Focus on 315 medical device complaints increased by more than 17 times

Medical Network News on March 18 is another year of 315, and another year of rights protection
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The 2021 "March 15" Gala will be broadcast on China Central Radio and Television Station
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The theme of this gala is "Boosting Consumption from the Heart".
It is hoped that through the power of integrity, everyone can live their ordinary lives happily, steadily increase their consumption power, improve the consumption environment, and enable residents to consume willingly and constructively.
A more transparent, more honest and trustworthy consumer market
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And medical treatment once again became a hot topic in this evening
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According to CCTV reporters, relevant search engines ignore their own regulatory responsibilities and allow false medical advertisements to be posted on the search platform.
Both UC Browser and 360 Search were named by CCTV
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In the "Analysis of the Acceptance of Complaints by the National Consumers Association in 2020" published by the China Consumers Association, according to the statistics on the acceptance of complaints by the National Consumers Association, in 2020, the National Consumers Association accepted 982,249 consumer complaints and resolved 749,317 complaints.
The resolution rate was 76.
29%, and the economic loss for consumers was RMB 1,563,930,000
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It is worth noting that among all the complaints, there were 439,351 commodity complaints, accounting for 44.
73% of the total complaints
.
Among the top ten consumer complaints hotspots in the commodity segment in 2020, medical devices rank among the top five.
Affected by the 2020 epidemic, medical device complaints have increased by more than 17 times compared with 2019
.
Figure 1: Top ten data sources for complaints in product segmentation areas in 2020: According to the nature of complaints on the official website of the China Consumers Association, the two prominent issues in the medical device category are price issues and quality issues.
Among 20051 complaints about medical devices , Price problems and quality problems accounted for 80% of the total complaints, price problems accounted for 56%, and quality problems accounted for 24%
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Figure 2: Data source of medical device complaints in 2020: China Consumers Association official website
　　1.
The short-term concentrated outbreak of complaints about sanitary and anti-epidemic supplies was
mainly affected by the outbreak of the new crown epidemic in early 2020.
Sanitary and anti-epidemic supplies such as medical masks and disinfectants have become hot spots for complaints.
Among them, the main complaints of consumers are: First, product quality is unqualified.
Some operators pretend to be shoddy and sell masks, disinfectants, and alcohol as counterfeit or "three noes" products
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Second, some operators are driving up prices, causing the prices of anti-epidemic supplies such as masks, alcohol, and thermometers to rise, and illegally making huge profits
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The third is the delay in delivery of anti-epidemic products purchased online, and even frequent cut orders
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Fourth, epidemic prevention products are sold through WeChat groups and Moments, and the purchase channels and product quality are not guaranteed
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Fifth, some operators confuse the efficacy and usage scenarios of ordinary masks, disposable medical masks, medical surgical masks, and medical protective masks to deceive consumers
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According to the report "Consumer Product Quality Complaints During the New Crown Period", more than 90% of complaints related to protective masks were made
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Consumers protective masks class products focus mainly concentrated in the mask is a regular product, if quality problems, the price is reasonable, timely delivery, and other protective effect whether the target
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Followed by the alcohol supplies, accounting for 4.
3%, including 75% rubbing alcohol concentration, alcohol swabs and the like
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Temperature measurement products is one of the main buyers of consumer goods, accounting for 1%, mainly for ear thermometers, forehead thermometer, infrared thermometer
.
2.
Reviewing medical device complaint cases, quality is a big issue Reviewing medical device complaints cases in various regions, quality issues have been mentioned many times
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As a medical device field closely related to the lives and health and safety of ordinary people, incidents such as the use of expired medical devices, the sale of fake masks, and the management of medical devices without qualified documents are chaotic and numerous, which not only defraud the people of hard-earned money, but also seriously endanger lives.
Health, the following is a summary of the classic cases of consumer rights protection announced by the market supervision departments of various urban areas to see the focus of this year's medical device complaints:
　　1.
Use of expired medical devices
In June 2020, law enforcement officers of the Nanzhao County Market Supervision and Administration Bureau conducted a law enforcement inspection on a staff hospital of a factory in Henan and found that the hospital’s medical printing film, a disposable sterile self-destructing syringe with a needle 0.
1ml, disposable The use of a sterile pull-back fixed-dose self-destructing syringe with a needle of 0.
5ml has exceeded the effective date of use, and law enforcement officers have detained and investigated the court in accordance with the law
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The Nanzhao County Market Supervision and Administration Bureau ordered the hospital involved in the case to correct the illegal behavior and imposed a penalty of confiscation of expired medical devices and a fine of 25,000 yuan to the state treasury
.

　　2.
Sales of counterfeit 3M masks.

From January 21 to 26, 2020, Li Dong, the legal representative of Beijing Jinghai Kangbaixin Pharmaceutical Co.
, Ltd.
, together with Li Yuzhang and Luo Hanyi purchased “3M” and “9001” from Gaomi City, Shandong Province, etc.
More than 500,000 masks with the words were sold to pharmacies or individuals in Chaoyang District, Beijing and other provinces and cities .
The total amount involved was more than 4 million yuan.
Later, the Chaoyang District Market Supervision Administration of Beijing found involved in many pharmacies and other places in Chaoyang District.
There are more than 24,000 masks
.
In June 2020, the Beijing Chaoyang District Court found Li Dong and other three defendants guilty of selling counterfeit and inferior products in the first instance, and Li Dong, the legal representative and general manager, was sentenced to 15 years in prison
.

