On December 23, the website of Guizhou Drug Administration published the notice of Guizhou drug administration on the flight inspection of the production, operation and use of medical devices in 2021. Through random sampling, Guizhou drug administration conducted flight inspection on 45 enterprises (5 manufacturing enterprises, 20 operating enterprises and 20 using units) in the production, operation and use of medical devices in nine cities (prefectures) and Gui’an New Area in four quarters, involving medical device manufacturers, operating enterprises and users for epidemic prevention and control, sterile and implantable medical device manufacturers Operating enterprises and users, distribution enterprises and users of selected products in centralized volume procurement, operating enterprises and users of medical devices that can be used for medical beauty, etc.
There were 45 units in this flight inspection, including 5 production enterprises, 20 operating enterprises and 20 users: 1 production enterprise did not carry out production activities after obtaining production license (Guizhou Shangjian qianpin Technology Co., Ltd.); One manufacturer was ordered to stop production (Guizhou Junjiang Industrial Co., Ltd.); 43 enterprises made rectification within a time limit and instructed the market supervision and Administration Bureau under its jurisdiction to urge enterprises to implement rectification.
Among them, the five manufacturers are Guizhou Angel Medical Equipment Co., Ltd., Guizhou Shangjian qianpin Technology Co., Ltd., Guizhou fuxianyuan Clothing Co., Ltd., Guizhou Kangqi Pharmaceutical Machinery Co., Ltd. and Guizhou Junjiang Industrial Co., Ltd.
The main problems in the inspection of the above enterprises are: (1) the implementation of the operation system of the production quality management system is not in place, and the batch production records provided are incomplete; (2) Batch production records are not matched with batch finished product inspection records; (3) The purchase records are incomplete, and the purchase records of main raw materials cannot be fully provided; (4) The warehouse management is chaotic, and some raw materials and finished products are not marked with location cards; (5) Incomplete equipment use and maintenance records.
The 20 operating enterprises are: Guizhou Zhixin Kant Medical Supply Chain Management Co., Ltd., Guizhou qiandakang medical device Co., Ltd., Guizhou huaruida Trading Co., Ltd., Guizhou Guangzhou Kingmed Diagnostics Group Co.Ltd(603882) Inspection Center Co., Ltd., Guizhou caihang Trading Co., Ltd., Guizhou Lilin Medical Technology Co., Ltd., Anshun jinfenghuang medical device Co., Ltd Shanghai Pharmaceutical holding Anshun Co., Ltd., Sinopharm holding Anshun Co., Ltd., Qiannan yuekang Technology Trade Co., Ltd., Sinopharm Guizhou Qiannan Co., Ltd., Guizhou xinhongkang Medical Instrument Co., Ltd., Guizhou Danhong Ankang Medical Technology Co., Ltd., Guizhou Gaocheng Medical Instrument Co., Ltd., Tongren Fantian Pharmaceutical Co., Ltd., Guizhou Bijie Pharmaceutical Co., Ltd Liupanshui Sante Pharmaceutical Co., Ltd., Sinopharm holding Qianxinan Co., Ltd., Qianxinan Siwei pharmaceutical chain Co., Ltd., and Qianxinan Hongtai Pharmaceutical Co., Ltd.
The main problems in the inspection of the above enterprises are as follows: (1) the person in charge of quality or the person in charge of quality management department is not on duty, and their responsibilities are not entrusted to corresponding personnel; (2) The purchase contracts and quality assurance agreements signed by some suppliers have expired; (3) No regular training for employees and no relevant training records; (4) The Thermohygrometer in the warehouse is not calibrated regularly; (5) Medical devices and non-medical devices in the warehouse are not stored separately; (6) There is no relevant return processing record for medical devices returned after sales; (7) Some medical devices stored in the warehouse are directly stacked on the ground; (8) No full-time or part-time personnel are assigned to take charge of after-sales management and adverse event monitoring and reporting.
The 20 users are Guiyang Aier Eye Hospital Group Co.Ltd(300015) hospital, Guizhou jinglang ophthalmic hospital, Guizhou plastic and oral cosmetic surgery hospital, Guiyang Xiuyan medical cosmetic hospital, Guiyang Yangming ophthalmic hospital, Nanming Meiyi Meiya oral clinic, Guizhou Provincial People’s Hospital, Guizhou Guangzhou Kingmed Diagnostics Group Co.Ltd(603882) inspection center, Zunyi Honghuagang District People’s Hospital, Renhuai people’s Hospital 302 Hospital of China Guihang group, Fuquan traditional Chinese medicine hospital, Fuquan first people’s Hospital, Longli County People’s Hospital, Guiding County People’s Hospital, Tongren people’s Hospital, Bijie first people’s Hospital, Hezhang County People’s Hospital, Hezhang Langlang stomatological clinic Co., Ltd., people’s Hospital of Southwest Guizhou Buyei and Miao Autonomous Prefecture.
The main problems in the inspection of the above units are: (1) the use quality management system of medical devices covering the whole process of quality management has not been established; (2) No incoming inspection records of medical devices or incomplete incoming inspection records; (3) The place where medical devices are stored is not equipped with temperature control equipment and there is no temperature data record; (4) Some medical devices are not regularly inspected and recorded according to the requirements of storage conditions and validity period; (5) The use records of implantable medical devices are incomplete; (6) No medical device maintenance and repair management system has been established, and there is no maintenance record of medical devices in the warehouse.
Guizhou Provincial Drug Administration said that during the flight inspection, the local market supervision bureau of the enterprise was required to send personnel to participate, and after the inspection, the inspection results were handed over to the local bureau to urge the enterprise to rectify. Through the inspection, the enterprise has enhanced its awareness of rule of law, responsibility, risk, quality, self-discipline and integrity, urged the enterprise to strictly implement the main responsibility, guaranteed the quality and safety of medical devices, and laid a foundation for promoting the high-quality development of medical devices in Guizhou Province.
(China Economic Net)
