In recent years, with the growth of my country's national economy and the development of medical and health, the medical device industry market has become more and more broad. In order to ensure the safety of public equipment, the state has implemented a medical device supervision and random inspection system, and this is an important basis for the quality of medical device supervision and the evaluation of the quality of medical device products. With the development and changes of my country's medical device technology, industry, and regulatory agencies, problems in supervision and random inspection have gradually become highlighted. The current situation of random inspection, problems in the process, and suggestions raised for problems.

1. Status situation

1.1 Policies and regulations

In order to strengthen the quality supervision and management of medical device products, and standardize the quality supervision of medical device quality supervision, in 2013, the former State Food and Drug Administration issued the "Regulations on the Management of Smash Supervision and Inspection of Medical Device Quality Supervision" [1] to further standardize medical device supervision and random inspection. Work, the General Administration revised the "Regulations on the Supervision and Administration of Medical Device" twice in 2014 and 2017 [2]. In March 2020, the State Drug Administration released the latest "Administrative Measures for the Massage Inspection and Inspection of Medical Devices".

1.2 Category

According to the category of medical equipment, sampling inspection starts with three links in production, operation, and use, covering two major categories of active and passive, involving 23 categories including disposable sanitation materials, in vitro diagnostic reagents, medical electrical, and dental dental equipment. According to the differences in the purpose of random inspection, medical device sampling inspection is divided into supervision and random inspection, that is, each year according to the sampling inspection plan of the medical device regulatory authorities at all levels, it is announced and announced according to the results of the random inspection. Features; risk monitoring, that is, to detect varieties or inspection items with certain risks, and conduct risk assessment of results, and make risk reports; special spot inspection, similar to risk monitoring, is a spot check on specific varieties; tracking and random inspections, is that it is, is that it is a random inspection. Spring inspections of unqualified products in previous years. The four samples are clear and targeted [3].

Among them, medical device supervision and random inspection are divided into national medical device supervision and random inspection, provincial medical device supervision and random inspection, prefecture -level and county -level medical device supervision and random inspection according to the different forms of organization and organizational units. Three sampling inspections complement each other and complement each other.

2. Existing problem

2.1 Technical requirements

Product technical requirements or execution standards are important basis for random inspection. The "Regulations on the Management of Substitute Inspection and Inspection and Inspection of the Quality Supervision of Medical Devices" The requirements for the sampling are "if the sample unit is a medical device production enterprise, the medical device production license shall be provided, and the medical device is extracted for medical device shall be provided. Copy of related materials such as product registration certificate and product registration standard "[1]. Sample sampling in the operation and use of the operation did not clearly stated that the technical requirements of the product were required, and the disadvantages of the sampling inspection work were added. The sampling unit often could not provide technical requirements, or provided defects, before changing, and no change orders and registered departments. Product technical requirements with inconsistencies in filing; if the requirements of the "Medical Devices Quality Supervision and Substitute Inspection and Inspection and Management Regulations\\ "Covering the seal\\

2.2 Sample confirmation aspect

In order to ensure the authenticity and legitimacy of the sample, the "Regulations on the Management of the Mass Supervision of Medical Device Quality Supervision" requires that after the sampling of the sample unit stores the medical device, the relevant unit shall cooperate with the sample confirmation. In the actual sampling inspection, after the manufacturer signed the sample and confirmation, the inspection agency can inspect the sample; and in the later period, when the company involving unqualified products is inspected confirm. Two samples confirmed and complicated, which is not conducive to law enforcement officers to handle the case.

2.3 Sample requirements

Due to the different levels of professionalism and understanding of sampling requirements, some problems have occurred during the sampling process. The study of the scheme is not deep enough, resulting in the number of samples does not meet the inspection requirements. A batch of samples are mixed with different batch numbers, models and samples near the failure period or damaged due to improper transport storage methods. The above issues directly lead to the failure to be inspected, judged by the inspection items, and are not conducive to the development of re -inspection. There are various varieties of medical equipment, involving a wide range of fields. In order to ensure the accuracy of supervision and sampling results, it is more special for sampling of some varieties. In actual sampling, the sampling person's irreversible or inspection items caused by ignoring special sampling requirements do not meet the standards of the standard, which reduces the accuracy and strictness of sampling. The technical requirements are not involved in the "key areas and non -critical areas of the product and non -critical areas, and the relevant statement from the manufacturer should be provided." If this relevant information is missing, the inspectors cannot distinguish the key areas of the product, and the judgment of the relevant inspection items will be deviated;在对医用电气进行抽样时，由于说明书是一项重要的检验项目，所以除了要求的证件资料外，还需要产品说明书且包装附件完整；而对诊断试剂的抽样要求更加复杂，除了基础的证件、 In addition to technical requirements and instructions, a series of auxiliary materials corresponding to the parameter settings, temperature control tables, and sample phase phase are needed. If this related materials are missing, the test of the reagent will not be performed. The requirements are also strict. Reagents, quality control products and calibrations should be preserved in different temperature conditions. If the temperature during transportation cannot be guaranteed, the reagent will fail, and the test results will eventually cause the test results to be inaccurate.

