US-based medical device maker Becton, Dickinson and Company (BD) has received the US Food and Drug Administration (FDA) 510(k) approval for its new-generation BD Alaris Infusion System.
The BD Alaris Infusion System is designed to enable both remediation and a return to full commercial operations for the most comprehensive infusion system in the US.
The FDA approval includes updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringes, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules.
It also covers a new software version with enhanced cybersecurity, along with interoperability with the most widely used electronic medical record (EMR) systems.
BD chairman, CEO and president Tom Polen said: “The 510(k) clearance of the updated BD Alaris Infusion System has been the number one priority for our teams who have been steadfast in their efforts to achieve this milestone, consistent with our commitment to quality.
“We are deeply committed to ensuring clinicians can continue to rely on our market-leading system to meet today’s most critical infusion needs.
“The features and enhancements incorporated into the updated BD Alaris Infusion System and subject to this clearance reinforce our advancements in smart, connected care, which delivers greater benefit to clinicians and patients and help improve health care system efficiency through better care coordination and utilization of actionable information.”
According to BD, Alaris is the only infusion system with a centralised user interface for up to four modules, large volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring.
With the single, comprehensive infusion system, hospitals and health systems can easily scale their infusion needs across delivery networks and provide interoperability with EMRs.
It allows health systems to view infusion status in real time and access an intuitive knowledge portal with actionable information related to clinician trends and drug and fluid libraries.
Furthermore, the BD Alaris Infusion System can also feed data to the BD HealthSight platform for enterprise medication management, said the medical device maker.
BD Medical segment president Mike Garrison said: “We are so grateful for the fact that for more than two decades, frontline clinicians have relied on the BD Alaris Infusion System and Guardrails Safety Software to deliver medications, fluids and blood products to support the care of their patients.
“Today, a majority of hospitals in the United States use the BD Alaris Infusion System to safely deliver IV therapies to patients, and this comprehensive clearance provides a foundation to support a steady, reliable cadence of innovation in infusion technologies from BD.
“The clearance also marks another major step in our journey to support our customers with deep clinical, operational and technical expertise in Infusion Therapy, Vascular Access and Connected Medication Management.”
