With the rapid development of modern information technology, traditional regulatory methods have been difficult to meet the requirements of the full traceability of medical devices. Establish an information-based traceability supervision platform and use modern technology to track and monitor the whole process of production, operation and use of medical devices, not only to find out the problems affecting product quality and safety in all aspects, but also to accurately locate and quickly track problem medical devices.
Regulatory informationization must be “speed upâ€
"The current medical device supervision method is still relatively traditional. The inspection of many links relies on manual methods, and it is difficult to find and trace the problem medical devices in a timely and accurate manner." A staff member of the China Medical Device Industry Association bluntly said, "In drug supervision, In most places, informationization supervision has been basically realized, and modern technology can be used to track and monitor the quality and safety of drugs from production to terminal. The medical device informationization and traceability supervision system has not been fully established."
The reporter learned that after years of development, the drug supervision work has formed a relatively standardized management system, especially the informationization supervision means played an important role in the traceability process. Once the problem drug is found, the regulatory authorities can control and track it in the first time through informational means, and “follow the vines†and trace the source of the problem. However, the localization of medical device supervision information construction is still in the stage of exploration and trial, and has not yet formed a unified and complete informationization supervision chain.
The relevant staff of China Medical Device Industry Association further analyzed the information asymmetry and concern of all aspects of medical device production, sales, use and supervision. Among them, the production companies have a lot of products that have produced batch or serial numbers, and they don’t know much about sales and use. Most of the operating companies only care about which batch or serial number of medical devices they have purchased. Insufficient understanding of actual production and use; most of the users use only those medical devices purchased, and have little insight into actual production and operation. In addition, most of the violations of medical devices now involve a wide range of areas and cross-regional occurrences. If the information is communicated and shared poorly, it is easy to cause the chain of control to be out of line and affect the traceability of the problematic products.
Today, when information technology is so developed, why is the medical device informationization supervision work relatively lagging behind?
Luo Zhang, a staff member of the Maanshan Food and Drug Administration of Anhui Province, believes that there are three main reasons: First, the relevant regulations have not yet specified specific requirements; second, there are a large variety of medical devices, and the production and operation enterprises are “multiple, small, and scatteredâ€, and the implementation of information supervision It is difficult; third is the lack of financial support.
Trace back to the "electronic eye"
The relevant staff of China Medical Device Industry Association said that although the "Quality Management Standards for Medical Device Production" put forward requirements for the construction of traceability system, it has not attracted enough attention from enterprises and the society. Although some companies have established a product quality traceability system and procedures on the surface, their implementation is in a form. The exposed problems are mainly the confusion of raw material procurement channels, incomplete original materials, incomplete bills, incomplete production information, and no inspection. Incomplete records or inspection records, incomplete sales records, etc. This has led to an increase in the difficulty for regulators to find the source of the problem, and it also provides an opportunity for counterfeit products.
“In April of this year, when I was investigating a company that produces intelligent medical monitoring equipment, I found that the inspection record of the enterprise is only the inspection record of finished products. According to the requirements of the traceability system, the inspection records should include incoming inspection, process inspection and finished product inspection. The identification information is not complete. Once the quality problem occurs, it will be very difficult to trace back. Although the regulatory authorities have proposed rectification opinions for the enterprise, there are very few local medical device supervisors, and the regulatory coverage and frequency have certain limitations. Establish an information-based retrospective supervision platform to identify problems and correct them in the same way as the 'electronic eyes' of the public security system," said the staff of the China Medical Device Industry Association.
"The establishment of an information-based retrospective supervision platform can effectively prevent and control medical equipment, so that there is nowhere to hide the problem product." Mr. Zhang, head of the Beijing branch of Shenyang Blue Ocean Lingji Software Technology Co., Ltd. said.
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