Whether the medical equipment of the hospital safe? Who is responsible for the problem ? How to safeguard rights when the accident happen?
The newly revised"Medical Devices Regulations"established the most stringent regulatory system covering the whole process.And long before the"Regulations" release,the State Food and Drug Administration has already begun work on rectifying the cheap lead glasses medical device industry.From mid-March,for a period of five months of medical devices"Five remediation"special action,carried out in the country,focusing on regulation of medical devices registered false reporting,illegal production and illegal business,hype,the use of unlicensed products and so on.
Sampling,strong inspection can not be guaranteed,it lay hidden for safety Worked in the medical device industry more than ten years Mr.Xu believes that lack sophisticated technology medical device industry,the overall industrial backwardness,is an important cause of domestic medical equipment industry worse than abroad.But in Chinese Medicine Association of Medical Device Materials Branch Secretary Chen Hongyan seems that the threshold is too low,lax supervision,lazy Responsibility chaos as a result of the medical device industry is currently facing the biggest problem.
Under the existing regulations,all medical device companies need to apply to the competent agency for"Medical Device Manufacturing Enterprise License"before you can apply for production licenses in the local business sector.Before the products get out the factory,this should be carried out in the factory in the inspection,sampling and accept the country,after the quality standards in order to enter the hands of the operators,by their products to sales terminals.However,some small businesses ignore internal inspection,sampling escaped the country after he met the acceptance lax operators,it will lead to poor quality products all the way to the green,to the market. Director of Department of Peking University People's Hospital Equipment Shen Chen Yang told reporters,when the device enters into the use of medical institutions,belongs to the state measurement detection range must undergo a compulsory annual measuring and testing to ensure its quality.However,Mr.Xu said that in some grassroots small hospital,because of poor management,can not guarantee strong inspection once a year,causing a problem of extended service of medical devices,planted health risks to users.
Medical institutions,strong sense of responsibility for the patient to recover "Although the quality of medical equipment,related to the life and health,but in the rights,whether institutions or the people themselves,are not strong enough sense of Responsibility."For example,you bought a home therapy device,found the problem to find manufacturers,manufacturers may apart from anything else and then replace it give you,you would not bother to chase a responsibility;If you buy a mask,Band-Aid kind of low- value products,if found good,that is most readily throw away,even the manufacturers are not look for.In the medical institutions,large hospitals simply do not survive inferior equipment,and small organizations to buy quality if there are problems,that is,directly to the manufacturer for repair or replacement.Events occur as long as there is no real threat to the life,inferior products will be able to muddle through,the manufacturer will be able to avoid liability.
It is understood that after the implementation of the"Medical Devices Regulations"issued in 2000,10 years,with the development and changes in China's medical equipment industry,which is not suitable for development of the industry situation even more prominent.For example,it is responsible for the chase would not provide details on the terms of the lack of bad product traceability system.
The newly revised"Supervision and Regulation of Medical Devices"provides medical equipment enterprises,and use of medical equipment purchased should pass inspection documents the supplier qualification and medical equipment,establish inspection record system.The second class,third class medical equipment wholesale business as well as Class III medical devices retail business ventures,sales records system should also be established.Medical equipment unit shall keep the original data acquired Class III medical devices,and to ensure that the information traceability.
No matter what the problem is now in the presence of the medical device market,the new draft amendments are introduced to the industry on a"safety valve",the management of medical devices and drug control in the same position.Of course,the law,also need to be strictly enforced to ensure excellent products,anesthesia ventilator industry health. Production will be the focus of regulation violations
With the launch of the special action,the medical device industry consolidation horn sounded.The official said that for a false registration application behavior,the second will focus on remediation,Class III medical devices registration untrue behavior for the first time,carried out in accordance with the provisions of the second,three types of medical equipment for the first time to submit an application for registration of producers of information (focus is on clinical trials report) and verification of the authenticity of tissue samples of the production process,the registration link in the report focus on verification.
Production is also a violation of content regulation.Disposable infusion equipment,single-use catheters (package) does not meet the criteria for raw materials and did not seek sterilization,condoms without filing unauthorized commissioned production,hemodialysis concentrates not according to the standard factory inspection,etc.,will be the focus of regulation.
In the circulation,illegal operation and will be glued to commence remediation hype behavior.For example,experiential approach to unauthorized sales of the second,three types of medical equipment,unlicensed plain lead eyewear colored decorative contact lenses,hearing aids,did not seek storage and transport in vitro diagnostic reagents and other acts.Again,back pain,myopia,diabetes and hypertension sticking classes,physical therapy medical devices for illegal propaganda;without the approval or approval of the content of tampering unauthorized release illegal advertising,exaggerating the effectiveness and scope of the product;use of medical research institutes or specialists,patient name and image to do to prove the efficacy of advertising and other unlawful acts,etc..