A Machine Learning Algorithm to Predict Medical Device Recall by the Food and Drug Administration.

ABSTRACT:

Introduction

Medical device recalls are important to the practice of emergency medicine, as unsafe devices include many ubiquitous items in emergency care, such as vascular access devices, ventilators, infusion pumps, video laryngoscopes, pulse oximetry sensors, and implantable cardioverter defibrillators. Identification of dangerous medical devices as early as possible is necessary to minimize patient harms while avoiding false positives to prevent removal of safe devices from use. While the United States Food and Drug Administration (FDA) employs an adverse event reporting program (MedWatch) and database (MAUDE), other data sources and methods might have utility to identify potentially dangerous medical devices. Our objective was to evaluate the sensitivity, specificity, and accu

SUBMITTER: Barbosa Slivinskis V 

PROVIDER: S-EPMC11908527 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature