Artificial intelligence related safety issues associated with FDA medical device reports

This is the authors' abstract. We don't add key points for this paper.

The Biden 2023 Artificial Intelligence (AI) Executive Order calls for the creation of a patient safety program. Patient safety reports are a natural starting point for identifying issues. We examined the feasibility of this approach by analyzing reports associated with AI/Machine Learning (ML)-enabled medical devices. Of the 429 reports reviewed, 108 (25.2%) were potentially AI/ML related, with 148 (34.5%) containing insufficient information to determine an AI/ML contribution. A more comprehensive approach is needed.