Below are tables summarizing recommendations for this guideline.
The ultimate goal of the Recommendations for Disinfection and Sterilization in Health-Care Facilities, 2008, is to reduce rates of health-care associated infections through appropriate use of both disinfection and sterilization. Each recommendation is categorized according to scientific evidence, theoretical rationale, applicability, and federal regulations. Examples are included in some recommendations to aid the reader; however, these examples are not intended to define the only method of implementing the recommendation. The CDC system for categorizing recommendations is defined in the following (Rankings) section.
Strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies.
Category IBStrongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies, and by a strong theoretical rationale.
Category ICRequired by state or federal regulations. Because of state differences, readers should not assume that the absence of an IC recommendation implies the absence of state regulations.
Category IISuggested for implementation and supported by suggestive clinical or epidemiologic studies or by a theoretical rationale.
No recommendationUnresolved issue. These include practices for which insufficient evidence or no consensus exists regarding efficacy.
| # | Recommendation | Category |
|---|---|---|
| 1.a. | Inform each worker of the possible health effects of his or her exposure to infectious agents (e.g., hepatitis B virus [HBV], hepatitis C virus, human immunodeficiency virus [HIV]), and/or chemicals (e.g., EtO, formaldehyde). The information should be consistent with Occupational Safety and Health Administration (OSHA) requirements and identify the areas and tasks in which potential exists for exposure. | II, IC |
| 1.b. | Educate health-care workers in the selection and proper use of personal protective equipment (PPE). | II, IC |
| 1.c. | Ensure that workers wear appropriate PPE to preclude exposure to infectious agents or chemicals through the respiratory system, skin, or mucous membranes of the eyes, nose, or mouth. PPE can include gloves, gowns, masks, and eye protection. The exact type of PPE depends on the infectious or chemical agent and the anticipated duration of exposure. The employer is responsible for making such equipment and training available. | II, IC |
| 1.d. | Establish a program for monitoring occupational exposure to regulated chemicals (e.g., formaldehyde, EtO) that adheres to state and federal regulations. | II, IC |
| 1.e. | Exclude healthcare workers with weeping dermatitis of hands from direct contact with patient-care equipment. | IB |
| # | Recommendation | Category |
|---|---|---|
| 2.a. | In hospitals, perform most cleaning, disinfection, and sterilization of patient-care devices in a central processing department in order to more easily control quality. | II |
| 2.b. | Meticulously clean patient-care items with water and detergent, or with water and enzymatic cleaners before high-level disinfection or sterilization procedures. | IB |
| 2.b.i. | Remove visible organic residue (e.g., residue of blood and tissue) and inorganic salts with cleaning. Use cleaning agents that are capable of removing visible organic and inorganic residues. | IB |
| 2.b.ii. | Clean medical devices as soon as practical after use (e.g., at the point of use) because soiled materials become dried onto the instruments. Dried or baked materials on the instrument make the removal process more difficult and the disinfection or sterilization process less effective or ineffective. | IB |
| 2.c. | Perform either manual cleaning (i.e., using friction) or mechanical cleaning (e.g., with ultrasonic cleaners, washer-disinfector, washer-sterilizers). | IB |
| 2.d. | If using an automatic washer/disinfector, ensure that the unit is used in accordance with the manufacturer’s recommendations. | IB |
| 2.e. | Ensure that the detergents or enzymatic cleaners selected are compatible with the metals and other materials used in medical instruments. Ensure that the rinse step is adequate for removing cleaning residues to levels that will not interfere with subsequent disinfection/sterilization processes. | II |
| 2.f. | Inspect equipment surfaces for breaks in integrity that would impair either cleaning or disinfection/sterilization. Discard or repair equipment that no longer functions as intended or cannot be properly cleaned, and disinfected or sterilized. | II |
