FDA frequently asked questions: Philips Respironics CPAP, BiPAP, and ventilator recall (July 29) – View

AASM response to the Philips PAP device recall (July 23) – View

AASM guidance in response to Philips recall of PAP devices

On June 14, 2021, Philips initiated a voluntary recall notification in the U.S. (and an international field safety notice) for specific Philips Respironics models of continuous positive airway pressure (CPAP), bilevel positive airway pressure (BPAP), and mechanical ventilator devices, stating that the recall is to “ensure patient safety in consultation with regulatory agencies.” The recall is to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in certain devices. Philips reports that the foam-related complaint rate in 2020 was low (0.03%). Read the AASM summary of the Philips announcement for additional details and refer to the Philips website for ongoing updates and comprehensive information. (See the links below.)

The AASM is providing the following information to help sleep centers and sleep medicine professionals understand their options. Members should consider discussing these options with their risk management team or counsel. This guidance document does not constitute legal advice and is not meant to substitute for the clinical or medical judgment of our clinicians or members. Additional information, including responses to frequently asked questions, will be made available by the AASM as soon as possible. Call Philips at 877-907-7508 for additional help and support.

Philips advises that patients using recalled BPAP and CPAP devices should stop using their devices and consult with their medical providers to determine the most appropriate options for continued treatment, based on the benefits of continuing therapy and potential identified risks. The AASM suggests that the medical provider prescribe for their patient a PAP device that is not affected by the recall. However, in the case that this is not an option, or another device is unavailable, then it is the AASM viewpoint that clinical factors such as comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles should inform the decision to continue or discontinue therapy. This decision should be made in concert between the patient and their medical provider. The ultimate judgment regarding any specific care must be made by the treating clinician and the patient, taking into consideration the individual circumstances of the patient, available treatment options, and resources. The AASM advises that patients contact their medical provider as soon as possible to discuss whether to continue or discontinue treatment.

Philips has identified the following to be among the potential health risks of using a recalled device:  airway inflammation; skin, eye, and respiratory tract irritation (including upper airway irritation); headache; asthma; toxic carcinogenic effects; cough; chest pressure; or sinus infection, and has recommended for users of their recalled BPAP and CPAP machines to discontinue treatment.

Note that this guidance document is based on public information provided by Philips as of June 18, 2021. Please submit questions about the Philips recall to the AASM at recall@aasm.org.

Considerations for Patient Notification

The AASM advises sleep centers and sleep medicine professionals to take the following steps to inform patients about the recall:

  • Consider mechanisms to identify patients who use a recalled Philips CPAP, BPAP, or mechanical ventilator device.
  • When possible, notify patients of the Philips recall. Download a Word document with a sample message to patients. (Updated 7/16/21)
  • Urge patients to use the Philips registration process to look up their device serial number and begin a claim if their unit is affected.
  • Philips also has provided a toll free phone number, 877-907-7508, with a Spanish-language option available.
  • Inform patients that Philips has stated that ozone-related products should not be used to clean PAP equipment. Patients should follow the cleaning methods described in their device’s “Instructions for Use.” (See the February 2020 FDA safety communication for more details.)
  • Advise patients to contact their medical provider to discuss treatment options.
  • Document all patient notifications.

The AASM advises sleep centers and sleep medicine professionals to consider the following strategies to help patients who have a Philips device that has been recalled. [Members of the sleep medicine community have developed a SAMPLE patient assessment tool (updated 6/23/21) and a SAMPLE pediatric patient assessment tool (updated 6/29/21).]

For Life-Sustaining Ventilator Devices: DO NOT stop use without talking to a medical provider

  • For patients who require the Trilogy 100 and 200 for emergency, life-sustaining therapy, if an alternate option for therapy does not exist, Philips advises that the benefit of continued usage of these devices may outweigh the risk.
  • Philips recommends using an inline bacterial filter to reduce exposure to degraded sound abatement foam particles.

