BD Obtains FDA 510(k) Clearance for Upgraded Alaris™ Infusion System

Saturday, July 22, 2023

BD (Becton, Dickinson and Company), a prominent global medical technology company, has achieved a significant milestone with the FDA 510(k) clearance for its updated BD Alaris™ Infusion System. This clearance enables remediation and a full return to commercial operations, making the BD Alaris™ Infusion System the most comprehensive infusion system available in the United States.

The clearance covers various hardware updates, including the Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring, and auto-identification modules. Additionally, it includes a new software version of the BD Alaris™ Infusion System, offering enhanced cybersecurity and interoperability features for smart, connected care, integrating seamlessly with commonly used electronic medical record (EMR) systems.

Tom Polen, Chairman, CEO, and President of BD, emphasized the company's commitment to quality and commended their teams' efforts in achieving this significant milestone. The updated BD Alaris™ Infusion System aims to address critical infusion needs while advancing smart, connected care, providing greater benefits to both clinicians and patients. It also contributes to improving healthcare system efficiency through better care coordination and utilization of actionable information.

This clearance reinforces BD's leadership in the infusion pump market, empowering hospitals and health systems to optimize workflows and deliver a higher standard of care, particularly in the context of staffing shortages and resource constraints in the healthcare environment.

The BD Alaris™ Infusion System boasts a centralized user interface, supporting up to four modules for major types of infusions, including large volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring. This comprehensive approach allows for easy scalability across integrated delivery networks and ensures interoperability with EMRs, offering simplicity and ease of use.

The system's wide customer base, extensive nurse training, and interoperability with EMRs set it apart from other options, streamlining infusion programming and enhancing efficiency for clinicians.

Moreover, the BD Alaris™ Infusion System integrates with the BD HealthSight™ platform for enterprise medication management, providing a unique combination of connective technologies, analytics, and expert services. This platform offers real-time infusion status and an intuitive knowledge portal with actionable information related to clinician trends, drug, and fluid libraries.

Mike Garrison, President of the BD Medical segment, expressed gratitude for the longstanding trust of frontline clinicians in the BD Alaris™ Infusion System. The system is widely used in a majority of U.S. hospitals for the safe delivery of IV therapies to patients. The comprehensive clearance marks a significant step forward in BD's journey to support its customers with expertise in Infusion Therapy, Vascular Access, and Connected Medication Management.

In conclusion, the FDA clearance for the updated BD Alaris™ Infusion System positions BD to continue innovating and providing reliable and cutting-edge infusion technologies to empower healthcare institutions in delivering optimal care to patients amidst the complexities of the modern healthcare landscape.


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