continued from Part 1, Steam Cycle Validation for Reusable Devices
So now that we understand what the FDA is looking for in Cleaning and Steam Cycle validation parameters for reusable kit systems, let’s next discuss the primary issue that arises in trying to meet those expectations.
A major issue when tasked with Cleaning and Steam Cycle validation parameters for reusable kit systems, is of course validating rugged processes at a reasonable cost. There are really two key drivers to sending validation costs into the stratosphere. The first is in having to validate several very different kit systems, the second is trying to provide multiple cleaning and steam sterilization options in your IFU to the hospital.
Let’s deal with the first issue. Some of our clients have come to us with 5 or more kit systems, representing 20+ kits, which were never previously validated or validated appropriately. The immediate expectation is that you will need to do 5 cleaning validations, and 5 steam cycle validations, which is a ton of work, time consuming and costly.
Before running off under the assumption that you must conduct all these validations, you should first look at the variation of the kit systems, focusing primarily on a risk –based assessment of device use, component materials composition and component complexity, and then secondarily on quantity of components in a kit, number of levels in the kit, and kit weight. If you begin to sort your kits in this manner, you will find that they are much more alike than their family names make them out to be. By regrouping kits by type rather than family, you are very likely to be able reduce the number of validations you will need to conduct. This is a critical process, and you should work with someone who has experience dealing with these types of validations when both justifying and writing the justifications for the consolidations.
The second issue is less complex from a regulatory perspective, but much more complex from a sales and marketing perspective. The simple issue is that hospitals, doctor’s offices, and surgery centers all prefer to run standard autoclave cycles and standard automatic washing cycles. If your IFU lists the cycle that hospital considers standard, it is easier for them to incorporate your kits into their normal process. The reason this is an issue is that for every parameter listed in an IFU, a validation needs to be done to prove those parameters.
There are 3 key points that you need to know before tackling this discussion with your sales or marketing folks.
- What autoclave parameters does FDA consider standard?
- How hard is it for a hospital to change parameters on their equipment?
- What types of automatic washing are available at hospitals?
We’ll tackle those next week…….
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