Field-Safety Notice and Recall of Sleep Care Devices by Philips Respironics

Abstract

On 14th June 2021, Philips Respironics issued a medical device recall notification (US only) and field-safety notice (International Markets) for mechanical ventilator devices including continuous positive airway pressure (CPAP), and bilevel positive airway pressure (bilevel PAP). This was in response to potential health risks related to the sound abatement foam component in these devices. The company had stated that they are working hard towards a resolution, which includes repair and replacement of the affected devices. The statement of Philips clearly declares that this is a recall notification for the US, and only a field-safety notice for the rest of the world. The advisory from Philips puts the ball in the court of the physician or Durable Medical Equipment (DME) provider to determine the most appropriate options for continued treatment of patients using the affected devices. Although the long-term effects of these recalled machines will continue to be a matter of concern for the patients, the patients must be supported by the providers with explanations, reassurances and hope.