Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital

Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients’ safety authorities, and should be anonymous, confidential, and non-punitive.

重症监护病房（Intensive Care Unit, ICU）依托多种技术资源，广泛使用各类医疗设备，例如呼吸机、生命体征监护仪、输液泵与注射泵等。本研究以某单一三级医疗中心的重症监护护士为研究对象，探究其应对医疗设备相关不良事件的实践方式，并评估其对国家医疗设备不良事件报告系统的认知水平，同时调研其获取风险信息更新的渠道。本研究共纳入沙特国王大学医疗城重症监护病房的297名护士参与医疗设备与不良事件报告相关调研，其中198名护士报告曾遭遇过因设备故障引发的不良事件。然而，其中195名护士并不了解用于上报此类事件的官方国家级报告系统。基于国际标准构建医疗设备安全操作框架具有重要现实意义。该报告系统应纳入国家患者安全主管部门，且需具备匿名性、保密性与非惩罚性特征。