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Three directions of medical device adverse event retrieval

Database, product name and manufacturer name are the three main directions of medical device adverse event monitoring.

The retrieval of medical device adverse events can be carried out in the direction of database, and different databases have their own characteristics. For example, China’s medical device adverse events information bulletin regularly notifies the adverse events of a certain type of products, while the medical device adverse events listed in medical device alert bulletin mainly come from the United States, the United Kingdom, Australia and Canada Medical device warning or recall data of home and region are not domestic reported data; MAUDE database of the United States is a full database, as long as medical device adverse events reported according to FDA regulations of the United States will be entered into the database; medical device adverse events / recall / alert information related databases of countries and regions such as the United Kingdom, Canada, Australia and Germany will be updated regularly. To retrieve medical device adverse events in the direction of database, it can be screened according to keywords, and it can also be accurately retrieved by limiting time or keyword location.

To carry out medical device adverse event retrieval in the direction of product name, you can enter the expected medical device product name on the database retrieval page for retrieval, and generally do not need to enter too specific product name.

When searching according to the name of medical device enterprise, if the enterprise is a foreign-funded enterprise, it is necessary to pay attention to the different representation of the enterprise name, such as case, abbreviation, etc.

Analysis of adverse events retrieval from specific cases

The contents of medical device adverse event monitoring research report may include but not limited to a brief overview of the monitoring purpose and monitoring plan of medical device adverse event; monitoring data sources; time range of adverse event retrieval; number of adverse events; source of reports; causes of adverse events; consequences of adverse events; proportion of various adverse events; measures taken for adverse events; and; The monitoring data and monitoring process can provide inspiration for technical review, post marketing supervision of products, or risk management of manufacturing enterprises.

In view of the large amount of data, 219 pieces of information were retrieved by limiting “productcode” to June 2019. After deleting 19 pieces of non adverse event information, the remaining 200 pieces were included in the analysis. The information in the database is extracted one by one, using Microsoft Excel software collected data from the source of the report, the medical device related information (including the name of the manufacturer, product name, type of medical device, problems of medical device), the occurrence time of adverse events, the time when FDA received adverse events, the type of adverse events, the causes of adverse events, and then analyzed the location of adverse events The main causes of adverse events were summarized, and the improvement measures were put forward from the aspects of operation, prosthesis design and postoperative nursing. The above analysis process and content can be used as reference for the analysis of similar medical device adverse events.

Analysis of adverse events to improve the level of risk control

The summary and analysis of medical device adverse events has a certain reference significance for medical device regulatory departments, production and operation enterprises and users to carry out risk control. For the regulatory department, the formulation and revision of medical device regulations, rules and normative documents can be carried out in combination with the analysis results of adverse events, so as to make the risk control and management of medical devices have laws and regulations to follow. Strengthen the post marketing supervision of medical devices, collect and summarize the adverse events, warning and recall information of medical devices on a regular basis, and release the announcement in time. At the same time, strengthen the supervision of medical device manufacturers, standardize their production process, and effectively reduce the probability of adverse events from the source. In addition, we should continue to promote scientific research on medical device supervision and build an evaluation system based on precise risk control.

Medical institutions should strengthen training and management, so that clinicians can master the standard operation requirements and equipment operation skills, and reduce the probability of adverse events. To further strengthen the combination of medical and engineering, and urge clinicians to communicate with medical device design engineers on the problems found in the clinical use of medical devices, so that clinicians can have a more comprehensive understanding of the medical devices used, and also help medical device design engineers to better design or improve medical devices. In addition, clinical rehabilitation guidance should be strengthened to remind patients of the key points to prevent premature failure of implants due to premature activities or improper operation. At the same time, clinicians should improve their awareness of medical device adverse events, avoid the risk of medical device use, and timely collect and report medical device adverse events.