Question:

Our facility has an "Event Related" policy on containers, wrap, & peel packs.  Corporate is now telling us that we need an outdate policy of 30 days on certain wrap.  Is this accurate?

- Beth

Answer:

I hate to waffle on you, but Yes and No.  All container filters, wraps, and peel packs have to go through "shelf-life" testing before they can be considered "event-related".  Depending on the manufacturer, some of these "shelf-life" testings only run for 30 days (the minimum amount required) which is why some facilities are now recommending a 30 day outdate policy.  Some "shelf-life" testings run for 180 - 365 days, but I've never seen one longer.  But this testing duration does not mean that your products can no longer be considered sterile after 30-365 days.  It just means that the manufacturer has not tested and validated it beyond that point.

My recommendation is to review the IFU's for your specific products, and review the specific wording in them.  Does is state the words, "event-related" in the IFU's?  Do they use the term "event-related" with a specific number of days associated?  Review your IFU's and investigate alternative products that have done longer "shelf-life" testing.  Then implement an outdate policy that you are comfortable with.  An outdating policy of 6 months to 1 year not only ensures that your wraps & peel packs are structurally sound, but it can help in the removal of instrumentation that is no longer used or needed from your shelves.