Patient Safety

Patient safety focuses on preventing errors, injuries, infections, and adverse events in healthcare through coordinated efforts by federal agencies, hospitals, health plans, and patients. The National Action Plan to Advance Patient Safety, developed by a steering committee of 27 organizations including federal agencies and patient advocates, provides a roadmap with 17 recommendations across four key areas: culture and leadership, patient engagement, workforce safety, and learning systems to drive total systems improvement and reduce preventable harm.

Federal Oversight and Monitoring

Agencies like the FDA play a central role by regulating medical products and responding to risks. They issue warning letters and safety alerts, oversee medical device recalls, and manage Emergency Use Authorizations during crises while tracking vaccine safety via VAERS. CMS enforces hospital standards, and patients contribute by reporting issues with drugs, devices, or blood products like those from donations directly to the FDA through established channels.

Systems and Engagement

Hospitals implement safety cultures, self-assessments, and goals from groups like the Joint Commission, while health plans incentivize improvements. Understanding device regulation empowers patients in shared decision-making, fostering engagement essential to the National Action Plan’s vision of safer care for all.