Promoting safe use of medical devices.

Although patient safety initiatives in the clinical environment have focused primarily on medication errors to date, medical devices also contribute significantly to patient injuries and deaths. This article addresses the Food and Drug Administration's (FDA) efforts to promote safe use of medical devices by nurses at the point of care. The nurses with whom we have discussed the effects of medical devices, and also those surveyed by the medical device industry and professional nursing associations, are concerned about the profound effects, both desired and undesired, that medical devices have on patient outcomes.

Providing quality end-of-life care.

End-of-life care involves not only the care of patients but also the care of those providing care for patients. The routine demands of providing care for patients in end-of-life situations often prevent nurses from working through the grief associated with the death of a patient, resulting in frustration, depression, stress, and eventually, burnout. It is important to recognize that grief and mourning are necessary steps in adjusting to the loss associated with the death of a patient or a loved one.

Risk of local adverse events following cardiac catheterization by hemostasis device use and gender.

Hemostasis devices are primarily used to stop bleeding from the femoral artery catheterization site after cardiac diagnostic or interventional procedures. Studies assessing the effectiveness of hemostatic devices compared to manual compression have produced mixed results regarding the relative risk of serious adverse events, such as hemorrhage. This study assessed the relative risk of serious complications following the use of the two main types of hemostasis devices (as compared with manual compression), and assessed the relative rates of these complications by gender.

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.