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Global Clinical Engineering Success Stories Product Tracking System Project Submitted by Name Affiliation National Global Clinical Engineering Success Stories Product Tracking System Project Submitted by Name Affiliation National association Location E-mail : Tuncay BAYRAK (Assistant Health Expert/Biomedical Engineer) : Turkey Medicines and Medical Devices Agency (Mo. H of Turkey) : Biyomed : Ankara/Turkey : tuncay. bayrak@titck. gov. tr Name Affiliation : Ali Sait SEPTİOĞLU (Medical Doctor/Vice President of the Agency) : Assoc. Prof. Dr. Osman Arıkan NACAR (Medical Doctor/ President of the Agency) : Turkey Medicines and Medical Devices Agency (Mo. H of Turkey)

Country Estimates in Brief Population 78, 741, 053 (2015) Population Growth Rate 13, 4% Country Estimates in Brief Population 78, 741, 053 (2015) Population Growth Rate 13, 4% (2014 -2015) Life Expectancy at Birth Female: 80. 7 Male: 75. 3 (2013 -2014) Infant Mortality Rate 11, 1% (2014) 13, 9% (2009) Number of Health Centers in Country • Health Centers: 30, 176 (2014) • The number of hospitals: 1, 507 (2015) * Mo. H: 883 (Managed by Regional Associations of Public Hospitals: 89), * University Hospitals: 70 * Private Hospitals: 554 Total Expenditure on Health as % of GDP 5, 4 % (2014) Sources (1) TUIK-Turkish Statistical Institution (www. tuik. gov. tr) (2) Mo. H of Turkey: www. tkhk. gov. tr January 2016 Global CE / HTM Success Stories 2

Country's Health Technology Program Product Tracking System Before • We have traditional medical device Country's Health Technology Program Product Tracking System Before • We have traditional medical device registration system • Medical devices with the same label name have registered with GS 1 barcodes, no unique identification of each medical device • No medical equipment tracking including health centers and patients Results • • • Medical device health policy development using general data Records are not enough for recall and post market surveillance Problems in reimbursement of medical devices Counterfeit and illegal production Unregistered economy January 2016 Global CE / HTM Success Stories 3

Country's Health Technology Program Product Tracking System: What we are doing? • The Product Country's Health Technology Program Product Tracking System: What we are doing? • The Product Tracking System Project aims at developing infrastructure to track all medical devices and cosmetic products manufactured in Turkey or imported from the production band to the place where they are sold and used. • Even the project covers medical devices and cosmetic products, within the context of Clinical Engineering, this story focuses on medical devices. • The System (Product Tracking System) is an e-state application with hundreds of thousands of users, which offers citizen oriented services. January 2016 Global CE / HTM Success Stories 4

Country's Health Technology Program Product Tracking System: What we are doing? Tracking and monitoring Country's Health Technology Program Product Tracking System: What we are doing? Tracking and monitoring Product Movements Module Product Withdrawal Module Citizen Oriented Services Product Inquiry Module Registered-on-Person Product Inquiry Module Compliant Reporting Module Product Management Product Tree Management Module Product Management Module Supporting Functions User, Organization and Authority Management Document and Certificate Management Module Reference Fields Management Module Log Management Module Announcement Module Scheuled Tasks Module User Management Module Organization Management Module Authority Management Module Clinical Engineering Market Surveillance and Inspection and Warning Maintenance and Repair Management Module Calibration Management Module Technical Personnel Certification Module Technical Service Management Module Calibration Organization Management Module Inspection Activities Module Warning Module Business Intelligence Predefined Reporting Module Map Oriented Reporting Module January 2016 Global CE / HTM Success Stories 5

Country's Health Technology Program Product Tracking System: What we are doing? • Completed Modules Country's Health Technology Program Product Tracking System: What we are doing? • Completed Modules – – – – – User Management Module Organization Management Module Authority Management Module Document and Certificate Management Module Reference Fields Management Module Log Management Module Product Tree Management Module Announcement Module Scheduled Tasks Module January 2016 – – – – Product Movements Module Product Withdrawal Module Inspection Activities Module Warning Module Predefined Reporting Module Product Inquiry Module Registered-on-Person Product Inquiry Module – Maintenance and Repair Management Module – Calibration Management Module Global CE / HTM Success Stories 6

Conclusions and Action Plan Expected Outcomes • To establish a National and Original infrastructure Conclusions and Action Plan Expected Outcomes • To establish a National and Original infrastructure which meets performance requirements to keep track of products • To contribute to ensuring patient safety and protection of public health, to identify and withdraw unsafe or expired products • To provide an infrastructure to ensure healthy and efficient execution of inspection services • To ensure rapid measures are taken against possible risks to occur during use of the products • To prevent movement of counterfeit and illegal products • To allow for developing health policies with up to date information • To prevent troubles with medical device refunds due to lack of product information • To contribute to prevent the unregistered economy January 2016 Global CE / HTM Success Stories 7

Conclusions and Action Plan • Working on – Technical Personnel Certification Module – Technical Conclusions and Action Plan • Working on – Technical Personnel Certification Module – Technical Service Management Module – Calibration Organization Management Module • To be worked – Compliant Reporting Module – Map Oriented Reporting Module • Optical products can be used for pilot application because they still have quarcode. • We are testing current version on the web site uts. saglik. gov. tr • Project deadline is May 2017 January 2016 Global CE / HTM Success Stories 8