　　3.
Dealing with medical devices without qualification documents.

In February 2020, the Houma City Market Supervision Administration inspected Tongren Pharmaceutical Co.
, Ltd.
according to the report and found that the company’s "Piaoan" brand disposable masks had no qualification certificates.
File
.
Tongren Pharmaceutical Co.
, Ltd.
constituted an illegal act of failing to implement the purchase inspection record system in accordance with the regulations and operating medical devices without conformity certification documents
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According to the "Regulations on the Supervision and Administration of Medical Devices", an administrative penalty of 30,000 yuan was imposed
.

　　4.
Pharmacies drive up device prices.

On January 26, 2020, the Market Supervision Bureau of Luyang District received a consumer complaint that the price of 3M masks sold by Hefei Guangshanyuan Pharmacy Co.
, Ltd.
at No.
421 Jinzhai Road, Hefei City was as high as 30 Every dollar, the bureau immediately sent law enforcement officers to the pharmacy involved to conduct on-site inspections
.
During the investigation of the case, not only did the parties not cooperate with the investigation, they also fabricated the purchase cost and provided false evidence materials
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It was found out that the parties’ fictional purchase cost of the 3M masks sold was in a situation of driving up prices
.
On February 13, 2020, the Luyang District Market Supervision Bureau imposed a fine of 350,000 yuan on the parties in accordance with relevant regulations
.

　　5.
False promotion of product efficacy
Shanghai Min En Medical Devices Co.
, Ltd.
invites lecturers to conduct so-called "health public welfare lectures" in the name of "Shanghai Five Entry Health Education Center"
.
The company’s sales staff have no medical experience and qualifications.
During the lecture, they took the opportunity to use the "Wein" brand low-medium frequency electronic pulse therapy instrument, "Nianli" brand hydrogen and other products as teaching aids for repeated live demonstrations, falsely promoting the product's efficacy and claiming that Treatment of frozen shoulder, cervical spondylosis, varicose veins, hypertension and other diseases
.
The Shanghai Municipal Market Supervision Bureau ordered the company's behavior to violate the provisions of the Consumer Rights Protection Law and imposed an administrative penalty of more than 610,000 yuan on the parties in accordance with the law
.

　　3.
Taking multiple measures simultaneously to strengthen the quality supervision
of medical devices.
Facing a large number of medical device quality complaints, the supervision of the medical device industry is gradually improving, and higher requirements are put forward on the supervision methods and strengths.

.
During the epidemic, in order to protect more lives, health and safety, the State Food and Drug Administration comprehensively strengthened the quality supervision of medical equipment for epidemic prevention and control, and carried out tests on new crown pneumonia virus detection reagents, medical masks, medical protective clothing, ventilators, infrared thermometers, etc.
A series of supervision measures have been adopted for important materials for epidemic prevention and control
.
One is to strengthen supervision and inspection
.
Strengthen the supervision and inspection of key links such as raw material procurement and production process control of production enterprises , and urge enterprises to organize production in strict accordance with legal requirements and standards
.
For the problems found, order the company to make rectifications in place, resolutely prevent substandard products from entering the market, and ensure the quality and safety of medical devices from the source
.
The second is to strengthen quality inspection
.
Carry out various forms of inspections, including emergency registration inspections, emergency evaluation inspections, and supervision and sampling inspections for epidemic prevention and control medical devices
.
The third is to strengthen supervision and inspection
.
The State Food and Drug Administration and the General Administration of Market Supervision have selected a number of capable law enforcement personnel to go to key provinces across the country to supervise and inspect the quality supervision of medical devices for epidemic prevention and control
.
The fourth is to severely crack down on violations of laws and regulations
.
Eight departments including the State Food and Drug Administration jointly organized a severe crackdown on illegal activities in the manufacture and sale of counterfeit and inferior medical devices, and effectively guaranteed the quality and safety of prevention and control of medical devices
.
The investigation and handling of relevant cases has been published on the website of the State Drug Administration
.
The fifth is to disclose the registration information in a timely manner
.
The relevant registration information of the approved products will be published on the website of the State Drug Administration, and updated in a timely manner based on the approval status, to provide a reference for purchasers to choose, and to facilitate the relevant departments to carry out export supervision work
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　　Concluding remarks
In the 31 years since the establishment of the 315 party, from the shady production of dentures in 2016, to the three-no orthokeratology lens (OK lens) in 2017, from the medical waste black industry in 2019, to the problematic hygiene and epidemic prevention products this year, "The Honest" The way of heaven is also the way of honesty and the way of people.
" From anti-counterfeiting and rights protection to exposing industry ills, from maintaining consumer safety to continuing to pay attention to the field of medical safety, as a field closely related to life, health and safety, all aspects of medical equipment No blemishes are tolerated
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With the support of national policies and the booming wave of medical devices, we hope that companies will not forget their original aspirations, keep moving forward while controlling the quality of the devices, and continue to devote themselves to serving humans and citizens with high-quality local medical device products.
Trusted product
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