Home medical equipment needs to be standardized: Dong'e Ejiao two sphygmomanometers on the black list
The State Food and Drug Administration has issued a report on the quality supervision and inspection results of six varieties of products, such as medical protective clothing, non-invasive automatic blood pressure monitor ( electronic blood pressure monitor ) and blood purification equipment, and three varieties of products have been inspected. Unqualified, involving 19 companies. Among them, two digital electronic sphygmomanometers produced by Aohua Medical Devices of Dong'e Ejiao were found to be unqualified for identification labels and instructions. Dong'e Ejiao products are famous on the black list In the recent National Medical Device Quality Announcement (No. 4, No. 12, 2016) issued by the State Food and Drug Administration, Dongya Ejiao Ahua Medical Devices Co., Ltd. (hereinafter referred to as “Yahua Medical Devicesâ€) The two digital electronic sphygmomanometers failed to qualify for the blacklist due to items such as logos. According to the announcement, the two unqualified digital electronic blood pressure monitor models of Ahua Medical Devices are DXW-2 and DXB-2 respectively, and the items such as identification labels and instructions are not in compliance with the standards. For the products found in the sampling that do not meet the standards, the Food and Drug Administration has requested the food and drug supervision and administration department of the locality to comply with the Regulations on the Supervision and Administration of Medical Devices and the Notice of the General Office of the Food and Drug Administration on Further Strengthening the Inspection of Medical Devices. Investigate and deal with related companies. At the same time, the Food and Drug Administration has ordered the relevant provincial food and drug supervision and administration departments to urge enterprises to ascertain the reasons as soon as possible, formulate rectification measures and rectify them on schedule, and the relevant disposal situation will be announced to the public before July 30. In order to understand the sales of the two products on the Ahua Medical Devices list in Beijing, Beijing Business Daily reporters visited the major pharmacies in Beijing and found no sales. Then the reporter contacted the IWA medical device sales staff to understand. The salesperson told reporters that the two products have not been produced since the beginning of this year, and there are no such products on the market. When asked why the production was discontinued, the salesperson said that "because the production cost is too high." In this regard, Shi Lichen, the head of Beijing Dingchen Medical Management Consulting Center, said that Ejiao itself is a health care product and is not very good at medical device management. According to the data, Iowa Medical Devices was founded in 1987 and reorganized by Dong'e Ejiao in April 2000. The newly established company has a registered capital of RMB 333,330, and the legal representative is Qin Yufeng, Chairman of Dong'e Ejiao. The company's main business is the production and sales of vitreous thermometers, electronic thermometers, electronic sphygmomanometers, blood glucose meters, medical plasters, medical adhesive plasters, and the shareholding ratio of Dong'e Ejiao is 36%. On May 21 this year, Dong'e Ejiao announced that it intends to transfer the equity of Ahua Medical Devices Co., Ltd., which is 36% of its shares, in accordance with the company's development strategy of focusing on blood, nourishing and health care business. In fact, as early as the beginning of 2010, Dong'e Ejiao had logged out of the information transfer of Ahua Medical Devices in the Beijing Stock Exchange. At that time, Dong E Ejiao also held a 60% stake in Iowa Medical Devices. At that time, the listing price was 16.8442 million yuan, and the reason for the transfer was also the non-main business exit. In the second half of 2013, Iowa Medical Devices increased its capital and shares, and Dong'e Ejiao's shareholding in Iowa Medical Devices was diluted from 60% to 36%. Home sphygmomanometer products have hidden dangers It is worth noting that in addition to the three medical disposable protective clothing, the remaining 21 items are all electronic blood pressure monitors. With the deepening of the concept of big health, more and more families choose to buy home medical devices such as electronic sphygmomanometers to understand their own physical conditions, which also makes the market capacity of home medical devices continue to expand, and more companies choose to enter home medical devices. market. However, with the continuous increase of the consumer market, the number of production enterprises is increasing, and the quality of some products is not up to standard. The quality of some home medical devices has become a hidden danger of current family health. The data shows that China's medical devices have developed rapidly in recent years, with sales growing from 17.9 billion yuan in 2001 to 255.6 billion yuan in 2014. Due to the high incidence of three high-grade chronic diseases, the domestic medical device market has developed rapidly. Sun Ningling, a professor at the Heart Center of Peking University People's Hospital, said that there are about 270 million patients with hypertension in China; one out of every four people aged 18 and over is a hypertensive patient; one in every 2-3 elderly people has high blood pressure. . Hypertension is a disease that is easy to find, easy to diagnose, and easy to treat. However, if it is not well controlled, it can easily cause severe cardiovascular and cerebrovascular diseases such as myocardial infarction, sudden cardiac death, and stroke. Therefore, many families choose to buy a home blood pressure meter to measure their blood pressure every day. Shi Lichen said that the state has strict auditing and regulatory standards for medical medical devices, but it has always been lacking in home medical devices. The technical content and production cost of home medical devices, especially electronic sphygmomanometers, are low. Various household sphygmomanometers, blood glucose meters, infrared ray instruments and other products are mixed, and many home medical devices enter the market without relevant approval number. "The quality of sphygmomanometers is a big problem for the pursuit of healthy people." Shi Lichen said frankly.
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