Smiths Medical, now part of ICU Medical since a 2022 acquisition, has encountered multiple safety issues, notably leading to the recall of several of its products. Recently, the company has been embroiled in a serious matter involving the recall of their portable ventilators – specifically the PneuPAC ParaPAC Plus P300 and P310 models. These events have further tarnished their reputation as they continue dealing with the fallout from previous concerns noted by authorities and stakeholders.
The Food and Drug Administration (FDA) categorized two recent recalls of these Smiths Medical ventilators as Class I, indicating that the issues present a significant risk of severe harm or death. The first recall arises from a defect where the patient outlet connector can loosen or detach entirely, a flaw already linked to one reported death and another injury. This issue prompts Smiths Medical to urge the examination of this connector before each use, advising that if any movement or looseness is detected, the device should be sidelined for repairs. Additionally, they recommend independent monitoring of patients’ blood oxygen and carbon dioxide levels and having an alternative ventilation method prepared.
The second recall confronts a separate issue, involving the tidal volume knob, which controls the air volume delivered to patients with each breath. Problems emerged when this knob was found to potentially shift from its set position, potentially leading to incorrect ventilation volumes being delivered—either too much or too little, thus posing a significant risk to patients. Over 12,000 units are affected by this recall. Smiths Medical’s guidance for handling devices affected by this issue is to remove them from service until they can be fixed.
Earlier in the year, Smiths Medical had already recalled thousands of other ventilators due to another severity—a malfunction where devices could deliver a continuous positive gas flow, disrupting the natural breathing cycle. This problem was associated with eight serious injuries. Furthermore, an earlier recall of defective tracheostomy tubes, linked to one death and 35 serious injuries, has added to the company’s ongoing challenges.
The cascade of product safety issues has come amid high-level corporate responses and changes. Daniel Woolson was appointed as the new president of ICU Medical starting October 1st, transitioning from his role as the general manager of infusion systems since 2017. Meanwhile, ICU Medical’s CEO, Vivek Jain, has acknowledged that resolving Smiths’ quality issues has proven more daunting than initially anticipated.
These recalls and the incidents leading to them underscore a tumultuous phase for Smiths Medical, fraught with challenges as they navigate remediation and ensuring user safety of their medical products. Their ability to quickly and effectively address these concerns might be essential for restoring confidence among customers, regulators, and investors in the reliability and safety of their products.
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