Questions/Answers

The Product Tracking System is an e-government application that provides citizen oriented services and has hundreds of thousands of users. This technical infrastructure has been developed with a national and unique product tracking and monitoring model so that medical devices and cosmetic products that are produced in our country or importee can be tracked from the production line to the place they are sold and to patients. With the ÜTS, medical devices and cosmetic products can be recorded, tracked and monitored, the inspection and recalling activities for these products are carried out efficiently and it will be possible to monitor the calibration, maintenance and repair of medical devices on a single system contributing to the protection of public health and providing access to safe products. It will become possible to determine health policies more efficiently with the processing of data on the ÜTS. At the same time the ÜTS is an e-government application that contains citizen oriented services and serves to provide use to a wide audience. As of June 2017 the producers and importers of medical devices have been entering their documents and device records on the ÜTS. The individual tracking of optical medical devices started on the ÜTS on September 11, 2017. The producer and importer companies of optical products have been making their production and import declarations for the optical individual products they produce and import over the ÜTS, then they have been making their delivery/receive notifications all the way to optician enterprises to make sure these individual products reach their destination. Optic devices are delivered to citizens with a delivery to consumer notification by the optical enterprises. As of October 2017 the inspection and warning activities concerning medical devices and cosmetic products are being conducted over the ÜTS.

- To record medical devices and cosmetic products - To establish a high performance National and Distinctive infrastructure to track products - To contribute to keeping patients safe and protecting public health - To provide the infrastructure needed to make sure inspection services are carried out efficiently and effectively - To ensure that measures are taken quickly against any risks that may arise during the use of products - To detect and recall unsafe or expired products - To enter the actions of medical devices between stakeholders on record - To monitor the calibration, maintenance and repair processes of medical devices over a single system - To enable health policies to be improved with up to date information - To prevent problems caused by missing product information in medical device refunds

On the ÜTS, services are provided to all stakeholders in the field of medical devices enabling them to do the following transactions, - Producers and Importers can do their document and medical device registration processes on the system, - Medical devices entering hospitals can be searched to check whether they are registered, - Medical device and company information can be provided to the Public Procurement Authority for medical device tenders, - Company and medical device information can be provided to the Social Security Institution for medical devices that are subject to refunds, - Inspection and warning activities for medical devices can be conducted, - The maintenance, calibration and repair processes for all medical devices subject to maintenance and calibration can be managed, - Citizens can access basic information on medical devices. The valuable data that is collected on the ÜTS as a result of these services enable health policies to be improved with up to date information.

The primary goals of ÜTS are to enable secure medical device access and to find out where unique product is. In addition to these, the concept behind ÜTS attaches great importance to the role of citizens as auditors. Before ÜTS, citizens had no means to be a part of this process. Now they will be able to query products they are to use, check if they are registered or not and find out additional information such as manufacturer information. By profound monitoring of calibration, maintenance and repair processes life cycles of medical devices will be tracked so that users are directed to safer products and it will be possible to take precautions. Regarding larger medical devices used in hospitals, citizens will get the opportunity to see their maintenance and calibration data. They will have chances to report complaints about products or their manufacturers. Moreover, citizens will be able to list implantable devices used on them, after validating personal information. The consumer will have the right to give feedback and complain about the product he is querying to the Republic of Turkey Ministry of Health.

ÜTS has become a new and comprehensive exemplary working model on the subject of “Product Singularizing and Management”. With ÜTS medical devices that are supplied to the market can be tracked from the time that they are supplied to the market until they reach the end user. The company supplying products to the market is obligated first to register their products on the ÜTS. Companies are also obligated to notify their products at a lot or individual level to the ÜTS for the product groups determined by the “Turkish Medicines and Medical Devices Agency (TİTCK)”. The products that are assigned on the ÜTS at lot or serial level can be tracked on the ÜTS up to the end user with receive / delivery notifications. It is possible to assign a product at individual level, to singularize it and to track it on the ÜTS. In this context the ÜTS has the feature of being a new and comprehensive exemplary working model. Citizens are able to query an individual medical device on the ÜTS and access basic information about the device.

The Social Security Institution is able to query individual product information on the ÜTS during refunding and prevent duplicate payments. This provides our country with significant savings. One of the main goals of the ÜTS is to provide access to secure medical devices and cosmetic products and to determine where the individual product is. With ÜTS citizens are able to query the medical devices they will use, check whether or not they are registered and check additional information like producer information and submit their complaints about the products or companies. With regard to medical device inventories used in hospitals, citizens will have the chance to see their maintenance and calibration information. By logging on to the system citizens can list the implantable medical devices that are being used on them.

- ÜTS has become a new and comprehensive exemplary working model on the subject of “Product Singularizing and Management”. - It is a tracking infrastructure that is the first of its kind in the world. - It is an important step in the Information Community transformation of our country.

ÜTS is an original endeavor developed in line with the needs and regulations of Turkey but at the same time compatible with the Unique Device Identification standard developed by the FDA.

- The ÜTS is financed by the Republic of Turkey Ministry of Health. - It was developed by TÜBİTAK BİLGEM YTE. - All agencies that are stakeholders have contributed at different levels and different scales to the development of the ÜTS.

