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and procedures meet all applicable IFUs for the VH2O2 sterilizers on the U.S. market. Figure 2 is a snapshot of the theoretical con- centration of sterilant (mg/L of VH2O2) and the total sterilant exposure time in minutes for each sterilizer model and cycle type. The in- tent of Figure 2 is to illustrate the broad use of VH2O2 cycle types on the U.S. market today. Back in the early 1990s, we had one VH2O2 sterilizer and one cycle, today we have six different VH2O2 sterilizers and over 15 cycle types. VH2O2 cycles are not all created equal. Because of these differences, the techniques and variability introduced by the operator play a significant role in assuring the load does not overwhelm the fixed amount of the unstable VH2O2 sterilant and result in a failed sterilization cycle.


We also observed two additional factors


that play a significant role in the successful use of the VH2O2 sterilization process that also depend on the experience and expertise of the operator: Residual moisture and the use of extra (nonessential) materials. You likely already know that residual moisture can directly impact VH2O2 sterilization, but are you aware of the effects of using extra materials in the load?


These factors — different cycle types, a


fixed amount of sterilant, a relatively un- stable molecule, residual moisture and use of extra nonessential materials — make a technique sensitive setting where the vari- ability introduced by the user regarding the composition and weight of the load can dra- matically affect the outcome of the VH2O2 sterilization process.


Let’s explore some of these items in more detail and review some common themes amongst users that demonstrate how a change in culture can help assure a success- ful outcome by preventing these factors from dramatically affecting the VH2O2 steriliza- tion processes.


Double check the sterilizer, packag- ing, and device IFUs. Is that item actu- ally labeled for VH2O2 sterilization? We have observed all too often plastic trays, rigid containers, and yes, entire device sets processed in VH2O2 sterilizers that were never tested, validated, nor labeled to be processed in VH2O2 sterilization. Upon dis- covery we heard a multitude of explanations for these procedural stumbles: • That is how we always processed these devices.


• That is how we did it in my old department. • We have never had any problems process- ing the devices this way.


• We want a quicker turnaround time for these devices, we don’t want to wait for a large steam load to cool.


*VH2O2 mg/L reported are estimates based on calculations from nominal liquid H2O2 volumes and reported sterilizer chamber volumes and from published product literature5


. **Reference exposure time details in STERIS Document# M3644EN2012-10, Rev. B.


• We were told it was OK. It is not OK to process items that are not


labeled for use in the process in a VH2O2 sterilizer. If there are devices or sets or loads that seem to have a higher frequency of failure in your VH2O2 sterilization process, double check your IFU for each item in the load. You might be surprised at what you find. Our observations in facilities across the world have included many items sterilized in VH2O2 that were never validated nor labeled for sterilization in the process. To begin, review your VH2O2 sterilizer operator’s manuals once again. We have found some noteworthy restrictions and helpful hints in these manuals. Here are some quotes from common VH2O2 sterilizer operator manuals: • Improper loading of the sterilizer may result in cycle cancellations and/or posi- tive biological indicator results. - STER- RAD100S Operator’s Manual v01/2009


• Do not stack instruments inside the trays. Do not stack trays. Do not stack trays with- in trays. Do not wrap instruments within the trays. - STERRAD 100NX v03/2011 and 100S Operator’s Manual v11/2009


• Configure loads with a combination of metal and nonmetal items - STERRAD 100S Operator’s Manual v11/2009


• Do NOT stack pouches on top of each other. – V-PRO maX Operator’s Manual v02/2011


• Do NOT stack trays within trays. Do NOT wrap instruments within a wrapped tray. –sV-PRO maX Operator’s Manual v02/2011


SELF-STUDY SERIES


Know and follow the sterilizer cycle’s validated weight limits


Until recently, it was very rare to encounter a sterile processing department that is inti- mately familiar with the validated weight limits for their VH2O2 cycles. Even rarer was the use of a scale to weigh individual loads prior to processing. Good sterilizer loading practices are critical for effective VH2O2 sterilization! Table 1 (next page) is a chart of weight limits for each VH2O2 sterilizer model and cycle. Always refer to the steril- izer manufacturer’s instructions for use for specific restrictions on devices allowed for each cycle type.


Completely dry devices according to manufacturer’s instructions for use Moisture is not a friend of VH2O2 steriliza- tion. The STERIS Corporation specifically calls out the incompatibility of moisture with hydrogen peroxide: “Materials NOT Compat- ible With Hydrogen Peroxide - Items that are NOT completely dry (V-PRO maX Operator’s Manual v02/2011). Excessive moisture in and around devices and packaging can cause automatic cycle cancellations and failure of our quality monitoring tools resulting in rejected sterilization cycles. Let’s review both scenarios and discuss why each can occur. Common VH2O2 sterilization processes begin with a very deep vacuum as compared to common steam sterilization cycles. As a comparison, if we were to equate these Page 32


Figure 2. Theoretical concentration of sterilant (mg/L of VH2O2) and total sterilant exposure times


hpnonline.com • HEALTHCARE PURCHASING NEWS • December 2018 31


Self-Study Test Answers: 1. A, 2. A, 3. B, 4. B, 5. A, 6. B, 7. A, 8. A, 9. A, 10. A

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