Abstract
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.
Highlights
Intensive care units (ICUs) are complex multidisciplinary work environments
This is a single center cross-sectional questionnaire-based survey that was conducted in February 2018 and targeted nurses working in the ICUs of King Saud University Medical City (KSUMC) in Riyadh, Saudi Arabia
In Saudi Arabia, this consists of a web-based electronic incident reporting system provided by the Medical Devices Sector of the Saudi Food and Drug Authority (SFDA). [13,14] This could lead to ambiguity since the SFDA defines adverse events related to medical devices as follows: “Adverse event: means any malfunction or deterioration in the characteristics and/or performances of a medical device, including any inadequacy in its labeling or the instructions for use that may lead to compromise the health or safety of patients, users or third parties.”
Summary
Intensive care units (ICUs) are complex multidisciplinary work environments. Efficient workflow in such areas depends on all team members’ knowledge and skills, including the medical and nursing staff, clinical pharmacists, respiratory therapists, dieticians, porters, and technicians, whose integrated efforts result in optimal patient care. This feature of the multidisciplinary team increases patient safety and improves the quality of care in the intensive care unit (ICU). The safe operation of these devices necessitates the availability of different procedures such
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