Medical network on August 22 - in order to strengthen quality supervision and management of medical equipment, security of medical equipment products use is safe and effective, the administration of state food and drug supervision and management of the organization of medical oxygen concentrator (medical oxygen generator), dental non-noble metal alloy casting (including the PFM alloy) and other three varieties 155 (sets) of product quality supervision and checking. The results of the sampling inspection are hereby announced as follows:
1. The sampling inspection project does not meet the standard prescribed medical device products, involving 15 batches of 3 varieties of 9 medical device manufacturers. Specific as follows:
(a) medical oxygen concentrator (medical oxygen generator) 3 enterprises 4 products. 2 medical molecular sieve oxygen producing machines produced by Beijing zhongliancorui technology development co., LTD., the oxygen concentration status indicator is not up to standard; Jiangsu, associating medical technology co., LTD. 1 SD series medical molecular sieve oxygen generator, fuzhou kang medical instrument co., LTD production of 1 medical oxygen concentrator, the influence of back pressure does not conform to the prescribed standards.
(2) 1 batch products of 1 enterprise of dental non-precious metal casting alloy (including ceramic alloy). 1 batch of nickel-base casting alloys produced by Shanghai medical device co., LTD. Dental materials factory.
(3) 10 batches of products from 5 enterprises with sterile vaginal expander. 1 batch of disposable sterile vaginal expander produced by henan yantan industrial co., LTD. 1 batch of disposable sterile vaginal expander produced by hunan ping an medical science & technology co., LTD., the residue of ethylene oxide is not in accordance with the standard; Nanchang city fu kang medical instrument co., LTD., the production of 2 batches the disposable use asepsis vaginal dilator, resistance to deformation ability is not in conformity with the prescribed standards, one batch structural strength is not in conformity with the prescribed standards; Nanchang kang jie medical health products co., LTD., the production of 2 batches the disposable use asepsis vaginal dilator, appearance does not conform to the prescribed standards, one batch resistance to deformation ability is not in conformity with the prescribed standards; Changzhou xiaochun medical equipment co., LTD. Produced 4 batches of disposable sterile vaginal expander, 2 batches of appearance, 2 batches of ethylene oxide residue did not meet the standard requirements.
The above sampling inspection does not meet the specifications of the product. See annex 1.
2. The items that are identified by the sampling inspection project as labels and specifications do not meet the standards specified in the medical device products, and there are 5 varieties of 5 medical device manufacturers, which are specific to:
Medical oxygen concentrator (medical oxygen generator) 5 enterprises 5 products. Hangzhou chong wei air separation technology co., LTD., Beijing quanta jian xiang technology co., LTD., jiangsu jianghang medical equipment co., LTD., one of the production of medical molecular sieve oxygen generator, division (changzhou) electronics co., LTD. Production of 1 small molecular sieve oxygen generator, Shanghai's bright medical equipment co., LTD., production of 1 medical oxygen generator, external markers do not conform to the prescribed standards.
The above sampling inspection does not meet the specifications of the product. See appendix 2.
3. All the items of the sampling inspection project are in conformity with the standard set of medical device products, which involve the three varieties of 54 medical device manufacturers, 135 batches (table), see annex 3.
Four, found in the above sampling does not conform to the standard products, the state food and drug administration has asked enterprises to local food and drug supervision and administration authority in accordance with the regulations on the supervision and administration of medical devices and the food and drug supervision bureau general office notice on further strengthening medical instrument sample work for drug safety (food do machinery supervisor [2016] 9), to investigate the related enterprises.
Relevant dealing with medical device manufacturing enterprise does not conform to the stipulations of the standard products, does not conform to the stipulations of the standard project risk assessment, according to the severity of the medical equipment defect level of recall, is voluntarily recalling and public recall information. The food and drug administration department in the place where the enterprise is located shall supervise the recall of enterprises, and the recalled shall be ordered to be recalled. Provided is not in conformity with the standards of medical equipment products cause harm to human body or there is evidence that may endanger human body health, can take to suspend production, management, use of emergency control measures. The relevant provincial food and drug supervision and administration departments should urge enterprises to find out the reasons as soon as possible, formulate corrective measures and put them in place as scheduled. The relevant disposal situation will be released to the society before September 8, 2017.
Hereby notice.
Annex: 1. The national medical equipment sampling inspection does not meet the standard product list
