降低安全风险小医院无法鉴别二手设备是否符合优良再造规范-MITA课件

GoodRefurbishmentPractices

forMedicalDevices

医疗器械优良再制造规范AndrewNorthupDirector,GlobalAffairsMITA美国医学影像与技术联盟全球事务主任

IntroductiontoMITA

MITA介绍Section1

MITA,theMedicalImaging&TechnologyAlliance

…adivisionofNEMA,foundedin1926

医学影像与技术联盟-北美电器制造商协会的一个分会，成立于1962年MITAistheleadingorganizationandcollectivevoiceofmedicalimagingequipment,radiationtherapyandradiopharmaceuticalmanufacturers,innovatorsandproductdevelopers.

作为领导组织，代表医学影像设备、放射治疗及放射药物制造商、研究开发者共同的声音。Itrepresentscompanieswhosesalescomprisemorethan90percentoftheglobalmarketformedicalimagingtechnology.

所代表的企业占医学影像技术90%以上的全球市场。Thesetechnologiesinclude:包括：medicalX-Rayequipment医学x-射线设备

computedtomography(CT)scannersCT扫描Ultrasound医用超声诊断设备nuclearimaging核医学成像设备Radiopharmaceuticals放射诊断药物radiationtherapyequipment放射治疗设备magneticresonanceimaging(MRI),核磁共振imaginginformationsystems影像信息系统Refurbishedequipmenthasmanybenefits…/翻新再造有许多利好Upgraded/升级:Imagequality/影像质量Functionalities/功能Accesstocare/可用性Safety/安全

Forlessthanthecostofnewequipment/

较新设备价格低Goodforhospitals/利于医院Goodforpatients/利于病患Goodforhealthsystems/利于医保系统Goodfortheenvironmentandcirculareconomy/利于环保和循环经济…however,saleofrefurbishedequipmentisbannedortightlyrestricted/

然而，翻新再造设备禁止进口或严限销售使用Manycountriesbanorrestrictsaleofrefurbishedequipment,orthepracticeofrefurbishingequipmentChinaisoneof5countriesthatbansimportandsaleofrefurbishedequipmentRestrictionshavebeenputinplacetoprotectthepublicfromunsafeequipmentUnintendedconsequence:patientsaredeniedaccesstosafe,high-qualityequipmentaswellApproximately3.4billionpeopleliveincountrieswhererefurbishedequipmentisnotanoption,inatimeoflimitedhealthsystembudgetsObjective:safeandhigh-qualityimagingequipment

目的：安全而高质量影像设备MITAleadseffortsoncreatingstandardsforGoodRefurbishmentPracticesforMedicalElectricalEquipmentMITAisanaccreditedstandardsdevelopingorganization(SDO)StandardswidelyusedforregulationofmedicaldevicesInternational,national,andindustrystandardsRegulatorsreferencestandardsintheirjurisdictions’regulationsISO13485–QualityManagementSystemsIEC60601–SafetyandeffectivenessofmedicaldevicesISO14971–RiskassessmentGoodRefurbishmentPractices(GRP)

优良再造规范MITA’sGRPStandardmandatestheminimumstepsthatmustbetakentoensureequipmentisrefurbishedtoguaranteesafetyandeffectiveness/MITA的翻新再造标准规定了最少步骤，保障翻新再造设备实现其安全有效Selection

De-installation

Refurbishment

InstallationWarrantyStep1/步骤1AndrewSelection

De-installation

Refurbishment

InstallationWarrantyAge/condition/年限和状态

Servicehistory/使用历史

Performance/性能表现

Upgradeabilityofsoftwareand

hardwarestatus/软硬件可升级否

Step2/步骤2Andrew

InstallationWarrantyInspection/检测

Shippinginoriginalpackingmaterial/原包装材料包装运输

De-installationSelection

RemanufactureStep3Selection

InstallationWarrantyCleaning,disinfectionandpainting(partialorfullpainting)清洁、消毒和喷漆(部分或全部喷漆)Replacementofwornparts更换磨损部件Checkingofcomponentsandsubsystems检查组件和子系统Installationoflatestapplicablesoftwareupdates安装最新的软件更新Replacementofexistingtube/coilsetc.basedoncustomerorders根据客户订单替换现有的管/线圈等Completesystemchecktomanufacturer’sspecification根据制造商的要求进行完整的系统检查ApplicationofaQualityseal加贴质量合格封条或标签

De-installation

RefurbishmentStep4AndrewWarrantyTransportationandinstallationbyqualified

serviceproviders

使用合格的服务提供商运输和安装

Start-upandsystemperformancecheck

启动和系统性能检查

Optionalapplicationtraining使用培训可供选择

InstallationSelection

De-installationRefurbishmentStep5AndrewSelectionWarrantytypicallyequivalenttoanewsystem提供与一个全新的系统一样的质量担保

Sparepartsavailabilityforaminimumof5

years备件可至少5年中可以提供Warranty

De-installation

Installation

RefurbishmentBenefitsofregulatingandstandardizingrefurbishment

规范翻新再造的好处Helpssmallandmediumhealthcareinstitutionsprovideadvancedtreatmentatlowerratesforpatients帮助中小医院提供先进但低价治疗手段Reducedhealthcarecostsandimprovedpatienthealth降低医保费用，改善健康

Acceleratestheupgradingoftheinfrastructureofmedicalinstitutionstomoremoderntechnologiesatlowercosts加速提升医疗机构设备现代化水平Inhibitsthespreadofunregulatedpre-ownedmedicalequipmentandreducessafetyandmarketrisks;medicalstafffromsmallhospitalsmaybeunder-trainedtodistinguishgoodremanufactureddevicesfrominferiorpre-owneddevices禁止二手设备非发转售，降低安全风险，小医院无法鉴别二手设备是否符合优良再造规范。

Regulatorychangesareneeded

需要法规变革Chinahascommittedtoexpandingaccesstohigh-qualityhealthcaretoallcitizens中国承诺向国民提供高质医疗服务National,provincial,andlocalauthoritiesmustdeliverhealthcarewhilebeingmindfulofbudgets各级政府需提供医保但需考虑费用预算MITAencouragesChineseregulatorsandstandardsagenciestoreviewtheirpoliciesonrefurbishedequipmentMITA鼓励立法者和标准机构重新考虑其再造政策China,Brazil,andotherrapidlydevelopingcountriesseevalueinsafeandhigh-qualityrefurbishedmedicalequipment中国、巴西及其他快速发展中国家认识到翻新再造医疗设备安全和高质量的价值MITAoffersexperienceandassistancetoChineseregulatorsandstandardsbodies。MITA愿意给中国政府和标准机构提供经验和帮助。Withyourhelp:

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