Category: Standards

Standards

ECRI Releases Resource to Mitigate Supply Chain Shortages

ECRI released a resource to help healthcare leaders mitigate risks of supply shortages caused by Hurricane Helene and a longshoremen strike.

Standards

ECRI and ISMP Celebrate World Patient Safety Day 2024

ECRI and ISMP celebrated World Patient Safety Day 2024 by promoting diagnostic safety and participating in advocacy events.

Standards

Understanding FDA’s Latest Rules on Medical Device Maintenance

The FDA's new guidance distinguishes between servicing and remanufacturing of medical devices, urging vigilance and regulatory adherence.

Servicing Legislation

Proposed Fair Repair Act Excludes Medical Devices

Congressman Joe Morelle introduced the Fair Repair Act, aiming to guarantee the right to repair products, excluding medical devices.

FDA Updates

Defibtech Recalls Chest Compression Devices for Malfunction

Defibtech is recalling its RMU-2000 ARM XR Chest Compression Devices due to a motor issue that may cause the device to stop compressions, leading to potential patient injury or death.

Government Regulations

Tackling Bias and Inequities in Healthcare

Two studies highlighted by The Joint Commission focus on improving handoff communication and integrating equity into root cause analysis to reduce adverse events in healthcare.

Cybersecurity

BIOTRONIK Selects Interlynk for SBOM Cybersecurity Compliance

Interlynk Inc. will support BIOTRONIK in meeting FDA cybersecurity requirements by providing Software Bill of Materials (SBOM) generation, vulnerability reporting, and open-source risk assessment for its medical devices.