1. Global Clinical Engineering Success Stories Establishment of National Health Technology Management System for Public Hospitals Name: Bilal BECEREN Affiliation: Public Hospitals Administration of Turkey (MoH of Turkey) National association: Biyomed Location: Ankara/Turkey E-mail: bilal.beceren@saglik.gov.tr Submitted by

2. January 2016 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) * MoH: 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) Global CE / HTM Success Stories2 Sources (1) TUIK-Turkish Statistical Institution (www.tuik.gov.tr) (2) MoH of Turkey: www.tkhk.gov.trwww.tuik.gov.tr

3. Country's Health Technology Program Establishment of National Health Technology Management System for Public Hospitals Before June 2013 Although Ministry of Health of Turkey has more than 800 hospitals, there was no systematic National Health Technology Management Program for these Public Hospitals There was some units named as “Maintenance Unit” but there wasn’t well- organized Clinical/Biomedical Engineering Units in Hospitals and in Association of Public Hospitals (Regional Managements of Hospitals) (except a few hospitals) There wasn’t appropriate inventory management system There wasn’t a proper medical equipment maintenance system, therefore it wasn’t possible to collect good data on medical equipment maintenance plans, uptime/downtime, spare parts, costs and etc. There wasn’t any control about infrastructure needed for medical equipment There wasn’t any process so that post market surveillance and vigilance requirements were ensured Mostly, there wasn’t technical staff contribution on technical specifications during the procurement process January 2016Global CE / HTM Success Stories3

4. Country's Health Technology Program Establishment of National Health Technology Management System for Public Hospitals Results and Problems It is not possible to perform needs assessment, budgeting, device and staff planning appropriately Total cost ownership assessment could not be performed There were communication problems after medical equipment failures Some equipment wasn’t used and was waiting to be repaired for long time Patient planning in case of emergencies was a problem Medical equipment was used inefficiently Medical Equipment that was not in operation, which required disposal, was still in inventory Same devices were purchased with different prices by different hospitals, even there was a central asset management system Equipment, with features that might not be used by hospital, was purchased In case of any recall by manufacturer/regulatory authorities, it was only possible to find the device according to manufacturer’s declaration Yearly inspection/test of medical equipment was not be performed in a proper way –Due to lack of inventory data Problems in needs assessment, budgeting, planning and procurement False nomenclature of medical devices Difficulties to find devices when there is recall/vigilance activities Problems in patient planning in emergencies January 2016Global CE / HTM Success Stories4

5. Country's Health Technology Program What We did? We worked on medical device nomenclature system; we redesigned the current inventory management software to ensure correct registration of the equipment in terms of name, description, manufacturer, model, condition, serial number, labeling and etc. We established clinical engineering units in each hospital and each regional public hospitals association; job descriptions and staff requirements were determined We trained regional clinical engineering managers about HTM system We designed a software that allows to analyze costs per equipment (including separate nomenclature for spare parts and consumables) We prepared example documents i.e. medical equipment maintenance schedule, inventory data collection form, disposal procedure, incident report procedure and etc. We prepared guidelines about how to perform registration to inventory, inspection/test of medical equipment January 2016Global CE / HTM Success Stories5

6. Country's Health Technology Program What We did? We are performing yearly audits in each hospital as part of general inspection of all health care services, during these audits our goal is to ensure the implementation of National Health Technology Program, we control if: –Clinical Engineering and Biomedical Storage organization, staff and communication channel are determined for each hospital region and central Clinical Engineering unit located in Ministry of Health –Each hospital is updating the inventory and the equipment located in the ambulances and home healthcare vehicles were registered –Contents of invoices comply with inventory –Consumable request form includes inventory identification number of the equipment –Staff responsible for each equipment was identified –Equipment labels comply with requirements –There are acceptance records of the equipment –Users were trained for operation of the medical equipment and there is necessary records –There are rules for up time is included in maintenance/warranty contracts and ensured as 95% –There are precautions for main power interruptions and fluctuations –There is a procedure for decommissioning and disposal of medical devices –There is medical equipment maintenance plan and procedures –Inspection, test and maintenance activities complies with guidelines –Medical gas controls are regular and appropriate January 2016Global CE / HTM Success Stories6

7. Conclusions and Action Plan Outcome Appropriate medical equipment inventory was obtained –At the beginning (August 2013) the data entered to the new inventory software was %0, in October 2014 it was 40% and in April 2015 it was 88%, that means 88% of all medical equipment is included in inventory with new nomenclature, manufacturer name, model and other inventory information –The equipment which is not in use, not repairable and needs disposal is eliminated. So the number of medical equipment was 709742 pieces in Oct 2014 and decreased to 656996 in April 2015. –The correct naming for medical equipment. For example before our study some ECG devices were registered with their manufacturer name i.e. MORTARA ELI 250/ EKG DEVICE, within the new nomenclature system Biomedical Type is ECG (ELECTROCARDIOGRAPH) and Biomedical Definition is ECG DEVICE, 12 LEAD, WITH MONITOR –Patient and service planning can be performed for emergencies and disasters National Medical Device Nomenclature System –38.047 code for general consumable/disposable medical devices, 4.331 codes for laboratory consumables, 1.639 code for surgical instruments, 2.754 for medical equipments, 6.852 codes for medical equipment related spare parts and consumables Price analysis for medical equipment and other medical devices –We have prices for 656996 medical equipments in the inventory and additionally for all other medical devices purchased by hospitals so it is possible to make price analysis using nomenclature system (codes including device type and definitions) and also by manufacturer name or gs1 barcodes Real costs of medical equipment maintenance were obtained –At the beginning of our study the maintenance costs were not entered appropriately. For one regional public hospitals association the medical equipment maintenance cost increased to 413% from Dec.2013 to Dec.2015. But in fact it is not an increase due to increase expenditures, it is an increase as a results of correct data acquisition by studies of Clinical Engineering Units. January 2016Global CE / HTM Success Stories7

8. Conclusions and Action Plan Outcomes (Cont’d) Equipment users are able to inform about equipment failures and clinical engineering unit is responsible for repair or out-service tracking with inventory identification number. %95 uptime is an obligation in the contracts. So vendors will try to keep the equipment in operation 95% of operation times. Efficient use of medical devices, expected life-time and productivity will be increased by improved maintenance and user trainings Needs assessment can be performed using inventory data Patient safety is improved by inspection/test of medical equipment for safe and proper functioning Patient safety will be improved by implementation of procedures of post market surveillance, vigilance and incident reporting Action Plan Improvements in medical device nomenclature system Improvements in inventory management Monitoring and improvement of HTM program according to audit results Studies on Computerized Medical Equipment Management Program (Currently: Inventory management, cost of maintenance and spare parts) Needs assessment of medical devices needs improvement January 2016Global CE / HTM Success Stories8