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    38 items of medical instruments are not qualified

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    In order to strengthen the supervision and management of the quality of medical devices and ensure the safety and effectiveness of the use of medical devices, the former State Food and Drug Administration organized supervision and spot checks on 12kinds of 467 batches of products, including disposable aseptic surgical film, ultrasound Doppler fetal monitor and medical surgical mask, totaling 38 batches of products. It does not conform to the standard. The details are as follows:

    1. Medical device products that are not in conformity with the standards of the selected items involve 26 batches of 9 varieties of 19 enterprises.

    Specifically:

    (1) Five batches of products from three enterprises that use aseptic surgical membranes at one time. One batch of disposable sterile surgical film produced by Chun'an County People and Medical Supplies Industry and Trade Co., Ltd. in Zhejiang Province does not meet the standards; three batches of disposable medical adhesive film surgical towel produced by Jiangxi Kemei Medical Instrument Group Co., Ltd. do not meet the standards; Hangzhou Xinhao Medical Department One batch of sterile surgical membranes produced by Technological Co., Ltd. do not meet the standard requirements for water vapor permeability and extensibility (extensibility and permanent deformation).

    (2) Semiconductor Laser Therapeutic Machine, one enterprise and one product. Limmer Laser GmbH produced a semiconductor laser therapeutic instrument (agent: Beijing Xinweitai Trading Co., Ltd.), the emergency laser terminator does not meet the standard requirements.

    (3) Vertical steam sterilizer 1 product of an enterprise. A vertical pressure steam sterilizer manufactured by Shanghai Boxun Industrial Co., Ltd. Medical Equipment Factory does not meet the standards.

    (4) Two batches of medical surgical masks produced by two enterprises. Each batch of surgical masks produced by Xinxiang Huaxi Sanitary Material Co., Ltd. and Shijiazhuang Kangan Medical Devices Co., Ltd. did not meet the standard requirements for gas exchange/pressure difference (p).

    (5) Four enterprises and four products of high potential therapeutic equipment. One high voltage potentiometer (agent: Ningbo Silver Medical Devices Co., Ltd.) produced by Medical Electronics Industry Co., Ltd., Guangzhou Okovi Electronics Co., Ltd. produced by a low-frequency high potential therapeutic machine, indicating lights and buttons, random documents do not meet the standard requirements; Hubei Yijiantang Science and Technology Co., Ltd. The input power of one potential therapeutic instrument does not conform to the standard; the symbols of one high voltage alternating electric field therapeutic instrument manufactured by Zhuhai Mingkang Electrical Equipment Co., Ltd. do not conform to the standard.

    (6) 8 batches of products from 5 enterprises using sterile vaginal dilators at one time. One batch of disposable aseptic vaginal dilators produced by Changchun Medical Polymer Co., Ltd., four batches of disposable aseptic vaginal dilators produced by Changzhou Shunfeng Plastic Co., Ltd., and one batch of disposable aseptic vaginal dilators produced by Xinxiang Huaxi Sanitary Material Co., Ltd., the residual amount of ethylene oxide is not up to the standard. Quasi-regulation: One batch of aseptic vaginal dilators produced by Henan Yadu Industrial Co., Ltd. and Henan Henan Henan North Sanitary Material Co., Ltd. can not meet the requirements of the standard.

    (7) Disposable sterile syringes (with needles) 1 batch of products from an enterprise. One batch of disposable sterile syringes with needles produced by Jiangsu Huada Medical Instruments Co., Ltd. did not meet the requirements of the standard.

    (8) Infusion pump (injection pump, analgesic pump, insulin pump) 2 enterprises 3 products. One medical injection pump and one infusion pump produced by Beijing Train of Thought High Medical Science and Technology Co., Ltd. do not meet the standard requirements for alarm; one injection pump produced by Guangzhou Huaxi Medical Science and Technology Co., Ltd. does not meet the standard requirements for input power.

    (9) One batch of orthodontic brackets produced by one enterprise. One batch of orthodontic brackets manufactured by Hangzhou Yahong Medical Equipment Co., Ltd. are not up to the standard in size (groove length, groove width and groove depth).

    2. The sampled items are medical devices which do not conform to the standard, such as labels, instructions and other items. They involve 12 enterprises with 5 varieties and 12 sets.

    Specifically:

    (1) Three products of three enterprises of ultrasound Doppler fetal monitor. One fetal/pregnant woman monitor manufactured by Philips Golden Kuwait (Shenzhen) Industrial Co., Ltd. does not conform to the standard, and the external marking and technical specifications of the equipment or components do not conform to the standard. The technical specifications of one fetal/mother monitor manufactured by Shenzhen Bessman Precision Instrument Co., Ltd. do not conform to the standard. Shenzhen Bangjian Biomedical Equipment Co., Ltd. produces an ultrasound Doppler fetal monitor. The external marks and technical specifications of the equipment or its components do not meet the standards.

    (2) Two products from two enterprises of medical ultrasonic nebulizer. One ultrasonic atomizer manufactured by Jiangsu Fulin Medical Equipment Co., Ltd. and one ultrasonic atomizer manufactured by Nanning Sanke Medical Devices Co., Ltd. do not meet the requirements of the standard.

    (3) Two enterprises and two products of semiconductor laser therapeutic machines. Limmer Laser GmbH (Agent: Beijing Xinweitai Trading Co., Ltd.) and Starcoman (Beijing) Technology Co., Ltd. produce one semiconductor laser therapeutic instrument each, the marking does not meet the standard requirements.

    (4) Three enterprises and three products of high potential therapeutic equipment. One high voltage potentiometric therapeutic instrument (agent: Ningbo Silver Medical Device Co., Ltd.) manufactured by Medical Electronics Industry Co., Ltd. of Zhuhai Medical Association, the external marking, operation instruction and technical instruction of equipment or equipment components do not meet the requirements of the standard; one potential therapeutic instrument, equipment or equipment manufactured by Wuhan Kangxi Science and Technology Development Co., Ltd. External marking of spare parts does not meet the standards; Zhuhai Mingkang Electrical Equipment has

    Published Date:12-01-2018  Viewed:
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