| # | Recommendation | Category |
|---|---|---|
| 3.a. | Before use on each patient, sterilize critical medical and surgical devices and instruments that enter normally sterile tissue or the vascular system or through which a sterile body fluid flows (e.g., blood). See recommendation 7g for exceptions. | IA |
| 3.b. | Provide, at a minimum, high-level disinfection for semicritical patient-care equipment (e.g., gastrointestinal endoscopes, endotracheal tubes, anesthesia breathing circuits, and respiratory therapy equipment) that touches either mucous membranes or nonintact skin. | IA |
| 3.c. | Perform low-level disinfection for noncritical patient-care surfaces (e.g., bedrails, over-the-bed table) and equipment (e.g., blood pressure cuff) that touch intact skin (see Recommendation 5g). | II |
| # | Recommendation | Category |
|---|---|---|
| 4.a. | Process noncritical patient-care devices using a disinfectant and the concentration of germicide listed in Table 1. | IB |
| 4.b. | Disinfect noncritical medical devices (e.g., blood pressure cuff) with an EPA-registered hospital disinfectant using the label’s safety precautions and use directions. Most EPA-registered hospital disinfectants have a label contact time of 10 minutes. However, multiple scientific studies have demonstrated the efficacy of hospital disinfectants against pathogens with a contact time of at least 1 minute. By law, all applicable label instructions on EPA-registered products must be followed. If the user selects exposure conditions that differ from those on the EPA-registered product label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA. | IB |
| 4.c. | Ensure that, at a minimum, noncritical patient-care devices are disinfected when visibly soiled and on a regular basis (such as after use on each patient or once daily or once weekly). | II |
| 4.d. | If dedicated, disposable devices are not available, disinfect noncritical patient-care equipment after using it on a patient who is on contact precautions before using this equipment on another patient. | IB |
Edit: An * indicates recommendations that were renumbered for clarity. The renumbering does not constitute change to the intent of the recommendations.
This recommendation was updated to reflect changes in Federal regulatory approvals: LIST K: EPA’s Registered Antimicrobial Products Effective against Clostridium difficile Spores external icon
Update: Use an EPA-registered sporicidal disinfectant in units with high rates of endemic Clostridium difficile infection or in an outbreak setting.
| # | Recommendation | Category |
|---|---|---|
| 6.a. | Do not perform disinfectant fogging for routine purposes in patient-care areas. |
Clarification Statement: CDC and HICPAC have recommendations in both 2003 Guidelines for Environmental Infection Control in Health-Care Facilities and the 2008 Guideline for Disinfection and Sterilization in Healthcare Facilities that state that the CDC does not support disinfectant fogging. Specifically, the 2003 and 2008 Guidelines state:
These recommendations refer to the spraying or fogging of chemicals (e.g., formaldehyde, phenol-based agents, or quaternary ammonium compounds) as a way to decontaminate environmental surfaces or disinfect the air in patient rooms. The recommendation against fogging was based on studies in the 1970’s that reported a lack of microbicidal efficacy (e.g., use of quaternary ammonium compounds in mist applications) but also adverse effects on healthcare workers and others in facilities where these methods were utilized. Furthermore, some of these chemicals are not EPA-registered for use in fogging-type applications.
These recommendations do not apply to newer technologies involving fogging for room decontamination (e.g., ozone mists, vaporized hydrogen peroxide) that have become available since the 2003 and 2008 recommendations were made. These newer technologies were assessed by CDC and HICPAC in the 2011 Guideline for the Prevention and Control of Norovirus Gastroenteritis Outbreaks in Healthcare Settings, which makes the recommendation:
“More research is required to clarify the effectiveness and reliability of fogging, UV irradiation, and ozone mists to reduce norovirus environmental contamination. (No recommendation/unresolved issue)”
The 2003 and 2008 recommendations still apply; however, CDC does not yet make a recommendation regarding these newer technologies. This issue will be revisited as additional evidence becomes available.
