China medical device adverse event reporting for 2021 via the National Medical Device Adverse Event Monitoring Information System showed 650,695 medical device adverse event reports, representing an increase of 21.39% over the previous year. The average number of reports was 461 per million population and represents an increase of 14.68% over the previous year.
Highlights
No clear correlation between adverse events and the medical devices involved has been found, nor has the risk of the products involved been found to be abnormally elevated.
In the adverse event reports received in 2021, the degree of injury was categorized as follows:
- 163 reports of death, accounting for 0.03% of the total number of reports;
- 36,610 reports of serious injuries, or 5.63% of the total number of reports;
- 613,922 reports defined the degree of injury as “others”, representing 94.35% of the total number of reports.
At the completion of this annual report, no clear correlation between the adverse events and the medical devices involved has been found, and no abnormal increase in the risk of the products involved has been found in the follow-up monitoring. But some reports are still in the process of investigation and evaluation, so the results do not represent the final conclusion of the safety evaluation of medical devices.
The top 10 medical device categories reported
| Ranking | Medical Device Classification Catalogue Category | Number of Reports | Percentage of Total Reports |
|---|---|---|---|
| 1 | Infusion, care and protective devices (14) | 292,627 | 49.85% |
| 2 | Medical examination and monitoring devices (07) | 63,385 | 10.80% |
| 3 | Physiotherapy devices (09) | 47,814 | 8.15% |
| 4 | Clinical laboratory devices (22) | 31,913 | 5.44% |
| 5 | Respiratory, anesthesia and first aid devices (08) | 28,620 | 4.88% |
| 6 | Medical imaging devices (06) | 19,549 | 3.33% |
| 7 | Obstetrics and gynaecology, assisted reproduction and contraceptives (18) | 16,917 | 2.88% |
| 8 | Blood transfusion, dialysis and cardiopulmonary bypass devices (10) | 16,110 | 2.74% |
| 9 | Passive surgical devices (02) | 14,121 | 2.41% |
| 10 | Stomatological devices (17) | 8,829 | 1.50% |
Over 80% of the reports are related to Class III and Class II medical devices
The breakdown of China medical device adverse event reports in 2021 according to classification risk were as follows:
- Class III medical devices – 224,287 reports accounting for 34.47%
- Class II medical devices – 305,645 reports accounting for 46.97%
- Class I medical devices – 57,108 reports accounting for 8.78%
- There were 63,655 reports that did not state the medical device risk classification, accounting for 9.78%.
Over 85% of the reports were made by users
- 562,928 adverse events were reported by users, accounting for 86.52%
- Registrants reported 14,853, or 2.28%
- Operating enterprises reported 72,567, accounting for 11.15%
Medical institutions were listed as the place of use for over 87% of adverse events reported
- 569,693 reports described the place of use of the medical device as “medical institutions”, accounting for 87.55%
- 67,369 reports listed “households” as the place of use, representing 10.35%.
Additional notes – word of caution about the data
Like most countries, medical device adverse event reports in China are collected and entered into a database through a spontaneous reporting system. This means that if it is suspected that an adverse event may be related to medical devices, it can be reported. However, it must be pointed out that events are subject to and can be affected by:
- degree of experience
- degree of understanding about the event
- the position held by the reporter.
Which means that the report of adverse events of medical devices may be one-sided and limited and lead to inaccurate judgment of the degree of injury, irregular filling of reports, imperfect information, etc. Events unrelated to medical devices may also be reported as adverse events, so there may be a deviation between the statistical results and the reality of medical device adverse events.
If you would like to know more about medical adverse event reporting and monitoring in China or our services for medical device registration and clinical trials, please contact Cisema.
