ECRI Convenes C-Suite Roundtables on Patient Safety and Quality Care
A new white paper shares insights from 17 healthcare executives on strengthening organizational resilience and continuous improvement.
Category: Standards
Standards
Latest
Standards
Latest
Federal Wheelchair Right to Repair Act Introduced in Congress
The proposed legislation would require manufacturers to provide parts, documentation, and tools, following similar laws passed in four states.
Standards
Latest
Philips Respironics Updates Use Instructions for Certain BiPAP DevicesÂ
Updated guidance addresses ventilator inoperative alarm failures that may lead to therapy loss, with 13 injuries and eight deaths reported.
Read More
MDUFA VI Process Officially Begins With FDA Public Meeting
AdvaMed leaders call for a continued focus on timely patient access and regulatory predictability as the FDA opens discussions on the next medical device user fee agreement.
Read More
New RTLS Upgrade Brings Staff Duress Coverage Beyond Hospital Walls
The RTLS platform now enables panic-button protection outdoors—extending support to parking lots, garages, and walking paths.
Read More
Joint Commission Launches Strategy to Tailor Accreditation for Children’s Hospitals
The new initiative aims to revise standards to better reflect the unique needs of pediatric patients.
Read More
Pros and Cons of Single-Use Versus Reprocessed Medical Devices
ECRI research examines safety, cost, and environmental tradeoffs of reusing versus discarding medical devices in hospitals.
Read More
Federal Agencies Warn of Interlock Ransomware Targeting Critical Infrastructure
A joint advisory outlines tactics and mitigations for the financially motivated Interlock ransomware, which uses rare methods like drive-by downloads and ClickFix social engineering for initial access.
Read More
White House, CMS Announce Industry Pledges to Support Health IT Interoperability
Federal officials announced voluntary pledges from major tech and healthcare firms to support a national interoperability framework aimed at improving data sharing and easing provider burden.
Read More
Court Upholds DMCA Repair Exemption for Medical Devices
A US District Court has upheld a rule allowing limited circumvention of copyright protections for the repair and maintenance of medical devices.
Read More
Strengthening Industry-Government Relationships Amid Leadership Transitions
Advocacy built on long-term relationships can help HTM professionals stay influential as agency leaders and lawmakers change.
Read More
Playbook for Managing Connected Medical Devices
A seven-step guide to managing and securing connected medical devices across healthcare delivery organizations.
Read More
Baxter’s Life2000 Cyber Recall Draws Attention to FDA’s Focus on Software Safety Risks
A cybersecurity vulnerability that prompted Baxter to recall certain Life2000 ventilators is being seen by some industry experts as part of a broader shift in how the FDA treats software-related risks.Â
Read More
FDA Issues Early Alert on Infusion Pump Issue from Baxter
The FDA issued an early alert under its recall communications pilot citing 79 injuries and two deaths linked to Baxter’s Novum IQ infusion pump.
Read More