IVUN

INTERNATIONAL VENTILATOR USERS NETWORK

 

an affiliate of Post-Polio Health International

CONNECTING

VENTILATOR USERS,

HEALTH PROFESSIONALS,

AND INDUSTRY

VENTILATOR-ASSISTED LIVING

VOLUME 35, NUMBER 6

DECEMBER 2021

philips_respironics_recall_notice.jpg

The following is an open letter from a number of disabled people in the US impacted by a recall of 13 ventilators, CPAPs and BiPaps manufactured by Philips Respironics including signatures by over two dozen organizations and groups. It is reprinted here with permission of those that drafted the letter and was originally published by Disability Visibility Project..........................MORE

While the recent recall by Philips Respironics may have taken many users of those devices by surprise, a recent investigation by the FDA found that the company may have known about the problem far earlier.The FDA report found that there were warnings from inside the company, including "at least 14 tests or assessments" from as early as 2016 where Philips’ staff were “aware of issues and concerns related to potential foam degradation.”.............................MORE

Ventilator-Assisted Living

Vol. 35, No. 6, December 2021

Editor: Brian Tiburzi

Designer: Brian Tiburzi

ISSN 1066-534X

© 2021 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.

 

Letter from Disabled Ventilator Users on Philips Respironics Recall

The following is an open letter from a number of disabled people in the US impacted by a recall of 13 ventilators, CPAPs and BiPaps manufactured by Philips Respironics including signatures by over two dozen organizations and groups. It is reprinted here with permission of those that drafted the letter and was originally published by Disability Visibility Project.

Rodney Mell

Head of Quality and Regulatory

Philips Respironics – Sleep and Respiratory Care

1740 Golden Mile Highway

Monroeville, PA 15146

 

Re: Philips Respironics Urgent Recall of Ventilators, CPAP, and Bi-Level PAP Medical Devices

 

August 25, 2021

 

Dear Mr. Mell:
 

The undersigned Philips Respironics device customers, disability advocates, and advocacy organizations submit the following response to the June 14, 2021 notice issued for the recall of thirteen models of ventilators, CPAP, and BiPAP machines.(1) While the recall advises that users immediately discontinue use of the affected machines, it provides a completely different advisory for users who rely on their devices for life-sustaining care. Philips advises those users not to stop using their devices but offers no concrete recommendation for their safety beyond consultation with their physicians.(2) Therefore, we write to request that Philips immediately develop and implement a device repair and/or replacement process and timeline that prioritizes users who depend on their equipment for survival or that Philips provide so-affected users with comparable devices from other manufacturers free-of-cost.

The notice states that the recall is due to the degradation of a polyester-based polyurethane sound abatement foam that “may enter the device’s air pathway and be ingested or inhaled” by the user.(3) The foam particles can also release certain chemicals (known as “off-gassing”).(4)  Extreme heat and humidity or the use of certain cleaning methods can exacerbate the degradation of the foam.(5) Risks of potential exposure include, but are not limited to, irritation of the skin, eyes, and respiratory tract; headache, asthma, adverse effects to other organs such as the liver and kidneys, and “carcinogenic effects.”(6)

 

As of the date of this letter, Philips users, especially those who depend on their devices for life-sustaining care, have been put on high alert about severe potential effects associated with the use of their devices with no clear explanation about what led to the discovery of these effects or ultimately to the recall of their devices. Philips Sleep and Respiratory Care Frequently Asked Questions (FAQs) states that Philips discovered the foam degradation and chemical emission problems through its “Quality Management system processes” in April 2021 but provides no details about what that process entails or how these issues were uncovered in the course of that process, leading to the recall notice issued approximately two months later in June 2021.(7) The FAQs also state that Philips has received reports and complaints about “possible patient impact” which it is “monitor[ing]”(8) but provides no details about specific reports, how this monitoring is occurring, or how users can access information being reported. Users deserve, require, and demand full transparency.

