Guideline:
Infection control during GI endoscopy
Bibliographic Source(s)
- ASGE Standards of Practice Committee Banerjee S Shen B Nelson DB Lichtenstein DR Baron TH Anderson MA Dominitz JA Gan SI Harrison ME Ikenberry SO Jagannath SB Fanelli RD Lee K van Guilder T Stewart LE. Infection control during GI endoscopy. Gastrointest Endosc 2008 May;67(6):781-90. [109 references] PubMed
Guideline Status
This is the current release of the guideline.
Guideline Category
Management
Prevention
Treatment
Intended Users
Allied Health Personnel
Nurses
Physicians
Guideline Objective(s)
- To provide information that may assist endoscopists in providing care to patients
- To disseminate information and promote understanding which leads to the prevention of infection as a result of a gastrointestinal endoscopy
Target Population
Patients undergoing an endoscopic examination
Interventions and Practices Considered
- Reprocessing of endoscopies
- Manual cleaning
- High-level disinfection (HLD)
- Sterilization
- Proper rinsing drying and storage
- Antibiotic prophylaxis for gastrointestinal (GI) endoscopic procedures
- General infection control procedures (e.g. single use of drug vials and use of gloves by health care workers)
- Use of precautions to avoid infection transmission
- Standard precautions
- Precautions at the institutional level
- Precautions in the endoscopy suite
- Use of personal protective equipment
- Postexposure prophylaxis
Major Outcomes Considered
- Incidence of infections (patient to patient; by endoscopy endogenous) after endoscopic procedures
- Effectiveness in preventing infections as a result of a gastrointestinal (GI) endoscopy
Methods Used to Collect/Select Evidence
Hand-searches of Published Literature (Primary Sources)
Hand-searches of Published Literature (Secondary Sources)
Searches of Electronic Databases
Description of Methods used to Collect/Select the Evidence
A search of the medical literature was performed by using PubMed supplemented by accessing the "related articles" feature of PubMed. Additional references were obtained from the bibliographies of the identified articles and from recommendations of expert consultants. When little or no data exist from well-designed prospective trials emphasis is given to results from large series and reports from recognized experts.
Number of Source Documents
Not stated
Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
See "Rating Scheme for the Strength of the Recommendations"
Methods Used to Analyze the Evidence
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence
Not stated
Methods Used to Formulate the Recommendations
Expert Consensus
Description of Methods Used to Formulate the Recommendations
Guidelines for appropriate use of endoscopy are based on critical review of the available data and expert consensus.
Rating Scheme for the Strength of the Recommendations
| Grade of Recommendation | Clarity of Benefit | Methodologic Strength Supporting Evidence | Implications |
|---|---|---|---|
| 1A | Clear | Randomized trials without important limitations | Strong recommendation; can be applied to most clinical settings |
| 1B | Clear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Strong recommendation; likely to apply to most practice settings |
| 1C+ | Clear | Overwhelming evidence from observational studies | Strong recommendation; can apply to most practice settings in most situations |
| 1C | Clear | Observational studies | Intermediate-strength recommendation; may change when stronger evidence is available |
| 2A | Unclear | Randomized trials without important limitations | Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values |
| 2B | Unclear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Weak recommendation; alternative approaches may be better under some circumstances |
| 2C | Unclear | Observational studies | Very weak recommendation; alternative approaches likely to be better under some circumstances |
| 3 | Unclear | Expert opinion only | Weak recommendation; likely to change as data become available |
*Adapted from Guyatt G Sinclair J Cook D et al. Moving from evidence to action. Grading recommendations: a qualitative approach. In: Guyatt G Rennie D editors. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.
Cost Analysis
A formal cost analysis was not performed and published cost analyses were not reviewed.
Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation
This document was reviewed and approved by the Governing Board of the American Society for Gastrointestinal Endoscopy. This document was reviewed and endorsed by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Guidelines Committee and Board of Governors.
Major Recommendations
Definitions for the grades of recommendation (1A to 3) are provided at the end of the "Major Recommendations."
Reprocessing of Endoscopes
Definitions
Cleaning: This is defined as the physical removal of organic material and/or soil usually by using water with detergents. This process is designed to remove microorganisms rather than to kill them.
Disinfection: Disinfection accomplishes the killing of most microorganisms and is commonly performed by using liquid chemical germicides (LCG). Three levels of disinfection are achievable: high intermediate and low depending on the amount and kind of microbial killing involved. High level disinfection (HLD) destroys vegetative microorganisms mycobacteria fungi small or nonlipid viruses medium or lipid viruses but not necessarily large numbers of bacterial spores. Chemical germicides registered as "sterilants" may be used for sterilization or for HLD depending on such factors as dilution contact time and frequency of reuse. The specifics of such factors may vary with each product and are included on approved labeling.
Sterilization: Sterilization is the act of killing all microbial life including the elimination of bacterial spores. It is most commonly achieved with heat or ethylene oxide gas. The Spaulding classification system allows categorization of medical devices based on the risk of infection involved with use. The categories of medical devices and their associated level of disinfection are as follows:
- Critical use items: Items that enter sterile tissue or vascular spaces and hence carry significant risk for infection if contaminated. These items include needles surgical instruments biopsy forceps and urinary catheters. Processing for reuse of these items requires sterilization. In some instances gastrointestinal (GI) endoscopes are sterilized when intended for use in sterile environments.
