Medical supply expiration dates

[kfariss]

If a medical item has a date of manufacture but does not have an expiration date, is there a time period to consider as expired? For example, a ureteral stent dated July 2005. Often there are items such a foley catheters, suction catheters, syringes left in emergency carts that are there for years. At what point should it be considered not to be used?

[JustBeachyNurse, LPN]

Check with the manufacturer as there is a limit for sterility

[kfariss]

I'm not as concerned about the sterility but about the integrity of the product. Is there a general rule such as; "throw it out after 5 years"?

[scottaprn]

Justbeachy is absolutely correct. Check with the manufacturer to determine how long the products are sterile.

In most (but not all) the product will be non sterile before the integrity of the product is degraded.

If I am your patient please don't put a non sterile product inside of me just because the integrity has not degraded.

[kfariss]

Thank you. Please be assured that we would never use an unsterile product. Often items may remain "sterile" because the package is intact, it has been safely stored and has no expiration date. These same item may be old enough that we (OR nursing) do not believe that it would be prudent to use. What we are seeking is a standard that can be presented to the nonclinical "numbers people" to support our stand. Their belief is "if the package is intact and there is no expiration date then it is still money on the shelf".

[JustBeachyNurse, LPN]

I know I found details on this exact issue when researching a few years back. Let me see if I can find the answer. I believe the standard was changed to add an expiration date to remove this issue.

Such as a foley that is degraded looking but "hasn't expired yet" so while clinical staff questions safe use , bean counters says "you are throwing away money"....

[JustBeachyNurse, LPN]

Aside from specific manufacturer recommendations do these articles help?

http://www.ormanager.com/wp-content/uploads/pdf/ORMVol26No5EventRelatedDating.pdf

http://www.infectioncontroltoday.com/articles/2002/04/time-versus-event-preserving-sterile-package-inte.aspx

http://www.spdceus.com/event_related.htm

http://www.spsmedical.com/education/articles/eliminatingsterileoutdates.html

When I worked in one facility where ordering & maintaining supplies and equipment was part of my job QA had me contact manufacturers regarding recommended expiration or use by dates especially if degradation of the item was a concern (such as a Foley catheter). Reps were more than willing to provide the QA/QC information needed to fulfill my SOP/QA requirements.

[shodobe]

Look in AORN Standards and you will find that yp\ou have event related issues here that as long as the package hasn't been dropped or has holes, etc... the item, as long as it doesn't have an expiration date, is sterile forever if need be. Most manufactuerers will have a hidden code to when the item was sterilized but I have never been told by any company how long the shelf life of an item is.There use to be many years ago the five year rule but it doesn't apply anymore because of the high cost of products. You don't want to be throwing out a $500 item just because it was made 5 years ago. Like I said go to the AORN Standards Manual for answers.