Abstract D12

Nurses and Medical Device Use
Sonia Swayze, C. Webb BSN, CCRN, RN, M. Couig MPH, FAAN, RN, G. White MS, RN, and B. Hefflin MD, MPH

Nurses at the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), evaluate medical devices for premarket approval and monitor postmarket device use. These medical devices are used for diagnostic purposes and patient care treatments. Nurses are the primary users of medical devices for direct patient care; however, there is minimal research on nurse experience with medical devices. A convenience sample of 54 registered nurses who attended professional meetings were surveyed to evaluate nurse experience with medical devices and to determine nurse awareness of Medwatch, FDA's medical products reporting program, which includes devices and drugs. A frequency analysis revealed that 94% of the nurses surveyed had concerns regarding adverse events associated with medical devices, yet 70% had not submitted medical device problem reports to FDA in the last two years and 57% were not aware of Medwatch prior to to their meeting. The top ten reported devices of concern were intravenous catheters, PCA and syringe pumps, cardiac monitors and defibrillators, sharps containers, blood glucose monitors, chest tube drainage systems, and orthopedic and autotransfusion devices. Additionally, 51% reported difficulty with initial use of a medical device; 51% reported lack of inservice/training as a factor responsible when a device is difficult to use; 24% had not recognized electromagnetic interference as a problem for medical devices; and 24% reported that devices passing safety checks prior to use, fail during use. These findings indicate that nurses are aware of and concerned about medical device problems, however, they lack knowledge about reporting these problems to FDA. Therefore, medical device education and problem reporting among nurses warrants further investigation.