UDI (Unique Device Identification) is a special medical device identification system established by the FDA in the United States. It is an identity identifier assigned to medical devices throughout their entire lifecycle and serves as their unique "ID card" in the product supply chain.
UDI consists of a Device Identification Number (DI) and a Production Identification Number (PI). The device identification DI belongs to static information, which is the identity identification of medical device products in the supply chain. It can be used as a "keyword" to enter the database and query the basic traceability information of the product.
The production identification PI belongs to dynamic information, which includes the serial number, batch number, production date, and expiration date of medical device products. It is a dynamic additional information of medical device products. It can be used in conjunction with DI to point to specific medical device products.
What are the benefits of promoting UDI for medical consumables?
The accelerated development of internationalization will inevitably put forward higher requirements for the sharing and transmission of data information on traditional Chinese medicine equipment throughout the supply chain. Faced with the current problems of scattered and lagging medical data informatization in China, a globally unified international standard is undoubtedly a necessary prerequisite for safeguarding the rights and interests of the government, patients, and enterprises. At the same time, it promotes the development of China's medical device industry towards international standards.
From the government's perspective, establishing a UDI system can unify the identification of medical devices from the source, which is conducive to strengthening the supervision and management of medical device development, production, operation, and use, improving the overall efficiency of medical device supervision, and innovating medical device supervision models.
Personnel from the Device Registration Department of the National Medical Products Administration stated that assigning an ID card to each medical device, tracing back to the smallest sales unit, can achieve full product lifecycle traceability. UDI can be used to carry out work in various links such as medical device production, sales, use, and post market re evaluation“
At the seminar, representatives also stated that the UDI pilot work cannot be separated from the joint promotion of various relevant departments. After the relevant departments achieve data sharing, the UDI pilot will not only help with medical device supervision and product traceability, but also promote the linkage of the three medical institutions. Secondly, by utilizing the unique identification of medical devices, different stages of application can be connected, effectively grasping the usage of hospital products.
Officials from the National Medical Insurance Administration stated that the medical insurance department has promoted the unique identification of medical devices as an important reform measure for the management of high-value medical consumables. The unique identification of medical devices can be applied to product procurement, settlement, and medical insurance payment, which is of great significance for promoting the rational use of medical devices.
At the enterprise level, UDI can help achieve full product traceability. At the same time, UDI helps enterprises connect their internal supply chain, connect information system data such as research and development and production, and assist in reporting adverse events and conducting re evaluations, as well as timely recall of defective products.
The advantages of the UDI system will gradually be reflected in the medical distribution system. The introduction of UDI in various medical device systems includes safety, traceability, and efficiency.
From a patient perspective, the UDI system can improve user safety, provide after-sales supervision for new medical devices, and assist in the innovation of medical devices.
Considering the safety of users, when the UDI system is complete, medical devices with quality risks will be easier to track and monitor. Feedback on adverse events can be more effective, and review and analysis can be more accurate. This helps users solve safety hazards as quickly as possible, and also facilitates the settlement of medical insurance..
Once counterfeit and shoddy products enter the market, it is easy for users to check the sales network information in the GUDID database to determine the authenticity of the products.
In fact, there have been many calls in the industry to promote UDI for high-risk products such as implants. After undergoing implantation surgery, the manufacturer information, specifications, and other implant product information of the implanted device are often the most concerning for patients. In emergency situations, relevant personnel can quickly and accurately understand the patient's situation by implanting product information.
Medical Device UDI is an international language
The implementation of UDI in medical devices has become an international trend. The United States, the European Union, Japan and other countries and regions are actively promoting UDI related work Zhang Zhijun, Vice President of China Academy of Food and Drug Control, said.
The International Forum of Medical Device Regulatory Agencies (IMDRF) proposed the "UDI System for Medical Devices" guidance document in 2011, which stated that UDI is no longer a unique identification code for medical devices in the United States, but has become a globally standardized UDI system for medical devices worldwide.
In 2013, the United States issued a regulation on the unique identification system for medical devices, which decided to gradually implement UDI in medical devices based on risk levels. The US FDA has issued multiple guidance documents regarding regulations, and currently UDI has been implemented for Class III and Class II medical devices.
In the same year, the European Union issued a proposal for a universal framework for a unique identification system for medical devices, and added a UDI chapter to the medical device regulations and in vitro diagnostic reagent regulations released in May 2018. Starting from May 2021, the UDI chapter will be gradually implemented according to the category and risk of medical device products.
Japan issued UDI barcode display notifications as early as 2008, with the aim of improving the efficiency of logistics and medical insurance settlement, and establishing a medical device database system.
The International Forum of Medical Device Regulatory Agencies (IMDRF) has established a dedicated UDI working group and has developed two technical documents to construct a framework for a globally coordinated UDI system. Xu Jinghe, Deputy Director of the National Medical Products Administration, bluntly stated that UDI is the international language of medical devices.
The unique identification of medical devices is an inevitable trend in the development of digital management in the information age, and it is the direction of innovation and efficiency improvement in global medical device regulatory methods.
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