The FDA granted 510(k) clearance to Becton Dickinson’s updated Alaris infusion pump, allowing the company to resume distribution of its system while remediating or replacing older Alaris devices still being used in the U.S. market.
Three years after the company issued a widespread recall of Alaris infusion pumps — due to several system-, software- and user-related issues — it is hoped that the FDA clearance for its updated Alaris system will allow for “return to full commercial operations,” according to BD’s chairman, president and CEO, Tom Polen.
“The updated Alaris System addresses all open recalls, with the latest hardware, a new version of software and important cybersecurity updates,” Polen said in a statement. “With this release, we’ve improved the fundamental capabilities and features of the Alaris System. This further embodies and demonstrates BD’s commitment to quality and developing smart, connected devices to support the safe and efficient care of patients.”
He added: “We now turn our attention to bringing the updated system to our customers, with an initial focus on remediating or replacing those systems currently operating in the U.S. market. The BD team is poised, eager and ready to execute this roll out with excellence. We intentionally retained our infusion sales representatives and enhanced our implementation and service teams during the 510(k) submission process to ensure we could execute seamlessly upon clearance.”
The FDA’s clearance includes several updated features for the system’s point-of-care unit, large volume pumps, syringe pumps, patient-controlled analgesia pumps, respiratory monitoring and auto-identification modules. In addition, the clearance covers updated software intended to enhance cybersecurity protection and allow the system to integrate with prevailing electronic medical record systems.
“Remediation of recalls will always be a top priority for BD, and our remediation plans go above and beyond all open recall requirements to ensure all devices are compliant with the 510(k) clearance, including the newest hardware, software and cybersecurity updates,” Ami Simunovich, chief quality and regulatory officer at BD, said in a press release. “We have made substantial investments to simplify, improve and evolve our processes, systems and policies to ensure we design, manufacture and sustain our products in compliance with changing global regulatory and safety requirements. We remain committed to delivering next-generation quality and compliance to our customers.”
Customers with questions regarding the updated 510(k) clearance or remediation of current Alaris systems can contact the company at: bd.com/explore-bd-alaris.