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Sterilization Archived Through 2012
 FAQ - Sterilization - Archived Through 2012

 

 

A graduate of our program recently called and asked about reusing sterilization bags. I commented that the integrity of the bag may be compromised through reuse. Do you have any information to share on this practice?

First and foremost, always consult the directions/instructions for use provided by the manufacturer of the product. Single use disposable items must be disposed after each use. Therefore, sterilization wraps and bags that are not designed for reuse should be disposed of after each use. Reusing single use sterilization wraps/bags/pouches can result in loss of chemical indicator ability, insecure sealing of the package, and an inability of the material to maintain sterility of the contents after processing.

The United States Food and Drug Administration (FDA) regulates sterilization packaging for medical devices intended for use in health care facilities. The term, "medical sterilization packaging systems" used by the FDA refers to sterilization wraps, sterilization packs, sterilization pouches, sterilization containers, sterilization trays, and sterilization cassettes, including related components such as trays, holders or mats, used by health care facilities to package and sterilize medical devices intended for either single use or reuse. (1)

These devices are regulated under 21 CFR §880.6850, Sterilization wrap, which reads:

A sterilization wrap (pack, sterilization wrapper, bag, or accessories) is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. (1)

This draft document may be viewed at:

http://www.fda.gov/cdrh/ode/guidance/1388.html

Resource:

1) FDA: http://www.fda.gov/cdrh/ode/guidance/1388.html

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