Which enterprises use medical equipment ID card?

Recently, Shanghai pharmaceutical regulatory bureau and Shanghai Health and Health Commission issued the work plan for promoting the pilot of medical device unique identification system in Shanghai (hereinafter referred to as the work plan) According to the work plan, 32 machinery enterprises and 12 other users in Shanghai were selected as the first batch of pilot units participating in the unique identification system, as shown in the table below: In fact, most of the machinery enterprises pay more attention to the timing of the implementation of the unique identification of all kinds of consumables In August this year, the State Food and Drug Administration issued the rules for the unique identification system of medical devices, saying that the specific steps for classification implementation will be formulated and published separately However, in October this year, the State Food and Drug Administration issued the notice on doing well in the first batch of issues related to the implementation of the unique identification of medical devices, announcing the first batch of devices to implement the unique identification of medical devices Including active surgical instruments, passive surgical instruments, nerve and cardiovascular surgical instruments, medical imaging instruments, blood transfusion, dialysis and cardiopulmonary bypass instruments, active implant instruments, passive implant instruments, infusion, nursing and protection instruments and ophthalmic instruments, a total of 9 categories and 64 high-risk category III medical instruments Shanghai's manufacturing and operating enterprises and users are not unfamiliar with the unique identification of devices Before that, Shanghai has accumulated a certain foundation in the traceability of implanted medical devices In 2006, the former Shanghai drug regulatory bureau required that the implanted medical devices entering Shanghai must be identified with UDI code, that enterprises should strictly implement international standards, keep the uniqueness and traceability of the code, and upload the hospital use data to the unified traceability management system of the city At the same time, all medical institutions are required to disclose the detailed list and traceability information of implant products to patients after surgery The industry generally regards it as the rudiment of UDI of medical devices in China After that, according to incomplete statistics, Beijing, Chongqing, Hunan, Hebei, Liaoning and other provinces and cities have also carried out a beneficial attempt of electronic retroactive supervision, and the state has also continuously put forward policies to promote medical device coding On January 20, 2012, the State Council issued the 12th Five Year Plan for national drug safety, which required to start the national unified coding of high-risk medical devices On March 7, 2014, the regulations on the supervision and administration of medical devices issued by the State Council showed that the use of advanced technology was encouraged to record the sales and use of medical devices On February 14, 2017, the national drug safety plan of the 13th five year plan issued by the State Council proposed to "build medical device coding system and formulate medical device coding rules" In February 2018, the former State Food and Drug Administration issued the rules of the general office of the General Administration of the people's Republic of China on soliciting public opinions on the unique identification system of medical devices (Draft), and then in August this year, the State Food and Drug Administration officially issued the rules on the unique identification system of medical devices The source of the unique identification of medical devices can be traced back to the end of last century In 1999, the American Medical Research Institute's representative report "no man is a saint: building a safer health system" disclosed that in the United States, as many as 98000 patients die of preventable medical errors in hospitals every year The report points out that medical errors caused by the wrong use of drugs and devices are the main causes of medical accidents, and most of them can be avoided By scanning before bed, the misuse of drugs and devices can be effectively avoided, thus greatly reducing medical costs The industry generally believes that the above research report is an opportunity for FDA to actively implement barcode management of drugs and medical devices In 2004, FDA issued a regulation requiring the use of bar code identification on drug labels, and FDA solicited opinions on whether this regulation should be extended to the field of medical devices Because UDI helps to reduce medical errors, facilitate recall, improve reimbursement methods and reduce counterfeit products, FDA gradually began to promote the implementation of UDI But judging from the implementation of FDA, the landing of UDI will face many challenges According to industry analysis, it is difficult to implement some types of medical devices Although the U.S FDA's relevant UDI regulations specify the compliance dates of various types of medical products, in the implementation process, due to the diversity of medical devices, some types of products are difficult to meet the regulatory requirements, so the U.S FDA has to postpone the compliance dates of specific types of products It can be seen that code compliance will also become a challenge for many enterprises Although FDA has issued UDI system: compliance guide for small enterprises for small enterprises, due to different types and regions of enterprises, as well as hardware purchase and personnel training, some enterprises still have difficulties in complying with UDI regulations.