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Clinical benefits of faster biological indicators


HAVING MY SAY by Rose Seavey MBA, BS, RN, CNOR, CRCST, CSPDT C


hanges to reusable medical devices pro- vide increased utility, but also increased complexity. Reprocessing these sophisti- cated devices requires multiple essential moni- toring tools including physical, chemical and biological monitors. Fortunately, our sterilization monitoring systems are also being improved through technological advancements.


Introduction of rapid BIs Arguably, one of the most beneficial steriliza- tion monitoring enhancements happened in the early 1990s with the introduction of rapid biological indicators (BIs). I distinctly remember the first time I heard about the ability to obtain a BI reading in one hour; I was at an Association of Operating Room Nurses (AORN) Congress when I first heard about this new technology for faster biological results for gravity sterilization cycles. As an operating room (OR) nurse special- izing in orthopedics, we often relied on gravity “flash” cycles. As the patients’ advocate, I had concerns about using instruments and implants on patients while sometimes waiting days for the assurance of a negative BI.


A few years later the rapid readout BI for pre-vacuum sterilization was cleared by the FDA. This allowed us to get the BI results of our terminally sterilized loads within 3 hours. That was a huge improvement compared to the standard of the day.


New solutions for today’s challenges Fast-forward to 2013 and consider the huge technological leap we have seen in healthcare in- strumentation and practice. We are now dealing with extremely complicated reusable medical devices, increased regulatory requirements, tight surgery schedules, more sophisticated steriliza- tion equipment, and multiple diseases that we did not know existed in the early 1990s. Now more than ever, we need to remain compliant with patient safety guidelines and best practices, and of course, among the tools we rely on are sterilization monitoring devices. Today’s challenging healthcare environment requires speed and excellence. The newly released 3M Attest Super Rapid Readout BIs provide quick, accurate results which can help to raise the level of safety for our patients while helping our facilities to be more efficient. Com- pleting our sterilization monitoring in 30 to 60 minutes is great news in our busy world. A study investigating the side-by-side perfor- mance of the new 3M Attest Super Rapid Biologi-


cal Indicators 1492V to 3M Attest Rapid Readout Biological Indicators 1292 was published in the February 2014 edition of the American Journal of Infection Control, a peer reviewed journal.1


The


study found that “The number and percent- age of fluorescent-positive 1- hour RRBIs were virtually identical to those of the 3-hour RRBIs after 1 and 3 hours of incubation, respectively’’ and concluded that, “The results of this study suggest that the 1-hour RRBI is equivalent to the 3-hour RRBI and would be suitable for use in monitoring dynamic-air removal steam sterilization cycles at both 132°C and 135°C per recommended practice guidelines.”1


Why are faster BI results beneficial?


Getting biological results faster means Sterile Processing (SP) can react more quickly to the needs of our main customers, the OR. Being able to release the sterilizer loads sooner means faster instrument turnover and less risk of emergency release, therefore improving our ability to keep patients safe from infection during surgical procedures. AAMI states, “All items removed from the


sterilizer after sterilization processing, including items packaged in rigid sterilization container systems, should remain on the sterilizer cart until adequately cooled.1


Although a minimum


cooling time of 30 minutes is recommended, adequate cooling could require 2 hours or more.1 Having all our monitoring results quickly, some- times even before the items are cooled, gives peace of mind as the patient advocate. The Centers for Disease Control, The As-


sociation for the Advancement of Medical Instrumentation (AAMI) and AORN all state that implants should be quarantined until the BI results are known.2,3,4


It is my professional


opinion that we should quarantine all loads, not just implants, until we have the results of all three types of monitors, physical, chemical, and biological. If my loved one were the patient that is the standard I would want followed.


Standardization and process improvement


The Joint Commission (TJC) wants to see stan- dardization and process improvement in our sterilization procedures. AAMI states “Biological indicators are the only sterilization process moni- toring device that provides a direct measure of the lethality of the process”, and should be used to routinely test sterilizer efficacy, for load release, and for sterilizer qualification.4


66 March 2014 • HEALTHCARE PURCHASING NEWS • www.hpnonline.com


John Eiland, a TJC surveyor who presented at the 2013 International Association of Health- care Central Service Materiel Management (IAHCSMM) conference, stated that, while we trust our processes, we must verify that we are performing those processes correctly. Eiland went on to say, “I would like you to do a BI every day, preferably every load.”5


. While this may


not be the current published recommendation, it certainly makes sense to me. As the patient advocate, there is justification for monitoring each load with a BI; after all, each of our patients deserve the same level of care, and that means doing all we can to help keep them safe. By monitoring every load with a BI, we virtu- ally eliminate the possibility of forgetting to run a BI with implant loads. Being able to read the BIs in less time means they are in and out of the incubator faster, a good thing when we follow best practices of running a BI in every load.


Reducing the need for IUSS Having a 1-hour BI result for pre-vac cycles means it is easier and quicker to perform the pre- ferred terminal sterilization in SP. That capability helps us to decrease the need for immediate-use steam sterilization on those late-arriving loaner sets or those special instruments that need quick turnover.


In those emergencies when Immediate-Use Steam Sterilization (IUSS) of an implant is ab- solutely necessary, having a faster BI means the BI result is more likely to be available before the procedure begins (or at least the patient might still be in the room).


Decreasing risks with recalls If we have a recall due to a sterilization pro- cess failure, having fast BI results allows us to respond more quickly, reducing the severity of the recall.


Decrease sterilizer downtime during qualification monitoring In the event that we need to do qualification testing of a sterilizer before putting it back into service, having the BI results faster means less down time which increases our efficiency.


Conclusion Sterilization monitoring has come a long way. From critical issues of patient care and safety, to operational issues related to the complexity of documentation and the requirements of sterilizer qualification, faster BI results can help ease the stress of a challenging SP environment. As the


HAVING MY SAY


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