CONF-15-Jolanda-Buijs-and-Jolyn-van-der-Beek.pdf

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1、Dutch market agreement on standardised,automated and global sharing of CSSD informationJolanda Buijs Erasmus MC Rotterdam (Netherlands)Jolyn van der Beek GS 1 NetherlandsAgenda1.History of medical device documentation 2.Implications for hospitals and medical device suppliers3.National working group

2、in the Netherlands 4.The role of the Dutch Association of Experts on Sterilisation of Medical Devices(VDSMH)5.The solution in Global Data Synchronisation Network(GDSN)6.Relation GDSN and barcode7.Whats in it for you!Legislation in the NetherlandsLegislation on sterilised medical devices in hospitals

3、(1983 and 2004)Mandatory documentation about:Equipment for cleaning,disinfection and sterilisationTo be sterilised medical devices in relation to the applied reprocessing methods 2011:Covenant on Safe Application of Medical Technology in hospitalsImpact on hospitals and suppliersWide variety in how

4、hospitals request product data Non-automated process:Risk of incorrect product data Labor-intensive for both hospitals and suppliers Product data not up-to-date Meeting“RAPS Netherlands Chapter”-May 2019 (Regulatory Affairs Professionals Society)Impactful collaborationQuick and easy access to produc

5、t data:Essential information for medical device assessmentPreparation of purchase file Focus VDSMHImportant product data for the Sterilisation Expert?Identification of the medical deviceCompliance to MDD/MDR (CE-certificate,Declaration of Conformity)Instructions for cleaning,desinfection and sterili

6、sationProduct image of(set of)instrumentsEducation of the CSSD-staffSolutionProduct data standardised,digitally and real-time available!Product data available through a digital connection to the instrument track&trace system in the Central Sterile Supply Department(CSSD)How are we going to do that?N

7、ot all essential product data available Limited access No possibility for integration with internal hospital systems(EHR/ERP)Why did the workgroup choose for GS1?Global sharing of product data through GDSN International not-for-profit partner,active in 116 countries 50 years of standardised product

8、identification Accredited issuing agency for Unique Device Identification(UDI)Uniform sharing of product data:GDSNThrough the Global Data Synchronisation Network(GDSN):suppliers and hospitals easily share product data worldwide95%of all Dutch hospitals are connected,mainly due to the national regula

9、tion:Dutch Implant Registry(LIR)Use of GDSN in HealthcareUse of product data medical devicesFor product files of all medical devices:Sterile/to sterilise or not sterile products Purchasing files,loaner sets,consigment Both reusable and single use devicesData on reprocessing Purchasing information Lo

10、gistical dataProduct data behind the barcodeScanning barcodes and using product data from GDSN is not newExisting processes:Procurement/purchasingLogistics Operating room RegistriesGDSN product data can be connected with:Electronic Health Record(EHR)Enterprise Resource Planning(ERP)Track&Trace Syste

11、m CSSDGDSNUnique Device Identification(UDI)on reusable devicesClasses medical devicesAssign UDIUDI on labelClass III26 May 202126 May 2021Classes IIa en IIb26 May 202126 May 2023Class I26 May 202126 May 2025UDI on reusable devices26 May 2021+2 yearsTransition period from MDD to MDR for certain devic

12、es:Class III and IIb:31 December 2027 Class IIa and I:31 December 2028What have we achievedtogether?The Uniform DatasetComplete and standardised dataset for all medical devices Fully integrated in GDSN One single source of truthUp-to-dateLess error-prone More efficientReal-time availableThe role of

13、GS1Support for suppliers and hospitals with product identification,data-exchange via GDSN and standardisation for regulatory complianceGlobal collaborationConnections with local GS1 organisations(including government,industry associations,suppliers and hospitals)Whats in it for you!Suppliers and hospitals(worldwide)benefit together.Using the exchange of product data via GDSN together.Would you like to know more or need help making this work in your country?Contact Jolyn van der Beek Contact Jolanda Buijsjolyn.vanderbeekgs1.nl j.buijserasmusmc.nl