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. We believe that professional nurses, individually and through their professional associations, can help address these concerns by becoming aware of how to share their observations with the FDA and by working with their professional associations to develop position statements that focus on achieving safe and desired patient outcomes. In this article we will identify factors contributing to adverse events related to medical devices, address the need for more medical device adverse-event reporting, describe position statements that have already been made by some professional associations, and share insights regarding future directions along with ideas for educating staff to use medical devices safely.
Food and Drug Administration, USA. nia.swayze@fda.hhs.gov
Sonia C
SC
Swayze
Suzanne E
SE
Rich
D018795:Device Approval / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D009740:Nursing Staff / Q000592:standards*; D012308:Risk Management / Q000379:methods; D017751:Safety Management / Q000379:methods*; D014481:United States; D014486:United States Food and Drug Administration