October 30, 2024
Alliance of Sleep Apnea Partners White Paper Spotlights Harmful Failures During Philips Respironics Recall
Report details recall’s impact on patients and healthcare providers, includes policy recommendations
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:
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Analysis of the recall's negative impact on patient care and healthcare provider management
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Identification of systemic gaps and communication failures that exacerbated challenges
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Policy recommendations to improve respiratory device regulation and patient safety
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Insights from discussions with patients, healthcare providers, sleep researchers, former FDA representatives, and policy analysts
The white paper’s proposed policy recommendations include:
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Creating a national respiratory device registry for improved recall communication and tracking
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Enhancing FDA authority on post-market surveillance of respiratory devices
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Reforming Medicare and Medicaid rules to facilitate timely replacement of recalled respiratory devices
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Amplifying patient voices in regulatory decision-making processes
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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.
July 11, 2024
Patient Alert: Information Regarding Recall of Inspire Implants
The U.S. Food and Drug Administration (FDA) has issued a Class I recall that affects 32 units of Model 3028 Inspire IV Implantable Pulse Generators (IPGs) manufactured by Inspire Medical Device Systems Inc. The IPGs are implantable hypoglossal nerve stimulators used as a therapy for obstructive sleep apnea. The FDA’s designation as a Class I recall means a device can cause a serious injury or death if the patient continues to use it. So far, no serious injuries or deaths related to this device have been reported to the FDA.
Patients are encouraged to contact their healthcare providers to schedule an appointment right away if they believe they have the affected implant. Patients can find the serial numbers for affected units on the FDA website.
The Inspire Medical Systems Inc. is calling this action as a correction, which means that the company is fixing the problem with the device in the location where it is used or sold. In this instance, Inspire Medical Systems Inc., first took action on June 17, 2024, by contacting healthcare providers using this device to provide specific instructions to notify affected patients of the recall. The company further asked the healthcare providers to:
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Encourage patients to come back to the clinic for a follow up to ensure the devices are working properly.
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Continue to monitor patients to check if the units are operating properly and consistently throughout the course of therapy.
In an email to the Alliance of Sleep Apnea Partners (ASAP), Inspire Medical Systems has assured us that patient safety continues to be of paramount importance to Inspire and that they will continue to cooperate fully and follow-up, as appropriate, with the appropriate regulatory authorities, including the FDA, health care providers, and all potentially impacted patients.
For more information, including contacting Inspire Medical Systems Inc., please visit the FDA website.
If you have questions or concerns, please contact ASAP at info@apneapartners.org immediately.
May 15, 2024
McCullough, Puleo Join ASAP Board of Directors
In April, ACIRAH Health, PBC, founder and chief executive Bridgette McCullough and sleep technologist and business development consultant Andre Puleo joined the ASAP board of directors.
Bridgette McCullough, PhD, MSL, is a lawyer and bioethicist who is IRB-certified in human subject research. She is familiar with life as a sleep apnea patient from the experiences of close family members who have had sleep apnea.
A survivor of colorectal cancer, she has researched gender barriers to clinical trials; committed to closing healthcare disparities in women, particularly African American women; and focused on creating a new paradigm of clinical research forwomen.
In 2021, she founded ACIRAH, which employs its innovative data platform to improve health outcomes of Black women by diversifying who gets access to health screenings and medical information. In her ASAP role, one of her priorities is to create a better pathway for sleep apnea clinical trials.
Andre Puleo gained the unique insight of working as a clinician in sleep labs before deploying his experience and technical expertise to identify global market opportunities and catalyze innovative product strategies on behalf of medical device and software companies in the sleep health space.
Collaborating with product management and engineering teams, he has aided development of and refined sleep-related technology, leading to improved product efficacy.
A sleep apnea patient, he also is a member of ASAP's Community Leadership Council. He is focused on contributing to the advancement of improved therapy and education for patients with obstructive sleep apnea.
“I am immensely proud to embark on this journey as a new board member for the Association of Sleep Apnea Partners," he said. "It's an honor to be part of an organization dedicated to advocating for those affected by obstructive sleep apnea, a cause close to my heart. Together, we will work tirelessly to raise awareness, support patients, and drive positive change in the lives of those living with this condition.”
April 18, 2024
ASAP Issues Statement on Zepbound as
Potential Sleep Apnea Therapy
®
In response to an April 17 announcement by Eli Lilly that tirzepatide (Zepbound) was significantly effective in reducing the number of trial participants’ sleep apnea events per hour, Alliance of Sleep Apnea Partners Executive Directive Director Monica Mallampalli, PhD, has issued the following statement:
“We applaud Eli Lilly’s latest success with tirzepatide, which could pave the way for a potential treatment for OSA in obese patients. We look forward to learning more about how these treatments might work in conjunction with other strategies to help improve sleep apnea patients’ health and quality of life. The next step is to ensure that this treatment is accessible and available to patients who need it upon its approval by the FDA as a sleep apnea therapy.”
