Reprocessing Single-use Medical Devices

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1、MARCH2002,VOL75NO3•Cohoon•ReprocessingSingle-useMedicalDevices557AORNJOURNALMARCH2002,VOL75NO3•Cohoon•557AORNJOURNALMARCH2002,VOL75NO3•Cohoon•TheFDAhasnotissuedregulationsthataddressthird-partyreprocessorsofSUDs.Undercurrentpolicy,third-partyreprocessorsaresubjecttoregi

2、stration,listing,qualityservice,labeling,andmedicaldevicereports.10TheoriginalrequirementsforlabelingmedicaldeviceswereABSTRACTHealthcareproviderstodayoftencanchoosebetweenreprocessedsingle-usedevices(SUDs)orSUDsfromoriginalequipmentmanufacturers.Theconcernaboutwhetherr

3、eprocessingissafeandshouldcontinuewasreflectedintheUSFoodandDrugAdministration'sdraftregulationsregardingreprocessingandreuseofSUDs；theGovernmentAccountingOfficestudyonSUDs；legislationintroducedatboththefederalandstatelevels；andCongressionalhearingsbytheUSHouseofRepresen

4、tativesandtheUSSenate.Thisarticleoffersareviewoftheseactivities.AORNJ75(March2002)557-567.BARBARAD.COHOON,RISAperioperativenursesearchingthesterilesupplyshelvesforbiopsyforcepsoftenhasachoicebetweenareprocessedsingle-usedevice(SUD)oraSUDfromtheoriginalequipmentmanufactur

5、er(OEM).Whichshallheorshechoose?Thisscenariotakesplacedailyinmorethanone-thirdofUShospitals.1Accordingtosome,thisis“medicine’sdirtylittlesecret,”andthereprocessingandreuseofSUDsare“medicalexperimentationwithoutpatientbenefit,writtenconsent,orevenpatientknowledge.’’2BACKG

6、ROUNDThefirstSUDwasdevelopedin1948.'Beforethattime,medicaldeviceswereintendedtobereusable.ThepracticeofreusingSUDsinitiallywasthoughttobesafe;however,inthelate1950s,aNewJerseydentistreusedsingle-usehypodermicneedles,whichresultedinninepatientsdyingfromhepatitis.4In1970,a

7、facilityintheUnitedKingdomreprocessedsingle-useoxygenatorsusedinheartbypasssurgery.Patientsconsequentlydevelopedfatalimmunereactionsfrompyrogensthathadnotbeenremovedproperlyfromtheoxygenators.5Duringthe1970sand1980s,technologyresultedinmedicaldevicedesignsthatinclude

8、dplastics.Originalequipmentmanufacturers,awareofthepotentialharmtopatientsduetoimproperreuse,begantolab