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Sterilization & Disinfectant Recommendations
The recommendations indicated below are to be used as general guidelines. Follow the specific sterilization or disinfection procedures that have been validated by your institution. Always carefully examine the physical integrity of the product after processing. Do not use if cracking or crazing is seen, or if parts fit together improperly after processing.
Reusable Plastics & Silicone Rubber Products

A thorough pre-washing of parts is necessary to remove foreign and/or organic contaminants.
Use a low alkaline soap (pH 8.5 or less) to preserve maximum useful life.

Sterilization: High Level Disinfection:
Steam Autoclave:
Sterilize according to validated parameters. Do not exceed 275°F (135°C).
Do not steam autoclave polycarbonate products.
Pasteurization:
Pasteurize at 153°F - 163°F (70°C +/ -3°) for minimum of 30 minutes.
Gamma Radiation :
Irradiate according to validated parameters. Some discoloration may occur.
Do not irradiate polyethylene products.

Chemical Disinfectants :
Disinfect according to validated parameters.
Follow the chemical manufacturer's recommendation for temperature and soak time.
Chemical disinfection should be followed by sterile water rinse.

Recommended Chemical: 2-4% Activated Glutaraldehyde
Exposure time should be based on the manufacturer's indication for use as a high-level disinfectant or sterilant.
Do not use alcohol or chemicals containing dimethyl ammonium chloride.

Ethylene Oxide:
Sterilize according to validated parameters. Do not exceed 131°F (55°C).
Allow ample aeration time in a well-ventilated area to dissipate the absorbed gas

Gas Plasma :
Sterilize according to validated parameters.
Disposable -- Single Patient Use Products

Instrumentation Industries, Inc. disposable products are designed for single-patient use. Pasteurization or chemical disinfection is recommended for most Single Patient Use products prior to usage. Do not steam autoclave!

Sterilization: High Level Disinfection:
STERRAD 100S: (Polystyrene Butadiene only)
Full short sterilization cycle (Hydrogen peroxide gas plasma,
55 minutes, 45°C - 55°C).
Pasteurization:
Pasteurize at 153°F - 163°F (70°C +/ -3°) for a minimum of 30 minutes.
  Cidex® OPA
Prepare Cidex® OPA solution. Use syringe to fill all crevices with Cidex® OPA, then totally submerge adapters in the disinfectant. Follow the manufacturer's instruction for temperature and soak time requirements.
Endotracheal Tube Changers

Endotracheal Tube Changers are designed for Single Patient Use only. Recommended High Level Disinfection methods are Pasteurization at 153°F - 163°F (70°C +/ -3°C) for a minimum of 30 minutes, or Chemical Disinfection. Sterilization can be performed in 100% ethylene oxide at 129°F (54°C) for 60 minutes. Sterilized tubes must be allowed to aerate for no less 12 hours to dissipate any residual gas.
Steam autoclave, gas plasma and gas radiation are not recommended processing methods.

Ventilator Tubing
Ventilator Tubing should be cleaned with a mild detergent followed by a sterile water rinse prior to processing.
Reusable Tubing: Single Patient Use Tubing:
• Steam Autoclave at 270°F (132°C)
• Pasteurize at 170°F (77°C)
• EtO at 131°F (55°C)
• Gamma Radiation
• EtO at 131°F (55C)
• Gamma Radiation

Reusable Neoprene Products
Test Lungs:
Clean:
Wipe the exterior with a soft cloth, water and a mild detergent or liquid soap. Rinse exterior (do not allow water to enter the bag). Allow to air dry.
Do not clean with alcohol.
Reusable Breathing Bags:
Clean:
Wipe mild detergents or liquid soap. Followed by a through rinse.
High Level Disinfection: Sterilization
Pasteurization
Pasteurize at 160°F - 170° for a mininum of 30 minutes. System should have a mechanism for removing all air pockets before initiation the cycle.
Caution: Plasma pasteurization will accelerate deterioration.
Steam:
Steam sterilize with temperature not exceeding 270°F (132°C). The temperature must never exceed 273°F (134°C).
Caution: Drying vacuums should be avoided.

Chemical Disinfectants
High level disinfection can be achieved using most cold sterilants. Follow the chemical manufactiurers' recommendations for temperature and soak time and remove all air pockets. Chemical disinfection should be followed by a sterilie water rinse.

Ethylene Oxide Gas:
Gas sterilize by using an Ethylene Oxide mixture at 125°F to 135°F. Follow the sterilizer manufacturers' recommendations for rubber articles. Allow ample aeration time in a wel-ventilated area to dissipate the absorbed gas. Consult the sterilizer manufacturers' recommendations of specific aeration periods.

Drying
If a mechanical dryer is used to dry the products following disinfection or sterilization, a bio clean dryer with a HEPA filter is recommended to prevent recontamination while drying. Do not exceed 140°F and remove the product as soon as all moisture has evaporaed. Exposures to elevated temperatures when the product is dry will significantly shorten product life.

Reusable Neoprene Products
Single Patient Use Breathing Bags:
Clean:
Wipe the exterior with a soft cloth, water and a mild detergent or liquid soap. Rinse exterior (do not allow water to enter the bag). Allow to air dry.
Do not clean with alcohol.
Metal Products
—Instrumentation Industries, Inc. metal products include all Brackets, Flexible Support Arms, Instant Flow Valves, and Manual Jet Ventilators. Clean these products by wiping the outside with a disinfectant on a soft cloth. Do not immerse, disassemble, use bleach, or sterilize.
Home Use
Wash parts in a mild liquid dish detergent. Parts should be thoroughly scrubbed in order to remove all contaminants. Rinse well; ensure all remaining detergent is removed. Soak parts for 20 minutes in a fresh vinegar solution that is 1 part vinegar and 3 parts water. (EXAMPLE: ½ cup vinegar and 1 ½ cup water).
Thoroughly rinse parts with water. Allow to air-dry on a clean towel. Do not wipe or dry with towel.
Download a Printable version of iii Sterilization & Disinfection Recommendations
 



 
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Instrumentation Industries, Inc.
is an ISO 13485:2003 certified
company and works in accordance with the
FDA’s Quality System Regulations.

Instrumentation
Industries, Inc.
2990 Industrial Blvd.
Bethel Park. PA 15102

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