Obesity is the strongest risk factor for obstructive sleep apnea (OSA) for both males and females. OSA may cause weight gain and weight gain may cause OSA, leading to a vicious cycle that can worsen patients’ health, impair their cognition, put them at higher risk of accidental injury through daytime sleepiness, and reduce their overall quality of life.
Research has shown that weight loss can reduce the severity of OSA symptoms and related cardiometabolic abnormalities that are associated with both OSA and obesity. But weight loss is not always the only factor in OSA, and patients who are not overweight can develop or continue to have sleep apnea. It’s important for sleep apnea patients to work with their healthcare providers to determine the best therapy or combination of therapies for them.
“Patients need to have choices that work for them, whether they use a particular treatment as a standalone or in combination with CPAP therapy,” said ASAP medical advisor Dr. Christopher Schmickl, Director of the Advanced Care and Electrostimulation for Sleep Apnea Program in the Sleep Clinic at UC San Diego. “I always encourage my patients to combine lifestyle modifications such as diet, exercise and behavior changes with any OSA therapy, so they can have better success in alleviating their OSA symptoms.”
In the phase 3 trial reported by Eli Lilly, tirzepatide was administered to adults living with moderate to severe OSA and obesity, with and without positive airway pressure (PAP) therapy, for a year and was significantly effective in reducing the apnea-hypopnea index (AHI) compared to a placebo; Eli Lilly also reported a 20% reduction in body weight. Currently, AHI is used as a marker to evaluate the severity of OSA and how well a particular treatment works. It is worth noting that 70% of participants in these trials were males who previously had shown resistance to weight loss with this type of therapy. Reported side effects were considered mild to moderate in severity.
Tirzepatide is a combination of two gut hormones called glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP) receptor agonist. Tirzepatide previously had been shown to significantly improve insulin sensitivity and reduce body weight. On November 8, 2023, tirzepatide injection was approved by the FDA for the treatment for chronic weight management and was commercialized in the U.S. as Zepbound®. It has also previously been approved under the trade name Mounjaro® to be used to improve blood glucose levels in adults with type-2 diabetes.
For more information and resources on sleep apnea, including symptoms and risk factors, visit the Alliance of Sleep Apnea Partners website at apneapartners.org.
About the Alliance of Sleep Apnea Partners
ASAP is a patient-led, U.S.-based 501c3 organization committed to promoting and advocating for the diagnosis, treatment, and management of sleep apnea on behalf of the patient community for optimal health of those suffering from sleep apnea. Learn more at apneapartners.org.
January 18, 2024
ASAP Forms Community Leadership Council
The Alliance of Sleep Apnea Partners (ASAP) is pleased to announce the formation of its first Community Leadership Council, which will extend ASAP’s outreach into the wider sleep apnea community, empower more members of that community, and strengthen the link between sleep apnea patients and ASAP.
The Community Leadership Council’s mission is two-fold:
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To elevate concerns, issues, and voices of people living with sleep-disordered breathing and obstructive sleep apnea to ASAP stakeholders to ensure patients’ needs are being addressed
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To promote patient awareness of ASAP and its goal to represent patient voices within their communities
Members of the council are
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David Bishop, a sleep equity advocate and the CEO and founder of the Sleep Equity Project, whose mission is to make sleep treatment accessible to all, regardless of socioeconomic status, gender identity, or geographical location.
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Andre Puleo, a former sleep technologist who worked as a clinician in sleep labs for more than 25 years and later became a global director for sleep diagnostics and therapy. He went on to establish his own healthcare consultancy, AP3 Consulting.
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Bob Stanton, a sleep apnea patient, former commercial truck driver, and current member of the ASAP board. A longtime patient advocate, he has presented at many sleep medicine conferences, co-authored twice in commentary articles in the Journal of Clinical Sleep Medicine, and been active in rule-making with the Federal Motor Carrier Safety Administration related to sleep apnea testing and treatment. Read his Apnea Story.
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Jasmine Steele, U.S. Air Force veteran, teacher, and sleep apnea patient. After learning that her sleep apnea was the root cause of her many health problems, she became determined to help others and raise awareness about the importance of treatment. Read her Apnea Story.
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Tom Wilson, founder of the Philips CPAP Recall Support Group. A former business executive, he founded the Facebook group after learning about the Philips Respironics CPAP/respiratory devices recall in 2021. Since then, he has focused on advocating for consumer rights and has engaged with both the federal government and national media to bring attention to the recall’s impact on patients.
