Imported medical equipment quality and safety

Medical instruments have a bearing on people's livelihood and medical problems. Medical equipment in China, especially on high-end equipment, is heavily dependent on foreign countries. Recently, a hospital in Qinghai Province reported the import of three hemodialysis devices and one set produced by B.Braun Avitum AG of Germany. Continuous blood purification system. During the process of on-site inspection by the Inspection and Quarantine Bureau of Qinghai Province, this batch of imported medical equipment was discovered to have the following potential safety hazards: The warning text on the Chinese label of the equipment did not meet the national standards. The warning text "No use in flammable anesthetic atmospheres" on the four devices is affixed to the back of the device, and the characters are small, the operator is not easy to identify, and the warning words are not in accordance with the requirements of national safety technical standards. In the case of attachment, the operator is prone to illegal operation and there is a potential safety hazard. This problem does not comply with clause 6 of Article 6 of the Medical Electrical Equipment Part 1: Safety General Requirements of GB 9706.1-2007 on "When used in warnings, guidelines, or diagrams: Placed in a prominent place and in operation The person with normal vision can see clearly.

In order to ensure the quality and safety of imported medical equipment, Qinghai Inspection and Quarantine Bureau has adopted the following measures to ensure safety: First, in response to problems found in import inspections, it promptly issued corrections to the recipients/consignees and manufacturers, requesting them to take technical measures. , In accordance with relevant standards in China to rectify existing problems, eliminate equipment safety hazards, and verified by technical personnel before equipment installation and commissioning. The second is to inform the manufacturer in writing that the medical equipment exported to China should fully consider the requirements of China's relevant laws and regulations and safety technical standards at the stage of product design and manufacture, and ensure that the quality and safety indicators of the product can meet China's mandatory regulations. Berenger-Aidon (Shanghai) Co., Ltd. promised to rectify the equipment that does not meet the standard requirements within a time limit. According to the company's reported information, Qinghai region imported a total of 44 similar equipment. Qinghai Inspection and Quarantine Bureau has asked the company to first notify the user of the relevant issues in the use of the process, and then as required to carry out rectification. The third is to notify the health department of Qinghai Province about the potential safety hazards of the imported medical devices, and at the same time to deploy special inspection teams to ensure the safety of medical devices manufactured by B.Braun Avitum AG in the Qinghai Province. Conduct a thorough investigation to eliminate potential safety hazards.

In view of the safety and quality problems existing in the above-mentioned hemodialysis devices and continuous blood purification systems may cause safety accidents during use, the Qinghai Inspection and Quarantine Bureau shall promptly report to the AQSIQ to investigate the quality and safety of the above-mentioned equipment and similar products nationwide and eliminate safety. Hidden dangers, and issuing warning notices depending on the situation. At the same time, it is recommended that Braun Adolescent (Shanghai) Co., Ltd. implement an active recall throughout the country and carry out rectification as required to eliminate potential safety hazards.