Beijing medicines supervise the intersection of administration bureau and dawn bright sub jade medical equipment Song Li, branch office of west city, like medicines, have certain risk in using, especially with human body's contact, long term administration for a long time, put into the medical equipment in the human body. In the planting into medical equipment, dept. of orthopedics plants into the thing and occupies significant proportion. With the development at full speed in relevant disciplines such as biotechnology, material studying, mechanical manufacturing technology,etc. in recent years, clinical diagnosis and treatment technology of dept. of orthopedics are promoted rapidly, the clinical practice that dept. of orthopedics plants into the thing is more and more extensive. But is accompanied by a large amount of application of these planting into medical equipment, the bad incident of medical equipment that will be correlated with planting into the thing. Supervise majority of medical equipment in the catalogue especially medical equipment of planting into etc.. How raise the intersection of supervision and efficiency, lower the intersection of product and risk, stop the great accident take place? I think that improving should stride three major thresholds to supervise the mechanism. A registration management of threshold has not integrated world according to statistics yet, the market value of the planting of our country into medical equipment accounts for 1/4 of total market value of market of domestic medical equipment. The native manufacturing enterprise of our country mainly produces the planting into medical equipment of end in low end and part at present, such as fixed apparatus, artificial joint and medicine coronary artery support,etc. in partial fracture, but the low-level homogeneity phenomenon of the products is serious, the middle, advanced market is basically monopolized by transnational enterprises. And should change the products overall arrangement, accelerate industry upgrading, management must go ahead of the rest, among them manage with the source particularly - -Registration management, in order to duplicate each other. At present, the following problems mainly exist in the planting into registration management of medical equipment of our country: The product classification of our country was not integrated with world, practise and disconnect with medical treatment too. For instance, the intersection of overwhelming majority and ordinary the intersection of fracture and inner fixture ' Set a fracture on the board, nails, excellent, needle) It is a large traditional product, clinical practice has already had a history of several dozen years, its security is fixed compared with validity, define it for the second type lower apparatus of risk abroad, and our country includes it in the third type highest apparatus of risk, equate five with the pacemaker, peripheral support. In fact, body position, using history both at home and abroad where no matter it plants into of our country, it is the innovative products, the entering of planting all apparatus stipulates without science as the third type apparatus method too generally. The apparatus of our country registers the listing condition and has not carried on thinningly according to products attribute, registration demands not to treat with a certain discrimination. Use the international standard material as to the manufacturing enterprise, the design principle is similar, manufacturing process is close to the registered products that kept the same with expectancy use, 510k that U.S.A. adopts the substance to be equivalent is put on record the principle, European Union examines the quality system key elements of enterprises, fulfilling requirements can be listed. The above-mentioned country generally only requires enterprises to make collection and analysis of the medical literature, might not require enterprises to make and apply the clinical trial of the listing products. And our country stipulates, if enterprises have adopted generally acknowledging better raw materials, even if the design, craft and expecting the use does not change, also must do the clinical trial to the upgrading products, this kind of regulation is too inflexible. According to the investigation, the native enterprises of our country should finish one and products -like registration of market, generally need to go through time for more than 3 years, costs between several 100,000 yuan and several million yuan; Apply for a piece of innovative products, need 5 years or so. In European Union or U.S.A., enterprises apply for the registration of and equate the apparatus with the substance that has already appeared on the market, it generally only takes several months. In Britain, from new idea, design, make sample, get, permit, merchandize, only need 3 years generally of apparatus, its expenses which registers links are considerably less than our country too. In fact, a lot of products which plant the entering apparatus manufacturing enterprise in our country have not got the registered licence of our country yet, but already authorized, found a good sale abroad through CE of European Union, a few enterprises register the products in U.S.A., and then export back to our country. Threshold two medical equipment can can lack the tracing back to medical equipment person who is trace back to, process the situation, sales situation, operating position and follow the trail of to raw materials and part source, products of the medical equipment, can trace back to the production, sale, operating position of each concrete medical equipment, can use the patient's situation, and the bad reaction produced by this clearly. When the quality problem happens in the planting into or getting involved medical equipment, can recall and monitor the patient who has already used the question products the question products immediately. In addition, it can also take precautions against illegal activities, what has been reused, planting entering, getting involved medical equipment fake on medical equipment in can tracing back to in front of no their true colourses will be appeared at once. Can it is reported medical equipment of our country little relevant law of tracing back to etc., level low. At present except that some files have required for medical equipment, other the intersection of medical equipment and relevant laws and regulations can person who is trace back to go on regulation and requirement to medical equipment. Secondly, the medical equipment can not stipulate detailedly and not there is not corresponding penalty clause, carry out strength to require weakly. Meanwhile, the can be traced back toing information asymmetry of the medical equipment. Production, sale and use of medical equipment, supervising each side not communicating smoothly, the information known is different, only know which lot number or sequence number of products to produce such as the manufacturing enterprise, but does not know its sales situation and operating position; Managing enterprises only knows what lot number or medical equipment of sequence number is bought, but does not know its condition of production and operating position; The applying unit only knows which lot number or medical equipment of sequence number to buy, and does not know its condition of production and sales situation; Supervising the unit can only confirm the corresponding situation according to inspection. The asymmetry of information, has offered the opportunity for imitating the medical equipment and reusing the disposable medical equipment. Research and clinical trial are two stages before the bad incident rate of cognition reported low medical equipment of the threshold three is divided into clinic like medicines. But the medical equipment exists in clinic is tried out actually or proved time is short, it is little for example to count and range narrow and design and application easy to disconnect, employ, make a reservation inaccurate, long-term effect know and the applicable crowd chooses to lean towards the question of resting on etc., the defect of some recessiveness is only put in the products into the market, expand the scope of application, use clinically through a large amount of, go through and prove for a long time, find. To its security after this makes medical equipment follow and enter the market as medical equipment with the bad incident report after entering the market, validity follows the important links appraised. The reason for producing the planting into bad incident of medical equipment of dept. of orthopedics is comparatively complicated, summing up mainly has the following several respect: Inherent risk made in product design; Limitation studied before being listed; Misleading of the operation instruction; It is unstandard to produce and sell business administration; Products quality problem; Improperly use; The patient does not follow the doctor's advice or is injured unexpectedly. It is still a new concept that the bad incident of the medical equipment is monitored at home at present, relevant laws and regulations and regulatory file are still imperfect, medical worker And monitor the concept to the bad incident of the medical equipment? 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