Medical network - on April 17, pay attention to the industry enterprises, the national work has started on sampling observation of quality of medical equipment. Compared with previous years, this year is not only the sampling scale, as well as unprecedented treatment of unqualified products.
Medical equipment the smoke is started, 68 varieties in dispute
On March 28, 2017 national medical instrument checking work can was held in Beijing.
Conference, this year will total organization of 68 kinds of security risk is high, the consumption of large, high social awareness of medical equipment products for quality checking. By the national and provincial two-stage sampling complement each other, forming regulation together, improve the sampling efficiency. To the unqualified products enterprise, also want to increase the investigation dynamics, supervise and urge the recall, and information disclosure.
In the start of the administration of drug safety after the meeting, the national many ShengJu has also launched the provincial sampling 2017 national medical devices.
Hainan province this year to undertake sampling, a total of 20 varieties of 40 batch, mainly relates to a use burette type infusion, metal bone screw and disposable venous blood collection and have a higher risk of medical equipment products. Before the end of may this year are expected to complete sampling task.
Anhui province will undertake the task of 43 varieties 120 batches sampling, is expected to also all finish at the end of may.
Hubei province will take six product checking tasks, specific include: ultrasonic doppler fetal monitoring equipment, medical ultrasonic atomizer, semiconductor laser therapy unit, disposable medical rubber examination gloves, cholesterol test reagents, the disposable protective clothing.
27 varieties to oversee a total of 64 products in yunnan province, including surgical blade 17 batch, infusion pump, injection pump, analgesia pump, insulin pump) 11 group, etc. As planned, all sampling work will be completed before the end of November.
The Tibet autonomous region sampling varieties include: metal bone screw, surgical blade, nerve and muscle stimulator, electric wheelchairs, respiratory tract with catheter (sputum suction tube), balloon dilatation catheter, drapes, gown, one-time use of nasal oxygen tube, disposable burette type infusion sets, disposable venous blood collection needles, disposable use asepsis operation film, disposable medical rubber examination gloves, medical electronic thermometer, disposable infusion sets, disposable use asepsis vaginal dilator. The sampling work to finish on June 1.
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According to the relevant notice, the object of the medical equipment quality to sample is not only the business enterprise, and the use of units, namely medical institutions at all levels. From purchase to check its for sale, with medical equipment products, whether there is a quality is not qualified, and label instructions do not conform to the standards stipulated by the problem.
Fly, restrictions on purchasing, unqualified products unprecedented penalties
And compared with previous years, the 2017 countries take efforts of medical equipment is also increased. Performance is one of the "increase the funds investment, expand the scale of sampling observation". Another big public the results of sampling inspection and disposal of unqualified products.
First of all, on the information disclosure, in 2017, the drug safety administration of national medical instrument quality announcement will strive to do a weekly period.
In 2016, the year is a total of 10 national medical instrument quality announcement, on average, less than a period of a month. This year, as of April 11, already released the seven, three recent period was also is sent every Monday.
Second, checking out the unqualified products production enterprises, will be covered by flight tests. This is in the national YiXie send out messages of the new supervision meeting.
In 2017, the state administration of drug safety will be on the basis of summarizing the 2016 fly inspection experience, arrange of taxation and ShengJu two level flight check. Provincial inspection of objects including: for two-stage sampling observation unqualified products production enterprises, do the whole flight check, and all inspection results publicly on the Internet.
Countries after smoking, unqualified products production enterprises must fly, this is new rules this year.
In addition, in 2017 also carried out centralized purchasing of medical equipment of the year, the national sampling check the unqualified products, is in accordance with the relevant provisions to be included in the record, limit or cancel the net purchase. The smoke in expanding scale, in scope are expanding, the predicament of buying and selling in the unqualified products will also be more clearly.
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