Nobel J J
ECRI, Plymouth Meeting, PA 19462-1298, USA.
Stud Health Technol Inform. 1996;28:29-35.
A significant number of patient injuries and deaths are associated with the use of medical devices. After several decades of experience in device evaluation and accident investigation, ECRI believes that many of these adverse effects could not be predicted in advance, even with the most sophisticated design validation techniques. Reporting networks with investigational capability that identify problem devices and provide feedback about adverse effects to manufacturers and medical device users are essential to meet the health communities obligation to provide safe and effective products and patient care.
大量的患者受伤和死亡事件与医疗设备的使用有关。在经过几十年的设备评估和事故调查经验后，医疗保健研究与质量机构（ECRI）认为，即使采用最先进的设计验证技术，其中许多不良反应也无法提前预测。具备调查能力的报告网络，能够识别有问题的设备，并向制造商和医疗设备使用者提供有关不良反应的反馈，这对于履行医疗界提供安全有效产品和患者护理的义务至关重要。
