Major investigation of potential safety hazards of medical devices and nine governance priorities, involving these devices and enterprises

 

 

 

In order to strengthen the risk management of medical devices, further improve the level of quality and safety assurance and promote the high-quality development of China's medical device industry, on March 26, the comprehensive Department of the State Food and Drug Administration issued the notice on carrying out the investigation and treatment of hidden dangers of quality and safety risks of medical devices (hereinafter referred to as the notice).

The notice clearly points out that it is necessary to carry out investigation and treatment of potential risks in the quality and safety of medical devices from four aspects: comprehensive investigation of potential risks, timely discovery and elimination of emerging and tendentious problems; The governance responsibility shall be fully implemented, and all responsibilities shall be implemented to each person; Comprehensively improve the management level; Quality assurance was comprehensively strengthened.

 

 

 

The nine key points of investigation and treatment include epidemic prevention and control of medical devices, centralized procurement of selected products, online sales of medical devices, supervision and sampling of unqualified enterprises, and products and enterprises with frequent complaints and reports.

 

 

 

1. Medical devices for epidemic prevention and control. Focus on COVID-19 detection reagent, respirator, medical protective clothing, medical mask and infrared thermometer and other epidemic prevention and control of medical devices, especially those for emergency commissioning and commissioning, cross boundary transfer, and defective products and defective quality system.

 

 

 

2. Purchase the selected products in a centralized manner. Focus on the national centralized procurement of selected products such as coronary stents, focus on whether the manufacturing enterprises strictly control the audit of raw materials and supplier management, whether the production process, quality control and finished product release control are in place, whether the traceability system is sound, and whether the adverse events found are investigated and evaluated in time; Whether the distribution unit of the selected products is transported and stored in strict accordance with the requirements of product instructions or labels, and make corresponding records; Whether the medical institution has done a good job in the procurement, acceptance, storage and other quality management of the selected products in accordance with the regulations.

 

 

 

3. Sterile and implantable medical devices. Organize a comprehensive risk investigation of sterile and implantable medical device enterprises, focusing on high-value medical consumables such as artificial joints, intraocular lenses, balloon dilation catheters, defibrillators, occluders, orthopedic materials, staplers and disposable sterile syringes.

 

 

 

Focus on checking whether the raw material procurement and supplier management of manufacturing enterprises meet the requirements, whether the key processes and special processes are identified and effectively controlled, whether the control of clean room (area) meets the requirements, and whether the requirements of process inspection, finished product inspection and finished product release are strictly implemented. The drug regulatory department shall inspect the whole project of sterile and implantable medical device manufacturing enterprises at least once a year; Whether the operating enterprise is engaged in the operation (online sales) of medical devices without permission (filing), and whether it is engaged in the operation (online sales) of medical devices without registration certificate or filing certificate; Whether the using unit purchases medical devices from suppliers with legal qualifications, and whether it purchases or uses medical devices that are not registered, without qualification certificates, expired, invalid or eliminated. The supervision and inspection of aseptic and implantable trading enterprises and users by the drug regulatory department shall not be less than 15% of the total number of relevant enterprises and units in the administrative region every year.

 

 

 

4. Sell medical devices online. Continue to carry out the "clean-up action", focusing on the investigation of medical devices for epidemic prevention and control, medical devices with concentrated complaints and public opinion, as well as the performance of legal obligations of third-party platforms for online trading services of medical devices. Focus on whether the product manual and label are consistent with the registered content; Whether the products are sold according to the scope of application and intended use of the registered products; Whether there are false assertions about the effectiveness of the product during sales, etc. The drug regulatory department shall supervise and inspect the third-party platform of medical device online trading service at least once a year and the online sales enterprise at least once every two years.

5. Supervise unqualified enterprises in sampling inspection. Focus on the investigation of unqualified enterprises of the same variety and unqualified enterprises of multiple varieties. Make full use of the means of quality supervision and sampling inspection of medical devices to find potential risk medical device manufacturers and products that need to be paid attention to, such as infusion pumps, disposable nasal oxygen tubes, nerve and muscle stimulators and other products. Deeply analyze the historical sampling data, mine the potential risks, and urge the enterprises to make practical rectification.

 

 

 

6. Adverse event monitoring indicates that there may be risk enterprises. Focus on the production enterprises and medical device products that may have serious problems found in adverse event monitoring, focus on checking whether the enterprise's quality management system operates effectively, check and confirm whether the products have potential quality and safety risks, and urge the enterprises to take targeted risk control measures.

 

 

 

7. Products and enterprises with frequent complaints and reports. Focus on injection of sodium hyaluronate, contact lenses, orthokeratology, radiofrequency skin hyperthermia, radio frequency ultrasonic lipid dissolving instrument, facial radiofrequency cosmetic instrument, artificial nose bridge implant, condom, spinal orthosis, juvenile myopia correction ophthalmology medical device, patch medical device, and medical cold compress sold under the name of "mechanical mask", and cold compress gel in the name of "toothpaste toothpaste". Dental desensitizer and other medical devices, comprehensively sort out the complaints and reports, and carry out follow-up investigation for enterprises that have completed investigation and disposal when necessary to ensure that the investigation and disposal measures are in place; For the problem clues that have not been investigated and disposed, carry out investigation in time to ensure that they are investigated to the end, verified and clarified, and effectively eliminate the hidden dangers of product quality and safety.

 

 

 

8. Innovative medical devices and related enterprises with conditional approval. The State Administration shall timely notify the list of relevant enterprises, and the provincial drug regulatory departments shall focus on the operation of the quality management system self inspection, raw material procurement, production process control, finished product inspection and adverse event monitoring system of relevant enterprises, especially whether the production process related to innovative medical devices and product innovation points has been effectively controlled, and whether the conditions attached to conditionally approved products have been effectively implemented.

 

 

 

9. The medical device registrant entrusts the production. Focus on whether the medical device registrant has established and improved the quality management system, whether it has the ability to ensure the quality and safety of medical devices in the whole life cycle, whether it has effectively carried out the self inspection of the quality management system, and whether it has carried out strict quality management for the entrusted production enterprises.

For the inspection methods, the notice points out that we should actively innovate the inspection mode. Drug regulatory departments at all levels can carry out investigation and management by cross examination, joint inspection, entrusted inspection, "Internet plus supervision" and so on, and organize the inspection of key enterprises by "tracking inspection" and "third party assessment". If the self-examination is not in place, the rectification is not in place, and the main responsibility of the enterprise is not implemented in place, the drug regulatory department shall interview the legal representative of the enterprise, publish the interview results to the society, and seriously investigate and deal with violations of laws and regulations.

 

 

 

The notice also requires that medical device manufacturers, operating enterprises (including online sales enterprises), users and third-party platforms of online trading services should conduct a comprehensive self-examination according to the requirements, form a standing book for the potential risks found in the self-examination, formulate a rectification plan, and take rectification measures in time to eliminate the potential risks. The self-examination form, rectification plan and implementation of rectification measures shall be submitted to the local drug regulatory department before June 30. Drug regulatory departments at all levels have strengthened the inspection of key enterprises and varieties, and urged enterprises to "conduct real self-examination, make early rectification, pay attention to management and ensure quality". Form a long-term mechanism and comprehensively improve the level and ability of supervision.

 

 

 

According to the data of the State Food and drug administration, by the end of 2019, there were 593000 class II and class III medical device operating enterprises in China, of which 347000 were operating only class II medical device products, 69000 were operating only class III medical device products, and 177000 were operating class II and class III medical device products at the same time. This also means that the next 590000 medical equipment enterprises will face a big test.