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| Medical equipment goes back! Zhejiang has begun |
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| Author：中国铭铉 企划部 Release Time：2017-9-12 12:12:08 Number Browse：915 |
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The application of the quality traceability system of denture products in zhejiang province and the application of the denture product quality tracking system will be held in jinhua city, zhejiang province, September 12, 2007. It is understood that from July 24, the "fixed product quality traceability system" (hereinafter referred to as "tracing system") in jinhua food and drug regulatory department is officially promoted in zhejiang province.
"Denture is a medical device which is closely related to people's livelihood and is also a high risk product. Therefore, jinhua bureau to explore 'traceability system is established, implemented step by step from production to use the full back, solves the problem such as the quality of the product traceability is not strong, greatly improve the efficiency of supervision." The director of the food and drug administration of jinhua city, shi xinhui, told reporters.
Explore the whole journey
Denture is commonly referred to as "false teeth", which is the second type of medical equipment managed by the state registration license. At present, there are five production enterprises in jinhua city, and more than 540 medical institutions of oral and dental clinics. The output value of the denture industry has remained in over 20 million yuan in recent years.
According to jinhua city bureau of medical device regulatory commissioner John Davy, jinhua denture is the low level of overall production, part of the enterprise quality risk awareness is poorer, the production processing environment is uneven, denture product tracing mechanism is not sound is the core problem. "Without cover from the production, processing and use of each link quality tracking system, the quality safety problems and accidents can't back in time, causing the investigation difficulty, responsibility does not reach the designated position, uncontrollable risks."
In January 2016, promulgated by the state council "about the opinions of the quickening construction of important product traceability system" (hereinafter referred to as "opinions"), made clear that "collect and record the traceability system construction is the product production, circulation, consumption information, realize the source available, accountable to chase, responsibility, strengthen the whole process of quality and safety management and risk control of the effective measures".
"The release of the opinion confirms the determination of jinhua to speed up the establishment of traceability system and provides guidance for the establishment of the traceability system." Dai weizhong said.
In the first half of 2016, jinhua city in zhejiang province was the first to successfully build customised denture production quality traceability system, have been incorporated into the city's five denture manufacturing enterprise, implementation of the regulation in the whole process of the production process.
Later, jinhua city tried to extend the traceability system to the use link. As of June this year, more than 540 medical institutions in the city have been included in the "traceability system", thus realizing the whole process of denture products from manufacturers to use terminals.
Building digital supervision
Based on the construction of "traceability system", jinhua city has built a whole system of "one card system and one platform".
"One card" is the quality guarantee card. Every denture produced in the city is shipped with a warranty card, which is delivered to the consumer by the doctor of the medical institution. By scanning the qr code on the card quality, consumers can direct the query to the product serial number, registration number, name of the site of factory, production license, date of production (use), telephone services, medical institutions information such as name, patient's name, facilitate denture product quality, traceability of adverse events, and after-sales service.
"One system" is the enterprise resource planning (ERP) management system of the denture production enterprise. Companies use the software management system, in accordance with the "medical equipment production and the quality control standard" requirement, by scanning gun real-time acquisition, computer generated save including orders, raw materials, suppliers, personnel qualification, customer qualification, production process and finished goods inspection, waste treatment and so on a series of production data information, realize to denture production and processing the whole process of quality control and management.
The "one platform" is the smart supervision platform of supervision. Including denture production quality trace monitoring module and denture use quality tracking module, enterprise ERP system production quality supervision management data information and intelligence platform of denture production quality tracing module upload real-time docking. Denture quality tracing module is used to the city medical institutions to use quality management to carry out the trace of customised denture, and have quality acceptance of the tiny ERP system function, after landing medical institutions dedicated account can directly manage the relevant data of denture production tracing module, denture products and record of quality and acceptance of goods.
Achieve win-win results
"The full coverage of the 'traceability system' has been a boon for regulators, manufacturers, healthcare providers and consumers alike." ShiXinHui, for example, in 2016, CCTV "3 · 15" the evening exposure such as Beijing north denture technology research co., LTD. 2 cases of companies using scrap produced denture, jinhua city bureau of rapid response, and that using "traceability system" to the city's all raw material stock situation of denture manufacturing enterprises, and every day the query, statistics, analysis the quantity of scrap steel, greatly improve the efficiency of supervision, to ensure the safety of the public with machinery.
According to the usage of "traceability system", jinhua, said an official with the new beauty denture co., LTD. After the application of the system of production enterprises, through the ERP management system software in regulating the behavior of production at the same time, also can fine, informationization, to carry out quality management and assessment of production technology, digital do the responsibility to the people, avoids the use of raw materials, abuse, improve the management efficiency, optimize the after-sales service system, played a role in the development of the enterprise.
The "traceability system" also has a great role to play in medical institutions. Jinhua city central hospital medical consumables management division section chief Zhou Qiuying introduction, hospital by applying the traceability system, implementing the system of inspection of goods electronically, quality management can be traced back, responsibility to post to people, reducing the medical disputes, improve the medical service level.
"The biggest beneficiaries of the establishment of the traceability system are patients." Zhou qiuying said that now patients need only use the mobile phone scan denture quality guarantee card on the qr code, can display the anti-counterfeiting certificate of the fixed denture. "Patient consumption is more transparent, use more assured, after-sales service is more convenient."
At present, jinhua city bureau is improving the "traceability system". ShiXinHui said that the current traceability system has been done to see, can check, the traceability of the digital regulator, the next task from digital regulation to analysis, judgement, can the wisdom of the early warning supervision development.
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