CONF-3-Niamh-McGrath.pdf

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1、Safety,cost and environmental impact of reprocessing single use medical devices(SUDs)An evidence reviewNiamh McGrath(nmcgrathhrb.ie/niamh_mcg93)Catherine Waldron,Leila Keshtkar,Ailish Farragher,Annette Burns,ine Teahan,Jean Longhrb.ieReprocessing“A process carried out on a used device in order to al

2、low its safe reuse including cleaning,disinfection,sterilisation and related procedures,as well as testing and restoring the technical and functional safety of the used device”Typically,of“reusable medical devices”o SUDs also reprocessedSingle use medical devices(SUDs)No manufacturer instructions on

3、 how to reprocess Intended to be used on one individual,during a single procedure SUD reprocessing undertaken with varying levels of quality and safety assuranceso Developed countries moving toward regulationhrb.ieEU Medical Device Regulation 2017(MDR)Opt-in to Article 17(2)-Any entity reprocessing

4、SUDs is viewed as the device manufacturer and must fulfil the full set of manufacturer requirements and obligations of the MDR as they apply to all manufacturers of medical devices.Prohibit all SUD reprocessing activitiesOpt-in to Article 17(3)-Health institutions reprocessing SUDs for reuse in-hous

5、e are exempt from certain manufacturer obligations with the exception of a limited set of specific obligations known as“common specifications.”Opt-in to Article 17(4)-an extension to 17(3),whereby any external reprocessorreprocessing SUDs on behalf of a health institution can benefit from the 17(3)d

6、erogation if the device is returned to the same health institution for reuse there.hrb.ieMixed opinions on SUD reprocessingSafety Belief that the device could not achieve a desired function and maintain patient safety standards No increased health risks(in regulated settings)Economic advantages Cost

7、-effectiveness is unknown Regulation has had mixed impactsEnvironmental benefitsEnvironmental impacts are unknownhrb.ieResearch questions1.What,if any,SUDs does the research evidence indicate can be reprocessed in line with the 2017 EU medical device regulation and other related approaches?2.What ar

8、e the financial costs,safety and environmental consequences of reusing SUDs which were reprocessed in line with the 2017 EU medical device regulation and other related approaches?3.How,if at all,do safety outcomes,environmental impacts,and costs associated with reprocessing SUDs in line with the 201

9、7 EU medical device regulation and other related approaches differ by SUD type?Methodshrb.ieReview designPROSPERO(International Prospective Register of Systematic Reviews)ID CRD42022365642Table 1.Summary of review inclusion criteria ElementCriteriaPopulationHuman patientsInterventionReprocessed SUD

10、studies using EU MDR reprocessing definitionComparisonFirst device useOutcomesSafety(patient or device)and device function,environmental impact and costs to patients or facilitiesStudy designsRCTs,NRCTs,observational studies,economic evaluations,LCAs Study yearFrom 1994LanguagesEnglish or GermanProt

11、ocolOutcome selectionProtocolSearchScreenData extractionCritical appraisalSynthesis and confidence assessment Reporthrb.ieSplitting studies by study settingIn vitro studiesStudies examining SUD reprocessing safety in a laboratory Limited valueIn vivo studiesStudies examining device or patient safety

12、,financial costs,or environmental impacts of reprocessing SUDs,during clinical care More valuableOutcome selectionCritical appraisalSynthesis and confidence assessment Outcome selectionCritical appraisalSynthesis and confidence assessment Limited analysis Full analysishrb.ieMedical Device Coordinati

13、on Group 2021-24(MDCG)Risk classificationsRisk:the potential for deterioration in the health of the patient when a device is usedFour“risk”categories Risk classification I(little risk)Risk classification IIa(unlikely risk)Risk classification IIb(potential risk of deterioration)Risk classification II

14、I(risk of death)hrb.ieLiterature searching,screening and data extractionSearch resources Four databases(Medline,Embase,Cochrane,Dimensions)Supplementary search to identify published,peer reviewed and grey literature itemsSingle-use medical devicesReprocessingPatient safetyCost and cost-effectiveness

15、Environmental impactsFigure 1 Search conceptsScreening By two independent reviewers(all stages)In Eppi-reviewer(using priority screening)Data extraction By two independent reviewers Into bespoke extraction formshrb.ieSynthesis and confidence assessmentSelection of review outcomes Primary:directly im

16、pact/account for patient safety(safety and cost),or contribute to global warmingSecondary:may indirectly impact patient safety(safety),didnt account indirect costs(costs),global warming health consequencesData synthesis Meta-analysis includingfeasibility assessment Narrative synthesisEligible study

