endoscope reprocessor (AER) to be removed from the U.S. marketplace by the Food and Drug Administration (Alvarado et al., 1991).
Such bacterial infections linked to the water bottle raise reasonable concerns about the potential for HAIs due to bacterial contamination of the tap water (in the water bottle) used for irrigation and lens cleaning during all types of GI endoscopic procedures.
“Superbugs” including carbapenem-resistant Enterobacteriaceae (CRE)
Along with these concerns, this article’s recommendation to use sterile water in the water bottle during GI endoscopy is in part due to the public, and both regulatory and accreditation agencies and organizations, placing a renewed focus on the quality and safety of many aspects of GI endoscopy (CDC, 2014; Medscape, 2014).
This enhanced scrutiny is an appropriate response to the recent emergence of “superbugs” and their association in 2013 with the largest outbreak of carbapenem-resistant Enterobacteriaceae (or, CRE) following GI endoscopy (namely, ERCP) performed at “Hospital X” in the mid-west (USA) (CDC, 2014).
In fact, reports published during the past few years document patient colonization, infection morbidity and mortality due to GI endoscopes contaminated with CRE and other multidrug-resistant bacteria (CDC, 2014; Medscape, 2014). (Read Dr. Muscarella’s article “Overlooked Outbreaks of “CRE” Following GI Endoscopy: A “Superbug” Epidemic in Our Midst?” — click here.)
K. pneumoniae that produce the enzyme K. pneumoniae carbapenemase (or, KPC) is an example of CRE.
Tap water (and other moist surfaces, including hand-washing sinks) in the healthcare setting is a documented reservoir of CRE (some strains of which are resistant to all antimicrobial therapy) and other types of multidrug-resistant bacteria, including multidrug-resistant (MDR) P. aeruginosa (Muscarella, 2004; Hota et al., 2009; Walsh et al., 2011; Starlander and Melhus, 2012; Kotsanas et al., 2013; Haeck, 2014).
For more about the risk of transmission of CRE during GI endoscopy, the reader is directed to Dr. Muscarella’s article: “Multiple Outbreaks of a ‘Nightmare Bacteria’ Linked to Contaminated Endoscopes in the U.S and Europe: Has a ‘Smoking Gun’ Been Found?” which is available by clicking here.
To be sure, the use of sterile water during the GI endoscopic procedure (and bacteria-free water for rinsing the GI endoscope during its reprocessing) eliminates the possibility of tap water contaminating the GI endoscope and infecting (or colonizing) patients with CRE and other antibiotic-resistant bacteria.
The possibility that the tap water was a reservoir for “Hospital X’s” outbreak strain of CRE, to date, has not been ruled out.
While both the under-reporting of HAIs and the risk of transmission of CRE (or other antibiotic-resistant bacteria) via water supplies are apt concerns, ASGE’s revised position in its 2014 guideline concluding the safety of using tap water during GI endoscopy appears to have considered neither.
