Verona, Wis.-based Epic has received FDA clearance for Deterioration Index Version 2, an updated version of its EHR-embedded tool that flags hospitalized patients at risk of clinical decline.
The FDA cleared the software in September through the 510(k) pathway. The agency found it substantially equivalent to AgileMD’s eCARTv5, a competing deterioration score. Epic submitted the application Jan. 2. The clearance does not include a predetermined change control plan.
The tool predicts whether an adult patient will need escalated care within 24 hours or die within 72 hours. Escalated care means an ICU transfer, a rapid response team call or a code. It applies to inpatients and observation patients, but not to long-term care, operating room, post-anesthesia care or labor and delivery settings. Its machine learning model uses 195 inputs from Epic’s EHR, including vital signs, lab results, nursing assessments, medications and diagnoses, to generate a score from 0 to 100. Each hospital sets its own alert thresholds.
Epic tested the model retrospectively on about 10.7 million score observations from three U.S. sites. It posted an area under the curve of 0.83 for the combined outcome and 0.94 for mortality alone. At the high-risk threshold, 28% of scores preceding a deterioration event were flagged, and 34% of flagged scores were followed by deterioration.
At the medium-risk threshold, the tool’s sensitivity was lower for Black patients (26%) and Hispanic patients (32%) than for white patients (51%). The gap between Black and white patients narrowed in a site-by-site analysis.
A 2024 study across seven Yale New Haven (Conn.) Health hospitals ranked the earlier index near the bottom of six early warning scores. That study also noted the index had not been formally vetted by the FDA. A separate NEJM AI study published in July linked the tool’s use at West Orange, N.J.-based RWJBarnabas Health to an 18% reduction in the risk-adjusted odds of in-hospital death among high-risk patients.
