Disposable medical gloves and other 3 kinds of national medical devices were sampled and 8 batches of unqualified

People's Daily Online, Beijing, April 19 (Xing Zheng) The reporter learned from the State Drug Administration that the State Drug Administration recently issued a notice on the release of the results of the national medical device supervision and sampling inspection (No. 1) (No. 11 of 2018).

It is reported that the sampling inspection was organized by the former State Food and Drug Administration to supervise and inspect 38 batches (sets) of products of three varieties, namely, disposable nasal oxygen tube, disposable medical rubber examination gloves and medical electronic thermometer, with a total of 8 batches (sets) of products not meeting the standards.

The annunciation displays as follows:

1. the medical device products whose sampling items do not meet the standards, 7 batches of 2 varieties from 6 enterprises are involved. Specifically:

Disposable use of nasal oxygen tube 4 enterprises 4 batches of products. Jiangsu Jiangyang Special Rubber and Plastic Products Co., Ltd., Suzhou Riyuexing Plastic Co., Ltd., and Yangzhou Jikang Medical Equipment Co., Ltd. produced one batch of disposable nasal oxygen tubes, and the sealing performance did not meet the standard requirements; Yangzhou Mingxing Medical and Plastic Equipment Co., Ltd. produced a batch of disposable nasal oxygen tubes, and the smoothness did not meet the standard requirements.

Disposable medical rubber examination gloves 2 enterprises 3 batches of products. The size of 2 batches of disposable medical rubber examination gloves produced by Robust Medical (Huanggang) Co., Ltd. does not meet the standard requirements. The size, breaking force before aging and breaking force after aging of a batch of disposable medical rubber examination gloves produced by Jilin Jinhao Medical Devices Co., Ltd. do not meet the standard requirements.

The 2. sampled items are medical device products whose identification labels, instructions and other items do not meet the standards, involving 1 variety and 1 set of 1 enterprise, specifically:

Medical electronic thermometer 1 enterprise 1 product. A medical electronic thermometer produced by Dongguan Jianbao Electronic Technology Co., Ltd., the external marks of the equipment or equipment components do not meet the standards.

3. sampling items all meet the standards of medical device products involving 30 batches (sets) of 3 varieties from 26 enterprises.

For the products found in the above sampling inspection that do not meet the standards, the former State Food and Drug Administration has required the provincial food and drug supervision and administration department where the enterprise is located to urge the relevant enterprises to carry out risk assessment on the products that do not meet the standards in accordance with the regulations on the supervision and administration of medical devices, and determine the recall level according to the severity of medical device defects, take the initiative to recall products and disclose the recall information.

At the same time, enterprises are ordered to find out the causes of unqualified products as soon as possible, formulate rectification measures and put them in place on schedule, announce the relevant disposal situation to the public before April 28, 2018, and report the relevant situation to the local provincial food and drug supervision and administration department in a timely manner.