In the last 6 months the FDA has begun to focus more closely on ensuring that reusable instrument and implant kit systems have been properly validated and that the parameters listed in the kit systems’ Instructions for Use (IFUs) have a substantive validation to support them. The FDA has identified that these types of products were being sterilized at hospitals per the manufacturers IFUs, but the parameters listed in the IFUs weren’t supported. This was typically due to one of three issues:
- The cycle was based on older kit system validations that were not applicable.
- The cycle was based on older kit system validations, the older system was applicable, but no detail was given as to why the initial validation was representative of the new kit system.
- Or in some cases the parameters were completely generic and with no validation to support them.
Several of our clients have come to us immediately following FDA audits with findings to update IFU validations.
The FDA guidance on acceptance criteria for steam sterilization is very clear. You must achieve a 6 Log10 reduction beyond inactivation of the bioburden. They also recommend that you utilize standard parameter cycles to achieve this Log reduction, to make it both easier for the hospital to process, while also increasing the likeliness of the hospital to sterilize to correct parameters.
While the guidance on acceptance criteria for steam sterilization has been clear, the cleaning guidance is a little bit more wishy washy (excuse the pun). I believe this is mostly based on the fact that it is hard to define what clean means. The guidance says flat out that there are no established acceptance criteria for residual marker levels. What the guidance does make clear is that:
- You must test for protein removal, and
- You must test for something else as protein removal data is not enough.
The markers recommended for the non-protein based test are carbohydrates, hemoglobin, endotoxins, lipids, sodium ions, or bioburden.
The last aspect that must be understood when trying to meet the FDA requirements is that you must have a stand-alone cleaning validation and a stand-alone sterilization validation. The FDA requires both, and the kit system’s Instructions for Use need to have both processes listed within them. The rationale for requiring both validations is that the products need to have debris (represented by protein) removed during cleaning to ensure debris does not hinder the sterilization process.
So now that we understand that the FDA is looking for validations for kit systems, what the FDA is hoping to see in those validations, and that you must have a validation for both cleaning and steam sterilization, we will next discuss what issues arise in trying to meet those expectations.
But we’ll get to that in our blog post next week… Part 2 Here
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