ÜTS, a project of the Ministry of Health in Turkey, ensures that medical devices are registered. ÜTS, a Product Tracking System, is a project in which domestic or imported products are followed until they reach the users. With this, patient safety is ensured, and the production of medical freezers, coolers, and other products is also under control. Devices or other medical products that are not registered in the product tracking system pose a threat to public health. Registering for this system is a legal obligation.
Coolermed, which produces medical cooling equipment, offers innovative freezer and cooler models that can be used for a long time. The most preferred medical freezer features are available in Coolermed freezers. Coolermed’s current strict monitoring procedures are supported by their UTS registration. So what are ÜTS and the medical freezer features registered by ÜTS in Turkey?
What is ÜTS in Turkey?
ÜTS, which stands out among the medical freezer features, is a project of the Ministry of Health in Turkey. It is also possible to define it as a project where all medical devices used in Turkey are recorded. The aims of the product tracking system, which facilitates the tracking of products:
- Registration of medical devices and medical products
- Creating an infrastructure that will facilitate product tracking
- Securing public health
- Increasing the efficiency and sustainability of device and product tracking
- Quickly solving problems that may arise from medical products and taking necessary precautions
- To facilitate the detection of illegal products and to prevent their use immediately
With the product inspection system, it becomes easier to reach reliable devices. With this project, which prevents the production of unregistered devices, healthy and reliable data-based control can be done. Thus, the use of resources becomes efficient. Data sharing between institutions is possible thanks to the devices registered to ÜTS in Turkey. The usage areas of the devices, where and for whom they are used, can also be tracked through this system. Because of all these benefits, ÜTS is a very valuable project for supervision and management in Turkey.
There are 8 different groups within the scope of the product tracking system project. These groups, especially tracking and monitoring, are divided into various branches: product management, clinical engineering, business intelligence, audit activities, and alert modules.
What is the Purpose of ÜTS Registered Medical Devices?
Medical devices, including freezers and coolers, are inspected by the Turkish Medicines and Medical Devices Agency. This institution works under the Ministry of Health and makes evaluations according to criteria in line with the ministry’s policies. The product tracking system registration is also processed and audited through this institution. In addition to ÜTS, device security is also inspected by the European Union.
Except for the devices produced for special research, all medical devices are subject to conformity assessment after production. In the evaluation made in this context, the question of whether the device is safe for users and patients is answered. Devices that succeed due to the inspection are marked with the letters CE. It means that products bearing these letters comply with the legislation and pass the necessary tests. Conformité Européenne or CE means “adaptation to Europe”. Devices registered to the product tracking system must have a user manual. In line with this guide, devices used for their intended purpose give a feeling of trust.
The question of how to register in the product tracking system is among the most frequently asked questions. An application is made through the website to register for the product tracking system. Authentication is done in the first step during registration. Other required information is typed after choosing the company and field of activity. These registration stages are renewed for each product. All cold chain equipment in health centers must be registered with ÜTS. The product tracking system controls refrigerators, cold boxes, vaccine transport containers, and freezers. Turkey is expected to have an ÜTS record for refrigerator and medical freezer features.
Medical Freezer Features
There are also medical freezers in the product tracking system. The medical freezer features registered to ÜTS allow safe use in Turkey. Many medical products need to be stored in the freezer. In accordance with the cold chain rules, it is also important that the freezers meet certain requirements completely. Medical freezer features approved by the Ministry of Health include:
- Medical products should be stored without any problems.
- Blood, products, vaccines, and drugs should be kept at the required temperature.
- Necessary conditions must be created so that medical products do not deteriorate, are not lost, and the cold chain is not broken.
- Among the medical freezer features, the need for functional use stands out.
- Freezers’ volume, durability, and quality allow for comfortable use.
- Since sensitive products are stored in freezers, it is essential to prevent heat transfer.
- Therefore, there should be a lock system on the doors of the freezers.
- In addition to storing medical products, they can also be used as stations, supporting efficient use.
- The medical freezer features must be carefully studied for the safe and stable transfer of blood, vaccines, serum, and other medicinal products. Freezers must be able to carry out long-term transfers without risk.
- Solar panels allow energy savings and are also among the medical freezer features.
- The body structure of the freezers is durable and robust, ensuring safe use outside.
- There are freezers of different volumes. Therefore, it is essential to consider the capacity when examining the medical freezer features. The products must be produced in capacities and features that can store thousands of units when necessary.
- Freezers are important in that degrees such as gross and net volumes, operating temperature, initial cooling temperature, and working area temperature are specified in the user manual.
Product Tracking System Certificate
In Turkey, it is necessary to register with the product tracking system after the production phase. In this context, all companies producing medical devices must be integrated into this system. Otherwise, a crime is committed. You can practically register for ÜTS and get your products approved. Serious sanctions can be applied to producers who do not register with the tracking system.
Medical Diagnostic Devices Regulation gains importance in medical freezer features. To make a production that meets the criteria requested by the Turkish Medicines and Medical Devices Agency, you can review the necessary documents where you can find the desired qualifications. By producing within the framework of these criteria, you can obtain the product tracking system certificate. The tracking system document shows that your devices comply with the requirements under the “Medical Diagnostic Devices Regulation.” These devices, which can be monitored and recorded, can be used safely.
While researching the medical freezer features, you can check whether ÜTS registers it in Turkey. Coolermed offers freezer and cooler models registered to the product tracking system. Coolermed medical cooler products provide comfort and safety. Freezer cabinets, blood cabinets, outdoor products, cooler/freezer combinations, lyophilizers, vaccine cabinets, and ultra-low temperature freezers are among the product alternatives offered by Coolermed.
You can read the previous article from the following link https://coolermed.com/problems-that-may-occur-in-a-blood-cooler-freezer-combi/