Category: Standards

Standards

FDA Cites Royal Philips for Manufacturing Violations in China

The FDA sent a warning letter to Royal Philips over its manufacturing practices at a plant in China that produced CT equipment.

Standards

Abbott Recalls HeartMate LVAS For Obstruction Issue

Abbott is recalling its HeartMate II and 3 LVAS due to Extrinsic Outflow Graft Obstruction, which can lead to severe health risks or death.

Standards

ICU Medical Infusion Pump, Software Nab FDA Clearance

ICU Medical Inc. announces that it has received U.S. Food and Drug Administration 510(k) regulatory clearance for the Plum Duo infusion pump with LifeShield infusion safety software. The products will be available in early 2024.

Servicing Legislation

AdvaMed, Opponents Spar About FTC Right to Repair Rulemaking

In what could be viewed as a controversial stance in the HTM field, AdvaMed submitted comments to the Federal Trade Commission (FTC), expressing concern at a proposed rule-making in favor of national “right to repair” standard. Their opponents hold a vastly different view.

FDA Updates

Vyaire Recalls AirLife Resuscitators for Life-Threatening Defect

Vyaire Medical is recalling certain AirLife Manual Resuscitators due to a life-threatening manufacturing defect.

Government Regulations

Joint Commission Names First President’s Fellowship Honoree

The Joint Commission's new President’s Fellowship for Healthcare Quality and Safety, led by professionals like Carla Pugh, MD, PhD, aims to enhance global healthcare outcomes through expertise utilization, career support, and innovation in performance assessment and improvement.

Cybersecurity

Medcrypt Joins Microsoft Copilot Cybersecurity Partner Program

Medcrypt is participating in the Microsoft Copilot for Security Partner Private Preview program to fortify cybersecurity within healthcare.