How has the FDA responded to the recall? (Updated 11/16/21)
On June 30, the FDA issued a safety communication in response to the recall. The statement urged patients who use a recalled device to talk to their health care provider to decide on a suitable treatment for their condition. The FDA also indicated that it is working with Philips to evaluate the issue and the company’s corrective actions. On July 22, the FDA issued two announcements (one for continuous and non-continuous ventilators and another for mechanical ventilation devices) indicating that it “has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.” On Nov. 12, an FDA news release provided an update that included an inspection closeout report with findings from recent inspections of a Philips manufacturing facility. The report includes new information about the silicone-based foam that Philips is using to repair and replace devices affected by the recall. On Nov. 12, the FDA also updated its safety communication and frequently asked questions.
What is the AASM doing to advocate for patients? (Updated 11/16/21)
The AASM and several medical societies and patient advocacy organizations submitted a letter on June 22 to the durable medical equipment (DME) Medicare administrative contractors (MACs) requesting support from the Centers for Medicare & Medicaid Services (CMS) for patients affected by the recall. The AASM also sent a similar letter to more than 200 private payer contacts. On June 28, the DME MACs posted FAQs for DME suppliers, which were revised July 16. The AASM has participated in multiple calls with FDA representatives to discuss the recall’s impact on patients and health care professionals.
How long will it take for Philips to repair and replace the recalled devices? (Updated 9/1/21)
During a phone call with professional society leaders on July 21, Philips indicated that it will take at least an estimated 9 to 12 months to repair or replace all recalled devices. They also noted that they estimate that about half of the devices in regular use in the U.S. that are affected by the recall have been registered to date. Philips also indicated that they had begun the process of replacing some of these registered devices with new DreamStation 2 machines, which have a different, silicone-based foam that is not included in the recall. Finally, Philips indicated that they are encouraging patients who have more than one recalled device (e.g., a “back-up” or travel device) to prioritize the repair and replacement of a single machine before seeking subsequent repair and replacement of a second device. On Sept. 1, Philips announced that it has received authorization from the FDA to begin repairing recalled DreamStation devices by replacing the sound abatement foam with a new material. Philips anticipates that its repair program will begin in September. The statement confirmed that Philips intends to complete the repair and replacement programs within approximately 12 months.
Will Medicare pay for a temporary PAP device for patients who are waiting for Philips to repair or replace a recalled device? (NEW 9/1/21)
An FAQ response posted by the DME MACs instructs DME suppliers that they can bill Medicare for a rental unit if they supply a Medicare beneficiary with an alternate PAP unit to use while the patient waits for Philips to repair or replace their recalled device.
Should filters be used with a recalled device? (Updated 8/12/21)
According to Philips, if physicians determine that a patient must continue using a life-sustaining mechanical ventilator device, providers are strongly urged to use an approved bacterial filter per Instructions for Use; it may reduce exposure to degraded sound abatement foam particles, though bacterial filters will not reduce exposure to potential volatile organic compounds (VOCs). However, according to supplemental information posted by Philips, testing results suggest these chemical emissions taper off during the initial days of use of a new device. Contact your DME supplier to identify the appropriate filter for your device. In August Philips posted supplemental clinical information about bacteria filters, indicating that they are “a part of the normal use of the Trilogy ventilators.” However, the document also explains multiple reasons why “bacteria filters should not be used on CPAP/BiLevel devices as a means of mitigating risk of PE-PUR foam chemical emission or particulate matter.”
Has Philips provided any new updates since the original recall announcement? (NEW 7/29/21)
Philips posted a document with “supplemental clinical information,” dated July 8, providing details from additional testing of the sound abatement foam in the recalled devices. Regarding foam degradation, Philips indicated that foam particle sizes down to 2.69 microns had been observed. However, Philips stated that the majority of particulates were of a size (more than 8 microns) that are unlikely to penetrate into the deep lung tissue. Philips concluded, “Based on the test data and information available to date, Philips believes that most degraded foam particulates are too big to be deeply inhaled.” Philips also noted that for affected mechanical ventilator devices (e.g., Trilogy), the use of a bacteria filter may mitigate exposure to foam particulates. Philips also tested for chemical emissions by running new devices at a high temperature (i.e., 95 degrees Fahrenheit) for 7 days (i.e., 168 hours). Philips indicates that two compounds of concern were emitted during testing. Testing results to date suggest that the emission of one compound dissipates to below detectable levels after the initial 24 hours of use of a new device. Results also suggest the emission of the other compound tapers off during the initial days of use of a new device.
What is the risk to regular users of recalled PAP machines? (Updated 7/29/21)
According to the FDA, the polyester-based polyurethane sound abatement foam, which is used to reduce sound and vibration in these affected devices, may break down and potentially enter the device’s air pathway. If this occurs, black debris from the foam or certain chemicals released into the device’s air pathway may be inhaled or swallowed by the person using the device. Philips has reported that the complaint rate in 2020 was low (0.03%). However, the company also has stated, “Philips acknowledges that the low complaint rate may not fully reflect the probability frequency or severity of the occurrence, because users may not detect the particulates and/or report the event to Philips.” According to the FDA, there have been more than 1,200 complaints and more than 100 injuries reported for this issue in continuous and non-continuous ventilators. The FDA also reports that there have been 83 complaints, no injuries, and no deaths reported for these issues in mechanical ventilation devices. The FDA indicates that the exposure to debris or chemicals could cause serious adverse events in patients such as irritation (skin, eye, and respiratory tract), inflammation, headache, asthma, hypersensitivity, nausea/vomiting, adverse effects to other organs (e.g., kidneys and liver) and toxic carcinogenic effects.
Do other PAP manufacturers use the same foam found in the recalled Philips devices? (Updated 7/8/21)
An FDA safety communication indicates that the FDA does not have evidence at this time that any other PAP machines are affected. An online statement from ResMed indicates that, “ResMed devices are safe to use and are not subject to Philips’ recall. ResMed devices use a different material than what Philips uses in their recalled machines.”
What is the risk to the patient associated with using a recalled device during one night for an in-lab titration?
Based on the information currently available from Philips, this risk is unknown.
Are there any tools to help guide decision-making in response to the recall?
To help guide decision-making, members of the sleep community have developed several flowcharts as examples that you can consider and adapt. These include this sample patient assessment tool and similar samples for both assessment of pediatric patients and triaging respiratory assist devices and home ventilators in patients with chronic respiratory failure, which are available in the June 25 AASM webinar slides. You can download an updated version of the sample pediatric patient assessment tool.