Edit: An * indicates recommendations that were renumbered for clarity. The renumbering does not constitute change to the intent of the recommendations.
| # | Recommendation | Category |
|---|---|---|
| 7.a. | To detect damaged endoscopes, test each flexible endoscope for leaks as part of each reprocessing cycle. Remove from clinical use any instrument that fails the leak test, and repair this instrument. | II |
| 7.b. | Immediately after use, meticulously clean the endoscope with an enzymatic cleaner that is compatible with the endoscope. Cleaning is necessary before both automated and manual disinfection. | IA |
| 7.c. | Disconnect and disassemble endoscopic components (e.g., suction valves) as completely as possible and completely immerse all components in the enzymatic cleaner. Steam sterilize these components if they are heat stable. | IB |
| 7.d. | Flush and brush all accessible channels to remove all organic (e.g., blood, tissue) and other residue. Clean the external surfaces and accessories of the devices by using a soft cloth or sponge or brushes. Continue brushing until no debris appears on the brush. | IA |
| 7.e. | Use cleaning brushes appropriate for the size of the endoscope channel or port (e.g., bristles should contact surfaces). Cleaning items (e.g., brushes, cloth) should be disposable or, if they are not disposable, they should be thoroughly cleaned and either high-level disinfected or sterilized after each use. | II |
| 7.f. | Discard enzymatic cleaners (or detergents) after each use because they are not microbicidal and, therefore, will not retard microbial growth. | IB |
| 7.g. | Process endoscopes (e.g., arthroscopes, cystoscope, laparoscopes) that pass through normally sterile tissues using a sterilization procedure before each use; if this is not feasible, provide at least high-level disinfection. High-level disinfection of arthroscopes, laparoscopes, and cystoscope should be followed by a sterile water rinse. | IB |
| 7.h. | Phase out endoscopes that are critical items (e.g., arthroscopes, laparoscopes) but cannot be steam sterilized. Replace these endoscopes with steam sterilizable instruments when feasible. | II |
| 7.i. | Mechanically clean reusable accessories inserted into endoscopes (e.g., biopsy forceps or other cutting instruments) that break the mucosal barrier (e.g., ultrasonically clean biopsy forceps) and then sterilize these items between each patient. | IA |
| 7.j. | Use ultrasonic cleaning of reusable endoscopic accessories to remove soil and organic material from hard-to-clean areas. | II |
| 7.k. | Process endoscopes and accessories that contact mucous membranes as semicritical items, and use at least high-level disinfection after use on each patient. | IA |
| 7.l. | Use an FDA-cleared sterilant or high-level disinfectant for sterilization or high-level disinfection (Table 1). | IA |
| 7.m. | After cleaning, use formulations containing glutaraldehyde, glutaraldehyde with phenol/phenate, ortho-phthalaldehyde, hydrogen peroxide, and both hydrogen peroxide and peracetic acid to achieve high-level disinfection followed by rinsing and drying (see Table 1 for recommended concentrations). | IB |
| 7.n. | Extend exposure times beyond the minimum effective time for disinfecting semicritical patient-care equipment cautiously and conservatively because extended exposure to a high-level disinfectant is more likely to damage delicate and intricate instruments such as flexible endoscopes. The exposure times vary among the Food and Drug Administration (FDA)-cleared high-level disinfectants (Table 2). | IB |
| 7.o. | Federal regulations are to follow the FDA-cleared label claim for high-level disinfectants. The FDA-cleared labels for high-level disinfection with >2% glutaraldehyde at 25ºC range from 20-90 minutes, depending upon the product based on three tier testing which includes AOAC sporicidal tests, simulated use testing with mycobacterial and in-use testing. | IC |
| 7.p. | Several scientific studies and professional organizations support the efficacy of >2% glutaraldehyde for 20 minutes at 20ºC; that efficacy assumes adequate cleaning prior to disinfection, whereas the FDA-cleared label claim incorporates an added margin of safety to accommodate possible lapses in cleaning practices. Facilities that have chosen to apply the 20 minute duration at 20ºC have done so based on the IA recommendation in the July 2003 SHEA position paper, “Multi-society Guideline for Reprocessing Flexible Gastrointestinal Endoscopes” |