3 - Storage Shelf life-CDC

Accessible version: https://www.cdc.
gov/infectioncontrol/guidelines/disinfection/
Guideline for Disinfection and

Sterilization in Healthcare
Facilities, 2008
Update: May 2019
William A. Rutala, Ph.D., M.P.H.1,2, David J. Weber, M.D., M.P.H.1,2, and the Healthcare
Infection Control Practices Advisory Committee (HICPAC)3
1Hospital Epidemiology
University of North Carolina Health Care System
Chapel Hill, NC 27514
2Division of Infectious Diseases

University of North Carolina School of Medicine
Chapel Hill, NC 27599-7030
1 of 163
Guideline for Disinfection and Sterilization in Healthcare Facilities (2008)
done only once. Multiple layers are still common practice due to the rigors of handling within the facility
even though the barrier efficacy of a single sheet of wrap has improved over the years 966. Written and
illustrated procedures for preparation of items to be packaged should be readily available and used by
personnel when packaging procedures are performed454.
Loading. All items to be sterilized should be arranged so all surfaces will be directly exposed to the
sterilizing agent. Thus, loading procedures must allow for free circulation of steam (or another sterilant)
around each item. Historically, it was recommended that muslin fabric packs should not exceed the
maximal dimensions, weight, and density of 12 inches wide × 12 inches high × 20 inches long, 12 lbs,
and 7.2 lbs per cubic foot, respectively. Due to the variety of textiles and metal/plastic containers on the
market, the textile and metal/plastic container manufacturer and the sterilizer manufacturers should be
consulted for instructions on pack preparation and density parameters819.
There are several important basic principles for loading a sterilizer: allow for proper sterilant
circulation; perforated trays should be placed so the tray is parallel to the shelf; nonperforated containers
should be placed on their edge (e.g., basins); small items should be loosely placed in wire baskets; and
peel packs should be placed on edge in perforated or mesh bottom racks or baskets 454, 811, 836.
Storage. Studies in the early 1970s suggested that wrapped surgical trays remained sterile for
varying periods depending on the type of material used to wrap the trays. Safe storage times for sterile
packs vary with the porosity of the wrapper and storage conditions (e.g., open versus closed cabinets).
Heat-sealed, plastic peel-down pouches and wrapped packs sealed in 3-mil (3/1000 inch) polyethylene
overwrap have been reported to be sterile for as long as 9 months after sterilization. The 3-mil
polyethylene is applied after sterilization to extend the shelf life for infrequently used items 967. Supplies
wrapped in double-thickness muslin comprising four layers, or equivalent, remain sterile for at least 30
days. Any item that has been sterilized should not be used after the expiration date has been exceeded
or if the sterilized package is wet, torn, or punctured.
Although some hospitals continue to date every sterilized product and use the time-related shelf-life
practice, many hospitals have switched to an event-related shelf-life practice. This latter practice
recognizes that the product should remain sterile until some event causes the item to become
contaminated (e.g., tear in packaging, packaging becomes wet, seal is broken) 968. Event-related factors
that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in
the environment), air movement, traffic, location, humidity, insects, vermin, flooding, storage area space,
open/closed shelving, temperature, and the properties of the wrap material966, 969. There are data that
support the event-related shelf-life practice970-972. One study examined the effect of time on the sterile
integrity of paper envelopes, peel pouches, and nylon sleeves. The most important finding was the
absence of a trend toward an increased rate of contamination over time for any pack when placed in
covered storage971. Another evaluated the effectiveness of event-related outdating by microbiologically
testing sterilized items. During the 2-year study period, all of the items tested were sterile 972. Thus,
contamination of a sterile item is event-related and the probability of contamination increases with
increased handling973.
Following the sterilization process, medical and surgical devices must be handled using aseptic
technique in order to prevent contamination. Sterile supplies should be stored far enough from the floor (8
to 10 inches), the ceiling (5 inches unless near a sprinkler head [18 inches from sprinkler head]), and the
outside walls (2 inches) to allow for adequate air circulation, ease of cleaning, and compliance with local
fire codes (e.g., supplies must be at least 18 inches from sprinkler heads). Medical and surgical supplies
should not be stored under sinks or in other locations where they can become wet. Sterile items that
become wet are considered contaminated because moisture brings with it microorganisms from the air
and surfaces. Closed or covered cabinets are ideal but open shelving may be used for storage. Any
package that has fallen or been dropped on the floor must be inspected for damage to the packaging and
contents (if the items are breakable). If the package is heat-sealed in impervious plastic and the seal is
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Guideline for Disinfection and

2Division of Infectious Diseases

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