Open coding system for issuing medical equipment ID card

UDI is the medical device ID card Among the many codes you see, it is the most important One article answers all your questions! At the end of the paper, the catalogue of 116 enterprises and 64 kinds of medical devices in the first pilot of the unique identification system is attached Medical device unique identification database online On December 10, according to the information on the official website of the State Food and drug administration, the unique identification database of medical devices was officially launched, and the application function of unique identification related data for pilot varieties was opened to pilot enterprises Unique device identification (UDI) is the electronic ID card of medical device products; The unique identification data carrier is the medium for storing or transmitting the unique identification of medical devices, and the unique identification database is the database for storing the product identification and associated information of the unique identification of medical devices; The three parts constitute the unique identification system of medical devices Why establish a unique identification system for medical devices? Because it is conducive to the rapid and accurate identification of medical devices in production, operation and use by means of information technology, to the sharing and integration of product supervision data, to the innovation of supervision mode, to the improvement of supervision efficiency, to the strengthening of the whole life cycle management of medical devices, to the combination of government supervision and social governance, and to the formation of a situation of social co governance To further improve the level of effective and safe protection of public use of equipment The medical device registrant / recorder shall be responsible for the data declaration and the authenticity, accuracy and uniqueness of the data UDI is known as the "ID card" of medical devices However, it should be noted that the most important thing of UDI is not only the uniqueness, but also the series connection An authority in the industry told saberland that, in fact, UDI is like an ID card, and other HCBS and medical insurance codes are like a bunch of bank card numbers They are all connected in series by UDI, so when designing UDI codes, they should also correspond to other codes Medical devices have codes in the drug administration, the health care Commission, the medical insurance bureau, the bidding classification code, even in tax and customs UDI is to connect these codes in series Previously, Wang Jian, director of the Medical Affairs Office of the medical support department of the General Hospital of the Chinese people's Liberation Army, explained UDI in this way "We use UDI to solve problems UDI is like ID card," he said The ID card and bank card are bound, and all economic activities are monitored; after we are bound with the air ticket, all outbound activities are monitored; including the binding with the hotel trip " UDI is the identity card of a product It can be bound to all management requirements Binding is a cross reference relationship No matter which coding system it is in, its identity card is the same UDI can also realize closed-loop traceability of the whole chain of medical devices According to Wang Jian, UDI can realize two-way traceability from product to patient, patient to product, which is of great significance to patient safety and product safety It can also be correlated with the customs to scan the product bar code If it is an imported product, the customs can also push the customs clearance information If there is a customs clearance information, it will come in through normal channels If there is no such information, it will be water cargo, which has a very good application value for fighting against water cargo in the future It can also realize adverse event reporting through UDI, simplify the operation and improve the accuracy of reporting Combine the regulations of GSP and Gup with the actual business to realize multi-dimensional and full cycle supervision More importantly, for the hospital, UDI can make the medical device information of the supplier clear at a glance in the system, and can see when the order is placed, when the supplier delivers goods, when the hospital receives goods, when the payment is paid, etc According to the requirements of the reform plan for high value medical consumables "to explore the connection and application of standardized codes in the registration, purchase and use of high value medical consumables": The medical insurance code field and the classification of consumables and equipment are added to the unique identification database of medical devices, so as to promote the whole chain linkage of medical devices from source production to clinical use In this way, multi-party data sharing can be realized and "three medical linkage" can be promoted On October 15, the official website of the State Food and Drug Administration issued the notice on matters related to the implementation of the first batch of medical device unique identification According to the circular, the unique identification system of medical devices will be implemented step by step In terms of variety scope: according to the risk degree and regulatory needs, some high-risk class III medical devices, such as active implants and passive implants, are determined as the only implementation varieties of the first batch of medical devices Nine categories and 64 varieties of pacemaker, hip prosthesis and plastic injection filler were listed in the first batch of products with unique identification of medical devices The unique identification database of medical devices is based on the principles of standardization, ease of use, openness and expansibility, with simple and friendly page design and convenient operation On the basis of fully considering the needs of users, it provides data declaration methods such as web page declaration, template import and interface docking, as well as data sharing methods such as web page online query, data bulk download and interface docking, All kinds of users choose their own declaration and sharing methods according to their actual needs to provide users with a good experience In order to facilitate the public to view the construction of the unique identification system of medical devices, the website "medical devices" section of the State Food and drug administration has set up a column "the unique identification system of medical devices" (as shown in Figure 1), Click to query relevant policies and regulations, work trends, database operation guide, etc (as shown in Figure 2) You can also enter the unique identification database declaration login page (as shown in Figure 3) through the page "declaration entry" At the same time, you can see the real-time statistics of declaration Next, SFDA will strengthen the guidance and services for the application of unique identification data of medical devices, and open the unique identification database query and sharing services to the pilot units in March 2020 according to the pilot work arrangement The first batch of medical device enterprises participating in the pilot of unique identification system Yes! This user manual is applicable to all registrants / filers and user operators of the code issuing institution who use this system Registration / filing method: The unique identification management information system of medical devices provides three data application ways for registrants / recorders Web page filling: after the registrant / filing person logs in the system, fill in and submit directly on the web page Batch import: after the registrant / filer logs in the system, download the data template provided by the system The registrant / filer prepares the data according to the requirements, and then imports the data in batch through the data template batch import function Declaration interface: the system provides API interface declaration data See "data interface description" column for specific requirements Code issuing institution: the code issuing institution shall log in the system, fill in the basic information and submit it Relevant basis will be published in the column of "code issuing organization and rules".