Advanced Sterilization Products (ASP)


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Table 1. Chamber weight limits per common sterilizer model and cycle types Model





vacuum level differences to scuba diving in the ocean (vacuum parameter of torrs to miles), VH2O2 sterilization would require an estimated 100 miles deeper dive than common steam sterilization processes. That’s a long way down and a big difference. The deep vacuum is required to remove residual air and moisture from the load and to help maintain the VH2O2 in a gaseous state (remember VH2O2 is a relatively unstable molecule). As we all are probably aware, residual moisture can be the root cause of a cancelled VH2O2 cycle during its initial deep vacuum phase. As the sterilizer pulls a deep vacuum, residual moisture will evaporate from de- vices and packaging. The residual moisture actually boils off the surface to form water va- por, but this vapor is cool, not hot. This newly formed water vapor slows down the deep vacuum process. The vacuum now must re- move the newly formed water vapor as well as the remaining air in the load and chamber. If the deep vacuum cannot reach the specified vacuum level within a specific time frame, the cycle will automatically cancel.

I would like to bust the myth that many of us believe that residual moisture always cancels the VH2O2 cycle. Residual moisture or water in the load does not always cancel the cycle. In some cases, the deep vacuum can remove residual moisture before the cycle cancels, but if this occurs we could develop the second problem with residual moisture, cold spots.

When residual moisture is evaporated from the load and packaging during the deep vacuum phase, the evaporation of the mois- ture will significantly cool the spot where the evaporation occurred. The principle is the same as sweating on a hot day, evaporating sweat cools us down. Evaporation of residual moisture can cool down spots on devices and packaging. This cold spot can result in condensation of the fixed amount of VH2O2 in that spot, making the VH2O2 unavailable for sterilization and subsequently resulting in an automatic cycle cancellation and/or

Non-Lumen9 Lumen9 Flexible9

Fast Non-Lumen9 Cycle 110

Weight (lb) Limit Not defined 10.7 10.7 21.4 21.4 10.7 13.2 50.0 19.6 24.0 11.0 75.0

failure of our quality monitoring tools and a rejected sterilization cycle.11

is not a friend of VH2O2 sterilization.

Stop the use of extra (nonessential) materials in VH2O2 sterilization Another important observation we have made was the use of extra materials in VH2O2 sterilization. For example, foam tray liners, polyethylene sheet tray liners, under- neath guard liners, bubble wrap tray liners and tray protectors, rubber corner protectors, foam pocketed instrument protectors, CI indicator holders, transport trays, oversized disposable sterilization wrap, 600 and 650 weight disposable sterilization wrap, and preformed disposable wraps are all examples of what we call extraneous or nonessential materials in use in healthcare facilities with failed VH2O2 sterilization cycles. As we have described because VH2O2 cycles use a fixed amount of sterilant, best practices would be to limit or eliminate the use of any extra materials that could absorb the fixed amount of available VH2O2 sterilant.

Furthermore, we found that many of the IFUs for these items do not call out any of the 15-plus individual VH2O2 cycles available. As we noted above, all of these cycles have many different design features and limita- tions. Which leads us to question, are each of these items validated for use in loads con- taining the maximum weight limit for each of the many different cycle types available? We have observed that these details can be important in VH2O2 sterilization and these details are not readily described in the IFUs for these nonessential items. As a best practice in line with our changing culture, we supplicate every Sterile Process- ing Department to review their use of these extra nonessential materials in VH2O2. A Sterile Processing Department could as- semble a cross functional team and conduct a risk assessment on why these materials are currently used in their VH2O2 process. Is the need to use these items still real and is the need still current? Could the department save

32 December 2018 • HEALTHCARE PURCHASING NEWS • Again, moisture

time by removing the use of these materials? Could the department save money by remov- ing the use of these materials? Is there a better practice or procedure? Eliminating the use of these extra nonessential materials could increase the robustness of the VH2O2 process while saving time and money. A review of your sterilizer’s operator’s manual will help develop your case. Here are some examples: • Select the proper size wrap for the items to be sterilized. —V-PRO maX Operator’s Manual v02/2011

• Do not use foam pads in instrument trays. They may absorb the hydrogen peroxide. —STERRAD 100S Operator’s Manual v11/2009

• Do NOT use tray mats that have not been cleared by FDA for use in the V-PRO Ster- ilization Trays. Do NOT use other padding with V-PRO Sterilization Trays. —V-PRO maX Operator’s Manual v02/2011

Every load monitoring (ELM) and quarantining all loads from VH2O2 sterilizers Another observation we have seen across the globe is an increased frequency of BI monitor- ing to every load monitoring combined with quarantining the load until the BI result is known. AAMI ST58 states: “A PCD with the appropriate BI should also be used at least daily, but preferably in every sterilization cycle.” (Section

AORN’s Guideline

for Sterilization is slightly more specific and states, “Routine sterilizer efficacy monitor- ing should be performed at least daily on each cycle type, preferably with each load.” (Recommendations XX.h.4 and XX.h.5)13 We have observed in hospitals, end-users typically place a BI and an internal CI in a peel-pouch indicated for use in VH2O2 steril- izers and then position the pouched BI in the sterilizer chamber as recommended by the sterilizer manufacturer. We have observed, when users switch to a BI that provides a result in minutes vs. days, they quickly move to every load monitoring (ELM) to provide a consistent level of patient care. In addition, the same users now quarantine every VH2O2 load until the BI result is known to mitigate the risk of large recalls should the sterilization cycle fail. The culture is changing.

FDA cleared BIs are acceptable to use! Unfortunately, misinformation has propa- gated through our industry regarding the use of BIs for VH2O2 sterilization, so we must address it here. Because an interna- tional standard does not yet exist, the global health care industry has no standardization on performance requirements for BIs used in VH2O2. In the U.S., the FDA regulates biological indicators used in healthcare fa- cilities and has a set of testing requirements

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