Build a solid foundation for smart supervision

From January 1, 2021, the unique identification of the first batch of medical device products will be officially implemented, marking that the unique device identification (UDI) work has entered the formal implementation stage from the pilot exploration stage and included in the first batch The medical devices in 69 categories of 9 categories in the product catalogue must meet the requirements of UDI regulations.

The formal implementation of UDI will improve the efficiency of medical device supervision, strengthen the management of the whole life cycle of medical devices, break through the information barriers between the subjects of medical devices, build a bridge between medical device government supervision departments, improve the transparency of medical device information, and create a joint construction The social governance pattern of co-governance and sharing is of great significance.

The legal system is basically completed

On December 21, 2020, the State Council’s executive meeting reviewed and approved the "Regulations on the Supervision and Administration of Medical Devices (Revised Draft)" (hereinafter referred to as the "Regulations"). UDI was formally written into the "Regulations", which established the legal status of UDI and made UDI Become one of the basic requirements that medical device products need to meet.

Prior to this, in July 2019, the General Office of the State Council issued the "Reform Plan for Governance of High-Value Medical Consumables", which clearly required the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration to jointly formulate the "Medical Device Unique Identification System Rules" (hereinafter referred to as "rule"). In August of the same year, the "Rules" were formally released and implemented on October 1 of the same year. With the intensive work of the State Council and its subordinate departments, the top-level design and establishment of UDI system regulations have been completed.

In 2020, UDI-related standard system construction work has also made progress. UDI’s basic requirements, system basic terminology, database basic data sets, and database filling guidelines and other industry-recommended standards have come into effect. These work have laid the foundation for the implementation of policies and regulations. Prepare the foundation.

Solid advancement and remarkable results in pilot projects

In July 2019, the State Food and Drug Administration and the National Health Commission jointly issued the "Pilot Work Plan for the Unique Identification System for Medical Devices", and UDI entered the pilot phase. The units participating in the first batch of UDI system pilots cover a wide range, including more than 200 medical device production and operation companies and users. In the future, many companies and users actively participate in the UDI pilot. The pilot units cover the source production of medical devices to clinical use. The entire chain of UDI ensures that the UDI system can be fully verified.

The UDI database, which is an important part of the UDI system, was officially launched on December 10, 2019, and the manufacturing companies participating in the pilot began to upload UDI data. From March 31, 2020, the State Food and Drug Administration will open the sharing function of the medical device unique identification database. The public, medical device manufacturers and medical institutions can query and use them in three ways: query, download, and interface docking. The opening of the UDI database provides an important platform support for the pilot work.

In addition, the State Food and Drug Administration has continuously strengthened the publicity and implementation of UDI policies and regulations, led the organization of UDI public welfare training, and promoted the smooth implementation of pilot work. The provincial drug supervision and administration departments participating in the pilot program formulate pilot work plans, carry out publicity and implementation training, guide pilot units to fill in data, etc., and test and improve UDI mechanisms, paths, and models.

After more than a year of piloting, the UDI system construction method and path have been effectively verified, and the pilot has achieved remarkable results.

Three-medicine linkage stimulates inner vitality

UDI is the "identity card" of medical devices, and it is the basis for the unique and accurate identification of medical devices. The implementation of UDI is to achieve accurate identification at all links in the entire life cycle of medical devices to facilitate supervision. However, there are three main bodies in the whole life cycle supervision of medical devices: medicine, medical treatment and medical insurance. The needs of each supervision body are different. To make UDI meet the supervision needs of all links at the same time, it needs to be in the formulation of policies and regulations, pilot practice, and promotion and implementation. To strengthen coordination and communication between departments.

