Category: Standards

Standards

Smiths Medical Recalls PneuPac paraPAC Plus Ventilator Kits

Smiths Medical is recalling its paraPAC Plus 300 and 310 Ventilator Kits due to a malfunction where the device may not cycle properly.

Standards

FDA Proposes Ban on Electrical Stimulation Devices

The U.S. FDA has proposed banning electrical stimulation devices for self-injurious or aggressive behavior due to significant risks, marking the second attempt at prohibition, with implications including potential treatment transitions for users and a thorough review of updated evidence and expert opinions.

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

FDA Seeks Public Comment on Premarket Cybersecurity Guidance

The FDA has developed a draft guidance for updates to its Premarket Cybersecurity Guidance and is seeking public comment.

Government Regulations

Hackensack Hospitals Meet Sustainable Healthcare Certification

Four Hackensack Meridian Health hospitals have achieved The Joint Commission’s Sustainable Healthcare Certification (SHC).

Cybersecurity

Change Healthcare Suffers Major Cyberattack

Change Healthcare was impacted by a cybersecurity incident in late February that has sent waves through the healthcare industry.