Class-6 Indicators
Class-6 Emulating Indicators
The newest and most exciting product to enter the US hospital sterilization market is the STERIS Class-6 emulating indicators…...I will get into the exciting part at the end of this, so please stay with me. Previously Class 6 emulating indicators were only available outside the
STERIS Class-6 indicators have received FDA approval for use and their supportive data has been submitted to AAMI as a viable tool to complement, more importantly to improve the validation of the sterilization process. Finally, an across the board early release product that provides as much information as a biological indicator.
As you know AAMI provides guidance to healthcare and a number of different industries. AAMI has not stated that Class-6 replaces anything, just that we can use them according to the manufacturer’s FDA approved written instructions.
More importantly AAMI does not recommend this product or any other nor do they make claims that it should not be used, they simply will rely on the FDA approval for use. This is NO different then any other device used in healthcare.
When do we release a load of instruments for use?
For years the procedure has been that one should not release a load or item that has required biological (BI) monitoring attached to it; this even though the sterilizer has reached all parameters according to the computerized print-out.
The fact is that in more hospitals then not, the release comes way before the BI has completed incubation…this in part is due to the need for the items immediate use and to defray any potential surgeon dissatisfaction.
We simply are not going to hold up a surgery that is in progress to wait for the 24 or 48 hour validation from a BI. The more important aspect is that we use a BI properly and document the results to support a QA along with the print-out from the sterilizer…following the manufacturers instructions.
The truth of the matter is that there rarely is a positive BI resulting in re-sterilization on any load be it an implant or routine load let alone flash sterilization. Most if not all positive BI’s are directly related to human error not the failure of the sterilization cycle. Remember, test parameters are completed in controlled environments that do not mimic hospital conditions. Our load and tray sizes are not tested by the device manufacturers, that is our job.
With steam there is more moisture related problems resulting in re-sterilization then positive BI’s, which is also generally related to human error and or poor steam quality. With EO there never is a positive BI at all, or at least in my last 22 years working in CS.
What makes this a better process?
Having and internal class-6 indicator along with challenge test pack that can be used to monitor and release all loads and all items in the load gives sterilization a tool to maintain a common sense approach while supporting AAMI guidance processes.
The exciting part is that STERIS provided us a class-6 challenge test pack associated to internal class-6 indicators that allows us to monitor the load from all aspects.
Validation testing becomes even more accurate and less expensive.
Even with visible moisture the BI will not fail!
Click on slides to enlarge
Now what has all this early release hoopla done for the world of sterilization in the past?
Frankly, it has allowed additional products on the market that increase cost to the hospitals by adding extra steps of little value.
All these early release/rapid read products have received FDA approval for use without AAMI endorsement, although they have never proven to emulate or mimic the BI. Let’s face it, once a product has received FDA clearance it can be used without AAMI approval.
Please understand, AAMI guidance publications are voluntary recommendations, not mandated requirements which more importantly are in place to support a process. Furthermore, no evidence-based studies exist to support the use of early release indicators or integrators in a hospital setting.
Strangely enough, most if not all of these products are manufactured by companies that do not make sterilizers yet claim their product provides sterility assurance. All this has accomplished is adding another product with little proof of its requirement for use at an additional cost to the hospital.
More importantly the bottom line for these manufacturers is making money by selling products utilizing vague guidance recommendations and scare tactics. Ask yourself, if these early release products were so good, then why haven’t the manufacturing sector been required to use them?
What we in sterilization need is a limited number of products that have the ability to provide us an immediate indication while mimicking the BI results as close as possible — Not focused on early release but instant readout from one cost effective simple product.The sterilizer printout is the first assurance with the second being the internal indicator followed by the BI. The time associated in dealing with BI’s and early release can be reduced with the combination of the right products resulting in lowered expenses and less confusion.
Additionally, expense is not just related to the individual cost of a product, it includes the overall handling.
Early release is the least of our problems when it comes to sterility assurance. We have numerous challenges associated to inconsistent load sizes, load configurations, dissimilar metals with varying heat tolerances, and to top it off extended cycles.Honestly, a BI placed in a flash sterilizer with little if and challenge to its design will yield a negative outcome. So too will early release products. The pre-sterilization disinfection process poses a higher risk when it comes to flash sterilization.
We need to insure accuracy in the large number of packaging configurations that we are dealing with.
The number of containers both wrapped and closed with combinations of plastics, metals, racks, holders, and limited space tolerances pose more sterility assurance challenges then early release.Supporting Service Providers
Class-6 also provides additional information to our sterilizer service providers when dealing with sterilizer malfunctions.
A service person can review the challenge test pack gaining additional knowledge needed to ascertain varying repair needs more quickly.
A big thank you to STERIS for replacing their class-5 with the new class-6, rather then adding another product into the already over supplied sterile validation arena.
Now they need to have their EPS washer validated to wash rigid scopes, cameras, light-cords, and a number of other cables that are currently receiving low-level cleaning prior to sterilization.
