Analysis of National Medical Devices from 2017 to 2018

2023-11-23


In 2017, 3505 batches of samples of 63 kinds of medical devices were taken by the State Party, and 302 batches of unqualified samples were detected, involving 43 varieties, and the unqualified detection rate was 8.6.

  
Among them, the unqualified detection rate of key regulatory varieties was 3.0, the unqualified detection rate of three types of medical devices was 5.7, and the unqualified detection rate of two types of medical devices was 10.8. The unqualified detection rate of active products was 27.9%, the unqualified detection rate of passive products was 3.1%, and the unqualified detection rate of in vitro diagnostic reagents was 0.5%. In terms of varieties, the unqualified detection rate was higher than the overall unqualified detection rate (8.6), a total of 27 varieties, a total of 243 batches. There are 11 varieties with the highest concentration of unqualified quantity, totaling 194 batches. The most concentrated varieties of unqualified number are electric hospital beds, semiconductor laser therapy machines, electric wheelchairs, light therapy equipment, non-invasive automatic measurement of sphygmomanometer (electronic sphygmomanometer), carbon dioxide laser therapy machine and so on.
  
In 2018, a total of 3158 batches of 62 kinds of medical devices were sampled, and 256 batches of unqualified samples were detected, involving 44 varieties, and the unqualified detection rate was 8.1.
  
Among them, the unqualified detection rate of key regulatory varieties was 5.8, the unqualified detection rate of three types of medical devices was 5.9, and the unqualified detection rate of two types of medical devices was 9.1. The non-conforming detection rate of active products was 17.9 per cent and that of passive products was 6.9 per cent,
  
The unqualified detection rate of in vitro diagnostic reagents was 4.5%. In terms of varieties, the unqualified detection rate was higher than the overall unqualified detection rate (8.1), a total of 27 varieties, a total of 192 batches. There are 11 varieties with the highest concentration of unqualified quantity, totaling 161 batches. The most concentrated varieties of unqualified number are disposable medical masks, non-invasive automatic measuring sphygmomanometer (electronic sphygmomanometer), abdominal puncture device, natural latex rubber condom, surgical gown, medical surgical mask, surgical suture (needle) and so on.
  
Most of the unqualified problems can be avoided. The author combed and found that from 2017 to 2018, the problems found by the national sampling were mainly concentrated in the following three aspects:
  
First, the detection rate of unqualified active medical devices is high.. The unqualified detection rate of state-pumped active medical devices was 27.9 percent in 2017 and 17.9 percent in 2018, both significantly higher than passive medical devices and in vitro diagnostic reagents. There are two reasons for this situation: First, the implementation of regulations and standards related to identification, labels, and instructions for active medical devices is far inferior to the other two types of products. The root cause is that companies do not pay attention to it, and some companies have misunderstood the standards. Second, the electrical safety project of active medical devices also has problems. Electrical safety is an important indicator of active medical devices, which is directly related to the safety of patients and users. Sampling inspection found that in the unqualified batches of specific electromagnetic wave therapeutic equipment, microwave treatment equipment, ultrasonic tooth cleaning equipment and other products, electrical safety items were frequently unqualified, which should be paid more attention.
  
Second, the level of passive medical device technology needs to be improved.. Combing the reasons for the unqualified passive medical devices, it is found that up to 56% of the unqualified reasons may be the problem of raw materials; the other is the process problem, which is mainly manifested in the appearance, size, loading, accuracy (flow), surface roughness, etc. In 2018, sampling inspection found that the size, volume, appearance and other production process is easy to control the project unqualified proportion of nearly 20%, indicating that to improve the level of passive medical device processing technology in China has a long way to go.
 

 

Third, there are concerns about the implementation of national and industry standards (hereinafter referred to as "national standards").. Analyzing the implementation of the national standards (including mandatory and recommended national standards) for the sampling inspection projects carried out in 2018 for the technical requirements of 62 varieties of products, it is found that there are 13 varieties with an overall standard implementation rate (overall standard implementation rate = the number of product technical requirements for all inspection projects that have implemented the corresponding national standards ÷ the total number of samples drawn for this variety × 100%) exceeding 90%, there are 16 varieties with a standard implementation rate of less than 60%. Although the implementation of the national standards for product technical requirements is not optimistic enough, the results of simultaneous inspections in accordance with the mandatory national standards and product technical requirements are different from the implementation of the standards. The reasons for this result are: first, the double-standard inspection is only for varieties that need to be subject to strong standards, and the recommended standards do not carry out double-standard inspection; Second, there are a number of products that fail to pass the inspection according to strong standards and product technical requirements. Third, it has exposed the phenomenon that some medical device manufacturers "register to produce two skins.
  
In addition to the above-mentioned systemic problems, the State Party has also found some problems that can be solved through development in China's medical device industry, such as unclear rules for the division of key areas of surgical gowns and surgical sheets, and the elimination of powdered disposable medical rubber examination gloves.
 

 

 

  

 

take multiple measures to solve problems in the industry,In view of the above problems, the author suggests the following:
 

 

First, medical device manufacturers should strengthen their own quality system construction. Strengthen the internal audit and self-examination of product identification, labels and instructions, and timely rectify problems found; Strengthen the design and procurement of spare parts for active medical devices, and the selection and acceptance of raw materials for passive medical devices; Do a good job in process control, purchase higher precision and reliability of manufacturing equipment, and improve the design and process level.
  
The second is to strengthen the handling of problem products and problem enterprises.. It is suggested that the drug supervision and administration departments of all provinces (autonomous regions and municipalities) should take the recall of unqualified products as the starting point, urge enterprises to investigate the causes of unqualified products, put forward rectification measures and implement rectification, and break the problems found in random inspection into parts and solve them one by one; at the same time, they should carry out flight inspection on enterprises that have been found to be unqualified for many years or many varieties, and use the strictest supervision to compress the living space of illegal enterprises.
  
The third is to increase the audit and inspection of medical device manufacturers.. It is recommended to issue detailed rules for the quality management standard inspection of active medical device manufacturers, focusing on the selection and evaluation of active medical device spare parts and passive medical device raw material suppliers, procurement control, incoming inspection, factory release and other aspects of inspection.
  
Fourth, the national level to strengthen the review of local guidance. Give guidance on the concepts that need to be clarified, the definition of management categories, and the main indicators that should be included in the technical requirements; during the review, limit the scope of use of some raw materials that have been gradually eliminated, and guide the industry to develop in a better direction.
  

The fifth is to further do a good job in the publicity of the national bank mark.. It is recommended that relevant departments continue to organize training for medical device companies and reviewers; local medical device technical review departments should also strengthen the study of standards and apply standard clauses and spirits to the review of product technical requirements.