2.4 Standards for non -qualified product penalties

On the website of the existing pharmaceutical regulatory authorities, most of the results of non -qualified products are confiscated and fined, and the results are relatively single; in the basis of punishment, just simply calculate the fines based on the value of the goods; punishment involving unqualified product companies It is not considered different from the risk level of its unqualified items. For example, although the appearance size and bacterial filtration efficiency, the risks of the external mark and the leakage current are different, the punishment standards are the same. 4]; Because the appearance, labels, and manuals are prone to unqualified situations [5], if they are the same as other project punishment standards, they also lack scientific and rational.

3. Work suggestion

3.1 Simplified working procedures

The current spot checks are relatively repeated and cumbersome in the process. In terms of sample confirmation, we suggest to cancel the sample confirmation steps in the inspection link, only retrieve the purchase voucher in the sample session, and confirm the samples of the manufacturer in the inspection and disposal link; in terms of the technical requirements for requesting The issuance certificate is issued by the manufacturer directly provided to the inspection agency within the time limit. In this way, it not only avoids the leakage of business secrets of enterprises, but also ensures that the inspection agency can obtain a complete and effective inspection basis in a short time.

3.2 Strengthen sampling training

Carrying out medical device supervision and random inspection work cannot be separated from professional sampling teams. In order to solve the problem of uneven professionalism of sampling personnel, relevant departments need to invest a large number of professional training. It is recommended that the sampling unit form a fixed sampling team to conduct the sampling team with a point -to -face sampling team. In -depth training, expanding the sampling inspection team, and improving the efficiency of professional skills and sampling inspection work.

3.3 Classification of non -qualified product punishment

When inspection and disposal of unqualified products, the product's own risk level and the severity of unqualified projects should be considered. It is recommended that the inspection agency divides the risk level of the inspection projects of various varieties, and regularly changes according to the situation and supervision needs to be revised. [4]; Based on the principle of punishment, the regulatory authorities refine the punishment measures, and consider the classification of unqualified product punishment in accordance with the risk level, and improve the rationality and scientificity of punishment.

4. Summary

As the medical device supervision and random inspection system is carried out as a regulatory means system and comprehensively, the actual problems encountered in the random inspection work gradually become highlighted, and further improvement needs to be improved in terms of overall planning, ideological consciousness, basic work and ability guarantee. Strengthening supervision and random inspections and solving the problem of random inspection work will not only have important significance to ensure the quality and safety of the product, but also have positive significance for the healthy development of the medical device market.

【references】

[1] State Administration of Food and Drug Administration. Medical equipment quality supervision and random inspection and inspection and management regulations [EB/OL]. [2013-10-11].

[2] Order of the State Council of the People's Republic of China (No. 650). Regulations on the supervision and management of medical device [EB/OL]. [2014-03-07].

[3] Guo Yan, Bai Jiefang, Hao Xiaoli, et al. Discussion on the problem of medical device supervision and random inspection [J]. China Medical Devices Information, 2019, 25 (17): 1-2, 12, 12.

[4] Li Pei, Li Xin, Qiang Xiaolong, etc. The study of classification and punishment for product companies to be classified and punished for medical device supervision.

[5] Zhang Xian, Zhang Binbin. Talk about the random inspection and inspection work and problem analysis of the quality supervision of medical equipment [J]. Chinese medical equipment information, 2018, 24 (5): 1-2, 31.

AAMI TIR 30 of the automatic disinfectant and the manual cleaning process is verified that the equipment contains pre -cleaning, applied artificial stains, confirms the elution method, simulate repeated pollution, repeated cleaning, and the final multi -indicator testing. Based on the above standards, the cleaning verification should choose at least two biochemical indicators to test based on risk assessment. Common indicators include protein residues, hemoglobin detection, carbohydrates, lipids and endotoxins. AAMI TIR 30 stipulates that the highest standard of protein residues is 6.4 mg/square centimeters, and hemoglobin and carbohydrates are not higher than 2.2 and 1.8 mg/square centimeters. Tir 30 has no detailed provisions on lipids, so it is necessary to determine based on risk assessment.

(2) Disinfection verification

Based on health risks AAMI TIR 12 and WS/T 367, disinfection is divided into three levels: high, medium and low. Different types of bacteria need to be used to measure disinfection levels. Optional bacteria contain Golden Polycin, Greenworm, E. coli, and E. coli, and E. coli, and E. coli, and E. coli,,, E. coli,,,,,,,,,,,,,,,,,,, terms, can be used. Crack Bybulis and/or branch bacteria. Verification includes inoculation of multiple bacteria, calculating recycling, neutralizing disinfection agent, and the final percentage of calculation. The neutral steps must follow the principle of USP 1227 guidance.

(3) Sterilization verification

For the common steam sterilization that can be repeatedly treated, the bacterial spore indicator can be selected according to the ISO 17664 and ISO 17665 to measure the aseptic level. AAMI TIR 12 also allows other commonly used sterilization methods, such as hydrogen peroxide and ethylene oxide -based ethylene oxide.