As a patient-focused organization, we understand the struggles and challenges confronting people who rely on PAP (Positive Airway Pressure) therapy devices. These devices are critical lifelines for patients suffering from sleep apnea and other respiratory disorders. But now that lifeline has been interrupted for millions of patients. In June 2021, the FDA recalled certain PAP medical devices manufactured by Philips Respironics over safety issues. The FDA declared the Philips recall a Class I recall, the administration’s most serious designation, indicating “a situation where there is a reasonable chance that a product will cause serious health problems or death.”

More than 115,000 medical device reports–including 561 deaths–were reported to the FDA. Patients reported symptoms and medical problems including cancer, pneumonia, asthma, infections, headache, cough, dyspnea (difficulty breathing), dizziness, nodules, and chest pain.

The recall affected more than 5 million CPAP devices in the United States. But many patients and their doctors were not even made aware the recall had occurred. 

This unprecedented recall revealed the urgent need for policy changes to protect the patients whose health depends on these vital medical tools.

Patients were left with stark choices: pay hundreds or more to purchase a new device if they could find one (limited due to prior chip shortages), use their faulty and potentially dangerous recalled devices for months while they waited for replacements from Philips, or put their health at greater risk by stopping treatment. Common-sense federal policy can help protect patients from this stressful and dangerous situation in the future.

To increase safety, transparency, and accountability around respiratory therapy, we urge Congress to: 

1. Establish a centralized national registry for respiratory devices. This would make it more efficient to track recalled machines and alert patients and their doctors.

2. Require automatic subrogation for insurance claims related to recalled devices. This change will mean insured patients can quickly get a replacement device without paying out-of-pocket and can safely continue their vital PAP therapy.

Concrete steps like these are crucial in safeguarding the well-being of individuals who depend on these medical devices. Approximately 1 billion people suffer from sleep apnea worldwide, and in the U.S. alone the condition contributes to an estimated $149 billion in annual economic losses. Add your voice to the growing number of patients who are pressing Congress to enact these policies to help all of us breathe easier.

For more information on our advocacy work related to this recall, please visit apneapartners.org/philips-recall-information.