Category: Standards

Standards

Medtronic Removes Tracheostomy Tube Over Risk of Flange Disconnection

Medtronic advises customers to return affected adult flexible tubes due to potential airway blockage and respiratory emergencies.

Standards

Medical Device Recall Volume Hits Three-Year Low, But Class I Events Rise

While total recalls and units affected declined in Q1 2025, the number of Class I events increased.

Standards

HHS, FDA Want to Slash Health Care Rules in 10-to-1 Deregulation Plan

The agencies are asking stakeholders to weigh in on a sweeping deregulatory initiative that will eliminate 10 regulations for every one introduced.

Servicing Legislation

Lawmaker Calls for Broader Military Adoption of Right to Repair Provisions

Rep Marie Gluesenkamp Perez commended the Army’s move to include right to repair in contracts and urged other branches to follow suit to reduce costs and boost readiness.

FDA Updates

FDA Plans Agency-Wide AI Rollout Following Scientific Review Pilot

The FDA will expand generative AI tools across all centers by June 30 following a successful scientific review pilot, aiming to reduce repetitive tasks and improve operational efficiency.

Government Regulations

ECRI Adds Tools to Help Health Leaders Quickly Judge New Treatments

Clinical evidence assessments now include data visualization features and equity insights to help healthcare leaders quickly evaluate the safety and effectiveness of treatments.

Cybersecurity

‘Data Breach Weekend Watch’ Launches Ahead of Memorial Day to Protect Hospitals from Cyberattacks

The no-cost initiative is designed to help hospitals and healthcare organizations detect and respond to cyber threats during long weekends—when breaches are most likely to go unnoticed due to reduced staffing.