Category: Safety

Safety

Texas Directs Healthcare Facilities to Align With FDA Medical Device Cybersecurity Guidance

State officials are urging hospitals to review device cybersecurity risks and align policies with FDA guidance.

CISA Issues Alert on Endpoint Management System Security After Stryker Cyberattack
Stryker Hit by Cyberattack Linked to Iran-Tied Hacking Group, Causing Global Network Outage
FDA Updates Medical Device Cybersecurity Guidance to Address New Federal Requirements
What 2025’s Healthcare Breaches Taught Us and Why 2026 Raises the Stakes
24×7 Appoints Medical Device Cybersecurity Expert to Advisory Board
Most Healthcare Organizations Report Operational or Clinical Impact From Cyber Threats

Safety

ECRI Leaders Share System-Level Falls Prevention Insights at National Patient Safety Meeting

ECRI leaders discussed how technologies such as AI-based monitoring and safety systems can affect falls prevention and why system-level evaluation is critical to avoid unintended risk.

Safety

Partnership Formed to Advance Medical Device Cybersecurity and Interoperability

The agreement will focus on delivering integrated solutions to support device cybersecurity, interoperability, and regulatory compliance from development through deployment.

Cybersecurity

US and Global Agencies Release ‘Shared Vision’ of Software Bill of Materials for Cybersecurity

The guidance promotes the use of a Software Bill of Materials to increase transparency in the software supply chain, impacting medical device security and vulnerability management.

Medical Device Errors

How Gaps in Requirements Traceability Fuel Recalls and Injuries

Breakdowns in linking requirements to design, risk, and verification are fueling software errors, compliance gaps, and costly recalls across device categories.

Fire Safety

Patient Dies After Defibrillator Fire at Tennessee Hospital

A patient using a defibrillator died at a southern-based medical center after the device erupted in fire and burned his body.

Hospital Safety

New Hospital Visitor System Features ‘Always-On’ Offline Capability

Managed from an Apple iPad, the system is designed to maintain visitor check-in, logging, and badge printing functions even during internet or power outages.