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Recall Of Sleep, Ventilator Devices Lead To International Patient Suits For Philips

 
• By Elizabeth Orr

Patients in Canada and the US are suing Philips over issues related to the company’s recent recall of CPAPs, BiPAPs, and mechanical ventilators.

Patients in at least two countries have filed class action lawsuits against Royal Philips in the wake of a high-profile recall of breathing and ventilator devices made by the company.

The Dutch manufacturer recalled certain bi-level positive airway pressure (BiPAP), continuous positive airway pressure (CPAP), and other mechanical ventilator devices in June because they incorporate noise-abatement foam that can break down over the time, causing risks to patients that Philips says include “headache, irritation, inflammation, respiratory issues, and possible toxic

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More from Policy & Regulation

Access To Library Tools Being Restored At US FDA

 
• By Sue Sutter and Derrick Gingery

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FDA Announces Classifications On 8 Device Types

 
• By Elizabeth Orr

The US Food and Drug Administration has announced new classifications for eight device types that reached market via the de novo process, with most of the newly classified products in the diagnostics sector.

Medical Devices Not The Focus Of FDA’s Plans To Step Up Foreign Inspections, Expert Says

 
• By Brian Bossetta

The US FDA recently announced plans to carry out more unannounced inspections of foreign facilities. But those inspections will primarily target drug producers, with less attention and resources allocated to those making devices.