Steam Cycle Validation for reusable Medical devices contd…
So a quick recap: We covered what the FDA was looking for in Cleaning and Steam Cycle validation parameters for reusable kit systems in Part 1 (Click here to read). We discussed cost being a primary issue with meeting the FDA’s requirements and one way to avoid the driver of cost increase in Part 2 (Click here to read). Today we will deal with how to avoid the other driver of costs – having too many cleaning and autoclave parameter options in your IFU.
Let us pick up with the three questions we left off with:
- 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?
FDA “Standard” Parameters
There are two types of autoclave cycles, one being gravity and the other being PreVac. What those two types refer to is the methods in which steam enters the sterilization chamber. With Gravity cycles, the machine relies on Gravity to pull the steam into the nooks and crannies of the kit and the kit’s devices. With PreVac, a vacuum is pulled on the chamber prior to the steam being injected, allowing the steam to penetrate much more quickly.
The FDA guidance calls out 5 different items: Wrapped Instruments, Textile Packs, Wrapped Utensils, Unwrapped nonporous items, and Unwrapped nonporous and porous items in mixed load. Based on the items we are discussing here, those being Wrapped Instruments, we will focus on those standard parameters.
There are only 3 Gravity standard parameters and 2 PreVac standard parameters, so only 5 options. The most commonly used parameters are 121oC for 30 minutes Gravity and 132oC for 4 minutes PreVac.
So let’s say that we validate to those parameters and it turns out that a specific hospital runs to one of the others, how hard is it for hospitals to change parameters? The answer is not hard at all.
Most Autoclaves have preprogrammed parameter settings that match those recommended by the FDA. To switch parameters is as easy as pushing a couple buttons and running a different cycle. Hospitals do try to stick to one parameter and having a parameter that doesn’t match their standard is a disadvantage. The reason for this is that they will either have to run your kit independently, which is more costly, or they are going to run your kit with every other kit Outside of your validated cycleprocess, which means it may not be effective. It will be important for you to determine if it is worth the cost of validating multiple parameters to eliminate the chance that either of these issues will occur.
So we reach our final question, what types of automatic washing are available at hospitals?
There are two primary types, one being ultrasonic cleaning, and the other washing/disinfecting. Neither piece of equipment is great at removing debris from kits. They do an okay job, but they are the equivalent of placing a dirty dish in your dishwasher without scrubbing it first. Also, some hospitals have ultrasonic washers, some have washer disinfectors, and some have neither. So when looking at the problem, and knowing that automatic washers aren’t that effective, what should you do? Our recommendation is to conduct a manual cleaning validation. Any hospital can manually clean, and every hospital should manually clean to some level, before they place the kit in an automatic washer.
To reduce costs, if you conduct just a manual cleaning validation, all locations will be able to clean your product, and then you will just have to decide if it is worth the additional cost to also validate an ultrasonic cleaner, a washer disinfector, or both, as an additional cleaning method.
So hopefully we have given you plenty of info on Cleaning and Steam Cycle validation. You should now be able to talk fluently about the regulations, the most common parameters to validate, how to keep validation costs low, and what does and doesn’t work when trying to clean instruments.
For any additional questions or to discuss your validation needs please fill out the form here and someone from LSO will immediately get back to you, or give us a call at 714-672-1090