University Research Compliance Office

Guideline #26

Sterile Surgery/Instrument Pack Labeling/Dating, Storage, & Shelf-life

1. References:

1.1. Guideline for Disinfection & Sterilization in Healthcare Facilities. Centers for Disease Control & Prevention (CDC) Infection Control, 18 Sep 2016

1.2. Sterilization: Packaging & Storage. Centers for Disease Control & Prevention (CDC) Oral Health, 26 Feb 2016

2. Purpose: To provide guidance to investigators for the proper labeling/dating, storage, and recommended shelf-life/expiration date for sterilized surgery/instrument packs.

3. Policy:

3.1. Sterilized surgical/instrument packs should be labeled with the following information as a minimum:

      • Autoclave tape and/or indicators that show that the pack has been successfully sterilized (required)
      • The date the pack was sterilized (required)
      • The sterilizer that was used (optional)
      • The sterilizer cycle or load number (optional)
      • The expiration date if applicable. (see 3.3. below)

3.2. Sterilized medical/surgical/instrument packs should ideally be stored in closed or covered cabinets but open shelving may be used. Sterile supplies should be stored NLT 10” off the floor, NLT 5” from the ceiling, NLT 18”
from a ceiling sprinkler head, and NLT 2” from the wall in order to allow for adequate circulation, ease of cleaning, and compliance with local fire codes. Sterile supplies should not be stored under sinks or other locations where
they may become wet.

3.3. The shelf-life/expiration date for sterilized medical/surgical/instrument packs or supplies is determined as follows:

3.3.1. The manufacturer’s expiration date marked on a sterile pack or medical supply item shall take precedence. Items that have exceeded the expiration date set by the manufacturer must not be used in live animal survival procedures.

3.3.2. The shelf-life/expiration date for medical/surgical/instrument packs or supplies that are sterilized/re-sterilized in-house is determined by the type of wrapper/packaging material as follows:

Type of Sterile Pack Wrapper/Packaging Material Shelf-Life/Expiration Date*
Double Thickness Muslin (4 layers) or equivalent 30 days
Paper 30 days
Heat sealed paper & plastic peel-down patches 1 year
Heat sealed paper/plastic peel-down patches w/ heat sealed 3-mil polyethylene overwrap Indefinite
Double Thickness Muslin (4 layers) w/ heat sealed 3-mil polyethylene overwrap Indefinite
Paper w/ heat sealed 3-mil polyethylene overwrap Indefinite
*NOTE: Any sterilized pack wrapper that becomes wet, torn, punctured, damaged in any way, dirty/dusty, etc. should not be used and must be re-packaged & re-sterilized.

 

LAST REVIEWED AND ADOPTED BY THE IACUC: January 4, 2024