Pkg Engineer

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

I am an engineer for a major orthopedic implant manufacturer, and am responsible for proving the claims we can make for product sterility. The primary standard we follow is ISO 11607, which is recognized by FDA, and it specifies the types of testing required to demonstrate sterility over time. This standard only applies to items provided to the hospital sterile, not items sterilized internally in central supply. Per this standard, we cannot claim our product is sterile without testing it. We also must prove (validate) the shelf-life of the product, meaning that if the package says the item is good for 5 years after the manufacture date – then we have already done testing to prove the product is sterile for at least 5 years. If we were shooting for a 10 year shelf-life, we still cannot make a 10 year claim until that testing is completed. Claiming a un-validated expiration date would actually be in violation of FDA regulations, IMHO. ALSO, if we passed 5 year testing but failed 6 year testing, you would not know this. …which is why I am surprise to see there are products claimed “Sterile” but without expiration date! I would think that based on materials you would at minimum conduct accelerated aging testing to provide some data that the product could even be sterile for a few years, otherwise they risk placing those patients at higher risk for infection. Im aware of ERS, and it is KEY to note that if the commercial mfgr of a product specifies a expiration date, this date must supersede the ERS protocol – I would make sure your protocol specifies this. The burden of proving the package sterility is on the manufacturer, and nobody can claim “infinite”. I would recommend contacting the manufacturer if there are questions on the shelf-life of the product, and they should be able to answer this question. If product is failing prior to a provided expiration date, I would definitely contact the manufacturer or FDA to report this as a complaint. At least this way they can be aware of the failures and make improvements.