The National Center for Adverse Event Monitoring has released its national annual report regarding the use of medical devices in China. The report highlights key statistics and insights into the monitoring and management of adverse events associated with medical devices.
Increase in Adverse Event Reports and Coverage
In 2022, the National Medical Device Adverse Event Monitoring Information System received over 690,000 medical device adverse event reports, marking a year-on-year increase of 6.79%. The average number of adverse event reports per million people was 493, an increase of 6.94% from the previous year. The county-level coverage rate of medical device adverse event reports in 28 provinces (autonomous regions, municipalities directly under the central government) reached 100%. The number of grassroots registered users of the medical device adverse event monitoring information system has continued to grow, surpassing 390,000, including 31,648 medical device registrants.
Special Inspections and Rectification Efforts
The center conducted special inspections for monitoring adverse events of medical devices across 18 enterprises throughout the year and supervised the completion of relevant rectification work. It has also engaged in extensive publicity and training, participated in international conferences, and focused on the research of medical device warning systems and key technologies in active monitoring of high-risk and implanted medical devices, thereby enhancing the intelligence of warning and modern monitoring and evaluation capabilities.
Analysis of Adverse Event Reports
Among the medical device adverse event reports received by the center, 0.02% of the total number of reports indicated fatalities, 6.48% severe injuries, and 93.5% other degrees of injury. The majority of relevant reports involved Class III and Class II medical devices, accounting for 35.14% and 47.45% of the total number of reports, respectively. Infusion, nursing, and protective devices were the most commonly reported categories of adverse events, accounting for 50.02% of all reports.-Fineline Info & Tech
