INTERNATIONAL VENTILATOR USERS NETWORK
an affiliate of Post-Polio Health International
VOLUME 37, NUMBER 5
In 2010, Philips Respironics, a leading medical device manufacturer, began receiving complaints about their redesigned breathing machines, which were intended to reduce noise and provide better sleep for users. These devices included ventilators used in critical care settings and the popular DreamStation machines designed for patients with sleep apnea. The reports described alarming issues with the machines, such as "black particles," "dirt and dust," and even an "oily-like" substance. This hinted at a concerning problem that would later become a major health crisis.............................................................MORE
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Vol. 37, No. 5, October 2023
Editor: Brian Tiburzi
Designer: Brian Tiburzi
Permission to reprint must be obtained from Post-Polio Health International (PHI) at firstname.lastname@example.org.
Troubling New Report Claims Philips Hid Problems from FDA
In 2010, Philips Respironics, a leading medical device manufacturer, began receiving complaints about their redesigned breathing machines, which were intended to reduce noise and provide better sleep for users. These devices included ventilators used in critical care settings and the popular DreamStation machines designed for patients with sleep apnea. The reports described alarming issues with the machines, such as "black particles," "dirt and dust," and even an "oily-like" substance. This hinted at a concerning problem that would later become a major health crisis.
Despite these early complaints, Philips Respironics did not promptly report the issues to the Food and Drug Administration (FDA), as is required by federal law, according to an explosive new investigation by ProPublica and the Pittsburgh Post-Gazette. Over the following decade, the number of complaints grew from dozens to hundreds, and eventually to thousands, with the descriptions becoming more alarming. The common thread was that the foam used in these devices was breaking down, deteriorating, and disintegrating within the machines. By 2015, it became evident that the foam was the specific source of the problem.
In June 2021, more than a decade after the initial reports, Philips announced a recall of millions of machines that had been distributed across the United States and numerous other countries. The company acknowledged that the foam used in these devices could disintegrate due to heat and humidity, releasing potentially "toxic and carcinogenic" materials into the respiratory tracts of users. Philips asserted that it acted promptly upon learning of the potential significance of the issue. However, the investigation by ProPublica and the Pittsburgh Post-Gazette, covering the 11 years leading up to the recall, tells a different story.
What Was Uncovered
The investigation revealed that Philips systematically concealed mounting evidence that their lucrative breathing machines posed serious health risks to users, in some cases causing severe illnesses or possibly even death. Federal law mandates that medical device manufacturers report patient injuries, deaths and malfunctions to the FDA within 30 days, but Philips failed to do so. Furthermore, the company didn't initiate a formal investigation into the issue until 2019, nine years after the initial wave of complaints and three years after internal tests confirmed the foam's degradation. During this time, Philips continued an aggressive global marketing campaign to promote the sale of these machines, even introducing new models equipped with the problematic foam.
The consequences of Philips's actions were far-reaching. These devices were used by infants, the elderly, and approximately 700,000 veterans. The company also introduced a new ventilator with the same hazardous foam during the early months of the COVID-19 pandemic. Philips's failure to warn the public meant that countless individuals were unknowingly exposed to potentially harmful substances, resulting in various unexplained health issues such as vomiting, dizziness, headaches, and newly diagnosed cancers of the lungs, throat, sinuses, and esophagus. Philips's actions were criticized by healthcare professionals, with one sleep clinic doctor describing the situation as "unconscionable." The ProPublica investigation interviewed over 200 individuals, including former company employees, doctors, toxicologists, patients, and family members of those affected. It also reviewed thousands of complaints submitted to Philips and government agencies, uncovering over 370 reports of deaths linked to the devices.
Since the recall, Philips has attempted to downplay the health risks associated with the foam, arguing that tests have shown the chemicals released fall within safety thresholds. Nevertheless, experts dispute these claims and have identified multiple instances of genotoxicity in the foam—meaning the material has the potential to cause cell mutations, a process that can lead to cancer. The health implications for affected individuals are significant, and many of them have taken legal action against Philips to seek accountability for their health issues. The investigation is ongoing as patients and healthcare professionals continue to grapple with the consequences of Philips's actions.
Signs of Trouble
As Philips Respironics faced a growing tide of complaints related to their breathing machines, the company simultaneously launched aggressive marketing campaigns to promote their devices worldwide. These campaigns reached cities like Toronto, Paris, and Sydney. Their advertisements declared that their machines were quieter than those of their competitors.
Despite their vigorous marketing, Philips encountered legal scrutiny. Beginning in 2012, the company struck deals with local medical equipment suppliers to sell their devices directly to patients, which attracted the attention of federal investigators. These arrangements allegedly involved providing suppliers with a database detailing doctors' prescribing practices, with an expectation that they would recommend Philips's machines, often covered by Medicare and other public programs. The government later accused Philips of running an illegal kickback scheme, ultimately reaching a $24 million settlement with the company, although Philips denied wrongdoing and agreed to the settlement to avoid the expense of further litigation.
