Coming! Medical device ID card manager like this (with analysis)

UDI is the boss and will string other codes On June 27, the National Health Insurance Bureau released the business coding rules and methods of medical consumables for medical insurance The whole industry felt that the medical devices would start to be coded uniformly, but it was strange that there were only medical consumables for medical insurance and other devices? Then, on July 3, the State Food and Drug Administration issued the pilot work of exploring the formation of a full chain linkage medical device unique identification system from source production to clinical use, which indicated that the UDI system for medical devices should be established On August 27, the "rules for unique identification system of medical devices" was issued It turns out that this UDI is the unified code for all medical devices However, it is puzzling that recently the statistical information center of the national health and Health Commission issued a letter on Soliciting Opinions on the classification code and identification code of medical consumables procurement and use management, and published the only code for each medical consumables product - HCBS code What is the relationship between these codes? To understand the relationship between these codes, UDI is the key point UDI is the abbreviation of unique device identification, known as "ID card" of medical devices However, it is important to note that UDI is not only unique, but also serial 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 When using UDI to connect various businesses in series, it will involve many management departments, including the health and Health Commission, the medical insurance bureau, the drug administration, etc Consumables have codes in the drug administration, the health care Commission, the health insurance bureau, the bidding classification code, even in the 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 Therefore, using UDI to realize the classification code and mapping Association of drug supervision, health care Commission, medical insurance, tax, customs and other relevant departments can keep the existing code of each department and province unchanged, and realize the unique identification of medical devices 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 On July 3 of this year, the State Food and Drug Administration issued the pilot work plan for the unique identification system of medical devices, which also said that the pilot application of the unique identification system in the production, operation, circulation and use of medical devices should be carried out to form the demonstration application standards and specifications To explore the application of unique identification in adverse event report, product recall and tracking of medical devices To explore the connection and application of the unique identification of medical devices in the fields of health care and medical insurance, and realize the data sharing of information platforms such as registration approval, clinical application and medical insurance settlement From the current published codes, there are specific rules for medical insurance consumables codes and HCBS consumables codes issued by the National Health Care Commission, indicating which parts of the codes are divided into and how to code each part with numbers and letters Only UDI, we haven't seen what it looks like so far Is UDI a specific code? The answer is: Yes and No Why not first According to the above industry introduction, UDI is a rule rather than a code, because no matter what the specific form of the code is, as long as it conforms to this rule, it can be incorporated into the system and used, that is to say, there may be multiple codes for UDI On August 27, the rules for unique identification system of medical devices issued by the State Food and Drug Administration explained the coding rules of UDI in detail, including the three principles of uniqueness, stability and scalability In addition, from the principle of scalability, we can see that the coding of UDI is not immutable and will adapt to the regulatory requirements and the continuous development of practical applications As for why it can also be said that UDI is coding, because under the rule of UDI, there must be actual coding It is understood that a UDI code will contain a lot of information, such as the specifications, models and other product information of medical devices, and information in the production process "Specifically, for example, in the production phase, UDI will require you to have several digits of the production date You need to put in the code, and then you need to code and scan the code in the circulation phase These codes are used in the use phase of medical institutions These parts of the code are put together under the UDI rules." Industry insiders said In addition, the above industry insiders also said to saberland device that there are two codes that can be applied in practice, one is GS1 code, which has been recognized in China, and the other is the code made by national pharmaceutical device, in the form of two-dimensional code We don't know what the UDI QR code looks like, but GS1 code is everywhere GS1 code is not a magic code Most of the codes used in supermarkets belong to GS1 code, which has been widely used in retail, manufacturing and health industry At present, more than 60 countries and regions in the world, such as the United States, Japan, Germany, the United Kingdom, France, Australia and Turkey, have adopted GS1 system to manage the identification of medical devices, drugs and other medical and health products GS1 code can be divided into commodity bar code, cross 25 bar code, gs1-128 bar code, RSS bar code, etc gs1-128 bar code is also known as "UCC / EAN-128 bar code" before According to Wang Jian, the GS1 code for medical devices originated from UCC established in 1973 in the United States, EAN in 1977 in Europe, and changed its name to "GS1" in 2005 Therefore, maybe gs1-128 bar code is just the UDI code for medical devices It is understood that the symbol structure of gs1-128 bar code includes the left blank area, two character start graph, data character, check character, stop character and right blank area, as shown in the following figure: