China's first medical device "electronic ID card" will land all real name system

Medicine Network May 22
May 20, the State Council Information Office held a press conference, the Meeting, China's Ministry of Industry and Information Technology spokesman Huang Libin introduced that the daily output of medical protective clothing from the initial less than 10,000 pieces to more than 700,000 pieces;Huang Libin introduced, since the outbreak, the cumulative supply to Hubei transferred medical protective clothing reached more than 7.7 million pieces, isolation clothing, surgical clothing reached more than 2.8 million pieces, medical isolation eye mask son mask reached more than 1.6 million, killing supplies reached more than 2,200 tons, infrared thermometer nearly 700,000 units, medical equipment reached 80,000 units (sets)the current overseas epidemic is still very serious, the need for epidemic prevention and control has greatly accelerated the global circulation of medical devices, at the same time, also make the traceability of medical devices is particularly importantat present, China's medical device unique identification database is officially open to the public to share, the public, medical device enterprises and medical institutions can be used for querynot only, in October this year, the State Drug Administration will organize the implementation of the pacemaker, coronary stent and other 9 categories of 64 medical device varieties of the unique identification workwhich means that China's first medical device "electronic ID card" will land, after landing each medical device will be able to trace back to the source, real name systemThe "electronic ID card" of a medical device is the unique identity of the medical device (Unique Identification Device, or UDI)before, the phenomenon of medical devices in circulation and use of no code or one thing multi-code is widespread, seriously affecting the production, circulation, use of medical devices and other links of the accurate identification of medical devices, it is difficult to achieve effective supervision and managementand the implementation of UDI, it is expected to achieve "one weapon, one code one identity", from the source of production, operation and circulation, to clinical use of all links "one-yard unicom."China in 2019 clearly put forward the "development of medical device unique identification system rules", and then, "medical device unique identification system pilot work program," "medical device unique marking system rules," "on the first batch of implementation of the medical device unique identification work related matters" and a series of related policy documents, proposed to use july 2019 to July 2020, the implementation of medical device unique identification pilot workparticipated in the pilot units, including Beijing University First Hospital and other 108 medical institutions and The National Pharmaceutical Group Medical Devices Research Institute Co., Ltdand other 116 medical device enterprisesIn order to promote the udi pilot application and realize the aggregation and sharing of data is an important prerequisite, for this reason, the State Drug Administration has co-ordinated the construction of a unique identification database for medical devices, collected product identification (DI) and related data, and at the same time,developed the "Medical Device Unique Identification Database Basic Data Set" "Medical Device Unique Identification Database Filling Guide" 2it is understood that in the early stage of database construction, the State Drug Administration has done a lot of research and demonstration work, in the process of setting standards to organize production enterprises, operating enterprises, hospitals, code agencies and other units to form a group of experts to carry out data itemclearanceafter many consultations, in order to meet the actual needs of enterprises and units of use, while taking into account the international common practice, so that the unique identification of China's medical devices in line with the "international language" standardsOn December 10, 2019, the unique identification database for medical devices was officially launched and the reporting function was opened to the pilot enterprisesMarch 31, the database further open database sharing function, to query, download, interface docking and other three ways, for the public, medical device production and operation enterprises and medical institutions and other parties to query and useopen data declaration function to pilot enterprises only from December 2019 to June 2020The declaration data from the pilot enterprises has been growing since the unique identification database of medical devices was launched, and more than 243,000 pieces of data have been collected, of which 92.34% are device products and 7.66% are in vitro diagnostic reagentsthe State Drug Administration said that the promotion of the unique identification of medical devices has been included in the National Drug Administration in 2020 key work, especially from October, will organize the implementation of the unique logo of 9 categories of 64 medical device varieties, simultaneous research and development of the second batch of implementation varieties and policiesthe first 64 varieties to implement the unique identification, including pacemakers, vascular stents, joint prosthetics and plastic fillers and other implantable products, are high-risk category 3 medical devicesin accordance with the Rules of the Unique Identification System for Medical Devices, these 64 medical device products after October 1, 2020 must have a unique identification of medical devices, and upload the relevant data to the unique identification database of medical devices before they can be listed for saleand before the first UDI implementation in October, it is also important to carry out publicity, training, pilot and other preparations for the parties concernedThe State Drug Administration said that the next step will continue to strengthen the training, sum up the udi pilot work experience, in preparation for the formal implementation of UDIat the same time, will continue to strengthen communication and coordination with the National HealthCommission and the National Health Insurance Administration, actively expand the udi in medical care, health care work applications, and promote the "three medical linkage."in fact, the implementation of the sole logo of theis a positive innovation for regulators, consumers, medical institutions and the entire medical device industrythrough information disclosure and data sharing, government management can achieve transparent traceability, intelligent supervision, medical institutions can reduce the use of weapons errors, improve the level of related managementAnnex 1 is the list of pilot enterprises and annex 2 is the list of pilot hospitals