While Philips subsidiary Philips Respironics continues an extensive program to repair and replace 5.5 million respirators following a June 2021 recall, primarily due to potential health risks associated with sound-absorbing polyester-based polyurethane (PE-PUR) foam, new problems are plaguing some of the repaired devices.
In mid-November, the FDA issued a recall update that affected certain continuous positive airway pressure (CPAP) and bi-level positive airway pressure (BiPAP) machines and mechanical ventilators, indicating that Philips had informed the agency that Philips Respironics Trilogy ventilators had been reworked. two new potential problems.
Firstly, the sound deadening silicone foam installed in the devices to replace the PE-PUR foam has the potential to separate from the plastic backing and could impact the performance of the device by possibly blocking the air inlet, thus lowering the inspiratory pressure. If the air pressure is significantly affected, the device may issue a ventilator alarm, such as the low inspiratory pressure alarm.
Additionally, traces of particles were found in the air path of some of the reworked fans. Preliminary third-party lab results identified PE-PUR and environmental debris in some samples, and only environmental debris in others.
For Philips, which also issued a public update on the matter last week, the new issues mark a setback for its ongoing repair efforts. While Philips Respironics investigates the issues, it has temporarily suspended repair of Trilogy 100/200 devices, according to the update.
A Philips spokesperson provided additional context on the new issues in an email to MedPage todaywriting in part: “It is important to note that this only affects Trilogy 100/200 ventilators (approximately 3% of affected devices registered worldwide), which have already been repaired. These issues do not affect any of the CPAP or BiPAP ventilators. sleep apnea devices that have been corrected.”
In its update, Philips said that repairs to the Trilogy 100/200 ventilators had begun in recent months and that Philips Respironics had detected both issues with the ventilators corrected “following a limited number of complaints from the United States. States and Japan”.
Elaborating on the issue of silicone foam separation, Philips stated that as of November 1, the observed occurrence rate of reportable events was less than 0.015% of the corrected Trilogy 100 devices. Based on the latest information available, the root cause was related to an assembly step when inserting the silicone foam, the company noted.
Additionally, pending investigation of the two new issues, Philips Respironics plans to take appropriate action if necessary.
Regarding the CPAP and BiPAP machines included in the June 2021 recall, Philips said in its update that they accounted for approximately 95% of affected devices, adding that repair and replacement of these devices were “in good way in the world”.
Specifically, the spokesperson said MedPage today that “more than 4 million replacement devices and repair kits have been produced, of which approximately 2 million have been shipped to the United States”
Shannon Sullivan, MD, pediatric sleep medicine specialist at Stanford Medicine and chair of the public safety committee for the American Academy of Sleep Medicine, said MedPage today that it is unclear where there may still be hot spots in the United States in terms of patients waiting for sleep apnea devices to be repaired or replaced. However, in her practice, the majority of cases have been mitigated in some way, she said.
Many patients’ CPAP or BiPAP machines were repaired or replaced at this point, while other patients switched to a different brand or therapy, she added.
Still, there is an occasional patient who comes to the clinic thinking their device isn’t affected when it is, she said, noting that she’s also worried about patients who aren’t. have not or have not been in contact with a physician specializing in sleep medicine. to discuss mitigation measures.
Last week, the FDA released another update containing information on medical device reports (MDRs) received from August 1 through October 31 that are believed to be associated with the failure or suspected failure of the PE-PUR foam used. in the respirators included in the recall.
In the most recent period, over 21,000 MDRs were received, including 91 death reports.
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