Among the related accidents caused by medical devices, 60% to 70% are caused by improper use of medical devices. If the infusion pump is improperly operated, the patient is poisoned, and improper use of the radiotherapy device leads to excessive dose. In the case of various improper use, the over-range use of medical devices is the most controversial and lacks sufficient attention.
I. Analysis of the status quo of over-range use
The out-of-range use of medical devices means that the use of medical devices exceeds the "product scope" of medical device registration. This "scope" defines the scope of application, applicable population and applicable location of the medical device.
1. The use of medical devices is beyond the scope of application
According to the requirements of the Regulations on the Supervision and Administration of Medical Devices, medical devices are marked with a clear scope of application at the time of registration, but in practice, they often appear outside the scope of application.
2. The use of medical devices is beyond the reach of the population
Medical devices should have a clear application population and taboo population. In medical practice, the scope of application for expanding the population of the hospital mainly includes the following aspects: (1) The equipment that can only be used for some people is used for the whole; 2 The patient is not fully understood before the examination, and the contraindications of the patient itself are ignored.
3. The use of medical equipment in super-applicable places
Medical devices have certain environmental standards to meet the requirements of temperature, humidity, ventilation, electromagnetic environment and radiation protection. Some hospitals neglect the corresponding regulations during construction, resulting in the use of medical devices in super-suitable places.
2. "Yes" and "Non" for over-range use
Unlike other types of misuse, the over-range use of medical devices often occurs with experienced medical staff, and in most cases, knowledge of over-range use is made, and some even in specific clinical practice based on acquired experience and skills. The "rethinking" of existing medical treatments and the exploration of the treatment process.
Not only medical devices, but also the use of drugs in the field of medicine is a common problem in clinical drug treatment. The research on the over-instruction drug use that has been queried does not simply classify the over-instruction drug as unreasonable, but on the basis of evidence-based evaluation of the existing super-instruction drug laws, regulations, policies and guidelines in various countries, pointing out the continuous practice of medical practice. The contradiction between the development and the slow update of the content of the drug manual is the main reason for the inevitable use of the drug in the super-instruction.
Although some super-instruction medications alleviate the dilemma of some diseases or conventional individuals without effective treatment of drugs, there are many hidden dangers in over-instruction. Ultra-instruction medication is not the same as irrational medication, but unreasonable medication often uses super-instruction medication as a manifestation. There is no need to resolve the contradiction between the effectiveness of over-the-counter medications for the treatment of specific diseases and individual groups and the risk of no clear basis for their use.
Compared with the ultra-instruction of drugs, the over-range use of medical devices is more complicated, and the research on input is relatively small. "The Stone of Other Hills" can be used for reference in medical device supervision. For example, you can refer to the expert consensus on the use of drugs to develop related products. In order to prevent the asymmetry of doctors and patients, sign the patient's informed consent when using the over-scope; learn from the rational drug use system, establish a rational use system for medical devices; improve the monitoring report system. Function, increase risk warning function, improve report quality, etc.
Third, the use of over-range to the technical review
In September 2017, Guangdong medical institutions reported a report of suspicious adverse events in 8 patients with tubal catheterization. After investigation, this type of product has been used in clinical over-application range.
Combined with the above case reflection, the risk of over-range use of medical devices is not only in terms of supervision, but also has some implications for the technical review. In order to better control risks, we should also pay attention to the following issues: 1 Product risk analysis should cover materials, design, circulation, storage, and clinical use as much as possible; 2 Manufacturers should master the clinical use of the product, and new to the clinical If the method of use or the intended treatment purpose is to be supported, the relevant product registration information should be reported in time. If it is not supported, the corresponding risk management measures should be taken. 3 The product manual should be further improved in clinical use, such as the fallopian tube catheter. The product should prompt the inspection of the integrity of the product after use; 4 relevant standards have further improved space, such as the standard of the fallopian tube catheter can be further clearly classified, for the products used for imaging and dredging in the technical indicators of fracture force Clear the minimum value.
In short, the over-range use of medical devices is insurmountable, and there is also a reasonable space in certain areas. However, medical device related regulations are not clearly defined. In order to better prevent the occurrence of adverse events, it is necessary for production enterprises, regulatory authorities, and clinical users to establish a better communication mechanism, formulate expert consensus on the over-use of related products, improve risk analysis, and reasonably assess residual risks to minimize defects. The incidence of events.
This article is taken from "China Medical Device Information Network"