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.
