From the State Drug Administration was informed that a few days ago, the State Drug Administration issued a circular (No. 1) on the release of the results of national medical device supervision and sampling (No. 11 of 2018).
It is reported that the sampling is the former State Food and Drug Administration organized the supervision and sampling of 38 batches (units) of products of 3 varieties of disposable nasal oxygen tubes, disposable medical rubber examination gloves, medical electronic thermometers, ***8 batches (units) of products do not meet the standard provisions.
Circular shows the following:
A, was sampled items do not meet the standard provisions of the medical device products, involving six companies of two varieties of 7 batches. Specifically:
Disposable nasal oxygen tube 4 enterprises 4 batches of products. Jiangsu Jiang Yang Special Rubber & Plastic Products Co., Ltd, Suzhou Riyuexing Plastics Co., Ltd, Yangzhou City, Jikang Medical Equipment Co., Ltd. production of a batch of disposable nasal oxygen tubes, sealing does not meet the standard provisions; Yangzhou City, Star Medical Plastic Equipment Co., Ltd. production of a batch of disposable nasal oxygen tubes, the smoothness does not comply with the standard.
Disposable medical rubber examination gloves 2 enterprises 3 batches of products. Ltd. produced 2 batches of disposable medical rubber examination gloves, size does not meet the standard provisions; Jilin Jinhao medical equipment limited liability company produced a batch of disposable medical rubber examination gloves, size, tearing force before aging, tearing force after aging does not meet the standard provisions.
Two, the sampling program for the identification of labels, instructions and other items do not meet the standard provisions of the medical device products, involving a variety of 1 enterprise 1 unit, specifically:
Medical electronic thermometer 1 enterprise 1 product. Dongguan Jianbao Electronic Technology Co., Ltd. production of a medical electronic thermometer, equipment or equipment components of the external labeling does not meet the standard requirements.
Three, the sampling program all meet the standard requirements of medical equipment products involving 26 enterprises of three varieties of 30 batches (units).
On the above sampling found in non-compliance with the standard products, the former State Food and Drug Administration has required the enterprise location of the provincial food and drug supervision and management departments to supervise the relevant enterprises in accordance with the "supervision and management of medical devices regulations," "Medical Device Recall Management Measures" and other laws and regulations on sampling non-compliance with the standard product risk assessment, according to the severity of the defects of the medical device to determine the level of recall, take the initiative to recall, and the medical device recall level. According to the severity of medical device defects to determine the level of recall, take the initiative to recall the product and publicize the recall information.
At the same time, the company was ordered to ascertain the reasons for the unqualified products as soon as possible, formulate rectification measures and rectify them in place on schedule, announce the relevant disposition to the society before April 28, 2018, and report the relevant information to the provincial food and drug supervision and management departments at the location in a timely manner.
Medical device failure is really a big deal. I hope the country can be strictly investigated!