HEALTHCARE SELF-STUDY SERIES N


PURCHASING EWS


June 2019 he el leon on hi cenl eice opic  eelope   elh e. he leon e miniee  neo elhce ei


Earn CEUs e cel  o he leon complee he eminion  he en o hi ecion. il he complee e n coin ee o Healthcare Purchasing News o in. e ill noi o i o he  pin coe o  pecen o hihe n o ill eceie  cei ce o compleion ihin  . eio leon e ille  .hpnonline.com.


Certifi cation he  eiicion o o eile ocein n iiion h peppoe hi ineice o one  conc ho o  peio o  e  e om he e o oiinl plic ion. ccel compleion o he leon n po e m e


ocmene  cili mnemen n hoe eco minine  he iniil nil e cei cion i eie.        . o iionl inomion ein cei cion conc    in ee ie  enon   • . eilepocein.o.


 nenionl ociion o elh


ce enl eice eiel nemen h peppoe hi ineice o . onin


in cion ei o  peio o hee e nil   . he ppol nme o hi leon i 3M-HPN 190905. o moe inomion iec n eion o


Healthcare Purchasing News   e. .


LEARNING OBJECTIVES


1. Review the four elements of a comprehensive sterilization monitoring program.


2. Discuss approaches to streamline periodic product testing.


3. Discuss AAMI and AORN guidance on the prepurchase evaluation of rigid containers.


Sponsored by:


Product testing


The overlooked 4th pillar of a robust sterilization process monitoring program by Susan Flynn


processing a new brand of container in your facility’s older sterilizers? Installing a new low temperature sterilizer? While the responsibility for validating sterilization parameters for reusable surgical instru- ments and packaging rests squarely with the device manufacturer, sterile processing professionals can and should perform prod- uct testing. Product testing can give you confi dence that a particular instrument set or container can be successfully processed in your facility in your sterilizers. In fact, product testing is one of the four pillars of a comprehensive sterilization quality assur- ance program, albeit the one that is probably the least often practiced. This article will review the recommendations on product testing provided in national standards and guidelines.


H


ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assur- ance in healthcare facilities, is the ‘go to’ docu- ment for steam sterilization. This resource was revised in 2017 and Table 2 and Section 13 describe the four pillars of a robust qual- ity assurance program: routine load release; routine sterilizer effi cacy testing; sterilizer ualifi cation testing; and periodic product testing.1


If you’re like most end-users that


call the 3M Sterilization Tech Line, you understand that ualifi cation testing, which includes three consecutive cycles with a biological indicator process challenge device (BI PCD) should be done after installing a new sterilizer or performing major repairs on an existing sterilizer. Your facility prob- ably has defi ned policies for routine release of both non-implant and implant loads and you are diligent about quarantining implants until the BI result is available. You probably conduct routine effi cacy testing of both your steam and vaporized hydrogen peroxide (VH2O2) sterilizers at least daily on each cycle type, if not every load, and include internal and external chemical in- dicators (CIs) in and on each item.


30 June 2019 • HEALTHCARE PURCHASING NEWS • hpnonline.com


as a new loaner tray ever given you pause because of its size, complex- ity, or density? Concerned about


Adherence to the recommended quality assurance program tends to be inconsistent, however, on the 4th recommended element: performing periodic product testing of routinely processed load items. Kudos to you if you already have a product testing plan in place for all methods of steriliza- tion! Intuitively, departments sometimes perform product testing when investigating a sterilization product failure, often uncov- ering a surprise in an IFU related to load size, container placement, and/or validated sterilization modality. Rather than being a reactive exercise, product testing can be a proactive method of verifying the ability to achieve sterilization parameters in your facility with your sterilizers and associated utilities. But sometimes the ambiguity of the requirements makes it easy to push product testing to the back burner. How often should we do it? How do we do it? Haven’t the de- vice and packaging manufacturers already validated sterilization parameters for their products? Why should we repeat their work in our department?


This last question leads us to review


two defi nitions provided in N ST77:2013, Containment devices for reusable medical device sterilization:  Verifi cation: “Documented procedures, performed in the user environment, for obtaining, recording, and interpreting the results required to establish that predeter- mined specifi cations have been met.2


 Validation: Documented procedure per- formed by the device manufacturer for obtaining, recording, and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifi cations.2 roduct testing aka verifi cation is not a replacement for the more extensive valida- tion testing performed by device manu- facturers. Product testing cannot be used, for example, to justify a shortened steam sterilization exposure time or a different VH2O2 cycle type than has been validated by the medical device manufacturer. It is used to demonstrate that the device manu-


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60  |  Page 61  |  Page 62  |  Page 63  |  Page 64  |  Page 65  |  Page 66  |  Page 67  |  Page 68  |  Page 69  |  Page 70  |  Page 71  |  Page 72  |  Page 73  |  Page 74  |  Page 75  |  Page 76  |  Page 77  |  Page 78  |  Page 79  |  Page 80