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