Disposable medical gloves and other 3 kinds of national medical equipment were sampled | 8 batches failed

Medical Network April 20 News reporter learned from the State Drug Administration, a few days ago the State Drug Administration issued a notice on the release of national medical device supervision sampling results (No. 1) (No. 11 of 2018).

It is reported that this sampling is the original national food drug The General Administration of Supervision and Administration organized a one-time use of nasal oxygen tubes, a one-time use of medical rubber examination gloves, and three batches of medical electronic thermometers 38 batches (Taiwan) of products were supervised spot checks, a total of 8 batches (Taiwan) products do not meet the standard requirements.

First, the items being sampled do not meet the requirements of the standard medical instruments Products, involving 6 enterprise The 2 varieties of 7 batches. Specifically:

Disposable nasal oxygen tube 4 companies 4 batches of products. Jiangsu Jiangyang Special Rubber & Plastic Products Co., Ltd., Suzhou Sunyuexing Plastics Co., Ltd., Yangzhou Jikang Medical Instruments Co., Ltd. each batch of disposable nasal Oxygen tube, sealing performance does not meet the standard requirements; Yangzhou Star Medical Equipment Co., Ltd. produced a batch of disposable nasal oxygen tube, smoothness does not meet the standard requirements.

Disposable medical rubber inspection gloves 2 companies 3 batches of products. 2 batches of disposable medical rubber inspection gloves produced by Robust Medical (Huanggang) Co., Ltd., the size does not meet the standard requirements; Jilin Jinhao Medical Devices Co., Ltd. One batch of disposable rubber gloves for medical use, size, tear force before aging, and tear force after aging do not meet the standard requirements.

2. The items to be sampled are labelled, the instructions and other items do not conform to the medical device products specified in the standard, and involve 1 set of 1 variety of 1 enterprise, which is specifically:

Medical electronic thermometer 1 company 1 product. Dongguan City Jian Bao Electronic Technology Co., Ltd. production of a medical electronic thermometer, equipment or equipment components outside the mark does not meet the standard requirements.

3. The medical equipment products that meet all the requirements of the sampling inspection project involve 30 batches of 30 varieties of 26 companies (Taiwan).

For the products not conforming to the standards found in the above sampling inspections, the former State Food and Drug Administration has asked the provincial food and drug supervision and management department where the enterprise is located to urge related enterprises to follow the "Regulations on the Supervision and Management of Medical Devices" and the "Measurement on the Recall of Medical Devices". Regulation Regulatory requirements do not meet the sampling check standard The product is subject to risk assessment, the level of recall is determined based on the severity of the defect in the medical device, and the product is recalled and recalled publicly.

At the same time, the company should be ordered to identify the cause of product non-conformity as soon as possible, formulate rectification measures and rectify them on time, and report the relevant disposal status to the public before April 28, 2018, and report the relevant situation to the local food and drug administration at the provincial level in a timely manner. department.