STERILE
PROCESSING UNIVERSITY
"Sterile Storage.....Or Is It?"
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The purpose of the sterile storage area, regardless of the location,
is to store the sterile devices until they are used. Sterile storage
can include facility-processed items, items from outside manufacturers
and clean but not sterile items. (NOTE: Yes, they can be stored in the
same location!) The sterilization process is multi-step to ensure a
safe product. Best practices for sterile storage are required to ensure
the sterility of the devices is not compromised. Sterility maintenance
can be affected by a number of events. This in-service will address
them.
Compromise of Sterility
Basically, there are three conditions than can compromise sterility; moisture, soil and physical damage. All of these events are affected by the storage and handling of the packages after sterilization.
The first opportunity to compromise sterility is immediately after sterilization. The Association for the Advancement of Medical Instrumentation recommends that after steam sterilization "items remain untouched on an autoclave rack for a period of 30 minutes to two hours" (based upon the load configuration, weight and density of sets). Yet, how often is the Sterile Processing Department asked to release items when they are still hot? Packs should never be touched while still hot. Autoclave carts containing freshly sterilized items should be placed in a low traffic area away from any air conditioning vents. Never place hot packs on a cool metal surface to prevent condensation from occurring. The second opportunity for compromise is the number of times a device is handled after sterilization. Do you know how many times your sterile packs are handled? What about items that are released to the OR then returned to SPD only to be released again? When did too much handling occur? How can you tell if the package is not damaged? Handling is also affected by good handwashing. Is there a handwash sink in your sterile storage area or adjacent to it to encourage frequent handwashing? If not, you may want to consider installing a waterless handwash dispenser.
When packs are handled, they should never be compressed. Do not overload carts/ bins. Any items that falls to the floor must be considered contaminated and returned to the Decontamination Area for complete re-processing.
When distributing items, the person releasing the pack should visually inspect the pack to ensure the packing has not been compromised; no tears, holes, stains. If noted, the pack should be re-processed.
Conversely, when receiving sterile product from outside vendors, or receiving items back into sterile storage (that have not been opened/used), it is the responsibility of the individual accepting the product to check for packaging integrity and for signs of contamination (e.g. staining of packaging material).
Packaging
Packaging materials should be selected based upon the item being contained. Often, dust covers (plastic bags of 2-3 mils in thickness) are applied after sterilization/cooling, to provide additional protection to trays that will remain in storage for a long time or will receive excess handling (e.g. items on the resuscitation cart).
Environmental Control
The sterile storage area should ideally be physically separated, enclosed, located close to the sterilization area and dust free with at least four air exchanges per hour. Humidity should not exceed 70% and temperature should not exceed 75oF1. A hygrometer (a device used to measure atmospheric humidity) should be located in the sterile storage area and the temperature and humidity levels documented daily. Any deviation from the normal range should be reported to engineering immediately.
There should be a restriction of entry into the sterile storage area. A policy and procedure is needed to document who has access to this area, attire needed, documentation of items removed, etc. This is especially true for hours when SPD is closed.
Carts, bins, etc. used to transport sterile supplies need to be kept clean. Outside shipping cartons are not permitted in the sterile storage area nor should cardboard cartons (e.g. if supplied as an inside container) be used for sterile storage as they are porous and cannot be cleaned. Corrugated cardboard permits dust and bacteria to harbor in the grooves. Always use impervious (plastic) bins for storage to facilitate cleaning.
Regardless
of the type of shelving used in the sterile storage area (open/wire
or closed), the shelves and bins must be kept clean and dust free. Unfortunately,
with the implementation of Event Related Sterility, the monthly ritual
of checking for outdates and cleaning bins seems to have been forgotten.
How can we maintain sterile supplies in dusty bins and shelves? We cannot.
When was the last time you inspected your sterile storage area?
 Correct Storage off floor |
 Bad Storage - Items up to the ceiling, leak in ceiling tile; cardboard boxes next to sterile product |
All
sterile storage should be at least 8-10 inches off the floor to permit
housekeeping to clean without splashing onto the packs on the bottom
shelf. Fire code requires that all storage be kept at least 18 inches
from any ceiling fixture (sprinkler) so the sprinkler's operation in
a fire is not impeded. In addition, storage should be kept at least
2 inches from an outside wall to prevent condensation from the outside
leaking through the wall and possibly contaminating packs. If your shelving
does not meet these criteria, you can place the items on the bottom
shelves in tote bins, which will protect them from splashes. If you
do not have solid top shelves, you might want to consider placing the
items on the top shelves inside tote bins as well to protect from overhead
leaks.
Never
store sterile product in areas when they can become wet. This includes
under sinks, near windows, near doors or near/under exposed pipes or
vents.
 Never store under a sink |
 Bad Storage- metal tray on top of paper wrapped trays |
 Bad Storage-crushed packages |
 Bad Storage- trays stacked |
 Peel Packs with creases |
 Bulk Storage |
 Storage labled correctly |
 Overstocked!!! |
There should be sufficient space for storage of sterile product. The only items, which are permitted to be stacked, are rigid containers. When wrapped trays are stacked, the weight of the trays may compress bacteria/dust inside sets. Packages should not be crushed or damaged.
When
was the last time you looked at the condition of your peel-packaged
items? I continuously see peel packaged items where multiple creases
arenoted in the packaging. At what point does sterility compromise take
place? Can you tell visually?
The floors to the sterile storage area must be cleaned daily. A procedure
for the SPD staff to clean the shelves and bins needs to be developed,
implemented and enforced.
Stock Arrangement
How the stock is arranged can affect efficient location of items. While
there are many ways
to arrange stock, the most common methodology is to arrange the items
by body system (e.g. all the GU supplies together, chest supplies, etc.).
All bins and shelves should be clearly labeled and there should be a
Master Locator List, which is readily available to any hospital personnel
permitted to enter this area during off-hours.
The
most commonly used items should be located at a convenient location,
usually middle shelves. Lighter items should be on top shelves and heavier
items on bottom shelves to prevent injuries. Non-skid stools may be
needed if you have short personnel working in this area.
One of the most expensive costs for a facility is outdated stock. This
should not happen and can be prevented if a good system of stock rotation
is employed. This should include items sterilized by the facility. The
"first in- first-out (FIFO) system is most commonly employed however
everyone must follow this practice in order for it to be successful
and avoid costly outdates. Sometimes, sales representatives will exchange
product that is not outdated as yet for product with a longer shelf
life however once it is outdated, the company will not accept it back.
SUMMARY
Processing personnel spend a great deal of time to properly decontaminate, package and sterilized devices. The facility also pays for sterile product from outside manufacturers. The final step in the process is sterility maintenance of devices. Everyone involved in handling sterile product must be educated in the proper care and handling of sterile products. Maintenance of the sterile storage area, including shelves, bins and transport carts is essential. Cost containment requires that we protect, handle, rotate and store the sterile products we are entrusted with. Concern for patient safety demands no less.
REFERENCES:
American Society for Healthcare Central Service Professionals. Training
Manual for Health Care Central Service Technicians. 2001.
Association
for the Advancement of Medical Instrumentation. "Steam Sterilization
and Sterility Assurance in Health Care Facilities - ST-46." 2002.
__________________________
1AAMI. Steam Sterility and Sterility Assurance in Healthcare
Facilities -ST-46". 2002.
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