In 2015, Philips was making efforts to dominate the market when the foam issue threatened to undermine their progress. According to the report, concerns were sparked within the company after an engineer inquired about the foam's condition. Subsequently, as new complaints emerged from Australia, Philips scientists convened emergency meetings to address the issue. An engineer explicitly raised the safety risk in an email to the foam supplier uncovered by the investigation, indicating that the foam was shedding and being drawn into the ventilator's air path, potentially endangering users. Although Philips started replacing the foam in some ventilators without notifying the FDA or the public, the vast majority of machines, including the popular DreamStation, remained unchanged. Customers were unaware of the issue even as debris began showing up on their bedsheets, pillows, and faces.
Despite being aware of potential risks related to the foam used in their devices, Philips remained largely silent about the issue until they unveiled a new device, the DreamStation 2, in April 2021. With this new model, Philips transitioned to foam designed to withstand heat and humidity, differentiating it from the older models. During an earnings call that month, the company disclosed the foam's risks for the first time, setting aside 250 million euros to address the problem. Philips reassured investors that the device remained safe for use. However, the company neglected to inform its customers, and complaints continued to pour in over the next six weeks.
Reports included patients experiencing black particles, respiratory ailments, and in some cases, life-threatening injuries. Philips eventually issued a voluntary recall in mid-June 2021, admitting that the foam could release chemicals or break into harmful particles. Potential health issues ranged from asthma and respiratory tract irritation to kidney and liver problems, and even cancer. Philips faces ongoing lawsuits from affected individuals and healthcare providers.
The recall prompted thousands of individuals to share their experiences of emergency room visits and unexplained illnesses caused by their devices. While Philips maintains that these reports do not prove a causal relationship between the devices and the illnesses, medical experts contacted by ProPublica claim that the reports are compelling evidence of a public health crisis that may have long-term repercussions.
Concerns over the safety of the foam persist, with research indicating genotoxicity, the ability to cause cellular mutations. Experts believe that the foam's chemical emissions pose unacceptable risks to patients. Despite the company's attempts to downplay these concerns, employees and testing insiders expressed doubts about Philips' claims regarding the foam's safety. The company is currently under investigation by the Justice Department regarding its testing practices and safety assertions. The full extent of the crisis and its health impacts may not be fully realized for years.
More than two years after the first recall, many patients remain upset over Philips’s handling of the crisis. The company recently reached a settlement in one of the federal lawsuits, agreeing to pay at least $479 million to reimburse affected customers and others for the costs of the defective machines. Ongoing legal challenges include more than 600 personal injury claims and a class-action suit seeking ongoing medical monitoring and research on the devices' dangers. Philips has attempted to distance itself from the crisis, however. Former company managers who spoke with ProPublica suggested that officials in Amsterdam were likely aware of the problem due to its significant impact and the devices' importance to the company's financial performance.
Ventilator users who have spoken to IVUN have almost universally expressed frustration and anger over how the company has handled the crises. Poor communication and insufficient solutions have led to rising anger from ventilator users and their families over how Philips has addressed the problem. “Right now, there’s a lot of confusion and fear over how these ventilators have affected us,” said Mary Williams of Houston, Texas. “It seems they had a chance to do the right thing but stayed silent. I feel like they really let us down.”
Senators Call for Emergency Funding to Secure Accessibility to Disability Services
A group of 18 Democrats in the U.S. Senate has introduced the Home and Community-Based Services (HCBS) Relief Act, which would provide extra funding for disability services for two years to address staffing shortages affecting Medicaid home and community-based services for people with disabilities. The bill offers states a 10-point increase in their federal Medicaid match, enabling them to enhance pay and benefits for direct support professionals, support recruitment efforts, aid family caregivers, and reduce waiting lists for services. Disability service providers have been relying on funding from the American Rescue Plan to address workforce challenges, but that funding is set to expire in March 2025, making the proposed bill essential for continuing to invest in stabilizing the workforce. Advocates emphasize the urgent need for long-term funding increases to address the ongoing crisis in the disability services sector.
Significant Issues Uncovered in IDEA Complaint Process
A report from the Council of Parent Attorneys and Advocates (COPAA) reveals significant problems in the Individuals with Disabilities Education Act (IDEA) complaint process. The study found that states often neglect to investigate credible IDEA complaints, and when they do, investigators may display bias and lack follow-through, leaving parents concerned about potential retaliation. The report highlights disparities in the outcomes of state complaints based on factors such as parents' race, income, and location, as well as discrepancies between states with more or less favorable results for families. It also raises concerns about conflict of interest, as state education departments can investigate even when their agency is the subject of a complaint. Many parents doubt the effectiveness of filing a state complaint, and fear retaliation from their child's school. The COPAA report urges federal, state, and local action to rectify the shortcomings in the IDEA complaint system and better protect students with disabilities and their families.
Reeve Foundation Seeks to Promote Accessibility to the Great Outdoors
In observance of Spinal Cord Injury Awareness Month, the Reeve Foundation has created 'Outdoors for Everyone,' an initiative to ensure the great outdoors is accessible and inclusive for all people – including those living with paralysis, their families, and caregivers. The initiative seeks to encourage those in the community and their caregivers to spend more time in nature by working with parks and outdoor recreational organizations on ways to improve accessibility outdoors. The Foundation’s Information Specialists will provide education about accessible parks, what to look for, and how to prepare for a journey into nature.