Additional rationale in support of the recommendation to use sterile water
In addition to: (i) many reports citing a healthcare facility’s water supply as the reservoir and cause of a bacterial outbreak, with associated patient morbidity and mortality; (ii) water being a documented reservoir of CRE and other multidrug-resistant bacteria; (iii) several recent reports documenting a contaminated GI endoscope’s transmission of these superbugs (CDC, 2014; Medscape, 2014); (iv) reports revealing the potentially significant under-reporting of medical errors, including HAIs; (v) a lack of follow-up surveillance to assess patient colonization with superbugs and other infectious microorganisms due to cross-infection following GI endoscopy; and (vi) the recommendations of several professional organizations including SGNA, other rationale in support of the use of sterile water in the water bottle during GI endoscopy include that:
- the manufacturers of GI endoscopes (i.e., FugiFilm, Olympus, Pentax) recommend in their respective operator’s manuals that clinicians “use sterile water only” for irrigation and/or lens cleaning, because the use of non-sterile (e.g., tap) water may result in patient infection. The use of tap water for irrigation would therefore seemingly be an off-label use of the GI endoscope;
- the same quality of water (whether tap or sterile) is generally used to fill the water bottle(s) used for irrigation and for cleaning of the GI endoscope’s lens (via the GI endoscope’s air/water system) during either upper or lower GI endoscopy (ASGE, 2003, 2011). All risks are not the same, and the risk of bacterial infections from tap water following one type of GI endoscopic procedure (e.g., colonoscopy) may not be the same as, and may be significantly lower than, that associated with another type (i.e., ERCP);
- improved water quality has been cited as an important measure for the prevention of transmission of antibiotic-resistance bacteria including CRE and other types of superbugs (Haeck, 2014);
- potentially pathogenic bacteria have been cultured from water bottles used during GI endoscopy (Agrawal and Rockey, 2013), and, despite ASGE’s updated guideline in 2014 stating that the use of tap water “has been shown to be safe,” tap water, especially that which has remained idle for a prolonged period of time, poses an increased risk of bacterial colonization; re-contamination of the previously reprocessed GI endoscope with waterborne microorganisms; and patient infection (Pentax Medical Company);
- no new or recent data have been published clearly warranting a change in practice, the revision of a recommendation shared by several organizations, and the replacement of sterile water with tap water (for irrigation and/or lens cleaning) during GI endoscopy;
- active measures for monitoring patients following GI endoscopy to rule out post-endoscopic bacterial infections and “superbug” colonizations are lacking (although the implementation of such measures this article recommends). Without patient tracking to ensure that none are colonized with potentially infectious bacteria following GI endoscopy, the safety of tap water used for irrigation during GI endoscopy cannot be certainly assured;
- nor can the safety of tap water used for irrigation during GI endoscopy be assured when the infection data (including those associated with the transmission of CRE following GI endoscopy) are incomplete due to HAIs reportedly being under-reported. This finding argues for adoption of a most circumspect approach (i.e., using sterile water instead of tap water for all GI endoscopic procedures, especially ERCP);
- several other infection-control and GI endoscopy organizations recommend the use of sterile water during GI endoscopy (ASGE 2003; ASGE, 2011) (see: Table 1);
- as ASGE acknowledges, surveyors associated with a medical facility’s re-accreditation have required that the GI endoscopy department use sterile water in the water bottle for both irrigation and cleaning of the GI endoscope’s lens (Deas and Sinsel, 2014); and
- patient infection, morbidity and mortality were linked in 2014 to tap water contaminated with atypical mycobacteria — click here for more details — causing officials of the Greenville Health System (South Carolina) to install a water filtration system throughout all of its campuses. According to the CDC, the cause of this outbreak (atypical Mycobacterium abscessus) is “often found in water supplies.”
A few other remarks
ASGE’s guideline in 2014 now asserting the safety of tap water for use during GI endoscopic procedures is at odds with several other organizations’ current recommendations, including SGNA’s (see: Table 1). (Remember that ASGE’s two “multi-society” guidelines published in 2003 and 2011 both “strongly recommend” the use of sterile water in the water bottle used for irrigation and lens cleaning during GI endoscopy.)
ASGE’s 2014 endorsement of the use of tap water for performing GI endoscopy more cost-effectively does not discriminate between the water quality used during upper or lower GI endoscopy, or for irrigation or lens cleaning, and therefore it is reasonable to conclude that ASGE is endorsing the use of tap water for all GI endoscopic procedures, including ERCP.
Another potential advantage of using sterile water for all GI procedures is that, in the event of disease transmission due to, say, faulty endoscope reprocessing – for example, horizontal transmission of the hepatitis C virus due to improper cleaning of a GI endoscope – an injured party might be provided an advantage if it can be soundly argued that the GI endoscopy unit’s overall practices lack enhanced measures to ensure quality and patient safety. The use of tap water could be an Achilles’ heel interpreted to show compromised quality for the sake of cost savings.
The reader is directed to Dr. Muscarella’s related article “A Legal Case and Verdict about Improperly Reprocessed GI Endoscopes” (click here).
