How should doctors guide patients after FDA sleep apnea recall?

By Sarah Handzel, BSN, RN | Medically reviewed by Kristen Fuller, MD
Published November 29, 2022

Key Takeaways

  • Recalls on certain Philips Respironics devices began in 2021 and continued into 2022.

  • Certain CPAP and BiPAP machines are included in the recall, as are certain types of masks featuring magnetic headgear clips.

  • Physicians should adhere to FDA guidelines on product use and advise patients on these guidelines as appropriate.

The FDA issued a Class I recall of several Philips Respironics products including a variety of sleep apnea masks and machines in 2022.[][] The most serious type of FDA recall, Class I is intended to prevent the use of products that may increase the risk of serious injury or death.

Much of the initial guidance provided by Philips urged those affected to talk with their doctor about possible solutions, as reported in an article published by NPR.[] Such directives have continued as the manufacturer works to repair or replace the affected products.

But physicians cannot simply provide new respiratory support devices to patients in need, as they are very expensive machines and are in short supply due to supply chain problems. As an alternative, doctors can counsel patients on the best ways to lower their risk of adverse events if their devices are recalled.

Foam, plastic, magnets pose health risks

Reports of harm to patients involving these Philips products began in 2021, according to the NPR article. The manufacturer’s CPAP machines, along with other respiratory devices, were linked to a variety of adverse events, including asthma, allergic reactions, and headache. Additional risks included cancer-causing effects on a variety of internal organ systems.

While Philips Respironics did issue a recall notice for around 5.5 million CPAP and BiPAP machines, safety issues continued to emerge.

The company issued additional recalls for BiPAP machines containing contaminated plastic, followed by a mass recall centered on some types of magnetic face masks.

Initial recall efforts centered around a certain type of polyester-based polyurethane foam used in many Philips Respironics breathing support devices, according to an article published by Fierce Biotech in September 2022.[]

This foam breaks down over time, leading to the potential inhalation of foam particles and other harmful chemicals into the lungs, as reported by Fierce Biotech in August 2022.[] This discovery led to the implementation of a massive, ongoing repair-and-replace program.

Other issues were discovered even as Philips worked to correct the initial foam issue. The company issued another recall after finding that some types of BiPAP machines contained contaminated plastic that could have released certain volatile organic compounds (VOCs), especially if the plastic makes up parts of the devices’ motors, according to the FDA.

In addition to potentially causing the BiPAP machine to fail, resulting in patient injury or death, devices containing this plastic may cause additional adverse effects as a result of inhalation of VOCs.

These effects could include:

  • Dizziness

  • Headache

  • Irritation of the mucus membranes and respiratory tract

  • Nausea or vomiting

  • Toxic and cancer-causing effects

Further devices that have come under scrutiny include six types of CPAP and BiPAP masks that all have magnetic headgear clips to help hold them in place. The magnets are reportedly powerful enough to cause injury—or even death—to users and people in close proximity to a mask, according to the FDA.

People with metallic objects in the body or with implanted metallic medical devices may be affected, including those with:

  • Aneurysm clips

  • Certain cochlear implants

  • Implantable ports and pumps, including insulin pumps

  • Implantable cardioverter defibrillators

  • Metallic cranial plates, screws, burr hole covers, and bone substitute devices

  • Neurostimulators

  • Pacemakers

This list is not comprehensive. Physicians should check the FDA’s medical device recalls database for updates on the serial and model numbers included in the recall.

How physicians can help patients

Physicians should identify patients at risk for adverse effects resulting from use of recalled respiratory support products. It may be unreasonable to expect individual doctors to provide a comprehensive solution to this issue, but they can advise patients to follow FDA guidelines while waiting for the repair or replacement of their recalled device.

For patients in acute care, alternative respiratory support devices are available and should be substituted for affected Philips CPAP and BiPAP machines.

In cases of home care, no action is necessary if the affected device has already been corrected or replaced. Additionally, each patient should register their device with Philips, regardless of repair status. This helps ensure that patients receive the latest information and guidance from the company.

Masks affected by the recall should be immediately replaced with a mask without magnet headgear clips, as long as the patient can tolerate such a substitution. Patients should be advised to use only non-magnetic masks for the duration of therapy, and they should dispose of magnetic masks.

Alternatively, physicians should consider counseling patients to continue using the magnet masks only if they adhere to updated instructions and they (or other people in close proximity) do not have any type of magnetic implant or other magnetic medical devices.

What this means for you

As recalls affect patients using Philips Respironics respiratory support devices, physicians are their first point of contact. Work to identify which patients may be affected by the recalls. Then, try to become familiar with the latest FDA guidelines on each of these devices to provide the most appropriate and up-to-date information available to your patients.

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