Relative risks of reported serious injury and death associated with hemostasis devices by gender.

PURPOSE: To assess relative risks by gender of reported serious injuries and deaths associated with the use of hemostasis devices, stratified by year of report, type of injury, and type of device.

METHODS

Reports from the Food and Drug Administration's Medical Device Reporting system and National Center for Health Statistics data on use of cardiac catheterization were used to estimate relative risks of reported serious injuries and deaths by gender.

RESULTS

Estimated risks of reported serious injuries and deaths associated with hemostasis devices were two to three times greater in females than in males for hemorrhage and hematoma (p < 0.0001), but there was no significant difference in risks by gender for infection.

CONCLUSIONS

Cardiac catheterization is sometimes associated with serious injuries and deaths. Among patients who receive hemostasis devices, the risk of these events are disproportionately greater in women.