Chapter 25

Hemostasis Devices

Dale R. Tavris MD, MPH

Dale R. Tavris MD, MPH

Epidemiologist

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

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Beverly Gallauresi RN

Beverly Gallauresi RN

Nurse Analyst

Product Evaluation Branch I, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Drive, HFZ-520, USA

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Ralph G. Brindis MD, MPH, FACC

Ralph G. Brindis MD, MPH, FACC

Regional Senior Advisor for Cardiovascular Diseases

Northern California Kaiser Permanente, 280 West MacArthur Boulevard, Oakland, CA 94611, USA

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First published: 02 March 2007

Summary

This chapter contains sections titled:

  • The ideal vascular hemostasis device

  • Origin of FDA concern with the postmarket performance of hemostasis devices

  • FDA study to evaluate the risk associated with hemostasis device use

  • Possible reasons for FDA findings of apparent protective effects of hemostasis devices

  • Follow-up FDA study to assess the safety of hemostasis devices

  • Conclusion

  • References

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