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Good day Samad,
The person or company who placed the original expiration date on the item no longer certifies the expired item is safe for patient use. If you use an item after the expiration date, you are giving the item a new expiration date. When you place a new expiration date on an item, you must provide the guarantee that the item is safe for patient use. You have correctly identified the two factors affecting shelf life that you must consider before you can guarantee the item is safe for patient use. The sterility maintenance of the items does not appear to be a problem because the items have been stored in a controlled environment. The second factor, the material is still good, is more likely to be a problem according to my experience. Items made from natural sources will naturally degrade over time. Examples include any items with latex such as gloves and syringe plungers; some kinds of sutures break down, etc. They slowly lose elasticity and there is a chance that they might fail (break) catastrophically. Plasticizers that give plastic items their unique qualities evaporate from plastic over time, changing the character of the plastic so the item has different qualities in use. It might become less flexible, or shatter in use. Almost all items manufactured commercially over the last decade have a label that says the item is sterile unless the packaging is compromised, except when then item inside degrades over time. The manufacturer that placed the expiration date on the item is often your best resource for learning why they put an expiration date on the item. They may be willing to share the studies they used in deciding to put an expiration date on the item, or if they are very generous, they may even exchange the outdated stock with fresh stock. The decision to extend an expiration date is not an "All or Nothing" decision; it must be done on a case-by-case basis after a study of the storage conditions and the material stored. I would also suggest getting the approval of the Risk Management department in your hospital before implementing a decision to extend an expiration date. When the rules changed allowing manufacturers to label items as "Sterile until package is compromised", this type of decision for the old, expiration-dated stock was common. Today, there is almost always a problem with material degradation with medical supplies that have an expiration date.
On an editorial note, I wonder why the items are outdating. Proper rotation of stock is an inventory control issue that may need to be addressed. The items maintained in storage are not used? Then why pay for storage space and maintenance of the items when space is always in short supply?
Regards, Pete
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