STEAMPlus is an immediate readout integrator for use in gravity, prevacuum and flash cycles. This product is tested to ST-60 and ISO 11140-1:2005 performance claims of Class 5 integrating integrators. Four inch strip has distinct pass/fail criteria and allows for easy removal from packs. The STEAMPlus is FDA cleared as, equivalent in performance to a biological indicator, and offers the highest level of sterility assurance from a chemical indicator. The STEAMPlus does not replace the routine use of a biological indicator.
Chemical Integrators
YOUR VERY OWN STERILITY ASSURANCE POLICY
So if multi-parameter internal/external chemical indicators verify pack sterilization parameters were met, and biological indicators ensure your entire load has achieved sterilization parameters...where do chemical integrators fit in? Pretty much right in the middle. Integrating indicators, generally known as chemical integrators, mimic the response of a biological indicator so closely that they allow you to confidently release non-implant loads before spore tests are received.
However, since chemical integrators (which are technically a form of chemical indicators) do not contain viable spores they can not replace weekly biological testing as they cannot directly measure the lethality of a sterilization process. To recap Type 5 Integrators are chemical indicators that react to all three parameters of sterilization (time, temperature, pressure) and very closely mimic biological indicators without requiring incubation. In fact, they are the only chemical indicator to parallel the biological indicators this closely. But again, although Type 5 indicators closely mimic biological monitoring they do not replace the need for weekly biological testing.
Biological monitoring is the gold standard for sterilizer performance testing as it contains viable, highly resistant spores. When a biological test is passed you can be confidant your sterilization procedures and parameters have all been met. Weekly biological monitoring is recommended by the Centers For Disease Control and can be performed with In-Office testing or by using third party Mail-In services.
HOW TYPE 5 STEAM INTEGRATORS WORK
Type 5 chemical indicators as defined by the Food and Drug Administration and the International Standards Organization contain a steam sensitive material that sequentially moves across the strip into a SAFE ZONE indicating all parameters of sterilization (time, temperature, steam) have been met. The Crosstex STEAM Plus Integrator is an example of a Type 5 chemical indicator and is intended for at least once a day use and for use in every load containing an implantable device. The benefit of a Type 5 chemical indicator is the ability to provide a distinct pass/fail result providing the confidence of sterility prior to releasing the load. Think of it as an insurance policy, or sterility assurance policy . . . the more frequently used, the less disruption of potential costly recalls when alerted to biological failures.
feature benefits of Type 5 Integrators include:
1. Ability to provide a distinct pass-or-fail result, providing confidence to safely release the instruments in every steam sterilization cycle.
2. Detects potential sterilizer failures which can result from incorrect packaging, overloading or malfunctions of the sterilizer.
3. Used as an additional monitoring tool for the release of sterilized loads versus quarantined loads until a biological indicator test result is reported as negative.
4. Used daily, or with every load, is a means of improving patient safety and reduces the cost and disruption of potential recalls when a biological indicator test fails.
5. Parallels the spore death curve in a normal steam sterilization range with a margin of safety.
Type 5 INTEGRATOR GUIDELINES
Of note, the CDC Guidelines for Infection Control in the Dental Healthcare Setting (2003) defines the use of weekly biological monitoring and should include the use of chemical monitoring to evaluate both the sterilizing conditions and the procedure’s effectiveness. Although no single quality assurance monitoring method assures that any item is sterile; rather a Type 5 integrator assures the conditions for sterilization to occur have been met.
While there is no reference to the use of a Type 5 integrator in the CDC guidelines, is it worth skipping this step? The average cost of an integrator strip is less than 50cents, yet it can provide enhanced confidence about the success of the sterilization process. When it comes to sterility assurance, it is always better to be safe than sorry.
Chemical Integrators
YOUR VERY OWN STERILITY ASSURANCE POLICY
So if multi-parameter internal/external chemical indicators verify pack sterilization parameters were met, and biological indicators ensure your entire load has achieved sterilization parameters...where do chemical integrators fit in? Pretty much right in the middle. Integrating indicators, generally known as chemical integrators, mimic the response of a biological indicator so closely that they allow you to confidently release non-implant loads before spore tests are received.
However, since chemical integrators (which are technically a form of chemical indicators) do not contain viable spores they can not replace weekly biological testing as they cannot directly measure the lethality of a sterilization process. To recap Type 5 Integrators are chemical indicators that react to all three parameters of sterilization (time, temperature, pressure) and very closely mimic biological indicators without requiring incubation. In fact, they are the only chemical indicator to parallel the biological indicators this closely. But again, although Type 5 indicators closely mimic biological monitoring they do not replace the need for weekly biological testing.
Biological monitoring is the gold standard for sterilizer performance testing as it contains viable, highly resistant spores. When a biological test is passed you can be confidant your sterilization procedures and parameters have all been met. Weekly biological monitoring is recommended by the Centers For Disease Control and can be performed with In-Office testing or by using third party Mail-In services.
HOW TYPE 5 STEAM INTEGRATORS WORK
Type 5 chemical indicators as defined by the Food and Drug Administration and the International Standards Organization contain a steam sensitive material that sequentially moves across the strip into a SAFE ZONE indicating all parameters of sterilization (time, temperature, steam) have been met. The Crosstex STEAM Plus Integrator is an example of a Type 5 chemical indicator and is intended for at least once a day use and for use in every load containing an implantable device. The benefit of a Type 5 chemical indicator is the ability to provide a distinct pass/fail result providing the confidence of sterility prior to releasing the load. Think of it as an insurance policy, or sterility assurance policy . . . the more frequently used, the less disruption of potential costly recalls when alerted to biological failures.
feature benefits of Type 5 Integrators include:
1. Ability to provide a distinct pass-or-fail result, providing confidence to safely release the instruments in every steam sterilization cycle.
2. Detects potential sterilizer failures which can result from incorrect packaging, overloading or malfunctions of the sterilizer.
3. Used as an additional monitoring tool for the release of sterilized loads versus quarantined loads until a biological indicator test result is reported as negative.
4. Used daily, or with every load, is a means of improving patient safety and reduces the cost and disruption of potential recalls when a biological indicator test fails.
5. Parallels the spore death curve in a normal steam sterilization range with a margin of safety.
Type 5 INTEGRATOR GUIDELINES
Of note, the CDC Guidelines for Infection Control in the Dental Healthcare Setting (2003) defines the use of weekly biological monitoring and should include the use of chemical monitoring to evaluate both the sterilizing conditions and the procedure’s effectiveness. Although no single quality assurance monitoring method assures that any item is sterile; rather a Type 5 integrator assures the conditions for sterilization to occur have been met.
While there is no reference to the use of a Type 5 integrator in the CDC guidelines, is it worth skipping this step? The average cost of an integrator strip is less than 50cents, yet it can provide enhanced confidence about the success of the sterilization process. When it comes to sterility assurance, it is always better to be safe than sorry.
