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

Autoři: Fahad Alsohime aff001;  Mohamad-Hani Temsah aff001;  Gamal Hasan aff002;  Ayman Al-Eyadhy aff001;  Sanaa Gulman aff002;  Haytam Issa aff002;  Omar Alsohime aff005
Působiště autorů: Pediatric Department, College of Medicine, King Saud University, Riyadh, Saudi Arabia aff001;  Pediatric Intensive Care Unit, King Saud University Medical City, Riyadh, Saudi Arabia aff002;  Prince Abdullah Ben Khalid Celiac Disease Research Chair, King Saud University, Riyadh, Saudi Arabia aff003;  Department of Pediatrics, Assiut Faculty of Medicine, Assiut University, Egypt aff004;  Standards and Guidelines Department, Medical Devices Sector, Saudi Food and Drug Authority, Riyadh, Saudi Arabia aff005
Vyšlo v časopise: PLoS ONE 14(10)
Kategorie: Research Article


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.

Klíčová slova:

Adverse events – Equipment – Intensive care units – Medical devices and equipment – Nurses – Questionnaires – Surveys – Pediatric critical care


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Článek vyšel v časopise


2019 Číslo 10
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