Relative risks of reported serious injury and death associated with hemostasis devices by gender.
OBJECTIVE
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.
Epidemiology Branch, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-541, Rockville, MD 20850, USA. Drt@cdrh.fda.gov
Dale R
DR
Tavris
Beverly
B
Gallauresi
Suzanne
S
Rich
Carlos
C
Bell
D015906:Angioplasty, Balloon, Coronary / Q000009:adverse effects*; D016208:Databases, Factual; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000009:adverse effects; D005260:Female; D005263:Femoral Artery; D006406:Hematoma / Q000209:etiology* / Q000401:mortality; D006470:Hemorrhage / Q000209:etiology* / Q000401:mortality; D006489:Hemostatic Techniques / Q000009:adverse effects* / Q000295:instrumentation; D006801:Humans; D007239:Infections / Q000209:etiology / Q000401:mortality; D008297:Male; D009309:National Center for Health Statistics, U.S.; D018570:Risk Assessment; D012737:Sex Factors; D013997:Time Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data; D014947:Wounds and Injuries