The nonprofit patient advocacy group Alliance of Sleep Apnea Partners (ASAP) today released a comprehensive white paper, "The Philips Respironics Recall: Shaping Policy for Better Patient Outcomes." This report examines the far-reaching consequences of the Food and Drug Administration’s 2021 recall of Philips Respironics CPAP, BiPAP, and ventilator devices. This is one of the largest medical device recalls in history, involving an estimated 15 million devices worldwide and 10 million in the United States alone.

 

Key highlights of the ASAP white paper include:

• Analysis of the recall's negative impact on patient care and healthcare provider management

• Identification of systemic gaps and communication failures that exacerbated challenges

• Policy recommendations to improve respiratory device regulation and patient safety

• Insights from discussions with patients, healthcare providers, sleep researchers, former FDA representatives, and policy analysts

 

The white paper’s proposed policy recommendations include:

1. Creating a national respiratory device registry for improved recall communication and tracking

2. Enhancing FDA authority on post-market surveillance of respiratory devices

3. Reforming Medicare and Medicaid rules to facilitate timely replacement of recalled respiratory devices

4. Amplifying patient voices in regulatory decision-making processes

5. Increasing support for research, innovation, and education around sleep apnea therapies

 

"This white paper serves as a call to action for industry, regulators, and policymakers to prioritize patient safety and improve communication during medical device recalls," said ASAP Executive Director Dr. Monica Mallampalli. "And it empowers patients to become effective advocates for awareness and change, both in policy and regulation, as well as during the development and post-market surveillance of these devices.” 

The report is based on a series of public panel discussions conducted by ASAP, which are available for free on the organization's YouTube channel (@ApneaPartners).

This project was made possible through a generous grant from the American Academy of Sleep Medicine Foundation.

For more information about the Alliance of Sleep Apnea Partners and to access the full white paper, please visit apneapartners.org.

 

About Alliance of Sleep Apnea Partners

ASAP is a patient-oriented nonprofit 501(c)(3) advocacy organization founded in 2018. Its mission is to promote and advocate for screening, diagnosis, treatment, and management for optimal health of those who suffer from sleep apnea.