Format Change [February 2017]
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Table 1A. Smooth, Hard Surface1,4
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time from 3-30 minutes) | Manufacturer’s recommendations | 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. | Ethyl or isopropyl alcohol (70-90%) | Ethyl or isopropyl alcohol (70-90%) |
| Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C) | Manufacturer’s recommendations | Ortho-phthalaldehyde (OPA) 0.55% | Sodium hypochlorite (5.25-6.15% household bleach diluted 1:500 provides >100 ppm available chlorine) 5 | Sodium hypochlorite (5.25-6.15% household bleach diluted 1:500 provides >100 ppm available chlorine) |
| Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). | Manufacturer’s recommendations | Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | Phenolic germicidal detergent solution (follow product label for use-dilution) | Phenolic germicidal detergent solution (follow product label for use-dilution) |
| 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. | 10 h at 20–25°C | Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | Iodophor germicidal detergent solution (follow product label for use-dilution) | Iodophor germicidal detergent solution (follow product label for use-dilution) |
| Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | 6 h | Wet pasteurization at 70°C for 30 minutes with detergent cleaning 6 | n/a | Quaternary ammonium germicidal detergent solution (follow product label for use-dilution) |
| Peracetic acidacid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C | 12 m at 50–56°C | Hypochlorite Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | 3–8 h | n/a | n/a | n/a |
Table 1B. Rubber Tubing and Catheters3,4
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time from 3-30 minutes) | Manufacturer’s recommendations | 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. | n/a | n/a |
| Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C) | Manufacturer’s recommendations | Ortho-phthalaldehyde (OPA) 0.55% | n/a | n/a |
| Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). | Manufacturer’s recommendations | Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | n/a | n/a |
| 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. | 10 h at 20-25°C | Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | 6 h | Wet pasteurization at 70°C for 30 minutes with detergent cleaning 6 | n/a | n/a |
| Peracetic acidacid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C | 12 m at 50-56°C | Hypochlorite Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | 3-8 h | n/a | n/a | n/a |
Table 1C. Polyethylene Tubing and Catheters3,4,7
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time from 3-30 minutes) | Manufacturer’s recommendations | 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. | n/a | n/a |
| Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C) | Manufacturer’s recommendations | Ortho-phthalaldehyde (OPA) 0.55% | n/a | n/a |
| Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). | Manufacturer’s recommendations | Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | n/a | n/a |
| 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. | 10 h at 20-25°C | Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | 6 h | Wet pasteurization at 70°C for 30 minutes with detergent cleaning 6 | n/a | n/a |
| Peracetic acidacid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C | 12 m at 50-56°C | Hypochlorite Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | 3-8 h | n/a | n/a | n/a |
Table 1D. Lensed Instruments4
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time from 3-30 minutes) | Manufacturer’s recommendations | 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. | n/a | n/a |
| Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C) | Manufacturer’s recommendations | Ortho-phthalaldehyde (OPA) 0.55% | n/a | n/a |
| Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). | Manufacturer’s recommendations | Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | n/a | n/a |
| 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. | 10 h at 20-25°C | Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | 6 h | Hypochlorite Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) | n/a | n/a |
| Peracetic acidacid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C | 12 m at 50-56°C | n/a | n/a | n/a |
| Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | 3-8 h | n/a | n/a | n/a |
Table 1E. Thermometers (Oral and Rectal)8
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| n/a | n/a | n/a | n/a | Ethyl or isopropyl alcohol (70-90%) 8 |
Table 1F. Hinged Instruments4
| Sterilization Procedure | Sterilization Exposure Time | High-level Disinfection (exposure time 12-30 m at ≥20°C)2,3 | Intermediate Disinfection (exposure time ≥1 m)9 | Low-level Disinfection (exposure time ≥1 m)9 |
|---|---|---|---|---|
| Heat sterilization, including steam or hot air (see manufacturer’s recommendations, steam sterilization processing time from 3-30 minutes) | Manufacturer’s recommendations | 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. | n/a | n/a |
| Ethylene oxide gas Ethylene oxide gas (see manufacturer’s recommendations, generally 1-6 hours processing time plus aeration time of 8-12 hours at 50-60°C) | Manufacturer’s recommendations | Ortho-phthalaldehyde (OPA) 0.55% | n/a | n/a |
| Hydrogen peroxide gas plasma (see manufacturer’s recommendations for internal diameter and length restrictions, processing time between 45-72 minutes). | Manufacturer’s recommendations | Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | n/a | n/a |
| 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. | 10 h at 20-25°C | Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide 7.5% (will corrode copper, zinc, and brass) | 6 h | Wet pasteurization at 70°C for 30 minutes with detergent cleaning 6 | n/a | n/a |
| Peracetic acidacid, concentration variable but 0.2% or greater is sporicidal. Peracetic acid immersion system operates at 50-56°C | 12 m at 50-56°C | Hypochlorite Hypochlorite, single use chlorine generated on-site by electrolyzing saline containing >650-675 active free chlorine; (will corrode metal instruments) | n/a | n/a |
| Hydrogen peroxide (7.35%) and 0.23% peracetic acidacid; hydrogen peroxide 1% and peracetic acid 0.08% (will corrode metal instruments) | 3-8 h | n/a | n/a | n/a |
Modified from Rutala and Simmons.15, 17, 18, 421The 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.
1See text for discussion of hydrotherapy.
2The 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 killM. tuberculosisand 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).
3Tubing must be completely filled for high-level disinfection and liquid chemical sterilization; care must be taken to avoid entrapment of air bubbles during immersion.
4Material compatibility should be investigated when appropriate.
5A 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 > 1,000 ppm available chlorine). This solution may corrode some surfaces.
6Pasteurization (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.
7Thermostability should be investigated when appropriate.
8Do not mix rectal and oral thermometers at any stage of handling or processing.
9By 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.
