Dive Brief:
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BD has accelerated its timeline for inspecting and replacing faulty bezels on its Alaris infusion delivery pumps after two more patients suffered injuries.
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A recall of the pumps began in 2017 but subsequently escalated and accelerated, culminating in BD committing to replace all bezels on the highest-risk devices within 12 months.
- BD shared news of the expedited timeline days after the FDA categorized the recall of more than 600,000 devices as a Class I event.
Dive Insight:
BD first flagged a problem with its Alaris pumps in 2017. Back then, BD warned that a fault with the bezels of pumps made in October and November 2011 could cause the devices to infuse more or less than the desired dose. Today, the recall covers devices made between 2011 and 2017 that may contain weakened plastic components that cause the bezel post to separate.
The latest action leaves the breadth of the recall unchanged but modifies BD’s response. In April, BD divided pumps into three priority categories — 1A, 1B and 2 — and committed to replacing all bezels in the top two groupings within 18 months. BD gave itself 36 months to address the lowest-priority pumps, which are yet to be linked to injuries to patients.
BD has now accelerated its timelines. The company has stopped differentiating between 1A and 1B pumps. Instead, it will treat all the pumps in those former categories as top priorities and work to fix their bezels within 12 months.
BD has also accelerated the remediation plan for priority 2 devices. Having initially given itself 36 months to replace the bezels, BD now plans to fix the pumps within 24 months. Priority 2 pumps were manufactured more recently and are thought to be less likely to contain components made from weakened plastic. All the devices that led to the 14 injuries reported to date fell in the priority 1 category.
Days before BD published the updated timelines, FDA issued a Class I recall notice in relation to the expanded action initiated by the company in April. The notice stated that there are 603,730 affected pump modules in commerce at sites across the U.S. and around the world.