CONCLUSION and SUMMARY
Consistent with the recommendations of SGNA, SHEA, ACG, AGA, AORN, APIC, and The Joint Commission, this article endorses a circumspect approach, recommending the use of sterile water (in lieu of tap water) to fill the water bottle during all GI endoscopic procedures.
Although most reported infections following GI endoscopy caused by exogenous bacteria are associated with the tap water used to rinse the GI endoscope during reprocessing, published data not only document the water bottle as a source of disease transmission (Agrawal and Rockey, 2013), but also do not rule out the potential for the transmission of superbugs and other multidrug-resistant bacteria via the tap water stored in the water bottle used during GI endoscopy.
This article agrees with Agrawal and Rockey’s (2013) proposal that: “there be a meeting organized that includes key stakeholders with the agenda being a discussion of best practices in endoscopy units. … One topic should be the routine use of sterile water. A white paper could then be written, pointing to specific group recommendations, including the need for further research, if necessary.” Well presented, Drs. Agrawal and Rockey. [The End]
Table 1. The date, title, link, instruction and rationale of the three guidelines published by ASGE in 2003, 2011 and 2014 discussing the recommended or approbated water quality.*
1. 2003: Multi-society guideline for reprocessing flexible gastrointestinal endoscopes (click here): “Sterile water should be used to fill the water bottle.** Category IB.” Also, “High-level disinfect or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure), and its connecting tube at least daily.”
— “Category IB” is defined in this guideline as “strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale.”
— This guideline references several reports, including an infection-control guideline, discussing water as a documented reservoir of healthcare-associated infections to justify this sterile-water instruction.
2. 2011: Multi-society guideline on reprocessing flexible gastrointestinal endoscopes: 2011 (click here): “Sterile water should be used to fill the water bottle.** Category IB.” Also, “High-level disinfect or sterilize the water bottle (used for cleaning the lens and irrigation during the procedure) and its connecting tube at least daily.”
— “Category IB” is identically defined in this guideline as “strongly recommended for implementation and supported by some experimental, clinical or epidemiologic studies and a strong theoretical rationale.”
— This guideline references several reports, including a federal guideline, discussing water as a documented reservoir of healthcare-associated infections to justify this sterile-water instruction.
3. 2014: Guidelines for safety in the gastrointestinal endoscopy unit (click here): “Although the multiple-society guideline recommends using sterile water in the irrigation bottle,** it is acceptable to use tap water because this has been shown to be safe.” This guideline adds that: “The rates of bacterial cultures are no different with the use of tap water versus sterile water, and neither has been associated with clinical infections.”
— Unlike its two preceding guidelines published in 2003 and 2011, this 2014 guideline does not associate this position with a “category” type (such as “Category IB”).
— Further, this guideline’s statement that “neither (tap water or sterile water) has been associated with clinical infections” is not consistent with the literature, which has documented many cases, including reports associating flexible endoscopy and GI endoscopy, particularly ERCP, with patient morbidity and mortality due to contaminated tap water.
* None of these three guidelines differentiates between the water quality or type used during upper versus lower GI endoscopy. It is therefore reasonable to conclude that ASGE intended the quality of water used for irrigation and lens cleansing during colonoscopy to be the same as that for lens cleansing during endoscopic retrograde cholangiopancreatography, or ERCP.
** The 2003 and 2011 multi-society guidelines instruct, in addition to sterile water being used in the water bottle for irrigation, that sterile water also be used to cleanse the GI endoscope’s lens during the procedure. In general, one type of water quality is used both for irrigation and lens cleaning (ASGE, 2011; ASGE, 2003).
- Agrawal D, Rockey D. Sterile water in endoscope: Habit, opinion or evidence. Gastroinest Endosc 2013;78(1):150-2.
- Allen JI, ALlen MO, Olson MM, et al. Pseudomonas infection of the biliary system resulting from use of a contaminated endoscope. Gastroenterology. 1987 Mar;92(3):759-63.