They've also created an 'Accessible Outdoor Checklist' for parks, recreation centers, and partners to ensure people living with paralysis and other disabilities are able to enjoy the outdoors. The checklist serves as an educational resource with recommendations and suggestions on how to strengthen accessibility and inclusivity throughout the entire outdoor experience.
Seeking Users of Negative Pressure Ventilation for Interview
Dr. Norma Braun is seeking to interview post-polio patients and others who can describe their experiences when in negative pressure devices (iron lungs, chest cuirasses), and who might have needed ventilatory support in later years. She plans to include patients’ experiences as part of a book chapter being written for the 21st century. This will be unique for a medical text. Any person so willing to be interviewed can be assured that no identifying data will be included. Your privacy will be protected.
The interviews will be conducted by phone or Zoom. Please contact Dr. Braun via her email, email@example.com.
My Time Inside an Iron Lung
Earlier this year, the Mütter Museum of the College of Physicians of Philadelphia produced a series of three short documentaries of polio survivors and their experiences inside iron lungs. This fascinating series, titled "My Time Inside an Iron Lung," featured Audrey King, Adolf Ratzka, and Thomas Fetterman. We've featured each video in previous editions of Ventilator-Assisted Living, but have collected them all below for ease of viewing. The interviews were conducted by Meredith Sellers and produced by Jonah Stern.
RECENT RELEVANT PUBLICATIONS
Prolonged mechanical ventilation and caregiver strain: Home vs. long-term care facility
Marcus EL, Jacobs JM, Stessman J.
“The number of patients treated with prolonged mechanical ventilation (PMV) is steadily rising. Traditionally treated within specialized long-term care facilities (LTCFs), healthcare providers are increasingly promoting homecare as a technologically safe, humane, and cheaper alternative. Little is known concerning their informal caregivers (ICGs), despite their crucial role in facilitating care. This study examines caregiver strain among the primary ICG of PMV patients treated at home vs. LTCF.”
Palliat Support Care. 2023 Jun;21(3):429-437. doi: 10.1017/S147895152200027X.
Quality of life in patients with chronic respiratory failure on home mechanical ventilation
D'Cruz RF, Kaltsakas G, Suh ES, Hart N.
“Home mechanical ventilation (HMV) is a treatment for chronic respiratory failure that has shown clinical and cost effectiveness in patients with underlying COPD, obesity-related respiratory failure and neuromuscular disease (NMD). By treating chronic respiratory failure with adequate adherence to HMV, improvement in patient-reported outcomes including health-related quality of life (HRQoL) have been evaluated using general and disease-specific quantitative, semi-qualitative and qualitative methods. However, the treatment response in terms of trajectory of change in HRQoL is not uniform across the restrictive and obstructive disease groups. In this review, the effect of HMV on HRQoL across the domains of symptom perception, physical wellbeing, mental wellbeing, anxiety, depression, self-efficacy and sleep quality in stable and post-acute COPD, rapidly progressive NMD (such as amyotrophic lateral sclerosis), inherited NMD (including Duchenne muscular dystrophy) and obesity-related respiratory failure will be discussed.”
Eur Respir Rev. 2023 May 3;32(168):220237. doi: 10.1183/16000617.0237-2022.
Chronic Neuromuscular Respiratory Failure and Home Assisted Ventilation
Carmona H, Graustein AD, Benditt JO.
“Chronic respiratory failure is a common, important complication of many types of neuromuscular and chest wall disorders. While the pathophysiology of each disease may be different, these disorders can variably affect all muscles involved in breathing, including inspiratory, expiratory, and bulbar muscles, ultimately leading to chronic respiratory failure and hypoventilation. The use of home assisted ventilation through noninvasive interfaces aims to improve the symptoms of hypoventilation, improve sleep quality, and, when possible, improve mortality. An increasing variety of interfaces has allowed for improved comfort and compliance. In a minority of scenarios, noninvasive ventilation is either not appropriate or no longer effective due to disease progression, and a transition to tracheal ventilation should be considered.”
Annu Rev Med. 2023 Jan 27;74:443-455. doi: 10.1146/annurev-med-043021-013620.
2024 CCHS FAMILY CONFERENCE
Next year's CCHS Family Conference will take place in Newport Beach, California, June 26-28, 2024, at the Newport Beach Renaissance Hotel. Registration and room blocks are expected to open in early January.
The ATS 2024 International Conference will be held in San Diego, California, May 17-22, 2024. More information can be found on the conference website. Registration is not yet available.
CHEST 2024 will be held in Boston, Massachusetts, October 6-9, 2024. Registration is not yet open, but hotels may be booked through a link on their site. The meeting promises to deliver the most up-to-date education in clinical pulmonary, critical care, and sleep medicine with world-class speakers, hands-on simulation opportunities, interactive educational games, and much more.