CONF-19-David-De-Baets.pdf

1、SURGICAL INSTRUMENT TRACEABILITY IN STERILIZATION:LEGAL OBLIGATION vs NECESSITY?Name:David De Baets&Olivier WilliemeAffiliation:CARE-NAM(Belgium)ContextCARE-NAMA brand-new sterilization platform established respectively at 1,6 and 35 km from 3 hospitals it serves around the city of Namur in Belgium(

2、CHU UCL NAMUR(2 sites)&Clinique Saint-Luc Bouge(1 site).Scheduled for fall 2024Challenge:Place of surgical instruments or RMD(Reusable Medical Devices)and the obligation or necessity to trace them Pitfalls to avoid when engaging in this approach2CARE-NAM Today-40.000 Instruments-4000 SKU-30.000 surg

3、eries/an3WHO-World Health Organization2ndGlobal Health Challenge 2009-WHO Surgical Safety Checklist4Legislation in EURegulation(EU-European Union)2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devicesTraceability obligation concerns Class III devicesArt 27,9:Member

4、 States encourage healthcare facilities and professionals to record and retain,preferably by electronic means,the UDI(Unique Device Identifier)provided to them.No requirement to register,only advice,to be implemented by May 26,2025 5Legislation in EURegulation(EU-European Union)2017/745 of the Europ

5、ean Parliament and of the Council of 5 April 2017 on medical devicesTraceability obligation concerns Class III devicesMost of surgical instrument reusable concerns Class I,IIa&IIb6Legislation in other countries outside EUOlivier WillimeFormer VP EORNAFormer member of the International Relations Comm

6、ittee of the AORNThe question:Are there any laws or regulations on the traceability of surgical instruments in your countries?Answers:It seemed that there were no binding texts on the subject,in any case to trace each instrument individually and specifically 7Global or local traceability at a glance