Expiration dates of sterile medical supplies.

debbyed · Aug 3, 2001

Our instution no longer puts expiration dates on sterile supplies, they put the date it was sterilized. Their rational is that is the package is intact it is still sterile.

It caused quite a bit of confusion for a while, we kept sending everything back to them.

fiestynurse · Aug 3, 2001

The new standard for sterile supplies is "event related," meaning as long as the package is still intact, it is still sterile. You do not need to put expiration dates on sterile packages anymore!

http://www.urmc.rochester.edu/strong/Sterile/eventrel.html

huckfinn · Aug 3, 2001

Thanks for the rapid responses but.....

I am familiar with internally sterilized pieces and expiration according to AORN recommendations. What I am asking is related to manufatured products with printed expiration dates on the outer and inner packaging.

sstns · Aug 3, 2001

I work in the Regulatory Affairs Department at a company that manufactures hemodialysis catheters. According to our Quality Control Department the product expires on the last day of the month.

Pam RN · Aug 3, 2001

Items that we get from manufacturers such as suture or dressings that do have an expiration date stamped on them such as 9-2001, we use the first day of the month. I asked our materials management guy and he said to be on the safe side it should be taken off the shelf the first day rather than the last day. It may not really matter but he was taking into account if there were a surprise inspection that it's better err on the side of being "too cautious". Hope this answers your question.

fiestynurse · Aug 5, 2001

Well, you didn't say "manufactured" sterile supplies. Now I feel dumb, I didn't even answer your question!

At the last facility that I worked, we discarded on the last day of the month. Supplies are just too expensive to be tossing out if they can still be used. If you follow a strict policy and procedure of checking your supplies regularly, you should not have to worry about surprise inspections. We had a check-list that we ran through on the last day of every month, where we checked all supplies and meds for expiration dates. We also made sure that when restocking, we always put the newer supplies in the back and pushed the older supplies to the front, so those get used first.

nurs4kids · Aug 5, 2001

I was a sup in Central Dist years ago, and unless it's changed in the past few years, it's the last day of the month.

Pkg Engineer · Jun 29, 2011

I recently just joined this site when I started researching Event Related Sterility (ERS) procedures. I work as a packaging engineer at a major medical device company who makes implants and instruments, and was suprised in the different viewpoints we have for event-based sterility (ERS) and packaging.

Any sterile product we sell contains an expiration date, and the date is supported by actual test data, including simulated distrubution, environmental conditioning, and accelerated ageing, and also real-time ageing tests. This is required by FDA, at least for the class of products we produce (Class II / Class III). The testing provides high assurance that the product will be sterile until the expiration date. Class I products like tounge depressors may not have the same requirments, but I cannot speak to this.

While I acknowledge there is nothing magical that happens to the sterile barrier system the day after it expires, the fact is that there is no more data to support a longer shelf life. I do not think ERS is a bad idea, but I dont think it should supersede a manufacturer's claim...

I would review AORN guidance and see if they reccomend "over-riding" the manufacture provided expiration dates. That does not sounds like a good idea IMHO.

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

http://www.aornjournal.org/article/S0001-2092(07)63297-9/abstract