The U.S. Food and Drug Administration, Center for Devices and Radiological Health announced today that they had qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems (UCSF LAD MDDT), through the Medical Device Development Tools (MDDT) program.
The University of California San Francisco (UCSF) Lethal Arrhythmia Database (LAD) Medical Device Development Tool (MDDT) version 1.0.0 is designed to:
- Provide a comprehensive set of data designed for the evaluation of algorithms utilized in hospital monitoring systems
- Test and report the performance of computerized methods to detect lethal cardiac arrhythmias in patient monitoring systems
- Assesses algorithms for detecting three lethal cardiac arrhythmias (asystole, ventricular tachycardia, and ventricular fibrillation) in adult hospital patients across three ICU settings (Cardiac, Medical/Surgical, and Neurological).
