"The application of the unique medical device identification (UDI) has broken the information barrier between medical institutions and medical device production and distribution companies, and has realized the traceability of medical device life cycle information." said An Zheng, Director of the Medical Engineering Department of China-Japan Friendship Hospital.

"For medical device manufacturers, the implementation of UDI coding has improved the company's product information management, promoted the effective establishment of an internal traceability system, facilitated the monitoring of adverse events and accurate recall of problem products, and reduced the company's operating costs." Said Zhao Hengkun, deputy general manager of Weigao Medical Products Group.

On July 24, the National Medical Products Administration held a medical device unique identification (UDI) system pilot work promotion meeting, which summarized the progress and effectiveness of the UDI system pilot work in stages-UDI in all links of the production, circulation and use of medical devices Demonstration applications have effectively promoted the entire chain linkage of medical devices from source production to final clinical use. Participants expressed their hope that the UDI system will achieve full subject coverage, full business integration, full chain closed loop, full cycle supervision, full service, and shared by the whole society in the future.

　　UDI successfully served all aspects of production, operation and use

　　 On July 1, 2019, the State Food and Drug Administration and the National Health Commission jointly issued the "Medical Device Unique Identification System Pilot Work Plan", officially starting the UDI pilot work. In August of the same year, the State Food and Drug Administration announced the first batch of 116 pilot medical device companies and 108 users who participated in the UDI system pilot.

　　 Over the past year, medical device companies have actively participated in the pilot, and medical institutions have continued to expand the application of unique identification. UDI has been demonstrated and applied in all links of the entire chain of medical device production, circulation and use.

　　 As one of the first batch of pilot medical device companies, Weigao Group currently has 5 subsidiaries implementing UDI traceability systems. According to Zhao Hengkun, the company has established a relatively complete UDI database: internally, it is connected to the ERP system and MES system; externally, it is connected with the data interface of the hospital management system; after the national UDI database is opened, it has also realized the interface with the national database. The docking realizes the product life cycle management.

　　Medical device operating companies play an important pivotal role in the product supply chain. For the promotion, implementation and coordinated application of UDI, operating companies play an important role as a “linkage”. "Organize and participate in UDI training, assist manufacturing companies in assigning codes, explore UDI application standards and specifications for operating companies, and explore the application of UDI full chain connection." Zhou Qiang, technical director of the Sinopharm Medical Device Research Institute, summarized the company's work in implementing UDI.

　　UDI also showed its talents in epidemic prevention and control. The Tianjin Drug Administration has explored and tried to incorporate epidemic prevention and control materials into the UDI pilot. "We will carry out UDI coding for two varieties of medical protective clothing and medical prevention and control masks, and explore the realization of accurate deployment of epidemic prevention materials by counting the inventory, flow and usage of epidemic prevention materials." Zhang Sheng, deputy director of Tianjin Municipal Drug Administration Past introduction.

On the hospital side, Cao Desen, director of the Medical Engineering Department of the Chinese People’s Liberation Army General Hospital, also gave a set of data: The hospital has reduced procurement processing time by 70% through UDI-based supply chain coordination; inventory turnover has increased by 30%, and management time has been reduced by 20 %; Read consumption through UDI, complete consumption billing in 1 second. "UDI can realize services such as code scanning and warehousing, billing, relocation, delivery, and inventory of medical devices, which greatly reduces the probability of errors and improves work efficiency." Cao Desen said.

　　 UDI runs through all links in the production, operation and use of medical devices, effectively improving the efficiency of accurate identification of the entire chain of medical devices, and ensuring the safety of medical device production and use. "This verifies the feasibility of implementing unique identification in all links of the entire medical device chain." In response, Changjiang Deyuan, Director of the Medical Device Registration Department of the State Drug Administration, said.

　　 Pilot "four beams and eight pillars" forming

　　 "What should I try for UDI pilot work? Test rules, test standards, test mechanisms, test paths, and test modes." Xu Jinghe, deputy director of the State Drug Administration, pointed out the purpose of UDI pilot work. It is understood that since the pilot work has been carried out for nearly a year, with the joint efforts of all parties, the UDI system framework has been basically established to realize UDI creation, code assignment, data upload and download, and sharing.

　　 At present, the drug regulatory department and the health department have worked together to establish a good work coordination mechanism. At the same time, the technical standards and informatization construction of UDI pilot projects are also advancing steadily.

Zhang Hui, deputy director of the Medical Device Standards Management Center of the State Food and Drug Administration, stated that the four UDI standards, including the Basic Requirements for the Unique Identification of Medical Devices and the Basic Data Set of the Unique Identification Database for Medical Devices, formulated by the center in the early stage, have all been released and targeted The relevant basic general standards have carried out special publicity and implementation training.

　　 At the same time, the Information Center of the State Drug Administration has also completed the construction of the UDI database. In December 2019, the medical device UDI database system went online; in March this year, the database provided shared services to the outside world through three methods: query, download, and interface docking. "As of mid-July, the UDI database has received more than 89,000 pieces of data and released a total of more than 53,000 pieces of publicized data." said Huang Guo, director of the Information Center of the State Drug Administration.

