Philips dropped the ball in sleep apnea machine recall: Inspectorate
Philips seriously dropped the ball when it came to recalling and replacing its sleep apnea devices, in which users could inhale or ingest foam particles and maybe incur health damage. The manufacturer fell "substantially and structurally" short in handling the recall and informing customers about what was happening, the Health and Youth Care Inspectorate (IGJ) said to Nieuwsuur.
The IGJ said it "constantly and increasingly sharply" addressed Philips about adequately communicating to those involved. Philips recalled the sleep apnea devices in June last year. Most users still have no idea when Philips will replace their device. Over 70 percent of Dutch users have not yet been helped, Philips said to Nieuwsuur. The company currently aims to give 90 percent of affected people worldwide a new or repaired machine by the end of this year.
Philips recalled the devices after it became clear that the sound-damping foam could crumble and release chemical gases if it came into contact with certain cleaning solutions. Initial data showed that people breathing or ingesting the foam particles could lead to health problems like headaches, asthma, organ damage, and carcinogens. Philips later released more reassuring interim research results saying that the gases released were in such a low concentration that they fall within the safety standards. Philips published the interim results but not the underlying reports.
Last week, the United States' inspectorate, the FDA, said that it had received 21,000 health reports from users of the recalled Philips devices. These included reports of cancer, pneumonia, headache, dizziness, and chest pain. The FDA also received reports of 124 deaths possibly linked to the recall. However, the U.S. authority stressed that these were just reports that still needed to be investigated.
Seemingly conflicting reports left many users wondering whether using their sleep apnea devices was safe. This uncertainty eats at the users, lawyer Mark de Hek, who is representing about 500 users, said to Nieuwsuur. He is holding Philips liable for that suffering.
Pulmonologists are also noticing the unrest among apnea patients, Monique Klaaver of pulmonologists' association NVALT said to the program. "Not only in the patients who use the Philips device but also in new patients who just got the apnea diagnosis. They sometimes hesitate whether they want to wear an apnea mask at all, while that is sometimes the only possible treatment for them." She called Philips' communication pathetic. You expect a multinational to be able to tell a patient when they can expect their new device, she said. "This is an essential medical device, not a broken vacuum cleaner."