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

PLoS One. 2019 Oct 24;14(10):e0224233. doi: 10.1371/journal.pone.0224233. eCollection 2019.

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.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Academic Medical Centers
  • Adverse Drug Reaction Reporting Systems / statistics & numerical data*
  • Cross-Sectional Studies
  • Equipment and Supplies / adverse effects*
  • Female
  • Humans
  • Intensive Care Units / organization & administration*
  • Male
  • Medical Errors / prevention & control*
  • Medical Errors / statistics & numerical data
  • Patient Safety
  • Personnel, Hospital / statistics & numerical data*
  • Risk Management
  • Surveys and Questionnaires
  • Tertiary Care Centers / standards*

Grants and funding

This work was supported by the Deanship of Scientific Research, King Saud University, Riyadh, Saudi Arabia (Research Project No R 17-02-45). The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.