In order to strengthen the safety supervision of listed medical devices and ensure the safety and effectiveness of human use of medical devices, China is stepping up the establishment of a monitoring report and re-evaluation system for medical device adverse events. In view of the fact that there is no complete medical device recall system at present, the author boldly designs a brief framework of medical device recall system in China based on the domestic situation and foreign experience.
In the envisaged framework of medical device recall system, there are three main subjects: medical device producers, sellers and hospitals (users). These three subjects are responsible for timely and actively reporting the accidents and adverse reactions of medical devices. Records of production, operation or use must be established, and a product quality tracking system must be established and implemented, so that products can be traced and responsibilities can be distinguished. This is the basis and necessary prerequisite for the implementation of the recall.
(A) the beginning of the recall
The beginning of the recall includes three parts:
1. Initiate product recall according to the reporting and handling mechanism of medical device accidents and adverse reactions.
First of all, it is necessary to establish and improve the reporting system of medical device accidents and adverse reactions. Establishing a fast and effective accident reporting system is an important measure to strengthen the supervision and management of medical devices, and it is also the need to connect with international practices and establish an international supervision network. The system must explicitly require medical device manufacturers, vendors and hospitals to report accidents and adverse reactions of medical device products in a timely and true manner, so as to minimize the influence scope and depth of products and protect people's lives as much as possible. The reporting system of medical device accidents and adverse reactions will also help to change the disadvantages of only evaluating medical devices before they are put on the market and then evaluating products after they are put on the market, so as to prevent the recurrence of adverse reactions.
Secondly, a report processing mechanism must be established to classify accident (adverse reaction) reports submitted by enterprises or hospitals according to the danger of products or the severity of accidents. Generally can be divided into three levels:
Red report. Use or contact with this product may lead to death or serious health deterioration (of patients, users or others), or there is reason to believe that contact with this product again will lead to death or serious health deterioration (of patients, users or others);
Yellow report. Before using or exposing the product, it may cause temporary health degradation (of patients, users or others) or pose little danger to health;
Green report. The product has low risk, and the possibility of health deterioration (of patients, users or others) is very small before using or exposing the product.
Among them, red and yellow reports must initiate product recall. Green report initiates product recall when necessary, or takes other feasible measures: strengthen supervision after products are listed; Modify product design and production; Repair defective products in time. The start of recall is generally decided by government departments and implemented by relevant enterprises, which is a passive product recall.
2. Enterprises take the initiative to recall products when they find problems.
The government can encourage enterprises to take the initiative to recall products when they find problems, so as to narrow down the scope of problematic products. The product recall in this case belongs to voluntary recall. Such recalls must be registered with the relevant departments of the local government when implemented, so that the government can conduct supervision and inspection when necessary.
3. In the process of inspection or other supervision, it is found that the production enterprises and sales enterprises violate the laws and regulations of medical devices in China, which may or have caused health hazards, and the products must also be recalled.
(2) Implementation, supervision and evaluation of the recall.
1. Implementation of the recall
Medical device manufacturers (manufacturers) and sales enterprises (importers) are the main persons in charge of product recall. They can recall products according to the necessary and effective information provided by production, sales or use records. In addition, they should also formulate their own product recall procedures and play a corresponding role when products need to be recalled to ensure the effectiveness and timeliness of the recall.
2. Recall supervision
The government divides product recalls into three grades: red, yellow and green, and conducts different levels of supervision according to the grades.
Red-level recall: monitoring the whole process, conducting on-site verification of recalled products, reviewing the handling of recalled products by enterprises and measures to prevent similar problems from happening again.
Yellow grade recall: monitor the implementation of recall, check the recall records of enterprises and understand the handling of recalled products.
Green level recall: general supervision.
3. Evaluation of recall results
The government strictly evaluates the recall results of medical device manufacturers (manufacturers) and sellers (importers).
(3) What the government needs to do in the recall system.
1. step up the establishment and improvement of the reporting system of medical device accidents and defects and the corresponding reporting and handling mechanism;
2. Requiring or ordering enterprises to recall products;
3. Supervise enterprise recall;
4. Provide technical guidance;
5. Evaluate the recall results and approve the end of the recall.
While carrying out all kinds of work, government departments should also attach great importance to the filing of relevant records, record and analyze each recall in detail, and understand the deep-seated situation such as the occurrence mode and development trend of product problems.
(four) the work that enterprises need to do in the recall system.
1. Timely and truthfully report medical device accidents and adverse reactions;
2. Implement product recall and save relevant documents;
3. Accept the government's supervision and inspection of the recall;
4. Modify the recall.
The above are some ideas about the medical device recall system, which is not yet mature. We believe that with the formulation and improvement of relevant laws and regulations, every link of research and development, production, management, use and recall of medical device products in China can be effectively monitored, and people will use medical device products more safely and effectively.