Drug Administration issued 2018 No. 2 medical device quality announcement

Pharmaceutical Network February 22 hearing to strengthen the quality supervision and management of medical devices to ensure the safe and effective use of medical device products, the State Food and Drug Administration organized radio frequency ablation equipment, medical cryogenic boxes, surgical blades and other 8 varieties of 65 batches (sets) Of the products were quality supervision sampling now sampling results announcement is as follows:

First, the sampling items are not in line with the provisions of the standard medical device products, involving three companies 2 varieties 3 batches. Specifically:

(A) one-time use of sterile vaginal dilators 2 companies 2 batches of products. Henan Hualin Medical Devices Co., Ltd. produced a batch of disposable sterile vaginal dilators, anti-deformation capacity, ethylene oxide residues Does not meet the standard requirements; Xinxiang Liqun Medical Devices Co., Ltd. produced a one-time use of sterile vaginal dilators, anti-deformation capacity does not meet the standards.

(B) of the surgical clothing 1 batches of 1 products. Henan Everest Medical Devices Co., Ltd. produced a batch of surgical gowns, resistance to microbial penetration, wet (product key areas), impermeability (product Key area) does not meet the standard requirements.

The above sampling does not meet the standard requirements of the specific circumstances of the product, see Annex 1.

Second, the sampling project for the identification labels, manuals and other items do not meet the standard requirements of medical equipment products, involving two companies 1 species 2 sets, specifically:

Medical oxygen concentrator (medical oxygen) 2 companies 2 products. Jiangsu Shuangsheng Medical Devices Co., Ltd. produced an oxygen machine, Shaanxi Electronic Technology Co., Ltd. produced a medical oxygen machine, the external tag Does not meet the standard requirements.

The above sampling does not meet the standard requirements of the specific circumstances of the product, see Annex 2.

Third, the sampling project All of the medical device products that meet the standard requirements involve 60 batches (sets) of 5 varieties of 29 enterprises, see Appendix 3.

Fourth, the relevant enterprises should carry out risk assessment of the products that fail to meet the standard requirements, determine the recall level according to the severity of medical device defects, take the initiative to recall the product and publicly recall the information, and at the same time, identify the cause of product failure and formulate rectification measures Rectification and reform in place on time, the disposal of the situation in the March 10, 2018 to the public, and promptly report the relevant circumstances to the provincial food drug Supervision and administration department.

Fifth, the sampling found in the non-compliance with the provisions of the standard products, the State Food and Drug Administration has asked the enterprise where the provincial food and drug administration in accordance with the "medical instruments Supervision and Administration Ordinance "and" General Office of the State Food and Drug Administration on further strengthening the medical device sampling inspection notice "(Food and Drug Administration supervision [2016] No. 9), the relevant enterprise Carry out investigation and handling, supervise the implementation of product recalls, investigation of unqualified causes, corrective measures and disclosure of information; products that cause harm to the human body or have evidence of possible harm to the human body health , They shall, according to law, take the emergency control measures of suspending the production, operation and use; if they need to suspend the import, they shall promptly make an administrative decision to the SAIC.The enterprises that fail to fulfill the above requirements shall, according to the law, be governed by the local food and drug regulatory authorities Serious investigation, the relevant information should be promptly made public.

Sixth, the implementation of the above, the relevant provincial food and drug administration in March 16, 2018 report to the Administration.

Special announcement.

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / lot number	Sampling unit	inspection entity	Does not meet the standard requirements
1	Disposable sterile vaginal dilators	Henan Hualin Medical Devices Co., Ltd.	Henan Hualin Medical Devices Co., Ltd.	Medium	March 02, 2017 170302	Henan Province Food and Drug Administration	Shanghai Medical Device Testing Institute	1. Anti-deformation ability; 2. Ethylene oxide residue
2	Disposable sterile vaginal dilators	Xinxiang Liqun Medical Devices Co., Ltd.	Xinxiang Liqun Medical Devices Co., Ltd.	Medium A translucent shaft rotation	170102	Henan Province Food and Drug Administration	Shanghai Medical Device Testing Institute	Anti-deformation ability
3	One-time use of surgical clothing	Everest Medical Devices Co., Ltd. in Henan Province	Everest Medical Devices Co., Ltd. in Henan Province	120 × 120cm Ⅱ type to strengthen Type B	May 21, 2016 160521SJ20000	Henan Province Food and Drug Administration	Shandong Province Medical Device Product Quality Inspection Center	1. Resistant to microbial penetration, wet (product key area); 2. Water barrier (product key area)

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / lot number / Serial number	Sampling unit	inspection entity	Does not meet the standard requirements
1	oxygen machine	Guizhou Kang Lok Technology Development Co., Ltd.	Jiangsu Shuangsheng Medical Devices Co., Ltd.	SS-3WB	20160623 160600001 160600149	Guizhou Province Food and Drug Administration	Sichuan Province Medical Device Testing Center	External markings
2	Medical oxygen machine	Shaanxi Minqi Electronic Technology Co., Ltd.	Shaanxi Minqi Electronic Technology Co., Ltd.	S3BPW	2017/04/25 20170406 AZ17Y040640	Shaanxi Provincial Food and Drug Administration	Sichuan Province Medical Device Testing Center	External markings

Food and Drug Administration

February 13, 2018