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Nicole Sondermann, a sleep coach, provides one-on-one coaching to patients who are referred for CPAP therapy. A board member of the Florida Association of Sleep Technologists, she also has provided education and training around the topics of shiftwork, sleep, and alertness. She primarily has focused on the transportation, first-responder, medical, and corporate workplace wellness.
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Karen Eichenbaum Wolk, a sleep apnea patient, was diagnosed with mild cognitive impairment that likely resulted from undiagnosed and untreated obstructive sleep apnea.
Through the Community Leadership Council, community leaders and ASAP will exchange information, explore strategic initiatives, and share practical and educational resources related to sleep apnea with a focus on improving patients’ quality of life and care.
Council members also will guide and inform the ASAP about key issues affecting the sleep apnea community. As part of their role as champions of patient well-being and of ASAP’s mission and vision, they also will be involved in meeting other stakeholders, such as policymakers, community members, scientists, and researchers.
Meet the Community Leadership Council members here.
About the Alliance of Sleep Apnea Partners:
ASAP is a U.S.-based 501(c)(3) organization committed to promoting diagnosis, treatment, and prevention of sleep apnea on behalf of the patient community to advance the lifelong well-being or sleep apnea patients.
January 5, 2024
ASAP Welcomes Lori Schulman, Lisa Tate to Board
The Alliance of Sleep Apnea Partners (ASAP) is pleased to announce that sleep consultant Lori Schulman and Health Futures Consulting President Lisa Tate are joining its board of directors. Both bring a wealth of expertise to ASAP's work as a patient-centered advocacy organization to promote diagnosis, treatment, and management of sleep apnea and make sleep apnea a national healthcare priority.
Lori Schulman has more than 25 years of success in building early-stage sleep tech, health tech, and digital health companies. She has participated in the launch of more than 10 health-focused companies, including her first sleep start-up in 1997. She also serves as a Mentor to the Digital Health Hub Foundation International growth accelerator program for health tech companies.
“When I was recruited to join an OSA alternative medical device company, that’s when the lightbulb went off for me regarding making patients aware of alternative therapies for OSA,” she said. “I believe more people would undergo diagnosis for OSA if they knew that there are CPAP alternatives for them to consider. I continue to support new technologies that improve patient outcomes.
“My passion for sleep care stems from speaking with thousands of patients and clinicians over the past 25+ years and finding optimal solutions for each patient. I’m interested in the focus of ASAP and believe that I can make a difference to the Board of Directors, as well as to the patients and organizations we serve.”
Lisa Tate is a health care leader, patient advocate, and fund developer with a particular focus on advancing women’s health and health equity. As President of Health Futures Consulting, she is a catalyst for the growth of nonprofits, supporting them in funding their missions to realize their visions. Her career has been devoted to improving patient health. She began her career in public affairs at the American Academy of Pediatrics and the National Association of Children’s Hospitals. She later moved into leadership positions with multiple nonprofits, including serving as CEO of WomenHeart: the National Coalition for Women with Heart Disease and founding strategist for the patient-advocacy organization Heart Valve Voice.
She currently serves as Director of Partnerships and Strategic Development for the American Medical Women’s Association and as Treasurer on the board of the Alliance for Women’s Health & Prevention.
“In my work, I have seen that sleep apnea doesn’t get the kind of attention that other sleep disorders do, despite its seriousness,” she said. “I’m interested in supporting ASAP in bringing more recognition to sleep apnea and ASAP so they can advance their work.”
About the Alliance of Sleep Apnea Partners:
ASAP is a U.S.-based 501(c)(3) organization committed to promoting screening, diagnosis, treatment, and management of sleep apnea on behalf of the patient community to advance the lifelong well-being or sleep apnea patients.
November 21, 2023
ResMed Issues a Safety Notice on Popular Masks
ResMed has put out a safety notice letter regarding some of their most popular masks that use magnets on the straps.
If you DO NOT have a medical implant/device that can interact with a magnet, this notice does not apply to you and you do not need to stop wearing your mask.
If you DO have a medical implant/device such as pacemaker or defibrillator (see link below to ResMed site for more information), switch to a spare mask without magnets. In case you don’t have a spare mask, keep using your CPAP with your current mask but contact your Durable Medical Equipment (DME) or mask provider as soon as you can to discuss a replacement.
This notice still applies if you are within six inches of someone else with an implanted device (your spouse or a child perhaps).
Please be aware that DMEs may not be available because of the Thanksgiving holiday. Call them after the holiday. Until then keep using your CPAP unless your doctor advises you to stop. Stopping your treatment could cause more problems.
For more information, please visit this link provided by ResMed.
