Sphygmomanometer, fat loss meter, contact lens: how can the public use it safely?

　　Xinhua News Agency, Beijing, October 25 -

　　Xinhua News Agency reporters Zhao Wenjun and Wang Kun

　　"Double 11" is coming soon, ranging from contact lenses and thermometers to sphygmomanometers and fat loss meters. Have you added these commonly used health and body products to the "shopping cart"?

In fact, these products belong to the category of medical devices. People are prone to misunderstandings when buying and using them. They need to learn to identify product quality and ensure safe use.

The "National Medical Device Safety Publicity Week" sponsored by the State Drug Administration closed on the 25th to popularize common sense of safe use and protect public health.

For products such as blood pressure monitors, check the registration number

　　Chen Shuqin, a resident of Mingrixingcheng Community, Economic and Technological Development Zone, Qinhuangdao City, Hebei Province, is 60 years old this year. Due to high blood pressure, she asked her child to buy an electronic sphygmomanometer from the Internet. After several tests, the results were different, and she went to the drugstore for testing Several times, there are still errors.

　　"Choose a sphygmomanometer and blood glucose meter. There are many brands. The key is whether it can measure accurately and whether it can be used." Chen Shuqin said that many elderly people expressed their opinions on the accuracy and service life of sphygmomanometer products. doubt.

　　Kangtai Medical System (Qinhuangdao) Co., Ltd. is a medical device manufacturer. Wang Hui, the project manager of the company’s R&D center, introduced that a qualified electronic sphygmomanometer needs more than 20 production processes, including the selection of raw materials, the production of substrates, From the assembly of the machine to the product packaging and storage, it needs to be inspected one by one, and a second random inspection is carried out before leaving the storage.

　　The person in charge of the Medical Device Technology Review Center of the State Food and Drug Administration introduced that some common products such as electronic sphygmomanometers, electronic thermometers, ultrasonic nebulizers, household ventilators, and some physical therapy equipment are all medical devices.

　　"Medical devices approved for listing will have a registration certificate or filing certificate. Although consumers cannot see this certificate, they can find the corresponding registration certificate number." The person in charge said that consumers need to write the product label and manual. Or find it on the product packaging and check it on the official website of the State Drug Administration. If the certificate number is true, the search result will show the product registration information, which is consistent with the content on the registration certificate.

If the registration certificate number cannot be found and its legality cannot be judged, the purchase cannot be made.

Fat loss meter products need to be clear about the risks of use

　　"Comprehensive shaping, safe and non-invasive, comfortable and painless." Recently, a focused ultrasound fat loss instrument that claims to "lie down and lose weight" has attracted many beauty lovers.

This instrument uses high-energy focused ultrasound to destroy fat cells in the subcutaneous fat layer of the abdomen.

From the perspective of the product principle, it seems to be suitable for everyone, then, is the legendary "Breaking Fat Black Technology" really safe and effective?

　　According to the person in charge of the Medical Device Technology Review Center of the State Food and Drug Administration, focused ultrasound fat loss is different from general weight loss or weight loss methods. The use of focused ultrasound fat loss devices is a medical behavior and must be used by qualified clinicians in medical institutions , Otherwise the risk cannot be controlled.

　　my country implements classified management of medical devices in accordance with the degree of risk, from low to high in order of class 1, class 2, and class 3.

The risk of a class of medical devices is low, and many products can be used for home use.

Some of the second-class medical devices can be used for home use.

Class III medical devices have high risks of use, and a small number of them can be used for home use, but they should be used in strict accordance with the scope of product registration certificate and the requirements of the instructions.

　　At present, some businesses in the market use free experience to promote sales, exaggerating the scope or intended use of medical device products.

Most of these products are Class II and Class III medical devices, such as thermal physiotherapy instruments, meridian-tong treatment instruments and various laser treatment instruments.

A slight improper operation by consumers can easily cause safety hazards.

　　Zhang Yong, director of the Pharmaceutical and Medical Device Supervision and Management Unit of the Market Supervision Bureau of Ningjin County, Hebei Province, said that products such as massage devices and skin beautification devices use power as power to drive the machines during use. Such products are called "active medical devices." There is a higher risk in use. It is recommended that consumers buy from legal medical device operators and manufacturers.

Online shopping of contact lenses and other products need to be cautious

　　In recent years, cosmetic contact lenses and contact lenses have been favored by consumers. Not only are there a wide variety of products, but online sales have also become the mainstream. The quality of products sold by various online shopping platforms and micro-businesses is mixed, which makes consumers almost a challenge when shopping. eye.

　　Zhang Kai, deputy chief of the Medical Device Supervision and Management Section of the Market Supervision Bureau of Xingtai City, Hebei Province, said that contact lens products belong to the third category of medical devices with a high degree of risk.

When consumers buy contact lenses, they need to do a number of checks to determine whether they are appropriate to wear and which contact lenses to wear. Online shopping is not recommended.

　　my country has clear regulatory requirements for medical device network operations.

In response to the unlicensed sales of merchants on some online shopping platforms and the sale of unlicensed medical devices and other online sales chaos, since this year, the State Food and Drug Administration has intensified its daily inspections of medical device network operators, and reported complaints and other channels. Promptly investigate clues of violations of laws and regulations.

　　Up to now, there are 268 third-party platforms for medical device online transaction services, and more than 97,000 medical device online sales companies across the country. The local market regulatory authorities have supervised and inspected third-party platform companies 180 times, ordered 87 corrections, and inspected more than online sales companies. 30,000 companies were ordered to correct 2,470 companies.

　　According to Zhang Wei, Director of the Medical Device Supervision Division of the Hebei Provincial Drug Administration, taking contact lenses as an example, the Hebei Provincial Drug Administration conducts special inspections on such high-risk medical devices every year.

Among them, epidemic prevention and control medical equipment, sodium hyaluronate for injection, sterile, contact lenses and other products are the key areas of supervision.

　　He suggested that when consumers purchase medical devices online, they should first check the qualifications of the seller, such as the medical device network operation record; secondly, check the legality of the product, such as the registration number and production license number; the last thing to pay attention to is certain Ask for bills or sales certificates.