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September 16, 2021
A sterilization pouch, or peel pack, is a disposable package used in a sterilizer to allow penetration of the sterilant to the items placed inside. After sterilization, these Class II Medical Devices maintain the sterility of the processed item.
A well-designed and correctly used sterilization pouch allows for effective sterilization, safe handling, and storage of all pouched items until needed for use. In addition to protecting items through this process, they also facilitate proper aseptic presentation of devices in an operating room. Much like the instruments they protect, sterilization pouches used in hospitals are also medical devices. Therefore, they require clearance by the Food and Drug Administration (FDA) and validation for use in specific sterilizers and cycles.
Sterilization Pouch being sealed in a heat sealer.
Sterilization pouches come in three designs:
There are two types of combination peel pouches:
A sterilization pouch consists of two main parts: medical grade paper, or Tyvek®, and a clear plastic film, held together by heat seal or with an adhesive. These materials are specifically designed to allow penetration of chemicals, heat, vapor, or steam.
It's important to remember that paper pouches are used in steam, and Tyvek is used in Vaporized Hydrogen Peroxide (VH2O2) sterilization, such as in V-PRO Low Temperature Sterilizers. Although they may look similar, when a pouch is used in the wrong sterilization process, a failure is likely to occur. Tyvek placed in steam will melt at higher temperatures. Paper placed in VH2O2 will absorb the sterilant vapors, which can hinder the sterilant from reaching the device. As well, paper that has absorbed VH2O2 can potentially damage instruments and can possibly catch on fire.
Peel pouches are used for lightweight, low-profile instruments or medical devices. Per ANSI/AAMI ST79, the pouch should be of the right size and strength to accommodate the item(s) being packaged. For example, using paper/plastic pouches for heavy metal instruments could result in sterility maintenance problems due to events such as inadequate drying or rips and tears during storage or handling.
As mentioned earlier, Sterilization Pouches are Class ll Medical devices designed to allow sterilant penetration into the pouch, as well as maintain sterility of the device inside the pouch after sterilization. To validate that the pouch meets these requirements, pouches undergo rigorous testing to confirm their performance.
One crucial and stringent test performed during validation is half-cycle sterilization testing. This testing is used to simulate medical devices under worst-case conditions and confirm microbicidal efficacy. This test requires highly resistant bacterial spores to be placed in a challenging location to sterilize, such as inside lumens. The device is then pouched and sterilized in a cycle programmed with half of the cycle’s exposure time. All of the viable bacterial spores must be eliminated at the end of the half-cycle for the test to be considered a success.
Sterilization pouches are single-use disposable devices and should not be reused. Any defects, tears, or damage also means the pouch should be discarded and not used for sterilization.
While there are no AAMI or AORN guidelines that state you must double peel pouch items for use in the Operating Room (OR), some ORs request certain items be double pouched to aid in aseptic presentation. Examples include several small items or instruments that might present a challenge during aseptic presentation.
When a pouch is validated by the manufacturer for double pouching, it is still important to review the pouch instructions for use. Make sure to follow your facility's policies and procedures when deciding whether to double pouch.
Tips for Double Pouching:
Considerations when selecting a sterilization pouch:
Tyvek® is a registered trademark of DuPont.
Chasity Seymour
Clinical Education Specialist
Chasity Seymour is a Clinical Education Specialist with more than 15 years of Operating Room, Sterile Processing, Education, Management and Operational experience in healthcare. In five years managing Sterile Processing, she helped guide improvements of three departments including construction planning and workflow improvements.
Tammy Gentry
Product Manager – Sterility Assurance Products
