White G G, Weick-Brady M D, Goldman S A, Gross T P, Kennedy D L, Lucas B S, Merritt K, Naschinski C
Food and Drug Administration, Rockville, MD 20857, USA.
CRNA. 1998 Nov;9(4):139-56.
Healthcare practitioners are the primary users of medical devices for direct patient care. As such, they are in the best position to recognize problems that result from the use of medical devices. The outcome of a device-related adverse event or product problem, as with any other medical product, can be serious and result in illness injury, or even death. The sooner that FDA learns about a problem, the sooner the agency can take action to protect patient and user safety. Healthcare practitioners are major contributors to the knowledge base related to device use and safety through astute monitoring, rapid identification of device-related problems, and reporting these problems. An understanding of the voluntary and mandatory mechanism of reporting will ensure that device problems are reported appropriately and in a timely manner. As the primary users of medical equipment for direct patient care, health care professionals have the training and expertise to improve patient care by reporting actual and suspected problems with medical devices.
医疗保健从业者是直接用于患者护理的医疗设备的主要使用者。因此，他们最有能力识别因使用医疗设备而产生的问题。与任何其他医疗产品一样，与设备相关的不良事件或产品问题的后果可能很严重，会导致疾病、伤害甚至死亡。FDA越早了解到问题，就能越早采取行动保护患者和使用者的安全。医疗保健从业者通过敏锐的监测、迅速识别与设备相关的问题并报告这些问题，对与设备使用和安全相关的知识库做出了重大贡献。了解自愿和强制报告机制将确保设备问题得到适当和及时的报告。作为直接用于患者护理的医疗设备的主要使用者，医疗保健专业人员具备通过报告医疗设备的实际和疑似问题来改善患者护理的培训和专业知识。
