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

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.

Technical Aspects of Intensive Care Unit Management: A Single-Center Experience at a Tertiary Academic Hospital

“…This low percentage could be due to a lack of awareness about the role of the SFDA as a source of medical device risk information and recalls. 2 The apparent lack of knowledge among the respondents could also be due to a lack of communication between the SFDA and healthcare providers.…”

“…This is a follow-up study of a previously conducted single-center, cross-sectional questionnaire-based survey conducted in February 2018 investigating the management of medical devices in ICUs. 2 The study targeted nurses working in ICUs at King Saud University Medical City (KSUMC), Riyadh, Saudi Arabia. The required representative sample collected to ensure a 95% confidence level and margin of error less than or equal to 5% was 218 of the 502 (43.4%) nurses working in the critical care units.…”

“…Additionally, there is the challenge of implementing guidelines to detect device misuse and report adverse events associated with the use of these devices to the appropriate authorities. 2 Thus, technical support teams should employ of user-friendly technologies to optimize patient care by properly managing technical issues related to different devices in ICUs.…”

Technical aspects of management in the intensive care unit: A single center experience from a tertiary academic hospital

“…This study is a follow-up of a previously conducted research on the management of medical devices in the ICUs; the previous study was a single-center, cross-sectional questionnaire-based survey conducted in February 2018. [2] The research targeted nurses working in ICUs at King Saud University Medical City (KSUMC), Riyadh, Saudi Arabia. The required representative sample collected to ensure a 95% con dence and margin of error equal to 5% was composed of 218 nurses out of the 502 nurses working in the critical care units.…”

“…Additionally, there is the challenge of implementing guidelines to detect device misuse and report adverse events associated with the use of these devices to the appropriate authorities. [2] Thus, technical support teams should seek better recognition of user-friendly technologies to optimize patient care by properly managing technical issues related to different devices in ICUs.…”