Expiration dates of sterile medical supplies.
- 0Aug 3, '01 by huckfinnIf the expiration date on a sterile supply (not drugs) is 9-2001, does it expire on the first day of September or midnight of the last day of September?
If your institution has rationale or a policy please include it in your reply.
- 0Aug 3, '01 by fiestynurseThe 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!
- 0Aug 3, '01 by Pam RNItems 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.
- 0Aug 4, '01 by fiestynurseWell, 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.
- 0Jun 29, '11 by Pkg EngineerI 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.