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SELF- Ozone Sterilization

SELF- STUDYSERIESLESSON NO. 83 JULY 2005 Ozone SterilizationLEARNING the properties of Ozone that make it an attractive low-temperature the brief history of Ozone advantages of using Ozone basic procedures required for Ozone background information about the safety of the Ozone Sterilization materials, items, and packaging that are or are not recommended for use with theozone Sterilization surgical devices that help physiciansperform modern miracles are constantly beingintroduced by medical technology. These newdevices also create new challenges for theCentral Service (CS) technicians who mustprocess them for reuse. Because of theireffectiveness and cost efficiency, steamsterilization units have long been the preferredmethod for reprocessing surgical devices. Thematerials used to construct many of the newestsurgical instruments, however, become damagedwhen they are processed in a heat or moistureenvironment and so, these devices require a low-temperature Sterilization oxide (EtO) has become the mostpopular low-temperature alternative because ofthe wide range of materials with which it can beused and because of its effectiveness indestroying microorganisms.

Objective 3: Discuss advantages of using ozone sterilization. Ozone’s ability to destroy pathogens at low cost in a worker-safe environment was noted

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Transcription of SELF- Ozone Sterilization

1 SELF- STUDYSERIESLESSON NO. 83 JULY 2005 Ozone SterilizationLEARNING the properties of Ozone that make it an attractive low-temperature the brief history of Ozone advantages of using Ozone basic procedures required for Ozone background information about the safety of the Ozone Sterilization materials, items, and packaging that are or are not recommended for use with theozone Sterilization surgical devices that help physiciansperform modern miracles are constantly beingintroduced by medical technology. These newdevices also create new challenges for theCentral Service (CS) technicians who mustprocess them for reuse. Because of theireffectiveness and cost efficiency, steamsterilization units have long been the preferredmethod for reprocessing surgical devices. Thematerials used to construct many of the newestsurgical instruments, however, become damagedwhen they are processed in a heat or moistureenvironment and so, these devices require a low-temperature Sterilization oxide (EtO) has become the mostpopular low-temperature alternative because ofthe wide range of materials with which it can beused and because of its effectiveness indestroying microorganisms.

2 Other popularalternatives include hydrogen peroxide gasplasma, liquid peracetic acid, and emerging technology for low-temperaturesterilization involves the use of Ozone . Theapplication of this system within a specificfacility must be carefully analyzed and may ormay not be applicable today, or in the Sterilization must be considered,however, and so this SELF- Study Lesson presentthe background information to do 1: Explain the properties of ozonethat make it an attractive low-temperaturesterilization people are familiar with Ozone . They mayknow about its benefits in the earth s upperatmosphere, where it protects us from the sun sharmful ultraviolet [UV] rays, and at groundlevel where it is a very powerful oxidizing has also been used as a germicide tosterilize foods, air, and drinking water thatcontain organic matter such as fungi, viruses,and bacterial spores.

3 In CS applications, onlyelectricity, water, and medical-grade oxygen areneeded to produce Ozone in a sterilizationsystem. Because these components are readilyavailable in hospitals, devices to be sterilized atan extremely cost-effective addition to low cost, Ozone sterilizationoffers another significant advantage inemployee safety. Because the Ozone sterilizerproduces its own sterilizing agent, the sterilantdoes not require any transportation or physicalcontact by technicians. It also releases onlyoxygen and water vapor into the the event of an Ozone leak in the sterilizer,the distinct smell of the sterilant would beapparent before a dangerous exposure level forhumans is 2: Review the brief history ofozone is a pale-blue gas with a characteristicpungent odor. It condenses to a dark blue liquidat -170o F (-112o C) and freezes at -315o F (-193o C).

4 It has been used for medicinalapplications since the late 1800s, when it wasused to therapeutically purify blood. By theearly 1900s, ozonated water was being used totreat numerous diseases including anemia,diabetes, influenza, and even canker World War I, Ozone was used to treatwounds, gangrene, and the after-effects ofpoisonous Ozone Sterilization system marketedtoday evolved from a concept submitted at a1991 meeting about the use of Ozone for watertreatment. By 1999, clinical trials had begun,and the Ozone sterilizer was licensed byCanada in 2002 and by the Food and DrugAdministration in series of SELF- study lessons oncentral service (CS) topics wasdeveloped by the InternationalAssociation of Healthcare CentralService Materiel Management(IAHCSMM).The lessons are administered byPurdue University s ContinuingEducation CEUsThe series can assist you inmaintaining your CS careful study of the lesson,complete the examination at theend of this section.

5 Mail theexamination and scoring fee toPurdue for grading. When youreceive notification of a passingscore of 70 percent or higher,forward this information toIAHCSMM and receive .2 Continuing Education Units(two points).This lesson is also available for oneCBSPD (formerly NICHSPDP)contact hour; please check theCBSPD box on the Request forScoring. Two attempts to achievea passing score are permitted perexamination. Previous lessons are available from Purdue at Lessons are valid forrecertification for three years afterinitial more informationDirect any questions toIAHCSMM at (312) 440-0078or Purdue University at (800) 3: Discuss advantages of usingozone s ability to destroy pathogens at lowcost in a worker-safe environment was notedbriefly above. By contrast, EtO is amutagen (a substance or agent that causes anincrease in the rate that genes change), acarcinogen (a cancer-causing substance), anda reproductive hazard.

