BD Receives FDA 510(k) Clearance for Updated BD Alaris™ Infusion System

BD has announced that the updated BD Alaris™ Infusion System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), which enables both remediation and a return to full commercial operations for the most comprehensive infusion syst

• BD Alaris™ Infusion System is the only modular and most comprehensive infusion system on the U.S. market that includes large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring, auto-identification, dose error reduction software and EMR interoperability
• BD Alaris™ Infusion System's unique "One System" platform securely connects all patient modules to provide care teams with a single, comprehensive patient view
• BD sales and service teams will begin actively engaging customers on next steps for their infusion devices; Operational capacity investments will enable rapid scale-up of BD Alaris™ Infusion System to begin distribution and remediation or replacement of existing devices
• BD does not expect any material incremental revenue contribution from the BD Alaris™ Infusion System for the remainder of FY23; Expects to absorb initial re-launch investments within FY23 guidance range

This clearance covers updated hardware features for Point-of-Care Unit (PCU), large volume pumps, syringe pumps, patient-controlled analgesia (PCA) pumps, respiratory monitoring and auto-identification modules. It also covers a new BD Alaris™ Infusion System software version with enhanced cybersecurity, along with interoperability features that enable smart, connected care with the most widely used electronic medical record (EMR) systems.

"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," said Tom Polen, chairman, CEO and president of BD. "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 deliver greater benefit to clinicians and patients and help improve health care system efficiency through better care coordination and utilization of actionable information."

Extending BD's Decades-Long Legacy of Leadership in Infusion Innovation

Today's clearance further enhances BD leadership in the infusion pump market. The updated BD Alaris™ Infusion System will help empower hospitals and health systems to optimize their workflows and deliver a higher standard of care, which has never been more important than in today's health care environment of staffing shortages and resource constraints.

The BD Alaris™ Infusion System is the only system with a centralized user interface for up to four modules for all major types of infusions, including large volume pumps, syringe pumps, and PCA therapy with optional respiratory monitoring. Having one, comprehensive infusion system enables hospitals and health systems to easily scale their infusion needs across an entire integrated delivery network and provide interoperability with EMRs. With a common Point-of-Care Unit, one interface controls all modules, which is different from other pumps on the market that have non-modular architecture. The "one system" approach offers ease, simplicity and scalability.

The BD Alaris™ Infusion System also has the largest breadth of customers, the largest number of nurses trained on its use and the broadest experience and largest number of customers with EMR interoperability. Without this type of digital connectivity, clinicians are often required to navigate time-consuming processes, taking multiple steps to manually program infusions. The BD Alaris™ Infusion System can also feed data to the BD HealthSight™ platform for enterprise medication management, which is a unique combination of connective technologies, analytics and expert services that turn information into insights among caregivers and create seamless visibility across BD medication management solutions. With this platform, health systems can view infusion status in real-time as well as access an intuitive knowledge portal with actionable information related to clinician trends and drug and fluid libraries.

"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," said Mike Garrison, president of the BD Medical segment. "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."