BD (Becton, Dickinson and Company announces that the updated BD Alaris Infusion System has received 510(k) clearance from the U.S. FDA, which enables both remediation and a return to full commercial operations for the infusion system.

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,” says 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,” Polen adds.

The FDA clearance further enhances BD status 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 healthcare environment of staffing shortages and resource constraints, according to the company.

The BD Alaris Infusion System features 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 a large customer base, and large 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.

“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,” said Mike Garrison, president of the BD medical segment. “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.”

Photo courtesy of BD