Assessing Equipment, Supplies, and Devices for Patient Safety Issues

Background: Medical equipment, supplies, and devices (ESD) serve a critical function in healthcare delivery and how they function can have patient safety consequences. ESD-related safety issues include malfunctions, physically missing ESDs, sterilization, and usability. Describing ESD-related safety issues from a human factors perspective that focuses on user interactions with ESDs can provide additional insights to address these issues. Methods: We manually reviewed ESD patient safety event reports submitted to the Pennsylvania Patient Safety Reporting System to identify ESD-related safety issues using a taxonomy that was informed by the Food and Drug Administration Manufacturer and User Facility Device Experience taxonomy. This taxonomy consisted of the following high-level categories: malfunctions, physically missing, sterilization, and usability. The type of ESD and associated components or ESD subtypes, event classification, and care area group were noted for each report. Results: Of the 450 reports reviewed, the most frequent ESD-related safety issue coded was malfunction (n=365 of 450, 81.1%) followed by sterilization (n=40 of 450, 8.9%), usability (n=36 of 450, 8.0%), and physically missing (n=9 of 450, 2.0%). Among the coded malfunctions, software/output problem (n=122 of 365, 33.4%) was the most frequent, followed by general malfunction (n=103 of 365, 28.2%); material integrity (n=72 of 365, 19.7%); and activation, positioning, or separation (n=68 of 365, 18.6%). The most frequent ESDs noted were infusion pump, instrument set, and intravenous, and the most frequent components/subtypes noted were alarm/alert, tubing, and tray. Conclusion: ESD-related patient safety issues, especially malfunctions, impact patient care despite current policies and practices to address these issues. Healthcare facilities may be able to address some ESD-related patient safety issues during procurement through use of the accompanying procurement assessment tool.