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.
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.”
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 risk to regular users of recalled PAP machines? (Updated 7/26/21)
Philips has reported that the complaint rate in 2020 was low (0.03%). However, it is unknown how many cases may have been unreported. 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.
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.”
How long will it take for Philips to repair and replace the recalled 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. Philips has stated that it will replace the current sound abatement foam with a new material after obtaining relevant regulatory clearances. Philips also has indicated that they will address all affected devices in the scope of this correction as expeditiously as possible.
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 7/26/21)
In addition to the AASM guidance, the following statements are available:
- American Thoracic Society: Recommendations for Sleep and Critical Care Medicine Professionals Regarding Philips Recall Notice
- Australian Department of Health | Therapeutic Goods Administration: Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators
- Canadian Sleep Society: Phillips Respironics Positive Pressure Device Recall
- DME MACs: Frequently Asked Questions – Philips Respironics Respiratory Products Recall
- European Respiratory Society: Recommendations for respiratory, sleep and critical care medicine professionals and patients regarding the Philips recall notice
- U.S. Food and Drug Administration: FDA Safety Communication
- U.S. Food and Drug Administration: Philips Respironics Recalls Certain Continuous and Non-Continuous Ventilators, including CPAP and BiPAP, Due to Risk of Exposure to Debris and Chemicals (NEW 7/22/21)
- U.S. Food and Drug Administration: Philips Respironics Recalls Certain Ventilators and BiPAP Machines Due to Potential Health Risks from PE-PUR Sound Abatement Foam (NEW 7/22/21)
- Veterans Health Administration National Center for Patient Safety: Philips CPAP Recall
- Sample sleep center message to patients (Word document)
- Sample acknowledgment, consent, and release (Word document) – NEW 7/16/21
- Guidance for patients (Sleep Education blog post)
Clinical Assessment Tools
Call Philips at 877-907-7508 for additional help and support. The following information is available online from Philips:
- Medical Device recall notification (U.S. only) / field safety notice (International Markets)
- Information for physicians and other medical care providers
- Sleep and respiratory care update: Clinical information for physicians
- Supplemental clinical information for physicians (NEW 7/8/21)
- Physician engagement letter
- Philips recall letter to device customers
- Press release: Philips issues recall notification
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 email@example.com.