"As a multinational medical device company, we feel that the formulation of China's UDI rules, standards, databases and other regulatory frameworks is deeply in line with international standards." Guo Ye, the regulatory director of BD Medical Devices (Shanghai) Co., Ltd., expressed full recognition of UDI system infrastructure. This system design in line with international standards has laid the foundation for the smooth implementation of UDI for import and export products.

　　 All this is inseparable from the active joint efforts of all parties concerned. In order to promote the orderly development of the UDI pilot work, the State Food and Drug Administration and the pilot provincial Food and Drug Administration actively expand the scope of coded products, pilot enterprises, and medical institutions, and continue to expand the coverage of UDI system construction. At the same time, multi-channel publicity and implementation of pilot policies, and actively guide enterprises to participate in the pilot.

　　 Guo Shuting, deputy director of the Shanghai Municipal Drug Administration, stated that the bureau took the initiative to contact and absorb qualified and willing medical device companies and users to participate in the pilot. At present, the types of pilot units are complete, with participation in all links, which are representative. He also suggested to further improve and refine the implementation rules of the UDI system, strengthen guidance on production, operation, use and supervision, and provide more operational guidelines.

Huang Weijun, deputy director of the Fujian Provincial Drug Administration, introduced that in order to promote the implementation of the pilot work, the bureau has clearly defined the division of labor for the pilot work. The Medical Device Supervision Division of the Provincial Drug Administration takes the lead and is specifically responsible for the pilot promotion of medical device manufacturers; market supervision in districts and cities The bureau takes the lead in the pilot promotion of operation and use links. "In this year's annual drug safety satisfaction rate evaluation, Fujian Province also listed the implementation of this work as an evaluation item." Huang Weijun said.

　　 It is understood that the UDI pilot work has absorbed 86 non-first pilot companies based on the original 116 pilot companies. Up to now, there are 309 registered users in the UDI system database.

　　 In addition, the drug regulatory department actively organized UDI pilot work research and policy publicity, and carried out on-site and online training for production and operation enterprises, code issuing institutions, medical institutions, and supervisors to help solve the difficulties in the pilot process. At the same time, real-time communication was conducted through WeChat groups and other methods to answer questions for pilot units. Guo Ye vividly referred to these WeChat platforms for guiding the implementation of UDI’s pilot projects as “regulations exchange through trains”. She said that this “through train” has improved the efficiency of the enterprise’s pilot work. The training intensity helps companies understand the policy and solve the problems encountered in implementation.

　　Explore the application of "three-medicine linkage"

On July 23, the Office of the State Council issued the "Key Tasks for Deepening the Reform of the Medical and Health System in the Second Half of 2020", clearly selecting some high-value medical consumables and other key varieties to implement the unique identification of medical devices, and exploring the implementation of high-value medical consumables registration, procurement, Use and other links to standardize the application of the code.

　　In fact, since the launch of the pilot work, the drug regulatory authorities, together with the health and medical insurance departments, have actively explored and promoted the application of UDI in the fields of medical care and medical insurance, laying a good foundation for boosting the "three-medicine linkage".

　　As early as January this year, the National Health Commission released the first batch of national key management lists of high-value medical consumables to strengthen the standardized management of high-value medical consumables. A person from the National Health Commission stated that UDI can help medical institutions strengthen the refined and scientific management of the entire life cycle of high-value medical consumables.

　　 Under the supervision and guidance of the State Food and Drug Administration, the pilot provincial Food and Drug Administration has also actively promoted the "three-medicine linkage" model according to local conditions.

The "Tianjin Municipal Medical Device Unique Identification System Pilot Work Plan" jointly issued by the Tianjin Drug Administration, Health Care and Medical Insurance Departments on May 25 has been clarified, actively strengthening communication and cooperation, and analyzing and studying the relationship between the drug regulatory UDI coding rules and medical insurance codes. Technical path to achieve two-code mapping. Zhang Shengxi said: "Within this year, data sharing will be realized in the Tianjin Medical Device Supervision Collaboration System and the Tianjin Medical Insurance Procurement System to improve the efficiency of medical device supervision and health management."

"Based on UDI, medical staff can quickly report medical device adverse events by scanning codes on WeChat, which is more convenient than traditional reporting methods. It can also support multiple description methods such as voice, pictures, and text, which improves the enthusiasm of medical staff to report adverse events. "Cao Desen believes that after the application of the UDI system, the number of medical device adverse events reported in the hospital has increased, which has strengthened the safety of medical device use.

The reporter learned that, in the future, the State Food and Drug Administration will continue to conduct in-depth research and promote the follow-up work of UDI system construction, summarize the phased experience into operation guidelines for production, operation, and use, and expand the application of UDI in the fields of medical care and medical insurance. Further promote the "three-medicine linkage".