by Jennifer Henderson: For Complete Post, Click Here…
Effects of recall reverberate through sleep medicine community.
More than a year after the start of a recall now involving more than 5 million breathing devices, doctors and patients are still feeling the effects as manufacturer Philips continues to remediate machines and weathers scrutiny from federal agencies.
The recall by subsidiary Philips Respironics has affected certain continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines and mechanical ventilators mainly due to potential health risks from polyester-based polyurethane (PE-PUR) sound abatement foam that was used in the machines.
Philips said at the time of the recall that the foam could degrade into particles that could enter the device’s air pathway and be ingested by the user, and that it could off-gas certain chemicals.
The issues, the company said at the time, could result in serious injury that could be life-threatening, cause permanent impairment, and/or require medical intervention. Potential health risks of particulate or chemical exposure range from irritation to toxic and carcinogenic effects, the company said.
Though the recall initially applied to between 3 and 4 million machines, that number has since grown to 5.5 million, according to the company.
Recalling such a mass of critical devices has posed several challenges. Philips still has work to do on a sprawling repair and replacement program, and federal agencies have continued to monitor the company’s progress and communications. On top of that, Philips has agreed to pay $24 million to settle kickback allegations that were being investigated by the U.S. Department of Justice (DOJ). Those allegations were unrelated to the recall and were originally brought by a whistleblower employee. (See this related story on Philips’ run-ins with the DOJ.)