- Semicritical use items: Items that come in contact with mucous membranes and do not ordinarily penetrate sterile tissue. These include thermometers endoscopes and anesthesia equipment. Processing for reuse of these items requires at least HLD.
- Noncritical items: Items that do not ordinarily touch the patient or touch only intact skin such as stethoscopes or patient carts. These items may be cleaned by low-level disinfection.
Summary
- Transmission of infection as a result of GI endoscopes is extremely rare and recently reported cases are invariably attributable to lapses in currently accepted endoscope reprocessing protocols or to defective equipment. (Level 1C+)
- Endoscopes should undergo HLD as recommended by governmental agencies and all pertinent professional organizations for the reprocessing of GI endoscopes. (Level 1C+)
- Extensive training of staff involved in endoscopic reprocessing is mandatory for quality assurance and for effective infection control. (Level 1C)
- General infection control principles should be adhered to at the endoscopy unit. (Level 1C+)
- Transmission of infection from patients to endoscopy personnel can be avoided by application of standard precautions. (Level 1C+)
Definitions:
| Grade of Recommendation | Clarity of Benefit | Methodologic Strength Supporting Evidence | Implications |
|---|---|---|---|
| 1A | Clear | Randomized trials without important limitations | Strong recommendation; can be applied to most clinical settings |
| 1B | Clear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Strong recommendation; likely to apply to most practice settings |
| 1C+ | Clear | Overwhelming evidence from observational studies | Strong recommendation; can apply to most practice settings in most situations |
| 1C | Clear | Observational studies | Intermediate-strength recommendation; may change when stronger evidence is available |
| 2A | Unclear | Randomized trials without important limitations | Intermediate-strength recommendation; best action may differ depending on circumstances or patients' or societal values |
| 2B | Unclear | Randomized trials with important limitations (inconsistent results nonfatal methodologic flaws) | Weak recommendation; alternative approaches may be better under some circumstances |
| 2C | Unclear | Observational studies | Very weak recommendation; alternative approaches likely to be better under some circumstances |
| 3 | Unclear | Expert opinion only | Weak recommendation; likely to change as data become available |
*Adapted from Guyatt G Sinclair J Cook D et al. Moving from evidence to action. Grading recommendations: a qualitative approach. In: Guyatt G Rennie D editors. Users' guides to the medical literature. Chicago: AMA Press; 2002. p. 599-608.
Clinical Algorithm(s)
None provided
Type of Evidence supporting the Recommendations
The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations").
Potential Benefits
Appropriate infection control during gastrointestinal (GI) endoscopy
Potential Harms
The efficacy of manual cleaning and high-level disinfection (HLD) is personnel dependent. Reprocessing failure incidents typically arise as a result of human error or because of equipment automatic endoscope reprocessor (AER) or product (HLD) failure.
Qualifying Statements
- Further controlled clinical studies may be needed to clarify aspects of this guideline. This guideline may be revised as necessary to account for changes in technology new data or other aspects of clinical practice. This guideline is intended to be an educational device to provide information that may assist endoscopists in providing care to patients.
- This guideline is not a rule and should not be construed as establishing a legal standard of care or as encouraging advocating requiring or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient's condition and available courses of action. Therefore clinical considerations may lead an endoscopist to take a course of action that varies from these guidelines.
Description of Implementation Strategy
An implementation strategy was not provided.
IOM Care Need
Getting Better
Staying Healthy
IOM Domain
Effectiveness
Safety
Bibliographic Source(s)
- ASGE Standards of Practice Committee Banerjee S Shen B Nelson DB Lichtenstein DR Baron TH Anderson MA Dominitz JA Gan SI Harrison ME Ikenberry SO Jagannath SB Fanelli RD Lee K van Guilder T Stewart LE. Infection control during GI endoscopy. Gastrointest Endosc 2008 May;67(6):781-90. [109 references] PubMed
Adaptation
Not applicable: The guideline was not adapted from another source.
Source(s) of Funding
American Society for Gastrointestinal Endoscopy
Guideline Committee
Standards of Practice Committee
Composition of Group that Authored the Guideline
Committee Members: Subhas Banerjee MD; Bo Shen MD; Douglas B. Nelson MD; David R. Lichtenstein MD; Todd H. Baron MD (Chair); Michelle A. Anderson MD; Jason A. Dominitz MD MHS; S. Ian Gan MD FRCPC; M. Edwyn Harrison MD; Steven O. Ikenberry MD; Sanjay B. Jagannath MD; Robert D. Fanelli MD SAGES Representative; Ken Lee MD NASPGHAN Representative; Trina van Guilder RN SGNA Representative; Leslie E. Stewart RN SGNA Representative
Financial Disclosures/Conflicts of Interest
Not stated
Guideline Status
This is the current release of the guideline.
Guideline Availability
Electronic copies: Available from the American Society for Gastrointestinal Endoscopy Web site.
Print copies: Available from the American Society for Gastrointestinal Endoscopy 1520 Kensington Road Suite 202 Oak Brook IL 60523
Availability of Companion Documents
None available
Patient Resources
None available
NGC STATUS
This NGC summary was completed by ECRI Institute on September 15 2008. The information was verified by the guideline developer on October 31 2008.
COPYRIGHT STATEMENT
This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions.
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