Stainless Steel Endoscopic Bent Catheter Tube For Medical Parts

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UDI Management Mode for Medical Supplies

The International Forum of Medical Device Regulators (IMDRF) has proposed the "UDI System for Medical Devices" and recommends the use of GS1 (Global Standard 1) coding to facilitate traceability of data used after the global market launch of medical devices. At present, the European Medical Device Industry Association and the United States industry associations and other organizations are actively developing UDI policies and regulations, the development of relevant marking requirements, to promote UDI in the country's regulatory management and application practices. China's National Drug Administration has also formulated the "basic requirements for the unique identification of medical devices" and "medical device unique identification system basic terminology" , for UDI in China's medical supplies regulatory applications have done the basic work. China's UDI coding mainly consists of product identification (product identifier, DI) and production identification (production bit, PI), corresponding to the GS1 code composition of the global trade item code (GTIN) and application code (application bit, AI), retrospective data including medical device product information, Manufacturer information, registration information, product serial number, production lot number, date of production, expiration date, etc.

At present, China's UDI coded medical supplies traceability information belongs to static information, including two aspects: First, traceable information content is static, can not achieve dynamic traceability of relevant information; As a result, retrospective management of full-lifecycle data cannot be truly realized, which is related to current limitations on technology management. The deployment of the national industrial Internet platform provides a viable solution to this problem.

Industrial Internet is an advanced form of Internet of Things application, is the Internet and a new generation of information technology and global industrial system all-round deep integration of the industry and application ecology, its through the international, national, industry, enterprise 4 nodes of the data identification and analysis, at the national level for the value of the Internet of Everything to provide a platform for the realization of the overall unified interconnection of people, machines, things, complete factors, the entire industrial chain, the full value chain, to achieve multi-node, multi-center data sharing application. On June 7, 2018, the Ministry of Industry and Information Technology issued the Action Plan for industrial Internet Development (2018-2020), which set the goal of building industrial Internet infrastructure and industrial system by the end of 2020. At present, China has completed the construction of the national industrial Internet platform, related technology in some fields have been applied.

The core of the industrial Internet of Things is the data sharing application after the Internet of Everything, and the identification analysis of data is the key technology to realize the industrial Internet. Identity is the establishment of unique and global product identification, that is, to give each connected object a unique "ID card" information, which is an important means to achieve information association index across enterprises and even the global. UDI, as a unified identification system in the field of national medical industry, can be directly applied to the industrial Internet. Identity resolution is based on unique identity information, complete the connection and sharing of the information hosted or related by the identity in different nodes and links.

The identity resolution architecture of China's industrial Internet includes 4 levels of nodes, namely, international root nodes, national top-level nodes, industry second-level nodes, enterprise nodes. At present, 5 countries top nodes have been online, respectively deployed in Beijing, Shanghai, Guangzhou, Wuhan, Chongqing, code 88; Enterprise node declaration can be completed through the industrial Internet resolution system to connect with each other, to achieve the mutual sharing of data.

In this study, Sino-Japanese friendly hospital will be medical supplies UDI and industrial Internet technology innovation combination, effectively solve the medical supplies in the whole life cycle management of different links in the "data island" problem, to achieve the medical supplies full life cycle data retrospective management. Medical supplies UDI data as the only identification of medical supplies information, carrying medical supplies production, circulation, clinical use of different links of data information, these data information stored in different management systems.

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