17、quality assessment The Downs and Black checklist Consensus Health Economic Criteria list Life cycle assessment checklistCertainty in the evidence assessment GRADE toolo Primary review outcomesResultshrb.ieFigure 2.Adapted PRISMA flow diagram showing review search resultsOverview of identified SUDsSe

18、arch resultsRecords identified=8213 Records screened=5041Records assessed for eligibility=569Records included=52(19 in vivo)Device groupingRespirators and facemasks Compression sleevesPulse oximeters External fixator devices Ophthalmic devices Internal fixator devices Surgical instruments(4 devices)

19、Endoscopic and laparoscopic devices(7 devices)Implantable cardiac devices(2 devices)Cardiac catheters and cannulas(4 devices)Device outcome categoriesSafetyIn-vitro:12 SUDsIn-vivo:9 SUDsCostIn-vivo:12 SUDsEnvironmentalIn-vivo:7 SUDsAll three outcome types were available for 2 SUDs(ultrasonic scalpel

20、 and laparoscopic sealer)hrb.ieSummary of in vitro studiesRisk class I Respirators and facemasks(n=19)Risk class IIa and IIb Surgical instruments for cutting/grasping(n=4)Risk class III Cardiac catheters and cannulas(n=7)Endoscopic/laparoscopic devices(n=2)Internal fixators(n=1)hrb.ie1.External fixa

21、tor devicesDomainReview findingOverview of studiesn=3(1998 2008),USAReprocessing oversightFDA regulations(n=2 studies)Research team quality criteria(n=1 study)Outcome(s)assessedSafety(n=2 studies),costs(n=2 studies)Safety outcome results summarySimilar odds of pin tract infections,reoperations,loss

22、of fixation and loosening of device componentsCosts outcome results summaryDirect savings ranged from 21%-45%(for all devices,during study periods)GRADE/study qualityVery low certainty evidence(pin tract infections,reoperations)1 low quality and 1 good quality study(direct costs)risk class Ihrb.ie2.

23、Deep vein thrombosis compression sleevesDomainReview findingOverview of studiesn=1(2016),USAReprocessing oversightFDA regulationsOutcome(s)assessedEnvironmental impacts,device life cycle costs(up to 5 reprocessing cycles)Env.outcome results summaryEnvironmental and human health outcomes reduced with

24、 each additional reprocessing cycleCost outcome results summaryDevice lifecycle related savings reportedIncremental savings decreased with each additional cycleGRADE/study quality68%of items on a transparency reporting checklistrisk class Ihrb.ie3.Pulse oximetersDomainReview findingOverview of studi

25、esn=1(2016),USAReprocessing oversightFDA regulationsOutcome(s)assessedEnvironmental impacts,device life cycle costs(up to 5 reprocessing cycles)Env.outcome results summaryAdverse environmental and human health outcomes reduced or remained the same with each additional reprocessing cycleCost outcome

26、results summaryDevice lifecycle related savings reportedIncremental savings decreased with each additional cycleGRADE/study quality68%of items on a transparency reporting checklistrisk class Ihrb.ie1.Ophthalmic devicesDomainReview findingOverview of studiesn=1(1996),USAReprocessing oversightFDA Comp

27、liance Policy GuideOutcome(s)assessedSafety,up to 4 reprocessing cyclesSafety outcome results summaryNo intraoperative or postoperative problems or complicationsNo association between no.device uses and procedure timeDevices available reduced with each reprocessing cycle(86%after the 1st cycle,to 50

28、%,then 23%,then 3%)GRADE/study qualityVery low certainty evidence(interoperative and postoperative complications)risk class IIahrb.ie2.Surgical instruments for grasping/cuttingDomainReview findingOverview of studiesn=1(2016),USAReprocessing oversightFDA regulationsOutcome(s)assessedEnvironmental imp

29、acts,device life cycle costs(up to 5 reprocessing cycles)Env.outcome results summaryAdverse environmental and human health outcomes reduced or remained the same with each additional reprocessing cycle Cost outcome results summaryDevice lifecycle related savings reportedIncremental savings were consi

30、stent with each additional reprocessing cycle($100 approx.)GRADE/study quality68%of items on a transparency reporting checklistRisk class IIb hrb.ie3.Endoscopic and laparoscopic devicesDomainReview findingOverview of studiesn=5(1999-2021),3 in USA,2 in EuropeReprocessing oversightFDA/EU MDR regulati

31、ons(n=3 studies)National regulations(n=1 study)Research team criteria(n=1 study)Devices laparoscopic sealerultrasonic scalpellinear suture machinessphincterotomesendoscopic trocars ultrasonic scissor tips Outcome(s)assessedSafety(n=3 studies)Costs(n=4 studies)Environmental impacts(n=1 study)Risk cla

