{"id":479638,"date":"2021-09-01T05:12:12","date_gmt":"2021-09-01T12:12:12","guid":{"rendered":"https:\/\/disabilityvisibilityproject.com\/?p=479638"},"modified":"2026-02-12T17:19:12","modified_gmt":"2026-02-13T01:19:12","slug":"letter-from-disabled-ventilator-users-on-philips-respironics-recall","status":"publish","type":"post","link":"https:\/\/disabilityvisibilityproject.com\/2021\/09\/01\/letter-from-disabled-ventilator-users-on-philips-respironics-recall\/","title":{"rendered":"Letter from Disabled Ventilator Users on Philips Respironics Recall"},"content":{"rendered":"

Below 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<\/a> including signatures by over two dozen organizations and groups. For more, check out the press release<\/a> from the New York Law School and a collection of links and Tweets.<\/a> Special thank you to artist Haley Brown<\/a> for creating artwork for our effort!<\/p>\n

Update: Philips announced a repair and replacement program<\/a> for one of their recalled models, the DreamStation, on September 1, 2021.<\/p>\n

11\/16\/21 update<\/strong>: read this new inspection report<\/a> by the FDA of Philips Respironics in the United States and this video from the YouTube channel CPAP Reviews<\/a> going through the report’s findings (November 14, 2021).<\/p>\n

Take Action<\/strong><\/p>\n

    \n
  1. If you are affected by the recall and want to sign on to this open letter and\/or speak to the media, complete this short form<\/a>.<\/li>\n
  2. Share this letter with your friends and family, elected representatives, and any media outlets who may not be aware of the recall.<\/li>\n
  3. If you use social media, share your experiences with hashtag #SuckYouPhilips<\/a>.<\/li>\n<\/ol>\n
    \"This
    This is a graphic illustration by Haley Brown with a bright cobalt blue background. There are black lungs filled with dark gray puffy clouds. In the left lung is a yellow canary bird with a red eye in a mid-flight attack pose. In the right lung there is a red circle. Around the lungs there is clear white tubing that is entwined. Above this graphic the white text reads: #SuckYouPhilips<\/figcaption><\/figure>\n

    Rodney Mell<\/span><\/p>\n

    Head of Quality and Regulatory<\/span><\/p>\n

    Philips Respironics \u2013 Sleep and Respiratory Care<\/span><\/p>\n

    1740 Golden Mile Highway<\/span><\/p>\n

    Monroeville, PA 15146<\/span><\/p>\n

     <\/p>\n

    Re: Philips Respironics Urgent Recall of Ventilators, CPAP, and Bi-Level PAP Medical Devices<\/span><\/p>\n

     <\/p>\n

    August 25, 2021<\/span><\/p>\n

     <\/p>\n

    Dear Mr. Mell:<\/span><\/p>\n

    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.\u00b9<\/span> 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.\u00b2<\/span>\u00a0 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.<\/span><\/p>\n

    The notice states that the recall is due to the degradation of a polyester-based polyurethane sound abatement foam that \u201cmay enter the device\u2019s air pathway and be ingested or inhaled\u201d by the user.\u00b3<\/span> The foam particles can also release certain chemicals (known as \u201coff-gassing\u201d).4<\/sup><\/span>\u00a0Extreme heat and humidity or the use of certain cleaning methods can exacerbate the degradation of the foam.5<\/sup><\/span> 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 \u201ccarcinogenic effects.\u201d6<\/sup><\/span><\/p>\n

    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 \u201cQuality Management system processes\u201d in April 2021 but provides no details about what that process entails or how these issues were uncovered in the course of that <\/span>process, leading to the recall notice issued approximately two months later in June 2021.7<\/sup><\/span> The FAQs also state that Philips has received reports and complaints about \u201cpossible patient impact\u201d which it is \u201cmonitor[ing ]\u201d8<\/sup><\/span> 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.<\/span><\/p>\n

    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\u2019 advice.<\/span><\/p>\n

    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 \u201creduce exposure to degraded sound abatement foam particles\u201d but \u201cwill not reduce exposure to potential Volatile Organic Compounds (VOCs).\u201d9<\/sup><\/span> VOCs have also been found to be carcinogenic.10<\/sup><\/span>\u00a0\u00a0<\/span><\/p>\n

    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<\/sup> Some doctors and DME providers whose patients and users depend on Philips\u2019 devices for life-sustaining care have repeated Philips\u2019 suggestion that customers use a bacterial filter.12<\/sup> 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<\/sup>\u00a0<\/span><\/p>\n

    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<\/sup><\/span><\/p>\n

    Finally, Philips\u2019 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 \u201cprioritize patients with \u2018more advanced clinical needs\u2019\u201d15<\/sup><\/span> in the repair and replacement process, it must articulate a concrete plan with timetables for how that will be done.\u00a0<\/span><\/p>\n

    Philips acknowledges that extreme heat and humidity exacerbate the degradation of the foam particles.16<\/sup><\/span> 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 wildfires17<\/sup><\/span> 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<\/sup><\/span> This is unacceptable.<\/span><\/p>\n

    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<\/sup><\/span> However, just as users\u2019 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.<\/span><\/p>\n

    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:<\/span><\/p>\n