Additionally, Philips cannot adequately address the harms of medically necessary continued use of their recalled devices by simply telling users to talk to their doctors. In order for users to effectively take advantage of that recommendation, Philips must disclose what communications it has had with healthcare providers and professionals about the recall. Disclosure of such communications should also include what, if anything, Philips knows about adverse health effects potentially associated with continued or long-term use of their recalled equipment and how to mitigate those effects. Otherwise, users have no way of assessing their physicians’ advice.

The information for physicians and other medical care providers listed on the Philips website includes only the aforementioned explanation about the degradation of the foam and the suggestion that patients use an inline bacterial filter that may “reduce exposure to degraded sound abatement foam particles” but “will not reduce exposure to potential Volatile Organic Compounds (VOCs).”(9) VOCs have also been found to be carcinogenic.(10)

Furthermore, some Philips users who have contacted their doctors or durable medical equipment (DME) providers have been unable to obtain definitive advice about the best way to protect themselves.(11) Some doctors and DME providers whose patients and users depend on Philips’ devices for life-sustaining care have repeated Philips’ suggestion that customers use a bacterial filter.(12) In addition to the uncertainty concerning whether bacterial filters effectively reduce exposure to the foam particles and the previously mentioned risks associated with VOCs, the FDA disputes the effectiveness of such filters in mitigating the risks of exposure to the foam.(13) 

Nevertheless, users who depend on their devices to live, many of whom are people with disabilities who cannot afford new devices or alternative treatments, have been forced to pay out-of-pocket for additional filters they cannot guarantee will help them.(14)

Finally, Philips’ registration process for the repair and replacement of affected machines is an important first step, but this step is insufficient and incomplete without a definitive timeline that prioritizes users who depend on their devices to live. While Philips has previously stated a desire to “prioritize patients with ‘more advanced clinical needs’”(15) in the repair and replacement process, it must articulate a concrete plan with timetables for how that will be done. 

Philips acknowledges that extreme heat and humidity exacerbate the degradation of the foam particles.(16) Yet, as of the date of this letter, in the middle of the summer months and more than two months after the issuance of the recall, many users of Philips equipment have been left with their recalled devices in conditions of intense heat, humidity, and even wildfires(17) that further jeopardize their equipment and health. After registering their devices, some users have been told to expect as long as a 12-month wait for a repair or replacement of their ventilators.(18) This is unacceptable.

In addition to being timely and prioritizing users who depend on their devices to live, Philips must implement a registration and repair process that is orderly and informative. Instead, several users who have contacted Philips about the recall have been redirected to apparent third-party contractors who have been either uninformed or unable to assist them.(19) However, just as users’ healthcare providers and their contracted DME providers have records of what and how many products they have sold or provided to patients, Philips should partner with these and other healthcare providers to identify and target users who rely on their equipment for life-sustaining care for immediate repairs and replacements.

Thus, based on the foregoing we request that Philips issue an updated and public statement about the recall that prioritizes the replacement and/or repair of devices of users who depend on their equipment for life-sustaining care by September 14, 2021. The statement should include an explicit plan detailing how the prioritization will be accomplished and a timeline for the initiation and completion of this repair or replacement process. This process must also be staffed by operators with up-to-date and accurate information. Additional or updated public information about the recall should also address the issues raised herein, including but not limited to, the following:

  • Information concerning how the identified issues that led to the recall were discovered in the Quality Management System process and what that process entails

  • How the findings of that process reported in April 2021 led to the recall of the affected devices in June 2021

  • How Philips has monitored/is monitoring reports and/or complaints about health effects associated with the use of the recalled devices and where users can access these reports and complaints

  • What specific information about the recall and potential health effects associated with the continued or long-term use of the affected devices has been communicated to healthcare providers and professionals.
     

We appreciate your attention to our concerns and anticipate continued communication as we continue to monitor your response to this dire issue that so gravely impacts Philips’ users in the communities we serve and represent.

