Medical Devices - Health Care Chief

The death toll linked to Phillips’ respiratory device recall reached 364 back in April 2021, Philips first began publicizing its issues with its bilevel positive airway pressure machines (BiPAP ) and continuous positive airway pressure machines (CPAP) when concerns were raised over the degrading foam in its DreamStation CPAP machines. Before that point, Philips had only sent 30 medical device reports (MDRs) to the FDA regarding the breakdown of PE-PUR foam in the last decade, now however, there are approximately 99,000 MDRs filed against the devices. Just over the past year, 21,000 MDRs have been filed against the recalled devices with complaints peaking from May to July 2022. Since then, although the rate of complaints has reduced, there has been a rise in the death toll. Datasets produced by the Food and Drug Administration (FDA) have listed 123 deaths overall in the first year of the recall; between the months of May to July of that year, the agency listed 45 deaths. The figure for August to October was initially out at 91 but has now gone up to 96 after the company’s review of the MDRs. These are the figures that have been reached after consulting Philips's review of the reports. Since the recall began in the summer of 2021, the rate of deaths per month has only risen each month and as of now, a total of 364 deaths reports have been received. In the final two months of last year alone, 82 deaths have been linked to Phillips’ respiratory device recall. These deaths were reported among the over 800 MDRs that the FDA received between November and December. The most recent figure is yet to be adjusted in light of the firm’s own review, but it is expected that it will be the highest death rate in the dataset. The number of deaths per month has been on the rise. For the last 3 reporting periods, figures rose from 15 to 41. Both Phillips and the FDA, however, have clarified that all the MDRs cannot be linked to the recall. Phillips, in fact, shared the results of its safety tests from last December that covered the majority of the recalled devices and it revealed that the disintegrating foam in the tested recalled devices was unlikely to have been the cause of harm for any patient. The volatile organic compounds released from the foam were not identified as an active threat to patients’ health. “The vast majority (93%) of the approximately 99,000 MDRs filed since April 2021 up to and including December 2022 are alleged technical malfunctions that do not involve serious injury,” Philips said. “Philips Respironics investigates all allegations of technical malfunction serious injury or death. Based on the investigations to date, Philips Respironics has found no conclusive data linking these devices and the deaths reported in certain of these MDRs.” Despite the fact that companies are still rolling out, Philips has continued to work on its repair-and-replace program for its 5.5 million recalled respiratory devices. In a recent update, the company shared that the production required for the delivery of the replacement device was almost 90% done and that the remediation program will likely finish within this year. To read more about this topic, click here.

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