November 8, 2023
Alliance of Sleep Apnea Partners Welcomes Co-Founder Kathy Page as Chair
The Alliance of Sleep Apnea Partners, the patient advocacy organization founded in 2018 by sleep apnea patients to promote diagnosis, treatment, and prevention of sleep apnea, has elected Kathy Page to chair its board.
Page, a co-founder and past president of ASAP, most recently had served as the nonprofit group’s vice-chair. She succeeds Sarah Gorman, who has served as chair since 2021. Like Gorman, Page is a sleep apnea patient.
In addition to her work with ASAP, Page also serves on the board of MyApnea.org and is a member of the American Thoracic Society’s Public Advisory Roundtable. She also has participated as a patient representative in Patient-Centered Outcomes Research Institute grant funding, has been active in various National Institutes of Health meetings on sleep apnea and restless leg syndrome, and has participated in three Food and Drug Administration grant processes as a patient specialist. She also participated in drafting the “Women & Sleep Apnea” toolkit jointly produced by the Society for Women’s Health Research and ASAP.
“I am honored to be elected as board chair of ASAP,” Page said. “I would like to thank Sarah Gorman for her leadership in ensuring ASAP is established as a patient advocacy organization. Sarah has been a mentor and friend to me for many years, and I have tremendously enjoyed working with her. I look forward to supporting ASAP’s continued growth and success in advocating for people living with sleep-disordered breathing and sleep apnea,” said Page, who is based in Smithton, Missouri.
“We are delighted to have Kathy in this leadership role, as she is very well respected among the patient community,” said Dr. Monica Mallampalli, ASAP’s executive director. “Kathy is passionate about patient advocacy and will be instrumental in ensuring ASAP continues to be patient-oriented and patient-focused.”
About the Alliance of Sleep Apnea Partners:
Founded by sleep apnea patients in 2018, the Alliance of Sleep Apnea Partners is committed to promoting diagnosis, treatment, and prevention of sleep apnea on behalf of the patient community to advance the state of patient care and lifelong well-being of sleep apnea patients. ASAP does this by empowering patients through awareness and education, building support services within the patient community, identifying critical issues and gaps in patient care, and advocating for patient-centered policies.
June 30, 2023
A Wake-Up Call for Sleep Health: President Biden’s CPAP Machine Use Highlights Importance of Diagnosing,
Treating Obstructive Sleep Apnea
Untreated OSA can lead to serious health problems, including heart disease and type 2 diabetes. But early diagnosis and treatment can deliver quality sleep—and better overall health.
The White House announced this week that President Biden, who previously had been diagnosed with obstructive sleep apnea, has recently started using a CPAP machine—also known as Continuous Positive Airway Pressure therapy—to treat this common condition.
“We are thrilled to hear that the President has been proactive about his sleep health and has chosen to take action by using the CPAP therapy,” says Dr. Monica Mallampalli, executive director of Alliance of Sleep Apnea Partners (ASAP), a patient-focused group committed to promoting diagnosis, treatment, and prevention of sleep apnea. More than 30 million people in the United States alone are thought to have obstructive sleep apnea, a chronic condition that causes a person to stop breathing periodically during sleep.
Continuous Positive Airway Pressure therapy currently is the gold standard for treating obstructive sleep apnea. It works by providing a constant flow of air pressure through a face mask to keep the wearer’s airways open during sleep. Although it can be difficult to get used to a CPAP machine, once patients adjust they often find they are able to breathe better, resulting in quality sleep and better overall health.
Obstructive sleep apnea causes a loss of oxygen that can be detrimental to overall health, including brain health. “Many chronic conditions such as heart disease, type 2 diabetes, and cognitive decline can be prevented or delayed if sleep apnea is diagnosed and treated early,” says ASAP Board Chair Sarah Gorman.
Unfortunately, many people with obstructive sleep apnea remain undiagnosed and untreated.
Although the condition mostly affects men, women also can suffer from sleep apnea and need to recognize their symptoms, which can sometimes be different from those in men. “It is extremely important for anyone who suspects they have trouble breathing at night to talk to their doctor and ask to be screened for sleep apnea,” Gorman says. “Early diagnosis and treatment can be a game-changer for many who are struggling from health consequences related to sleep apnea.”
For more information and resources on sleep apnea, including symptoms and risk factors, visit the Alliance of Sleep Apnea Partners website at apneapartners.org.
About the Alliance of Sleep Apnea Partners: ASAP is a U.S.-based 501c3 organization committed to promoting diagnosis, treatment, and prevention of sleep apnea on behalf of the patient community to advance the lifelong well-being of sleep apnea patients.
For more details or to schedule an interview, contact:
410-963-1261