Regards,

 

Alice Wong                                

Sandy Ho

Diane Coleman

Ingrid Tischer

Kathy Flaherty

Mike Volkman

Rachel Tanenhaus

Finn Gardiner

Heather Watkins

 

American Association of People with Disabilities

Association of Programs for Rural Independent Living

Autistic Women & Non-Binary Network

Autistic Self Advocacy Network

Center for Independence of the Disabled, New York

Civil Rights and Disability Justice Clinic, New York Law School

Civil Rights Education and Enforcement Center (CREEC)

Disability & Intersectionality Summit

Disability Rights Advocates

Disability Rights California

Disability Rights Education and Defense Fund (DREDF)

Disability Rights New York

Disability Policy Consortium

Disability Visibility Project

Fat Legal Advocacy, Rights, and Education (FLARE) Project

Little Lobbyists

National Association of the Deaf

National Center for Law and Economic Justice

National Council on Independent Living

National Disabled Law Students Association

NMD United

#NoBodyIsDisposable Coalition

Not Dead Yet

Paralyzed Veterans of America

Senior & Disability Action

United Spinal Association

 

1 Philips, Urgent: Medical Device Recall, https://www.philips.com (follow “Recalls” hyperlink at the bottom of the page; then click on “Field safety notice” and click on “Recall notification” under the Device registration and recall contact information heading) (last visited Aug. 19, 2021).

2 Id. at 2.

3 Id. at 1.

4 Id. at 1.

5 Id. at 1.

6 Id. at 1.

7 Philips, Sleep and Respiratory Care Update: Frequently Asked Questions, https://www.philips.com (follow “Recalls” hyperlink at the bottom of the page; then click on “Field safety notice” and click on “FAQs” under the Durable Medical Equipment Providers, Distributors, or Medical Institutions heading), 11 (last visited Aug. 19, 2021) [hereinafter “Frequently Asked Questions”]; see also Philip’s First-Quarter Results 2021, Philips News Center-Global (April 26, 2021), https://www.philips.com/a-w/about/news/archive/corpcomms/news/press/2021/philips-first-quarter-results-2021.html (last visited Aug. 19, 2021).

8 Frequently Asked Questions, supra note 7, at 2, 6, and 7.  

9 Medical Device Recall Notification: Information for Physicians and Other Medical Care Providers, https://www.usa.philips.com/healthcare/e/sleep/communications/src-update/information-for-physicians-and-providers (last visited Aug. 14, 2021)

10 Volatile Organic Compounds, American Lung Association, https://www.lung.org/clean-air/at-home/indoor-air-pollutants/volatile-organic-compounds (last visited Aug. 19, 2021).

11 Kait Sanchez, A Recall of Philips Respiratory Devices Has Left Users Stranded, Verge (Aug. 5, 2021), https://www.theverge.com/2021/8/5/22609651/philips-recall-respironics-ventilators-cpap-bipap.

12 See Sanchez, supra note 11. 

13 Certain Philips Respironics Ventilators, BiPAP, and CPAP Machines Recalled Due to Potential Health Risks: FDA Safety Communication, U.S. Food & Drug Administration (June 30, 2021), https://www.fda.gov/medical-devices/safety-communications/certain-philips-respironics-ventilators-bipap-and-cpap-machines-recalled-due-potential-health-risks?#actions

14 See Sanchez, supra note 11.

15 Joshua Brockman, Breathing Machine Recall Over Possible Cancer Risk Leaves Millions Scrambling for Substitutes, N.Y. Times (Aug. 17, 2021), https://www.nytimes.com/2021/08/17/health/cpap-breathing-devices-recall.html.

16 Frequently Asked Questions, supra note 7, at 12.

17 See Sanchez, supra note 11.

18 @AndersenFields, Twitter (Aug. 19, 2021, 6:32 PM), https://twitter.com/AndersenFields/status/1428484976312344577

19 See Sanchez, supra note 11.

FDA Investigation Faults Philips' Handling of Ventilator Issues 

 

While the recent recall by Philips Respironics may have taken many users of those devices by surprise, a recent investigation by the FDA found that the company may have known about the problem far earlier. (See the full report.)

