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Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 [PDF - 948 KB]

Table 1. Methods of sterilization and disinfection.

    Sterilization   Disinfection  
    Critical items (will enter tissue or vascular system or blood will flow through them) High-level (semicritical items; [except dental] will come in contact with mucous membrane or nonintact skin) Intermediate-level (some semicritical items1 and noncritical items) Low-level (noncritical items; will come in contact with intact skin)
Object Procedure Exposure time Procedure (exposure time 12-30 min at ≥20°C)2,3 Procedure (exposure time ≥ 1 m) 9 Procedure (exposure time ≥ 1 m) 9
Smooth, hard Surface1,4 A MR D K K
D 10 h at 20-25°C H N N
F 6 h I6   O
G 12 m at 50-56°C J    
H 3-8 h      
Rubber tubing and catheters3,4 A MR D    
B MR E    
C MR F    
D 10 h at 20-25°C H    
F 6 h I6    
G 12 m at 50-56°C J    
H 3-8 h      
Polyethylene tubing and catheters3,4,7 A MR D    
B MR E    
C MR F    
D 10 h at 20-25°C H    
F 6 h I6    
G 12 m at 50-56°C J    
H 3-8 h      
Lensed instruments4 A MR D    
  B MR E    
  C MR F    
  D 10 h at 20-25°C H    
  F 6 h J    
  G 12 m at 50-56°C      
  H 3-8 h      
Thermometers (oral and rectal)8
Hinged instruments4
A MR D   K8
B MR E    
C MR F    
D 10 h at 20-25°C H    
F 6 h I6    
G 12 m at 50-56°C J    
H 3-8 h      

Modified from Rutala and Simmons. 15, 17, 18, 421 The selection and use of disinfectants in the healthcare field is dynamic, and products may become available that are not in existence when this guideline was written. As newer disinfectants become available, persons or committees responsible for selecting disinfectants and sterilization processes should be guided by products cleared by the FDA and the EPA as well as information in the scientific literature. 104

A, Heat sterilization, including steam or hot air (see manufacturer's recommendations, steam sterilization processing time from 3-30 minutes)
B, Ethylene oxide gas (see manufacturer's recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C)
C, Hydrogen peroxide gas plasma (see manufacturer's recommendations for internal diameter and length restrictions, processing time between 45-72 minutes).
D, Glutaraldehyde-based formulations (>2% glutaraldehyde, caution should be exercised with all glutaraldehyde formulations when further in-use dilution is anticipated); glutaraldehyde (1.12%) and 1.93% phenol/phenate. One glutaraldehyde-based product has a high-level disinfection claim of 5 minutes at 35°C.
E, Ortho-phthalaldehyde (OPA) 0.55%
F, Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass)
G, Peracetic acid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C.
H, Hydrogen peroxide (7.35%) and 0.23% peracetic acid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments)
I, Wet pasteurization at 70°C for 30 minutes with detergent cleaning
J, Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments)
K, Ethyl or isopropyl alcohol (70-90%)
L, Sodium hypochlorite (5.25-6.15% household bleach diluted 1:500 provides >100 ppm available chlorine)
M, Phenolic germicidal detergent solution (follow product label for use-dilution)
N, Iodophor germicidal detergent solution (follow product label for use-dilution)
O, Quaternary ammonium germicidal detergent solution (follow product label for use-dilution)
MR, Manufacturer's recommendations
NA, Not applicable

  1. See text for discussion of hydrotherapy.
  2. The longer the exposure to a disinfectant, the more likely it is that all microorganisms will be eliminated. Follow the FDA-cleared high-level disinfection claim. Ten-minute exposure is not adequate to disinfect many objects, especially those that are difficult to clean because they have narrow channels or other areas that can harbor organic material and bacteria. Twenty-minute exposure at 20°C is the minimum time needed to reliably kill M. tuberculosis and nontuberculous mycobacteria with a 2% glutaraldehyde. Some high-level disinfectants have a reduced exposure time (e.g., ortho-phthalaldehyde at 12 minutes at 20°C) because of their rapid activity against mycobacteria or reduced exposure time due to increased mycobactericidal activity at elevated temperature (e.g., 2.5% glutaraldehyde at 5 minutes at 35°C, 0.55% OPA at 5 min at 25°C in automated endoscope reprocessor).
  3. Tubing must be completely filled for high-level disinfection and liquid chemical sterilization; care must be taken to avoid entrapment of air bubbles during immersion.
  4. Material compatibility should be investigated when appropriate.
  5. A concentration of 1000 ppm available chlorine should be considered where cultures or concentrated preparations of microorganisms have spilled (5.25% to 6.15% household bleach diluted 1:50 provides > 1000 ppm available chlorine). This solution may corrode some surfaces.
  6. Pasteurization (washer-disinfector) of respiratory therapy or anesthesia equipment is a recognized alternative to high-level disinfection. Some data challenge the efficacy of some pasteurization units.
  7. Thermostability should be investigated when appropriate.
  8. Do not mix rectal and oral thermometers at any stage of handling or processing.
  9. 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 products label, the user assumes liability from any injuries resulting from off-label use and is potentially subject to enforcement action under FIFRA.

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