Sterilization of Reusable Products
It is the responsibility of the institution that is operating sterilization equipment to validate the equipment. In order to sterilize a reusable product using an autoclave, it must first be properly cleaned and/or disinfected, and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products in an 8 inch diameter or greater. Do not put the original product packaging through an autoclave cycle; it will not withstand the sterilization temperature. Some products must not be autoclaved. Refer to product instruction or contact customer service for specific parameters regarding autoclave sterilization methods.
Autoclave chamber loading should not exceed 10 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted, it should be taken out of service immediately.
Cleaning & Sterilization
Cook manufactures sterile and nonsterile medical devices.
Cook's in-house sterilization facility uses an environmentally friendly mixture of ethylene oxide (ETO) as a sterilant. ETO is used because of its compatibility with a wide variety of manufacturing materials, including Tyvek® sealed packaging.
Over the years, Tyvek has proven to be an excellent microbial barrier in maintaining product sterility over shelf life, as long as the package seal is intact and not exposed to hostile environmental storage conditions, including temperatures above 104°F (40°C), a relative humidity above 90% and condensing humidity.
Cook's use of Tyvek sealed packages in our validated industrial sterilization process allows for the efficient processing of the quality products you have come to depend upon. As with most industrial sterilization processes, the sterilization parameters used cannot be duplicated by most institution sterilizers. It is for this reason that we have developed and tested sterilization cycles based on AAMI-recommended practices to achieve a sterility level of 10-6.
If AAMI Standards and Recommended Practices for sterilization are not available at your institution, you can contact AAMI at 703-525-4890 or 800-332-2264, ext. 217.
Validation is a documented procedure for obtaining, recording and interpreting the results needed to show that a process will consistently yield a product complying with predetermined specifications.
Tyvek® is a registered trademark of E.I. DuPont de Nemours & Co.
Sterilization of Disposable and Reusable Products Using Ethylene Oxide
It is the responsibility of the institution that is operating sterilization equipment to validate that equipment. In order to sterilize a reusable Cook product using ETO, it must first be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products 8 inches in diameter or greater. Disposable products either accidentally opened and not used and/or ordered nonsterile may be sterilized one time only. Some products must not be ETO sterilized. Refer to product instructions or contact customer service for the proper sterilization method. Table 1 shows the recommended ETO sterilization cycle parameters:
| TABLE I - ETO CYCLE PARAMETERS | |
| PARAMETER | SET POINT |
| Pre-Vacuum Pressure | 2.0 psia (-25.9" Hg Vac) |
| Relative Humidity | 60% RH |
| Humidity Dwell | 20 minutes |
| Chamber Temperature | 54.4°C (130°F) |
| Exposure Pressure | To Be Determined (1) |
| Exposure Dwell | 2 hours |
| ETO Concentration | 600 mg/L |
| Post-Vacuums | 3 |
| Post-Vacuum Pressure | 2.0 psia (-25.9" Hg Vac) |
| Air Wash (2) | 5 minutes |
| Aeration Temperature | 54.4°C (130°F) |
| Aeration Dwell | 12 hours |
| Air Changes During Aeration | 90 per hour |
ETO sterilizer chamber loading should not exceed 11 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted prior to sterilizing, it should be taken out of service immediately.
Sterilization of Reusable Products Using An Autoclave
It is the responsibility of the institution that is operating sterilization equipment to validate that equipment. In order to sterilize a reusable Cook product using an autoclave, it must first be properly cleaned and/or disinfected according the product instructions and then packaged using AAMI recommended practices. During product handling, attention should be given to coil products in an 8 inch diameter or greater. Do not place the original product packaging in an autoclave; it will not withstand the sterilization temperature. Some products must not be autoclaved. Refer to product instructions or contact customer service for the proper sterilization method. Table II shows the recommended autoclave cycle parameters for Cook reusable products.
| TABLE II - AUTOCLAVE CYCLE PARAMETERS | |
| PARAMETER | SET POINT |
| Cycle Type | Pre-Vacuum |
| Pre-Vacuum Pressure | 2.5 psia (-24.8" Hg Vac) |
| Chamber Exposure Temperature | 132.2°C (270°F) |
| Chamber Exposure Pressure | 41.8 psia (27.1 psig) |
| Exposure Dwell | 5 minutes |
Autoclave chamber loading should not exceed 10 products per cubic foot of chamber space or exceed the usable chamber space. If any damage to a product is noted prior to sterilizing, it should be taken out of service immediately.
Questions & Answers
A number of questions are frequently asked by customers concerning the sterilization or resterilization of Cook products. Some of these questions are answered below.
Disposable Products
Question: Under what conditions should a sterile product labeled “disposable - intended for one-time use” or “disposable - single use only” not be sterilized?
Answer: Cook does not recommend the sterilization of “disposable - intended for one-time use” or “disposable - single use only” products that have been used, stored beyond labeled expiration date or subjected to hostile environmental storage conditions, including temperatures above 104°F (40°C), a relative humidity above 90% and condensing humidity.
Question: If a sterile product labeled as “disposable - intended for one-time use” or “disposable - single use only” is accidentally opened and then not used, can it be sterilized?
Answer: Yes, the product can be sterilized using a validated ethylene oxide sterilization cycle. However, the product must be repackaged using AAMI recommended practices prior to sterilization.
Question: Can “disposable - intended for one-time use” or “disposable - single use only” product ordered as nonsterile be sterilized?
Answer: Yes, the product can be sterilized using a validated ethylene oxide sterilization cycle if the product is supplied in a Tyvek pouch or Tyvek sealed tray. Otherwise, it must be repackaged using AAMI recommended practices prior to sterilization.
Question: Can Cook advise me of the ethylene oxide sterilization cycle to use on one of its “disposable - intended for one-time use” or “disposable - single use only” products either accidentally opened and not used and/or ordered nonsterile?
Answer: Yes. The cycle parameters for sterilizing disposable products are shown in Table 1 of the ethylene oxide sterilization section of Cleaning and Sterilization and may be used one time only.
Reusable Products
Question: Can the original package in which Cook provides its reusable products be ETO sterilized?
Answer: Product provided in a Tyvek pouch or a Tyvek sealed tray may be ETO sterilized. Other Cook packaging configurations must be repackaged using AAMI recommended practices prior to sterilization.
Question: Can the original package in which Cook provides its reusable products be placed in an autoclave?
Answer: No, original Cook packaging materials for reusable products cannot withstand autoclave cycle parameters.
Question: Can Cook advise me of the proper ethylene oxide sterilization cycle to use on its reusable products?
Answer: Yes, Cook has validated an ethylene oxide sterilization cycle that can be used in an institutional setting. However, the product must be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices (AAMI, ST41) prior to sterilization.
Question: Can Cook advise me of the autoclave cycle to use for its reusable products?
Answer: Yes. Cook has validated an autoclave cycle that can be used in an institutional setting. However, the product must be properly cleaned and/or disinfected according to product instructions and then packaged using AAMI recommended practices (AAMI, SSSA) prior to sterilization.
Question: Can Cook reusable products be disinfected by means of cold disinfectants?
Answer: Yes. Cook reusable products can be disinfected using cold disinfectants. Refer to cold disinfectant manufacturer's instructions for recommended use.