No

ÜTS is adaptable to other contexts. Architecture behind unique product tracking and monitoring was not specifically designed for medical devices. So, it is possible to track and monitor products in other contexts singularly with same ÜTS structure.

The ÜTS has been developed in accordance with the legislation on medical devices and is an information system that monitors public health and patient safety. Legally binding elements have made use of the ÜTS mandatory in certain fields. Refunds are made for medical devices by the Social Security Institution on the pre-condition that they are registered on the ÜTS. This makes the use of ÜTS unavoidable especially for medical devices that are in the scope of refunding. Since registration on ÜTS is sought for medical devices that enter hospitals, this makes use of ÜTS mandatory.

Since the medical devices and product groups that are included in the scope of tracking will increase every year and the number of notifications that will be received instantly by the ÜTS will increase in direct proportion to this, a flexible and scalable structure has been planned to maintain the performance of the ÜTS. Since the ÜTS will receive millions of notifications daily the system must be able to provide services without interruption. Therefore the ÜTS has been developed with an infrastructure that can function 24/7. With consideration for the fact that legislation and needs can change, the ÜTS has been planned with a modular form that enables technical changes to be made so that changes can be reflected easily on the application. The changes that are made will be reflected on the application in a form that impacts internal and external user the least.

Yes

When developing the ÜTS five workshops were organized with the widespread participation of companies, concerned public agencies and nongovernmental organizations to make accurate and complete determination of needs and to confirm these needs. During these workshops the comments of participants were recorded and considered later when developing the ÜTS. Medical Device Importer companies and Medical Device Manufacturer companies are now actively using the application. “Application Satisfaction Surveys” and “Software Support Satisfaction Surveys” are being given to company users over the application in 6 month period on a regular basis. The results of these surveys and the comments received on these surveys are being utilized to improve satisfaction ratings.

Application Satisfaction Surveys Results Date May.15 December.15 March.16 October.16 March.17 April.17 June.17 Number of Participants 52 49 20 67 17 26 8 Results 76,82 80,88 79,11 81,11 85,08 84,62 90 Software Support Satisfaction Results Date June.16 September.16 June.17 Number of Participants 131 86 150 Results 71,25 70,05 67,31 Application Satisfaction According to Surveys, the satisfaction of users is observed to increase over time. Developed as user-friendly and developed for the needs of users, ÜTS is revised every day according to the opinions and suggestions of the users. In this respect, it is expected that the satisfaction of the UTS increases as the usage increases. According to Software Support Satisfaction Surveys, it seems that users have certain satisfaction with application support. However, there has been a decrease in user satisfaction over time. It is estimated that the reason for this decline is due to the fact that ÜTS is a multi-stakeholder and multi-integrated initiative. Problems arising from other applications which the ÜTS integrated are also forwarded to the ÜTS support point. Since an improvement can not be made by the ÜTS team about the applications connected with the integration; overall ÜTS support satisfaction is falling. It is working more intensely with stakeholders to increase this satisfaction.

Indicators that were used are: - Application Satisfaction Surveys - Software Support Satisfaction Surveys - Workshops

Turkish Medicines and Medical Devices Agency (TİTCK) Was worked with in all the phases of the planning, analysis and design stages of the ÜTS. The Social Security Institution (SGK) The SGK does not make payments for any medical devices that are not on the ÜTS. In this context the basic information and registration status of products are notified to the SGK through web services. We worked together with the SGK in the analysis and development stages. They have also revised their own system in line with this work. Directorate General of Public Hospitals (KHGM) The medical devices that enter the inventory of Health Institutions are checked on the ÜTS. In order to conduct this check web services have been assigned to the KHGM. We worked together with the KHGM in the analysis and development stages of this integration. They have also revised their own system in line with this work. Public Procurement Authority (KİK) KİK checks the companies and the products that are the subject of tenders and their documents on the ÜTS for medical device tenders held by hospitals. . In order to conduct this check web services have been assigned to the KİK. We worked together with the KİK in the analysis and development stages of this integration. They have also revised their own system in line with this work. Medical Device Producers / Importers – Cosmetics Producers / Importers The main users of the ÜTS are the Medical Device Producers / Importers – Cosmetics Producers / Importers. Sector representatives participated in all the workshops and the ÜTS was shaped with their views. Plus a core task group was formed from the medical device sector. During the monthly meetings with this group the demands concerning ÜTS are evaluated and the new developments on the ÜTS are notified to them. Citizens With this application citizens are able to submit all of their views on the application directly to the Administration and the Project Team.

- The legislation on the newly developed system must be prepared in advance. - ÜTS is a tracking system and it is not possible to start tracking all products at the same time. Therefore the question of which product groups will be in the scope of tracking and when these product groups will start to be tracked needs to be answered in advance. A road map on this subject must definitely be planned and notified to the stakeholders in advance. - Serial or lot based product tracking is possible on the ÜTS. It must be clarified in advance which product groups are to be tracked serially and which will be tracked by lot and this information must be shared with stakeholders. Companies must be allowed some time to do individual or lot based labeling on their products. - It is necessary to decide in advance on the barcode standard that is to be used and to provide stakeholders with this information ahead of time. Time will be needed for companies to clarify the method they will follow for labeling.