General Administration of Food and Drug Administration: 7 batches of 9 medical devices sampling failed

Pharmaceutical Network November 23 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 electro-acupuncture treatment device, drug fumigation treatment equipment 11 batches of 54 batches (Taiwan) Product quality supervision and 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 6 companies in 4 varieties 7 batches (Taiwan). Specifically:

(1) Body compression therapy equipment 1 companies for 1 set Biointerpress Systems, Inc. 1 batch intermittent air pressure meter (Attorney: Beijing Shuai medicine Technology Co., Ltd.), protective grounding, functional grounding and potential equalization do not meet the standard requirements.

(2) 2 sets of metal spine rods 2 batches of products Zhejiang Kehui Medical Devices Co., Ltd. produced 2 batches of spine internal fixation - rod system (connecting rods), the surface roughness does not meet the standard requirements; Suzhou Yan Rongbolter Medical Devices Co., Ltd. produced a batch of spinal internal fixation system, the appearance does not meet the standard requirements.

(C) of the medical surgical masks 1 batches of products 1. Guangzhou Luohua Medical Devices Industrial Co., Ltd. produced a one-time use of medical surgical masks, filtration efficiency does not meet the standards.

(D) Surgery List 2 companies 2 batches of products. JIDA Medical Devices Technology Co., Ltd. produced 1 batch of disposable surgical kits (in the single), tensile strength, dry state (product non-key areas) Meet the standard requirements; Nanchang Wei material Medical Devices Co., Ltd. produced a single-use single-time operation, tensile strength, dry state (product key areas), tensile strength, wet state (product key areas) standard regulation.

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

Second, the sampling items for the labeling, manuals and other items do not meet the standard requirements of medical equipment products, involving two companies 2 varieties 2, specifically:

(1) Electro-acupuncture treatment instrument 1 enterprise 1 set of products, Sichuan Hengming Science and Technology Development Co., Ltd. 1 set of acupoint treatment instrument, random documents do not meet the standard requirements.

(2) Body compression therapy equipment 1 companies 1 product Bio Compression Systems, Inc. 1 batch intermittent air pressure meter (proxy Person: Beijing Xiuhe Medical Technology Co., Ltd.), the controller and the instrument's mark, the random document does not conform to the standard rule.

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

Third, sampling all projects in line with the provisions of the standard medical instruments 33 products involved enterprise The 46 batches of 9 varieties (Taiwan), see Annex 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 as scheduled, the disposal situation announced to the public before December 6, 2017, and promptly report the relevant situation to the provincial food drug Supervision and administration department.

Fifth, the sampling found in the product does not meet the standard requirements, the State Food and Drug Administration has asked the provincial food and Drug Administration where the enterprise located in accordance with the "Medical Device Supervision Regulations" and "General Office of Food and Drug Administration on the further strengthening Medical device inspection work "(Food and Drug Administration supervision [2016] No. 9), the relevant enterprises to investigate and deal with, supervision of the enterprise product recall, the reasons for the non-conformities investigation, corrective measures and the implementation of the disclosure of information ; Products that cause harm to the human body or have evidence that may endanger the health of human beings shall, according to law, take emergency control measures of suspending the production, operation and use; and if they need to suspend the importation, they shall timely make administrative decisions to the SAIC. Where the above requirements are met, the provincial food and drug supervision and administration department at the locality to be investigated and dealt with shall be severely punished according to law, and the relevant information shall be disclosed to the public promptly.

Sixth, the implementation of the above conditions, the relevant provincial food and drug supervision and management department on December 10 report to the Administration.

Special announcement.

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / serial number	Sampling unit	inspection entity	Does not meet the standard requirements
1	Intermittent air pressure meter	Beijing Xiuhe Medical Technology Co., Ltd.	Bio Compression Systems, Inc. (Attorney: Beijing Xiuhe Medical Technology Co., Ltd.)	IC-1545-DL	/5000178	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center	Protective grounding, functional grounding and potential equalization
2	Spinal Fixator - Spike System (Connecting Rod)	Zhejiang Kehui Medical Devices Co., Ltd.	Zhejiang Kehui Medical Devices Co., Ltd.	100mm J2X04	2016-04-21 16190293	Zhejiang Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center	Surface roughness
3	Spinal Fixator - Spike System (Connecting Rod)	Zhejiang Kehui Medical Devices Co., Ltd.	Zhejiang Kehui Medical Devices Co., Ltd.	90mm J2X04	160307 16170029	Zhejiang Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center	Surface roughness
4	Spinal fixation system	Suzhou Yan Rong Bolt Medical Devices Co., Ltd.	Suzhou Yan Rong Bolt Medical Devices Co., Ltd.	Model: RSS Ⅲ type; Specifications: 5.5 × 200 bar	/16022026T	Jiangsu Province Food and Drug Administration	Beijing Medical Device Inspection Institute	Exterior
5	Disposable medical surgical masks	Nanxi Mountain Hospital of Guangxi Zhuang Autonomous Region	Guangzhou Lu Hua Medical Devices Industrial Co., Ltd.	Lace-type ear hanging expansion size (17.5 ± 1) × (17 ± 1) cm	December 24, 2015 20151224	Guangxi Zhuang Autonomous Region Food and Drug Administration	Shanghai Medical Device Testing Institute	Filtration efficiency
6	One-time use surgical bag single	Panjin Jin Wo Hospital	Jining City, up to medical equipment Technology Co., Ltd.	200 × 100cm	20151102/	Liaoning Province Food and Drug Administration	Beijing Medical Device Inspection Institute	Tensile strength, dry state (product non-critical area)
7	Single use of surgery alone	People's Hospital of Tibet Autonomous Region	Nanchang Wei material medical equipment Limited	Model: A type pad single; Specifications: 120 × 80	January 08, 2016	Tibet Autonomous Region Food and Drug Administration	Beijing Medical Device Inspection Institute	1. Tensile strength, dry state (product key area); 2. Tensile strength, wet state (product key area); 3. Sterility

Serial number	Mark the product name	Was spot checks	Marking manufacturers	Specification	Production date / serial number	Sampling unit	inspection entity	Does not meet the standard requirements
1	Meridian therapy instrument	Sichuan Hengming Technology Development Co., Ltd.	Sichuan Hengming Technology Development Co., Ltd.	HM6805-I-5	2016.03.20 1160302009	Sichuan Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center	random document
2	Intermittent air pressure meter	Beijing Xiuhe Medical Technology Co., Ltd.	Bio Compression Systems, Inc. (Attorney: Beijing Xiuhe Medical Technology Co., Ltd.)	IC-1545-DL	/5000178	Beijing Food and Drug Administration	Tianjin Medical Device Quality Supervision and Inspection Center	1. Controller and instrumentation tags; 2. Random files

Food and Drug Administration

November 7, 2017