ÜTS, a project of the Ministry of Health, ensures that medical devices are registered.
ÜTS, Product Tracking System, is a project in which domestic or imported products are followed until they reach the users. With ÜTS, 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 ÜTS 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 is ÜTS and what are the medical freezer features registered by ÜTS?
What is ÜTS?
ÜTS, which stands out among the medical freezer features, is a project of the Ministry of Health. The answer to the question of what a product tracking system is very important today. It is possible to define UTS 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. Thanks to the devices registered to ÜTS, data sharing between institutions is possible. 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.
There are 8 different groups within the scope of the product tracking system project. These groups, especially tracking and monitoring, are divided into different branches such as product management, clinical engineering, business intelligence, audit activities, and alert modules.
ÜTS Registered Medical Devices
Medical devices are defined according to the Medical Device Regulation determined by the Ministry of Health. Medical devices can be used in hospitals, health centers, community health centers and many different organizations related to the sector. Medical devices are used during the diagnosis, follow-up and treatment of the disease. Medical devices include a wide variety of product alternatives. The freezers we mentioned in this article are also among the 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 a 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 achieve success as a result of 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. To register for the product tracking system, an application is made through the website. Authentication is done in the first step during registration. After choosing the company and field of activity, other required information is typed. These registration stages are renewed for each product.
All cold chain equipment in health centers must be registered with ÜTS. Refrigerators, cold boxes, vaccine transport containers and freezers are controlled by the product tracking system. It is expected that there will be a ÜTS record among the 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. 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 able to be stored without any problems.
- Blood, 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 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 being able to store medical products, they can also be used as stations; supports efficient use.
- For the safe and stable transfer of blood, vaccine, serum and other medicinal products, the medical freezer features must be carefully studied. Freezers must be able to carry out long-term transfers without risk.
- Solar panels, which allow energy savings, 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 need to be produced in capacities and features that can store thousands of units when necessary.
- Freezers are important 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
It is a necessity 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. In order 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 criteria under the “Medical Diagnostic Devices Regulation”. These devices, which can be monitored and recorded, can be used safely.
While researching about the medical freezer features, you can check whether it is registered by ÜTS. Coolermed offers freezer and cooler models registered to the product tracking system. Coolermed medical cooler products provide comfortable and safe use. Freezer cabinets, blood cabinets, outdoor products, cooler/freezer combinations, lyophilizer, 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/en/problems-that-may-occur-in-a-blood-cooler-freezer-combi/