Since the start of 2020, BD’s Alaris infusion pumps have been the subject of more than half-a-dozen Class I hardware and software recalls, a handful of cybersecurity warnings and a years-long distribution hold.
But with a newly bestowed 510(k) clearance from the FDA, the company now hopes to get the Alaris system back on track.
BD announced the agency’s nod Friday afternoon. It covers a handful of upgrades to the Alaris system’s hardware and software, including, among others, new features for the system’s various pumps and built-in patient monitoring modules, as well as a software update that tightens up cybersecurity protections and allows the pumps to integrate with popular electronic health record systems.
The new green light comes more than three years after BD paused its distribution—and about two years after submitting the 510(k) application covering updates to correct the issues that sparked the hold. In a statement Monday, BD CEO Tom Polen said securing the regulatory OK will allow the company’s Alaris line to “return to full commercial operations.”
“The Alaris system is a vital tool in patient care, and we will continue to strive to bring further innovation and utility to this system in the coming years,” he said, adding, “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.”
Polen continued, “The BD team is poised, eager and ready to execute this rollout 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. We’ve also worked hard to ensure we have the necessary plans in place to meet customer demand by increasing our manufacturing capacity, strengthening our supply chains and increasing supplier redundancy.”
The distribution hold began in early 2020, shortly after BD began a recall of the Alaris systems that February. The recall, which covered around 774,000 of the pumps, stemmed from a handful of reported software issues, including system errors that could potentially delay or interrupt the therapy regimens delivered via the infusion pump systems.
A slew of additional recalls followed, including Class I alerts pertaining to possible broken elements of the systems’ hardware, faulty replacement pieces, a potentially unresponsive built-in keyboard and more.
More recently, BD has identified several possible hacking risks within the extended ecosystem of Alaris software. The latest of these warnings came earlier this month and described eight vulnerabilities affecting Alaris systems equipped with Guardrails Suite MX, a medication safety and quality improvement software—though BD told Fierce Medtech in a statement at the time that “existing product control measures effectively reduce the probability of harm” with all eight issues.
Polen noted in his statement Monday that the newly FDA-cleared Alaris system “addresses all open recalls,” spanning all recent hardware, software and cybersecurity issues.