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Sterilization Wraps Compliance

TJC infection control standards IC.02.02.01 EPs 4 & 5 state:

4Does the organization implement infection prevention & control activities when doing the following: Storing medical equipment, devices, and supplies?
5Does the organization implement infection prevention & control activities when doing the following: When reprocessing single-use devices, does the organization implement infection prevention and control activities that are consistent with regulatory and professional standards?

Sterilization wraps, endotracheal tube storage, and yankeur storage are items that often come into question during facility surveys or practice reviews. When undergoing accreditation, surveyors are diligent to ask for instructions for use and your policy.  This is to make sure that organizations are abiding by the manufacturer guidelines as well as the facility policies and procedures.  An organization’s policy can always be stricter than a regulation or guideline, but it cannot be more lenient.

Sterilization wraps (or “blue wrap” as it is often called) are utilized to preserve sterility of wrapped products after sterilization. Depending on the company, these wraps are validated for 30 days to one year.  Often, items that are sterilized are sent into other clinics or areas of the hospital outside of temperature and humidity-controlled areas.  Most facilities have gone to event related sterilization standards.  However, since these wraps are validated for a year or less, items that are processed with them need to be returned for sterilization based on how long the wrap is valid for.

In order to continue using these wraps beyond the validated shelf-life, an organization needs to contact the vendor to see if they can be utilized in the event-related manner, with the proper risk assessment and supporting policies.  Here is an example of a letter from a vendor, Halyard Health, Inc , communicating the intended use of their wraps. (no endorsement implied)

Endotracheal (ET) tubes and yankeurs packaged as single use devices should be stored to be kept free from contamination.  If an organization chooses to pre-open ET tubes or yankeurs, a review of the product instructions for use, risk assessment and policy to support the process must be in place.  It is recommended that any of these practices be evaluated and implemented in conjunction with your infection prevention team.

It is recommended that risk assessments and endorsement letters should be kept on file and reviewed by quality personnel as required by the organization.

Kimberly Merritt

Author Kimberly Merritt

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