The FDA report found that there were warnings from inside the company, including "at least 14 tests or assessments" from as early as 2016 where Philips’ staff were “aware of issues and concerns related to potential foam degradation.” The FDA cited internal emails at Philips from as far back as 2015 between a Philips employee and someone at their foam supplier that “implies that a customer made [Phillips] aware of polyester polyurethane foam degradation issues.”

 

Furthermore, in 2018 inspectors found emails between Philips’ staff that showed the had conducted internal tests confirming that foam could fall apart when exposed to high humidity or heat. Even knowing this, Philips chose not to alter the design and continued to use the foam in the now-recalled devices. 

Perhaps most damningly, the FDA’s inspection found Philips’ Executive Management knew of the foam degradation issue from "as early as January of 2020, or earlier, but implemented no corrective actions until April 2021."

For its part, the FDA has said that their investigator’s list of inspection observations does not constitute a final FDA determination of whether any condition is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. The FDA will review the company’s response and the totality of information available to the agency in determining appropriate next steps. 

ADVOCACY

 

Can You Afford a Home-Care Worker?

Home health care can cost over $4,000 per month. AARP shares resources and government programs to help make in home care and nursing affordable

“Planning for in-home care is a lot like the Chinese adage about planting a tree: The best time was 20 years ago, and the second best time is today.

“Older Americans determined to stay in their own homes are likely to need help at some point — for a few hours a day or 24/7 — with household chores, nursing services and personal care. And with the 65-plus population projected to grow from 56 million in 2020 to 73 million in 2030, the need for home health care will only increase.”

Read the full article.

Infrastructure Bill to Improve Access to Mass Transit Stations

Disability Scoop outlined some of the ways the new infrastructure bill will improve access to public transit ("No More Stairs: Cash Influx To Make Transit More Accessible"). Money included in the $1.2 trillion infrastructure bill signed into law by President Joe Biden last month aims to make public transportation more accessible.


The new federal All Stations Accessibility Program will provide $1.75 billion in competitive grants over five years to state and local governments to upgrade older rail transit stations that remain inaccessible to people with disabilities. It’s part of the larger bipartisan infrastructure law, which provides nearly $107 billion for public transit; agencies also can use that money to improve accessibility.
 

People with disabilities are legally guaranteed equal access to public transit under the 1990 Americans with Disabilities Act. The law prohibits public transportation authorities from discriminating against people with disabilities and requires that transit stations, vehicles and facilities built or acquired after that date must be accessible.

But older transit systems with stations that were not accessible when the ADA became law were required only to identify “key stations” and make them accessible.

Currently 28% of the country’s 3,447 rail transit stations are not accessible, according to the Federal Transit Administration.

 

NETWORKING

From COPD Canada: A Patient Charter for Chronic Obstructive Pulmonary Disease (COPD)

Representatives of three national patient organizations along with seven clinicians discussed the value of establishing a Patient Charter as a potential starting point for discussions on how to reform care for patients with COPD. The Charter, initiated and funded by AstraZeneca, aims to set a standard for what people with COPD should expect from their ongoing care. These expectations are in line with the current best practice understanding from existing COPD services, to offer consensus on global standards of COPD care and drive timely, evidence-based treatment to maintain health status, minimize symptoms and prevent exacerbations.

 

The document outlines six principles of quality care that patients should expect to receive, wherever they live. The principle concepts were developed by a working group of 20 clinicians and patient advocacy group representatives and refined by the committee of experts who authored the COPD Patient Charter.