32、ss IIb Safety outcome results summarySimilar odds of reoperations and postoperative complications Similar average procedure time and length of hospital stayhrb.ieDomainReview findingCost outcome results summaryDirect savings from$282(laparoscopic sealer/divider)to$65961(sphincterotomes)and 14623.61(

33、suture machine)to 75932.55(ultrasonic scalpel),total devices/patients included during the studySavings reduced after accounting for indirect costsIncremental cost savings diminished(ultrasonic scalpel and endoscopic trocar)or remained consistent(laparoscopic sealer)with each subsequent reprocessing

34、cycleEnv.outcome results summaryAdverse environmental outcomes increased for ultrasonic scalpel and reduced for endoscopic trocars and laparoscopic sealersGRADE/study qualityVery low certainty evidence(complications,indirect costs)Safety study quality:good or excellent(n=3 studies)Cost study quality

35、:low(n=1 study)or good(n=2 studies)68%of items on a transparency reporting checklistRisk class IIb 3.Endoscopic and laparoscopic deviceshrb.ie1.Cardiac catheter devices DomainReview findingOverview of studiesN=6(1994 2019),2 in the USA and in Europe,1 in the UK and in CanadaReprocessing oversightFDA

36、/EU MDR regulations(n=2 studies)Research team criteria(n=2 studies)Local hospital policy(n=1 study)Did not say(n=1 study)Outcome(s)assessedSafety(n=4 studies),costs(n=2 studies)Safety outcome results summaryNo difference in the odds of major complications in 2 of 3 studies or minor complications in

37、2 studies.No difference in procedure time in 3 of 4 studies or fluoroscopy times in 3 of 4 studies.Similar volume of contrast dye used in 2 of 3 studies.risk class III hrb.ie1.Cardiac catheter devicesDomainReview findingCost outcome results summaryDirect cost savings ranged from 12.5%(balloon cathet

38、ers)to 33%(ablation catheters)to 42%(EP catheters)across devices/patients(n=1 study)Indirect cost savings estimated at$129 per patient(n=1 study)GRADE/study qualityVery low certainty evidence(complications,indirect costs)Safety study quality:poor(n=1 study),fair or good quality(n=3 studies)Cost stud

39、y quality:low quality(n=1 study),moderate quality(n=1 study)risk class III hrb.ie2.Implantable cardiac devices DomainReview findingOverview of studiesN=4(1998 2019),3 in Europe and 1 in MexicoReprocessing oversightLocal hospital policy(n=2 studies)Research team criteria(n=2 studies)Outcome(s)assesse

40、dSafety(n=4 studies)Safety outcome results summarySimilar odds of new and reused device malfunctionMeta-analysis for two safety outcomes:infections and unexpected battery depletionFigure 3.Forest plot of the rate of device related infections in studies of new compared with reused implantable cathete

41、r devicesFigure 4.Forest plot of the odds of unexpected battery depletion in studies of new compared with reused implantable catheter deviceshrb.ie2.Implantable cardiac devices(contd.)GRADE/study qualityVery low certainty evidence(device associated infection,unexpected battery depletion)Fair or good

42、 study quality(n=4 studies)DomainReview findingDiscussionRQ 2:Safety,cost and environmental impacts No difference in adverse patient safety outcomes(in-vitro)oFew studies and very low certainty in the evidence Cost-effectiveness still unknownDevice life cycle savings reportedConclusionsRQ 1:What SUD

43、s can be reprocessed?Too few in-vitro studies for any one SUDSome SUDs were reused(once)without additional adverse patient safety impacts but certainty in the evidence is very lowoExternal fixator devices(n=2)and implantable cardiac devices(n=4)Environmental benefit reportedEmerging area of research

44、hrb.ieConclusionsRQ 3:Differences by devicesSafety outcomes Extent safety studied differed(e.g.,patient versus device outcomes)Volume of evidence differed by device Cost outcomes Direct cost savings differed by device Device life cycle cost savings differed by deviceEnvironmental outcomes Environmen

45、tal benefits differed by devices hrb.ieStrengths,limitations and future directions Broad review focus Reprocessing definition Inclusion of in-vitro studies Information specialist Followed best research practicesFuture researchCall for good-quality RCTs of patient safety persistsCall for economic eva

46、luations examining cost-effectiveness persists Primary research on environmental effects is neededIdentified areas for methodological development in LCA research applied to healthcare and health services researchResearchers should endeavour to report on regulatory or related requirementso examine the association between“reprocessing oversight”and safety,cost-effectiveness and environmental impacts xReview team lacked clinical expertise xLanguage restrictionxLimited study by device types,xLimited study of the impact of regulation on review outcomesQuestions?