Friday, September 24, 2010

New Product Eliminates Sterilizer Recalls

Introduction
The STEAMPlus Tray Record Card can eliminate the recall of improperly processed loads in steam sterilizers. It should be kept as a permanent, "physical record" of sterility assurance. As the largest sterilizer testing laboratory in North America, SPSmedical works with thousands of healthcare facilities to document proper sterilization cycles through the weekly use of biological indicators per CDC, AAMI and AORN guidelines.


Problem
With the growing concern over blood borne diseases e.g. hepatitis and HIV, all facilities that reprocess instruments need to document the sterility of every load. While biological indicators are considered the highest level of sterility assurance, they are living spores that require incubation at 55-60ยบC for 2-7 days after processing before results are known. If the spore grows, the sterilizer has failed and the load is considered non-sterile. Sterilizers that do not pass this important test should be taken out of service until repaired and successfully re-tested. Herein lies the problem - what if the test load was not sterile and the instruments were used? What about all the other loads processed in between the weekly test load? Are they sterile or did they just get hot? How do facilities decide which load each week to check for sterility? And who decides?

Mechanical gauges built into steam sterilizers do provide time, temperature and pressure readings for each load; however, these readings are taken at the drain, not inside the packages within the load. Color change indicators are available for placement on the outside and/or inside of packages, but most turn as soon as the sterilizer gets hot. For this reason, the FDA considers color change indicators only process indicators and not sterility indicators.

Solution
The STEAMPlus is FDA cleared as equal in performance to a biological indicator plus a safety factor. Inexpensive and requiring no incubation, this advanced technology allows users to immediately release processed loads as sterile with both peace of mind and legal documentation. Easy to use and interpret, the STEAMPlus is for all Steam processes (gravity, vacuum or flash). Available individually (SSI-100) attached to a 3" x 5" Tray Record Card (TRC-050), the STEAMPlus can be permanently retained as "physical proof" of sterilization. For the highest level of sterility assurance and to comply with industry standards, SPSmedical recommends testing weekly with biological indicators and use a STEAMPlus with every load.


Conclusion
When used with every load, the STEAMPlus can eliminate the release of non-sterile loads, which means never again having to contact staff, doctors and patients about using non-sterile instruments. In addition to SPSmedical's testing, several independent laboratory studies* have concluded the STEAMPlus "integrates the process variables of steam sterilization in a manner which is equivalent to the kinetics of spore destruction and that it offers an immediate indication as to whether or not a load is sterile. Furthermore, this information is presented as an unambiguous, quantitative and permanent indicator." For more information and product samples, call your authorized SPSmedical distributor or contact SPSmedical directly.

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