A+Patient+Charter+for+COPD-1.png

Ventilator User Sakina Mustan Tells Her Story

Sakina Mustan, a Indian-Canadian woman living in Toronto, recently detailed her journey for Imagine the World as One, a disability lifestyle magazine. The article, "Breaking Barriers", details her battle with muscular dystrophy and the challenges she has faced as a mother, daughter, and sister. It follows her from Mumbai, where her father passed away from muscular dystrophy when she was just a teenager, to Toronto, Canada, where she emigrated with her husband and children two decades ago. The full article can be found at https://issuu.com/imaginetheworldasone/docs/issue_4_pdf_final/8.

Mustan.png

RECENT RELEVANT

PUBLICATIONS

 

Home health care for mechanical ventilation-dependent patients: A grounded theory study

Khankeh HR, Ebadi A, Norouzi Tabrizi K, Moradian ST.

“The number of people requiring home mechanical ventilation is increasing. Both family and patients experience a quite different situation. There is a significant knowledge gap about the caring process, families and health care team responsibilities, challenges they face, and how they manage. This study aimed to discover the process of home health care (HHC) to mechanical ventilation-dependent patients.... Families experience a challenging situation during care delivery to mechanical ventilation-dependent patients at home. The most important challenge is insufficient insurance coverage and an inappropriate legal framework for service delivery. Hence, the study results could be used by policymakers to improve HHC policies.

Health Soc Care Community. 2021 Nov 18. doi: 10.1111/hsc.13654. Epub ahead of print. 

Alrø AB, Klitnaes C, Dreyer P.

Personal care assistants' lived experience of working in the home setting with children and adults on mechanical ventilation

PCAs had to balance on a knife's edge when working with children and adults on mechanical ventilation in the home setting and try to strike a happy medium. Enduring the job required a proper physical and mental work environment, and thorough preparation, achieved not only through technical training, but also through learning how to be part of a professional relationship characterised by mutual respect and matched expectations.

Scand J Caring Sci. 2021 Dec 15. doi: 10.1111/scs.13056. Epub ahead of print.

Brandt H, Simon DM, Kasi AS.

Ventilator change in children on home mechanical ventilation affected by the Philips respironics trilogy ventilator recall

“The Philips Respironics recall notification issued in June 2021 affected many of their positive airway pressure devices and mechanical ventilators including the Trilogy 100 and 200 ventilators that are often utilized in children using home positive pressure ventilation via tracheostomy (PPV-T). Optimal strategies to replace ventilators in children using home PPV-T affected by the Philips recall are unknown. We conducted a retrospective study of children using home PPV-T with recalled Trilogy ventilators who underwent inpatient ventilator change to non-recalled portable home ventilators (PHV) using our collaborative institutional protocol. During the study period, there were 40 children using PPV-T with recalled Trilogy ventilators and 19 patients underwent inpatient ventilator change either during an elective hospitalization (n = 8) or during an unscheduled or postoperative hospitalization (n = 11). The median duration of hospitalization for ventilator change was 2 days (interquartile range: 6 days) and generally 1 day for patients admitted solely for ventilator change. In children using PPV-T with recalled Trilogy ventilators, a systematic protocol collaborating with the patients, physicians, and durable medical equipment companies may optimize transition to nonrecalled PHVs.”

Pediatr Pulmonol. 2022 Jan;57(1):43-48. doi: 10.1002/ppul.25730. Epub 2021 Oct 21.

EDUCATIONAL

OPPORTUNITIES

 

JIVD/ERCA Conference in 2022

JIVD.png

The 4th International Joint Meeting of the JIVD (Journes Internationales de Ventilation Domicile) and ERCA (European Respiratory Care Association) will be held March 3-5, 2022, at Cité Centre de Congrès, Lyon, France. For more information, go to www.jivd-erca2022.com.

ATS 2022 International Conference

The American Thoracic Society 2022 International Conference will be held May 13-18, 2022, in San Francisco, California. Get more info at https://conference.thoracic.org.

CCHS Network Family Conference 2022

Next year's CCHS Network Family Conference will take place July 19-22, 2022, in Newport Beach, California. Family conferences foster a supportive and collaborative CCHS union between professionals and families, all with the intent of improving outcomes for CCHS patients.