6 It is also explosiveand dangerous to handle, and the Occupa-tional Safety and Health Administration(OSHA) has indicated a desire to ban its addition to all these drawbacks, Instru-ments sterilized with the EtO process mustbe aerated for 12 to 24 hours, which requiresa relatively large inventory of medicaldevices. The residual level of EtO releasedinto the environment must also be monitoredcarefully to assure that no environmentalproblems are cost of sterilizing with Ozone ismuch less than with EtO. For example, theozone required for one Sterilization cyclecosts less than ten cents; the same steriliza-tion cycle with EtO has a sterilant cost ofmore than $ Another economicadvantage to the use of Ozone sterilizationarises from the ability to use the instrumentsas soon as they complete the sterilizationprocess, requiring a smaller instrumentinventory than with the EtO testing has suggested thepossibility that Ozone Sterilization maydeactivate prions, the infectious protein thatcauses Creutzfeldt-Jakob Disease (CJD) inhumans.

7 This disease can be transmittedbetween patients when contaminatedsurgical instruments are used even after thedevices have been processed with today scommon Sterilization methods. While furthertesting incorporating a relatively longtimeframe is required, Ozone Sterilization spotential for reducing the spread of CJDfrom contaminated instruments is manufacturer of the Ozone sterilizer isnow developing a test device to helpdetermine whether prions are destroyedduring the Sterilization 4: Summarize the basicprocedures required for Ozone to be sterilized with Ozone mustbe prepared for Sterilization according to theguidelines issued by regulatory or profes-sional organizations and from the applicableinstrument manufacturers. All infectioncontrol practices and procedures used bythe CS department for processinginstruments by any other method shouldalso be used for Ozone Ozone Sterilization process usestwo identical half-cycles.

8 After thechamber is loaded with instruments, thedoor is closed, and the cycle begins. First,a vacuum is created within the chamber,followed by a humidification is then injected into the chamberand the Sterilization process begins. Afterthe half-cycle is reached, the previoussteps are repeated. A final ventilationphase is used to remove Ozone from thechamber and the packaging within the Sterilization cycle, acatalytic agent is used to transform theozone into oxygen. There are no toxic/hazardous residues or waste productsassociated with the process, and no toxicgas is vented into the , biological, and chemicalindicators are used to complete thesterilization assurance Typical process (mechanical)functions are monitored during the cycleand, at the end of each cycle, processparameters are printed for review andretention. During the Sterilization cycle,if a parameter is not reached, the cyclewill abort, and the reason for theinterruption will be displayed on a screenand routine process monitoring, asterilization test pack is placed directlyin the load.

9 This test pack should be usedin each Sterilization cycle. A biologicalindicator is placed in a syringe with acatheter tip, followed by a chemicalindicator. The plunger diaphragm isinserted into the syringe which, in turn, isplaced in a Sterilization pouch beforebeing sealed. (A routine Ozone test packclosely resembles an Association forAdvancement of Medical Instrumenta-tion [AAMI] routine EtO test pack.)The syringe serves as an Ozone absorber,and the biological indicator is a microbialchallenge. Concurrent biological monitor-ing is done, using geobacillusstearothermophilus in a SELF- containedvial, to provide a sterility assurance level(SAL) of 10-6. The chemical indicatorresembles a small sticker and containschemicals that change color when theparameters required for Sterilization havebeen Sterilization cycle lasts approxi-mately four and one-quarter hours attemperatures from 85o - 94o F (30o - 35oC).

10 Objective 5: Present backgroundinformation about the safety of theozone Sterilization exposure to any sterilant can bea health and safety hazard. At low levels, Ozone can be a respiratory irritant, and itcauses more serious effects at higher has established a short-termexposure limit of no greater than partsper million (ppm) over a fifteen-minuteperiod, and an exposure limit of no greaterthan ppm as an eight hour time-weighted human nose can detect Ozone atlevels of approximately ppm, so aCentral Service technician will typically beaware of Ozone in the environment longbefore a hazard exists. In addition, becausethe sterilizer creates a negative pressurechamber during the processing cycle, anyleaks would enter the chamber and theozone would be diluted before entering manufacturer recommends that thesterilizer unit be placed in a room with atleast ten air exchanges per 6: Note materials, items, andpackaging that are or are not recom-mended for use with the ozonesterilization medical devices should always beprocessed by following the devicemanufacturer s provided by the manufacturerof the Sterilization equipment that applyspecifically to the Sterilization processshould also be followed of the wide variety of heat-sensitive devices and changes in instrumentmodel designs, material and devicecompatibility must be identified on anindividual basis.


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