- Alvarado CJ, Stolz SM, Maki DG. Nosocomial infections from contaminated endoscopes: a flawed automated endoscope washer. An investigation using molecular epidemiology. Am J Med 1991 Sep 16;91(3B):272S-280S.
- Bass DH, Oliver S, Bornman PC. Pseudomonas septicaemia after endoscopic retrograde cholangiopancreatography–an unresolved problem. S Afr Med J 1990 May 19;77(10):509-11.
- California Watch. Review finds hospital-acquired infections went unreported. August 10, 2012.
- Chedekel L. Hospital Errors Persist, State Probes Rare. Connecticut Health Investigative Team
- Centers for DIsease Control and Prevention (CDC). Notes from the Field: New Delhi Metallo-β-Lactamase–Producing Escherichia coli Associated with Endoscopic Retrograde Cholangiopancreatography — Illinois, 2013. MMWR January 3, 2014 / 62(51);1051-1051.
- Classen DC, Jacobson JA, Burke JP, et al. Serious Pseudomonas infections associated with ebdoscopic rertograde cholangiopancreatography, Am J Med 1988 Mar;84:590-6.
- Consumers Union. Public Disclosure Will Encourage Hospitals to Improve Infection Practices. October, 2007.
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- Deas T, Sinsel L. Ensuring patient safety and optimizing efficiency during gastrointestinal endoscopy. AORN J 2014 Mar;99(3):396-406.
- Dirlam Langlay AM, Ofstead CL, Mueller NJ, et al. Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg. Am J Infect Control 2013 Dec;41(12):1188-94.
- FujiFilm Medical Systems USA. Reprocessing summary and guide for FujiFilm flexible endoscopes. FRG-120323.
- Gastmeier P, Vonberg RP. Klebsiella spp. in endoscopy-associated infections: we may only be seeing the tip of the iceberg. Infection 2014 Feb;42(1):15-21.
- Haeck T. Fresh warnings about deaths from drug-resistant bacteria. MyNorthwest.com May 19, 2014.
- Hota S, Hirji Z, Stockton K, et al. Outbreak of Multidrug-Resistant Pseudomonas aeruginosa Colonization and Infection Secondary to Imperfect Intensive Care Unit Room Design. Infect Control Hosp Epidemiol 2009 Jan;30(1):25-33.
- Kotsanas D, Wijesooriya W, Korman T, et al. “Down the drain”: carbapenem-resistant bacteria in intensive care unit patients and hand-washing sinks. MJA 2013; 198: 267–269.
- Medscape [Kelly JC].CDC Confirms Superbug Transmission via Endoscopy. Medscape Medical News January 03, 2014.
- Muscarella LF. Contribution of Tap Water and Environmental Surfaces to Nosocomial Transmission of Antibiotic‐Resistant Pseudomonas aeruginosa. Infect Control Hosp Epidemiol 2004 Apr;25(4):342-345.
- Muscarella LF. Inconsistencies in Endoscope-Reprocessing and Infection-Control Guidelines: The Importance of Endoscope Drying. Am J Gastroenterol 2006;101:2147–2154.
- Muscarella LF. Investigation and prevention of infectious outbreaks during endoscopic retrograde cholangiopancreatography. Endoscopy 2010 Nov;42(11):957-9.
- O’Connor HJ, Axon ATR. Gastrointestinal endoscopy: infection and disinfection. Gut 1983;24(1067-1077).
- Olympus America. Olympus EVIS EXERA II 180 series upper and lower GI endoscopes’ operator manual.
- Pentax Medical Company. Owner’s Manual for Pentax Video GI Scopes: EG-290Kp and EC-380LKp.
- Puterbaugh M, Barde C, Van Enk R. Endoscopy water source: tap or sterile water? Gastroenterol Nurs 1997;20:203-6.
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Article by: Lawrence F Muscarella, PhD, the president of: LFM Healthcare Solutions, LLC, a quality improvement company. Updated: 11-18-2014, Rev A.