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# 2 FDA Recommendations in Patient Safety Report
- URL: https://www.fdaweb.com/2-fda-recommendations-in-patient-safety-report/
- Published: 2023-09-12T12:00:00.000Z
- Updated: 2026-09-14T18:55:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155306

A report submitted by the President’s Council of Advisors on Science and Technology to President **Joseph Biden** on “A Transformational Effort on Patient Safety” contains two recommendations for FDA action. The [report](https://www.whitehouse.gov/wp-content/uploads/2023/09/PCAST%5FPatient-Safety-Report%5FSept2023.pdf?ref=fdaweb.com) says patient safety is an urgent national public health issue, with recent data showing about one in four Medicare patients experience adverse events during hospitalizations. More than 40% of the events are preventable, it says.

The report suggests that FDA consider defining a risk rating system for medical devices that provides specific guidance for devices according to levels of risk and requires routine post-marketing surveillance for evaluation of the devices, especially when new technology is being deployed clinically.

The second recommendation is that several HHS agencies collaborate with FDA to consider establishing a program of “AI for Patient Safety,” aimed at pooling and sharing best practices and providing information on the integration of technologies for sensing and monitoring, data analytics, and AI systems within current hospital workflows.