With the continuous improvement of medical standards, medical devices have been widely used in the fields of disease diagnosis, prevention, monitoring, treatment and rehabilitation. Any medical device that has been approved for marketing is not absolutely safe. Only through continuous monitoring of medical device adverse events can adverse events be detected in a timely and effective manner and provide a scientific basis for regulatory authorities to take corresponding administrative measures for products with potential safety hazards. Avoid or reduce the recurrence of similar adverse events. At present, many countries and regions have established medical device adverse event monitoring systems, and regularly publish the collected adverse events for public retrieval (see the table for the retrieval sources of medical device adverse events in some countries). Knowing how to retrieve information on medical device adverse events in various countries and regions, and mastering the method of aggregate analysis of retrieved medical device adverse events is of great significance to improving the safety and effectiveness of medical devices.

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 search for medical device adverse events can be based on databases. Different databases have their own characteristics. For example, China's "Medical Device Adverse Event Information Bulletin" is a regular notification of adverse events of a certain type of product, while the "Medical Device Alert Newsletter" The medical device adverse events listed in are mainly derived from the medical device warning or recall data in the United States, the United Kingdom, Australia, Canada and other countries and regions, not the data reported in the country; the United States MAUDE database is a full database, as long as it is reported in accordance with the US FDA regulations Medical device adverse events will be entered into the database; the database of medical device adverse events/recall/alert information in the United Kingdom, Canada, Australia, Germany and other countries and regions will be updated regularly. Retrieval of medical device adverse events in the direction of the database can be screened based on keywords, and can also be accurately retrieved by means of time limitation or keyword location.

To carry out the search of medical device adverse events in the direction of the product name, the search can be performed by entering the product name of the medical device expected to be searched on the database search page. Generally, there is no need to enter too specific product names.

When searching based on the name of a medical device company, if the company is a foreign-funded company, you need to pay attention to the different ways of expressing the company name, such as capitalization, abbreviation, etc.

Retrieval and analysis of adverse events from specific cases

The content of the medical device adverse event monitoring research report may include, but is not limited to, a brief overview of the medical device adverse event monitoring purpose, monitoring plan, etc.; the source of monitoring data; the time range for retrieving the adverse event; the number of adverse events; the source of the report; the adverse event Causes of occurrence; consequences of adverse events; the proportion of various adverse events; measures taken in response to adverse events; the monitoring data and monitoring process have implications for technical review, post-marketing supervision of products, or risk management of manufacturing companies.

What are the ways to start the search and analysis of medical device adverse events? Take the FDA website MAUDE database for the total hip replacement system adverse event search as an example. In view of the large amount of data, the author restricts the "productcode" and the time limit is 2019 In June, a total of 219 pieces of information were retrieved. After 19 pieces of non-adverse event information were deleted, the remaining 200 pieces of information were included in the analysis. Extract the information in the database one by one, and use Microsoft Excel software to extract the source of the report, the medical device related information (including the name of the manufacturer, product name, medical device type, and medical device problems), the time of occurrence of the adverse event, The FDA collects data on the time when the adverse event is received, the type of the adverse event, the cause of the adverse event, etc., and then the site of the adverse event, the number of cases of the adverse event during or after the operation, and the proportion of clear revisions after the operation A statistical analysis was carried out, and the main reasons for adverse events were summarized, and improvement measures were proposed from the aspects of surgical operation, prosthesis design, and postoperative care. The above analysis process and content can be used as a reference for the analysis of adverse events of similar medical devices.

Adverse event analysis improves risk control level

The summary analysis of medical device adverse events has certain reference significance for the risk control of medical device supervision departments, production and operation enterprises and users. Regarding the regulatory authorities, they can combine the results of adverse event analysis to develop and revise medical device regulations, rules and regulatory documents, so that medical device risk control and management can be followed by laws and regulations. Strengthen the post-market supervision of medical devices, regularly collect and summarize information on adverse events, warnings and recalls of medical devices after the market, and issue announcements in a timely manner. At the same time, strengthen the supervision of medical device manufacturers, standardize their production processes, 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 to enable clinicians to master standard surgical requirements and instrument operation skills, and reduce the probability of adverse events. Further strengthen the integration of medicine and work, and encourage 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 well. In addition, clinical rehabilitation guidance should be strengthened to remind patients to pay attention to points after surgery to prevent premature failure of the implant due to premature activity or improper operation. At the same time, clinicians should also improve their awareness of medical device adverse events, avoid the risks of medical device use, and collect and report medical device adverse events in a timely manner.

Manufacturers should strengthen the risk management and control of the entire life cycle of medical devices, fully identify the potential risks of medical devices, and take appropriate measures to reduce the risks to an acceptable level.