In the related accidents caused by medical apparatus and instruments, 60% ~ 70% is caused by improper use medical devices, such as infusion pump improper operation lead to poisoning patients, lead to excessive dose radiation instrument of improper use.
In case of improper use, medical apparatus and instruments make use of the most controversial, also lack enough attention.
A, make use of make use of the current situation analysis of medical apparatus and instruments, refers to the medical equipment use behavior is beyond the medical device registration 'product scope'.
The 'scope' defines the scope of application of medical apparatus and instruments, applicable people and the suitable place, etc.
Medical apparatus and instruments of scope of use according to the requirement of the regulations on the supervision and administration of medical devices, medical apparatus and instruments were marked at the time of registration, the applicable scope of the clear but often appear in actual application are beyond the scope of use.
Medical apparatus and instruments of applicable people use medical devices should have definite applicable people crowd and taboos.
Hospital in medical practice, expand the crowd scope mainly has the following several aspects: (1) will only be used in equipment is used for the whole population;
(2) check prior to patients with comprehensive understanding, ignoring is contraindicated in patients with.
Medical apparatus and instruments of application places using the use of medical equipment has certain environmental standards, to meet the established temperature and humidity, ventilation, electromagnetic environment, such as radiation protection requirements.
Part of the hospital neglect the corresponding provisions in the construction, causing medical equipment application places use.
Second, make use of 'yes' and 'off' is different from other types of improper use, medical apparatus and instruments for make use of their more experienced medical staff, and most of the time to make use of knowledge, some even in specific clinical practice according to have experience and skills to the existing 'reflection' and to explore the treatment process of diagnosis and treatment methods.
Pay medical devices, pharmaceutical field manual medicine is also common problems in clinical drug treatment.
Query to exceed manual medicine related research has not simply will exceed manual medicine as unreasonable, but in the evidence-based evaluation of existing super manual drug laws, regulations, policies, guidelines, on the basis of pointed out that the continuous development of medical practice and drug instruction content updates slow the contradiction between the two is the description of the main causes of drug use behavior inevitably.
Although some super specification relieves the conventional drug treatment when some disease or individual without effective treatment drug, but exceed manual medicine has many hidden dangers.
Drug use is not the same as super specification and the rational use of drugs, but not often exceed manual medicine as the form of expression for the rational use of drugs.
Super specifications the effectiveness of the drug for the treatment of specific diseases and individual groups with no clear use based on the contradiction between the risk of be solved.
Of super specifications than medication, medical apparatus and instruments make use of more complex, relatively few studies have been conducted.
'Mountain' in the medical device regulatory can draw lessons from.
For example, can be the reference drug formulation related products super instruction using expert consensus;
In order to prevent the medical information asymmetry, beyond signed when using patients' informed consent;
Reference system for the rational use of drugs and medical equipment fair use system regulation;
Improve the monitoring report system function, increase the risk early warning function, improve the quality of the report, etc.
Three, make use of technical evaluation of enlightenment in September 2017, medical institutions in guangdong province centralized reported 8 cases of fallopian tube catheterization medical instrument fracture in patients with suspected adverse event reporting.
After investigation, the product has clinical scope of usage.
Combined with the example above, medical apparatus and instruments make use of risk not only in terms of regulation, also has some enlightenment for technical review link.
To better control risk, but also should pay attention to the following questions: (1) product risk analysis should cover material, design, distribution, storage, as well as the clinical use of each link;
(2) production enterprises should grasp the clinical use of products, there is a new method of use or anticipated for the clinical treatment, such as changing support should be timely reported to the relevant product registration information, such as not to support the corresponding risk management measures should be taken;
(3) product instruction for clinical use of the warning still need further perfect, such as fallopian tube catheter products should prompt to use after inspection on product integrity, etc. ;
(4) the standards and improve space, such as fallopian tube catheter can be further defined in the standard classification, for imaging and dredge the products on the technical indexes such as breaking power clear low respectively.
In a word, make use the medical apparatus and instruments in certain areas, has a reasonable space.
However, medical apparatus and instruments related laws and regulations is not clearly defined.
To better guard against adverse events, still need to production enterprise, regulatory, clinical use of units set up more perfect communication mechanism, to develop related products make use of expert consensus, perfect the risk analysis and reasonable assessment of residual risk, reduce the incidence of adverse events to the greatest extent.
This article from the 'China medical equipment information network'