At the beginning of the implementation of UDI, the National Food and Drug Administration, the National Health Commission, and the National Medical Insurance Administration jointly formulated the "Rules". During the pilot process, the drug regulatory authority communicated and cooperated closely with the health department and the medical insurance department, strengthened the connection of UDI data, and gradually realized high-value medical care. Cohesion application of consumables registration, procurement, and use of coding standards. In the first batch of UDI products, special consideration was given to the products in the "First Batch of National High-value Medical Consumables Key Management List" (hereinafter referred to as "List") issued by the General Office of the National Health Commission. Ear prostheses, spinal interbody fixation/replacement systems, absorbable surgical hemostatic materials, penile prostheses, implantable drug infusion devices, 5 high-risk third-class medical devices have been added to the first batch of UDI-implemented varieties , And encourage the first batch of other varieties in the "List" to implement unique identification.

UDI needs to solve cross-system, cross-platform, and cross-regional issues in the application process of UDI in medical institutions. Only when UDI is associated with the hospital code and medical insurance classification code of medical institutions can the benefits of UDI be fully reflected, so as to meet the needs of all parties and further stimulate The inner vitality of UDI.

Formally implemented, enterprises are facing big exams

According to the UDI implementation steps, the medical device registrant/filer is the source of UDI code and directly affects the later application of UDI. The registrant/filer is responsible for data declaration and is responsible for the authenticity, accuracy, and uniqueness of the data. Therefore, the formal implementation of UDI is a big test for the registrant/filer.

According to the requirements of the "Rules", the registrant/filer shall submit the UDI product identification in the registration/filing management system when applying for medical device registration, registration change or filing; the product identification and related The data is uploaded to the UDI database. That is, from January 1, 2021, the registrants/filers listed in the first batch of product catalogues must comply with the above requirements. This new change will directly test the company's compliance capabilities. Companies need to invest more resources and consume more costs to meet UDI implementation requirements, such as adjusting the quality management system related procedures, selecting a suitable code issuing agency, assigning specialized personnel to complete data upload, proofreading and maintenance, and purchasing or updating related coding equipment , Carry out UDI policy and regulation training, adjust the existing internal management system and UDI docking, etc.

At present, the first batch of products implemented are all high-risk three types of medical devices. Relatively speaking, these companies have strong management capabilities and a good quality management foundation. Most companies have already met UDI related regulations before the implementation of UDI. Claim. With the continuous advancement of UDI implementation, medium and low-risk Class II and Class I medical devices will gradually be included in the scope of implementation, and the types of products will increase. Some products meet UDI requirements and have certain technical difficulties. Said that meeting UDI requirements will be a long-term and arduous challenge.

In the process of UDI implementation, the operating company is an intermediate link, which has the characteristics of connecting the previous and the next. Its docking upstream companies are numerous, and the products that can meet the UDI requirements account for only a part of the total products. Most upstream companies currently do not have the ability to assign codes. In addition, the operating companies involved in complex product categories, and higher requirements for management capabilities. At the same time, the management requirements of downstream medical institutions faced by operating companies are also more complicated and vary greatly. There will also be many information docking problems in the implementation of UDI.

Smart supervision strengthens social co-governance

Medical device supervision and implementation of UDI has become a global consensus. UDI marks medical devices from the source, which can reduce medical errors, improve medical quality, and reduce medical costs during the application process. However, the diversity and complexity of medical devices make it difficult to implement UDI overnight. It is necessary to mobilize the collective wisdom of all participants in order to develop the potential of UDI more reasonably.

In the long run, the implementation of UDI can also improve the effectiveness of supervision and lay a solid foundation for the realization of the digitalization of supervision. In the future, the barriers caused by "information islands" will be gradually eliminated, and counterfeit and inferior medical devices will hardly gain a foothold. UDI introduces social forces in the implementation process, and delegates the coding function to a third-party code issuing agency with rich experience to further strengthen social co-construction and co-governance. With the opening and sharing of the UDI database, the public can conveniently inquire about medical device information, and the transparency of information has been further improved. These have laid an important cornerstone for social co-governance.

Although the UDI of the first batch of products has been officially implemented, the work of UDI is far from over, and the construction process of the UDI system will still be full of challenges. By building a communication platform for all parties in the construction process and issuing more guidance documents, the pace of UDI construction will be faster, and the level of accurate management of the entire life cycle of medical devices will be greatly improved.

Author: Zhang Peiming, associate professor of Shanghai Medical College