AUTHOR BIOGRAPHIES
Raj M. Ratwani, PhD, MedStar Health National Center for Human Factors in Healthcare
Raj M. Ratwani is the director of the MedStar Health National Center for Human Factors in Healthcare, vice president of scientific affairs at the MedStar Health Research Institute, and an associate professor at Georgetown University School of Medicine.
Katharine T. Adams, MS, MedStar Health National Center for Human Factors in Healthcare
Katharine T. Adams is a data scientist at the MedStar Health National Center for Human Factors in Healthcare.
Tracy C. Kim, MPS, MedStar Health National Center for Human Factors in Healthcare
Tracy C. Kim is a research and program manager at the MedStar Health National Center for Human Factors in Healthcare.
Deanna-Nicole C. Busog, BS, MedStar Health National Center for Human Factors in Healthcare
Deanna-Nicole C. Busog is a senior research associate at the MedStar Health National Center for Human Factors in Healthcare.
Jessica L. Howe, MA, MedStar Health National Center for Human Factors in Healthcare
Jessica L. Howe is a research scientist and system safety specialist at the MedStar Health National Center for Human Factors in Healthcare.
Rebecca Jones, MBA, RN*, Patient Safety Authority
Rebecca Jones (rebejones@pa.gov) is the director of Data Science and Research at the Patient Safety Authority and founder and director of the PSA’s Center of Excellence for Improving Diagnosis.
Seth Krevat, MD, MedStar Health National Center for Human Factors in Healthcare
Seth Krevat is the senior medical director at the MedStar Health National Center for Human Factors in Healthcare and an assistant professor at Georgetown University School
Abstract
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.
Conclusions
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.
Keywords
equipment, medical device, human factors, patient safety