For BPAP and CPAP Devices

  • At this time, Philips has not disclosed a timeline to repair and replace recalled devices. However, because the recall involves millions of PAP devices, it may take some time before this process is complete.
  • Discuss treatment options with the patient, taking into consideration comorbidities, severity of symptoms, risks associated with PAP discontinuation, and safety-sensitive roles.
    • When possible, consider procuring another PAP device that is not affected by the recall.
    • Consider the appropriateness of alternative treatment options, including positional therapy, oral appliance therapy, and surgery.
    • Consider the appropriateness of behavioral strategies such as weight loss, exercise, and avoidance of alcohol and sedatives before bedtime.
    • Consider whether continued use of a recalled device is necessary. In its clinical information for physicians, Philips advises that “physicians should evaluate the benefits of treatment vs the risk of exposure, with the context of patient conditions, to determine the most appropriate care plan.”
      • Benefits may include reduced risk of cardiovascular events, drowsy driving, falls, and workplace accidents.
      • Philips reports that, “The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects.” Philips reports that the foam-related complaint rate in 2020 was low (0.03%). Philips believes that most
        degraded foam particulates are too big to be deeply inhaled, according to a July 8 supplemental update from Philips. (Updated 7/16/21)
      • Philips reports that, “The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic and carcinogenic effects.” Philips reports that it “has received no reports regarding patient impact related to chemical emissions.” A July 8 supplemental update from Philips indicates that two compounds of concern were emitted during 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. The emission of the other compound tapers off during the initial days of use of a new device. (Updated 7/16/21)
      • Identify whether the device has been exposed to an ozone-based cleaner or high heat and high humidity environments. Philips indicates that these factors can exacerbate foam degradation.
    • If you make a clinical recommendation to continue device use, Philips indicates that you should instruct the patient to follow the cleaning procedure per the device’s “Instructions for Use.”
      • Provide notice of the recall, documenting patient consent to the continued treatment using a recalled device.
    • Document the patient’s decision or intention in the electronic health record (EHR).

Consider the following strategies for in-lab use of Philips devices that have been recalled:

  • Consider removing recalled devices from service, using other PAP devices in the lab as available.
  • If other PAP devices are unavailable, consider postponing titration or converting split-night studies to full-night diagnostic studies followed by home titration with auto-adjusting PAP (APAP), taking into consideration comorbidities, severity of symptoms, safety-sensitive roles, and payer approval requirements.
    • Consider whether continued in-lab use of a recalled device is necessary. In its clinical information for physicians, Philips advises that “physicians should evaluate the benefits of treatment vs the risk of exposure, with the context of patient conditions, to determine the most appropriate care plan.”
    • Ensure temperature control systems that prevent the high heat and high humidity environments, which Philips indicates can contribute to foam degradation.
    • Avoid using ozone-based cleaners, which Philips indicates can exacerbate foam degradation.
  • If you continue to use a recalled device for in-lab titrations, provide written notice of the recall in advance of, or when patients arrive for, their appointment, documenting patient consent to the titration study using a recalled device. Download a Word document with a sample acknowledgment, consent, and release. (NEW 7/16/21)
  • If you continue to use a recalled device for in-lab titrations, visually inspect the device before and after each use, looking for black debris/foam particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). If particles are detected, immediately remove the device from service.
  • Continue to follow the cleaning procedures per each device’s “Instructions for Use.”

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.

How has the FDA responded to the recall? (NEW 7/29/21)

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. During a phone call with professional society leaders on July 21, Philips representatives indicated that the company is waiting for FDA feedback so that it can begin repairing recalled devices by changing the sound abatement foam. 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.”

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.

How long will it take for Philips to repair and replace the recalled devices? (Updated 7/29/21)

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. Philips representatives stated that the company is waiting for FDA feedback so that it can begin repairing recalled devices by changing the sound abatement foam. 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.

Should filters be used with a recalled device? (Updated 7/16/21)

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. Philips has made no public recommendation for or against the use of filters with recalled BPAP and CPAP devices.

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.

What is the AASM doing to advocate for patients?

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.

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.

Is additional guidance available from other professional societies or government organizations? (Updated 7/30/21)

In addition to the AASM guidance, the following statements are available: