IVUN
INTERNATIONAL VENTILATOR USERS NETWORK
an affiliate of Post-Polio Health International
VENTILATOR-ASSISTED LIVING
VOLUME 38, NUMBER 1
FEBRUARY 2024
Philips Respironics, a leading manufacturer of ventilators, reached a settlement with the Food and Drug Administration (FDA) on January 29th over ongoing issues plaguing its ventilators, BiPAP and CPAP machines. The settlement between Philips and the FDA marks a significant development in the ongoing efforts to mitigate the risks posed by these devices. As part of the consent decree, Philips is mandated to adhere to a comprehensive set of standards outlined by the FDA. The implementation of these standards is expected to unfold over a multiyear period, ensuring that stringent quality controls are established and maintained before the company can resume sales in the US market.................................................................................................MORE
CONNECTING
VENTILATOR USERS,
HEALTH PROFESSIONALS,
AND INDUSTRY
ADDITIONAL SECTIONS
Advocacy
Educate, discuss, take action
Networking
Sharing the work of others
Recent Relevant Publications
Summaries, links to selected professional, disability, disease journals and newsletters
Educational Opportunities
Conferences and webinars for health professionals and ventilator users
Ventilator-Assisted Living
Vol. 38, No. 1, February 2024
Editor: Brian Tiburzi
Designer: Brian Tiburzi
ISSN 1066-534X
© 2024 Post-Polio Health International.
Permission to reprint must be obtained from Post-Polio Health International (PHI) at info@post-polio.org.
Ventilator users, health professionals, non-profits, company representatives – send comments and updates to info@ventusers.org.
Philips and FDA Reach Consent Decree Over Recalled Devices
Philips Respironics, a leading manufacturer of ventilators, reached a settlement with the Food and Drug Administration (FDA) on January 29th over ongoing issues plaguing its ventilators, BiPAP and CPAP machines. The settlement between Philips and the FDA marks a significant development in the ongoing efforts to mitigate the risks posed by these devices. As part of the consent decree, Philips is mandated to adhere to a comprehensive set of standards outlined by the FDA. The implementation of these standards is expected to unfold over a multiyear period, ensuring that stringent quality controls are established and maintained before the company can resume sales in the US market.
The saga began with reports surfacing that these devices were emitting bits of foam and potentially harmful gases into users' airways. Such revelations sparked significant concern over the safety of these devices, prompting Philips to initiate a massive recall affecting millions of units. The recall, initiated in June 2021, was billed by the company as a proactive measure undertaken to address the potential risks associated with the use of their products.
While specific details of the settlement are yet to be disclosed pending finalization in court, Philips has assured its customers that it will continue to provide support for existing devices. This includes repair services and ongoing maintenance for individuals reliant on these machines for their respiratory needs.
Moving forward, stakeholders anticipate close scrutiny of Philips' compliance with the agreed-upon standards and the effectiveness of measures implemented to address the issues identified. The resolution of this matter serves as a reminder of the critical role played by regulatory agencies in upholding safety standards within the healthcare industry and the responsibility of manufacturers to prioritize consumer well-being.
Understanding the Settlement
The consent decree, though not yet finalized, will likely have significant implications for users of home mechanical ventilation. Here are some of the issues IVUN will be tracking in the months and years ahead:
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Disruption in Access to Care: The halt in sales of Philips Respironics ventilators could disrupt access to care for individuals who require these devices for daily use. With new sales suspended, individuals seeking to initiate therapy or replace outdated equipment may encounter challenges in obtaining suitable alternatives, potentially leading to gaps in treatment.
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Safety Concerns: The underlying reason for the halt in sales—reports of foam disintegration and emission of potentially harmful gases—raises significant safety concerns for users of Philips Respironics devices. IVUN has heard from many of its members who have had to continue using the recalled devices while waiting for alternative devices to become available or while waiting on the company to fix the issue. These issues could pose risks to respiratory health and exacerbate existing medical conditions.
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Dependence on Existing Devices: While Philips has committed to continuing repair services and support for existing devices, users may face uncertainty regarding the long-term availability and reliability of their equipment. Dependence on aging devices, coupled with concerns over potential safety risks, can contribute to heightened anxiety and stress among individuals reliant on these machines for daily respiratory support.
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Impact on Healthcare Providers: Healthcare providers responsible for prescribing and managing home mechanical ventilation may face challenges in navigating alternative treatment options and addressing patient concerns. Ensuring continuity of care and maintaining patient safety become paramount considerations in managing the implications of this development.
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Regulatory Scrutiny and Consumer Confidence: The recall and subsequent settlement underscore the importance of rigorous regulatory oversight in ensuring the safety and effectiveness of medical devices. For users of home mechanical ventilation, regulatory actions serve as a critical safeguard against potential risks and reinforce confidence in the devices they rely on for essential respiratory support.
In summary, the decision by Philips Respironics to halt sales of breathing machines in the US following the FDA settlement significantly impacts users of home mechanical ventilation. It underscores the importance of addressing safety concerns, ensuring access to reliable equipment, and maintaining regulatory standards to safeguard the health and well-being of individuals reliant on these life-sustaining devices.
The agreement with the FDA will have implications across the healthcare landscape, particularly for individuals who rely on these devices for managing respiratory conditions. Some analysts have predicted it may be another 2-5 years before Philips can resume sales in the US. The company has already agreed to pay out $479 million last September as part of a separate settlement with plaintiffs meant to cover financial losses related to repairing or replacing the recalled devices. A separate lawsuit related to adverse health effects caused by the defective devices is pending.
Philips has additional information about the recall and guidance for patients on its website. It should be noted, though, that the FDA has found some of Philips’ safety claims related to the affected devices to be “unpersuasive.”
Possible Ventilator Circuit Odor Problem
Warren Peascoe, PhD (Chemistry)
Does anyone else have a problem with ventilator circuits with a strange odor? Normally I receive circuits that get changed every two weeks. I recently received a supply from a new manufacturer and noticed a strange smell as soon as the sealed packages were brought into the room. When I opened the package, the odor increased and was definitely coming from the circuit. Blowing air through it for a half hour did not reduce the odor. After handling the circuit, my hands even smelled of the odor, and it was difficult to wash off with soap and water. I used the circuit for fifteen minutes as I tried to sleep. After that time, I could still smell the odor as I breathed through my face mask. I decided it was not worth risking my health and replaced it with an unopened circuit from the prior manufacturer. My physician and family have confirmed the odor.
Photograph shows a Respironics 1073223 (Disposable Adult Active Circuit No Water Trap). I’ve used this type of circuit for many years to connect a Philips Respironics Trilogy 100 ventilator using Active PAP PC mode for sleep apnea. The large hose carries air from the ventilator to the face mask. The two thin tubes use air pressure to open and close an air vent for exhaled breath.
My investigations indicate that Philips Respironics stopped manufacturing the type of circuit shown above. When it became difficult to get these circuits, my home medical supplier found another vendor. The circuits, which smelled, were VC1001 Adult Active Ventilator Circuits Lot 5039. They were supplied by Sunset Healthcare Solutions and made in Turkey. I returned an unopened circuit for testing. When I contacted the supplier, they replied:
“Our QA team evaluated the returned unopened package and found the product met our standards. In addition, biocompatibility test reports show that the product does not affect the in vitro cytotoxicity due to the quantitative and qualitative analyses based on the criteria set out by ISO protocols.”
I have reported this incident to the Food and Drug Administration (FDA). I am hoping to determine if this is a one-time problem or if it is widespread. Without identifying the chemical causing the odor, I cannot research its toxicity. If you have experienced an odor with circuits or other breathing air hoses or know of someone who has, please contact IVUN (info@ventusers.org, 314-534-0475).
ADVOCACY
Paying Tribute to Disability Activist Brooke Ellison (1978-2024)
IVUN joins the disability community in mourning the passing of Brooke Ellison. Ellison, an advocate for ventilator users and for disability rights who defied all odds after being paralyzed from the neck down in a childhood car accident, passed away on February 4th in Stony Brook, New York, at the age of 45 due to complications of quadriplegia.
Ellison's life was a testament to her unwavering resilience and determination. Despite the devastating accident at the age of 11, she relentlessly pursued her education and advocacy work. Graduating magna cum laude from Harvard University with a Bachelor of Science degree in cognitive neuroscience in 2000, she continued her academic journey, earning a master’s degree in public policy from Harvard’s Kennedy School of Government and a doctorate in sociology from Stony Brook University in 2012.
Ellison joined the faculty at Stony Brook University in 2012 as an associate professor of bioethics. Once there, she co-founded VENTure Think Tank along with Dr. Pamela Block. VENTure's goal was to serve as an idea-generating body to address the unique challenges faced by people dependent on ventilators and others with complex health conditions who require a similar level of technological and medical intervention in their lives. They sought to improve and utilize technology, perform and synthesize research, and create shifts in social and political policy in order to help these populations to live longer and richer lives.
Ellison made significant contributions to academia and published two books, "Miracles Happen: One Mother, One Daughter, One Journey" and "Look Both Ways." Throughout her life, she remained a national spokeswoman for people with disabilities and an advocate for stem cell research.
Protecting Health Care for All Patients Act Passed in House
The U.S. House of Representatives recently voted on the Protecting Health Care for All Patients Act, passing it with a narrow margin of 211 to 208 along party lines. This legislation aims to prevent federal health programs, including Medicaid, from utilizing a metric known as Quality-Adjusted Life Years (QALYs) to assess the cost-effectiveness of treatments. QALYs have been criticized for potentially discriminating against individuals with disabilities by undervaluing their quality of life. The bill, championed by Rep. Cathy McMorris Rodgers, seeks to extend existing protections against QALYs from Medicare to all federal health programs, aligning with recommendations from the National Council on Disability. However, despite support from over 90 disability and health advocacy groups, Democrats in Congress and the White House are opposing the bill, concerned that it could undermine existing protections and divert funds from crucial public health initiatives.
Democrats opposing the legislation argue that it could weaken established laws and hinder efforts to negotiate fair prices for prescription drugs. Rep. Frank Pallone, among others, attempted to introduce an amendment to safeguard the government's ability to lower drug prices, but this proposal was rejected by Republicans. Critics fear that the bill could set a precedent for restricting the use of value measures by federal agencies and states. Despite bipartisan calls for action, the bill's future remains uncertain as debates continue over its potential implications for healthcare access and affordability.
DOJ Seeks To Enforce Accessibility Standards For Medical Equipment
The U.S. Department of Justice is proposing a rule under the Americans with Disabilities Act (ADA) to address the lack of accessibility in doctor's offices and health care clinics operated by state or local governments. This rule aims to establish technical standards that outline the responsibilities of these facilities in providing accessible equipment for people with disabilities. The proposal comes in response to numerous complaints citing instances where individuals with disabilities were denied basic services due to inaccessible equipment, such as examination tables and weight scales. The proposed rule adopts accessibility standards set by the U.S. Access Board in 2017 for various diagnostic equipment used in health care settings. If finalized, the rule would require covered entities to ensure accessibility and provide assistance to patients with disabilities during medical exams.
NETWORKING
EP Magazine's Annual Health Care Issue Now Available
EP Magazine’s Annual Healthcare Issue contains a wide selection of articles for parents and caretakers who are raising children and youth with special healthcare needs, including families who have multiple children with disabilities. Further topics include early intervention, oral care, medical bills and physical fitness – concerns faced by most families, but especially challenging to those with special needs. Check it out at www.epmagazine.com.
New Book: The Girl in the Iron Lung
Released in November, The Girl in the Iron Lung chronicles the life of Dianne O’Dell, who was diagnosed with polio at the age of three and lived in an iron lung for 58 years until her death in 2008. She is noted as one of the longest-surviving victims of polio to have spent most of her life inside an iron lung, lying flat on her back for nearly six decades.
Her entire world was the iron lung, but she adapted. She learned to write with her toes and loved to paint pictures. She graduated from high school and took college classes. She tutored children, spoke at her local Rotary Club, and wrote a children’s book to encourage young people, especially those with physical disabilities, to never give up. The Girl in the Iron Lung tells the story of Dianne’s challenging, but rewarding life, and the efforts of her loving family to care for her daily needs.
RECENT RELEVANT PUBLICATIONS
Caregiver education before hospital discharge for children on home-invasive mechanical ventilation
Zirek F, Çobanoğlu N.
“Children on home invasive mechanical ventilation necessitate specialized equipment, continuous monitoring, and multidisciplinary care. Transitioning these children from hospital to home care is complex, demanding careful planning. Guidelines and observational studies emphasize the importance of a standardized, comprehensive, and staged educational approach for caregiver education in discharge planning, yet program variations persist, lacking standardized checklists. This review aims to offer insights into crucial factors for a successful transition from hospital to home care for children using home-invasive mechanical ventilation while also developing comprehensive caregiver checklists to ensure high-quality care, taking into account families' socioeconomic status.”
Pediatr Pulmonol. 2023 Dec 22. doi: 10.1002/ppul.26803.
Development and pilot-testing of an evidence-based quality indicator set for home mechanical ventilation care: the OVER-BEAS project
Schutzmeier M, Brandstetter LS, Stangl S, Ahnert J, Grau A, Gerken L, Klingshirn H, Reuschenbach B, Skazel T, Kippnich M, Wurmb T, Heuschmann P, Haas K.
“The number of patients depending on home mechanical ventilation (HMV) has increased substantially in Germany in recent years. These patients receive long-term care in different nursing facilities (nursing home, shared living community, private home). However, there are limited data available on the quality of care of HMV patients. The aim of the OVER-BEAS project was to identify quality indicators (QIs) of HMV care using an evidence-based approach.”
BMC Health Serv Res. 2024 Jan 30;24(1):152. doi: 10.1186/s12913-024-10583-2.
Pseudo-obstructive sleep disordered breathing – definition and progression in Spinal Muscular Atrophy
Trucco F, Dastagir S, Tan HL.
“Pseudo-obstructive SDB has been characterised in paediatric SMA type 2 naïve from treatments. It is prevalent in these patients as the expression of the known imbalance between intercostal and diaphragmatic weakness. The number of pseudo-obstructive events tended to increase with age and disease progression and was reduced by NIV initiation. Prospective studies on wider SMA cohorts are planned to further define their clinical implications”
Sleep Med. 2024 Feb 2;115:61-65. doi: 10.1016/j.sleep.2024.02.005.
EDUCATIONAL
OPPORTUNITIES
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. Register online.
ATS 2024
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.
CHEST 2024
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.