By Genni Burkhart
In June of this year, Philips Respironics issued a recall for multiple models of their bi-level positive air pressure (BiPAP), continuous positive air pressure (CPAP), and ventilator machines manufactured before April 26, 2021 due to potential health risks from faulty components. The Food and Drug Administration (FDA) identified this as a Class I recall, the most serious type of recall issued as, “life-threatening, cause permanent impairment and require medical intervention.” At issue is the polyester-based polyurethane foam used to dampen sound and vibration in the machines. This foam can degrade over time, causing the user to breathe in toxic chemicals and swallow “black debris.”
Asthma, skin and respiratory tract irritation, and “toxic and carcinogenic effects” to organs such as the kidneys and liver are just some of the dangers posed by these recalled devices, says the FDA. Compounding the issue, many patients are reported to only have learned about the recall on social media, not from their medical distributors or physicians. After contacting Philips directly they’re placed on a waitlist for a replacement with no shipment date in sight.
Dentists and OSA Patients
Dentists are often part of a collaborative team of medical professionals, including sleep specialists and primary care doctors, that assist in providing long-term care for patients with obstructive sleep apnea (OSA). Dentists contribute care by providing periodic dental and periodontal assessment, as well as fabrication and maintenance of properly fitted oral appliances for safe use.
According to the ADA, dentists can screen patients for OSA through oral clinical exams and patient health histories that can recognize risk factors such as: large tongue or tonsils; mandibular retrognathia or micrognathia; large neck circumference; nocturnal choking or gasping; obesity; loud or irregular snoring; or breathing pauses during sleep (if reported by bed partner). Patients that present with OSA symptoms can then be referred to their primary care physician or sleep specialists for further diagnosis and examination.
Supply and Demand
According to a recent article in the New York Times by Joshua Brockman, Royal Philips, the parent company of Philips Respironics, claims that of the estimated 24 million Americans with obstructive sleep apnea, upwards of two million people are using these recalled devices.
Philips Respironics has submitted a repair and replacement program for the defective components to the FDA and begun mass producing the repair kits and replacement devices. However, before they can be shipped to customers, they must clear testing and regulatory hurdles, causing uncertainty among physicians and their patients who depend on these machines for life-sustaining treatment. They’re left not knowing when to expect new devices, or repair kits for existing ones, as the FDA will first need to review the testing data provided by Philips, and then authorize shipment.
These delays are compounded by the current delta variant surge of COVID-19 across the country, placing unprecedented demand for some of the recalled products, particularly ventilators needed in ERs and ICUs. This backlog of orders is creating a supply shortage for manufacturers already impacted by the prolonged pandemic.
A daily briefing posted on August 19th by the Advisory Board reports that a survey of home medical equipment suppliers done in April of 2020 found that, “more than half reported supply-chain delays for CPAP machines, and 62% reported delays of up to 60 days.” And the Philips recall has "certainly exacerbated" these issues,” according to the CEO of the American Association for Homecare, Thomas Ryan. Ryan continues in the briefing by the Advisory Board, "Given the shortages of materials to make these devices, such as resins and computer chip modules, and transportation bottlenecks, I expect that supply will continue to lag behind demand into 2022," Ryan said. He continues, "It is becoming a crisis." (United Healthcare Blog, Advisory Board, 8/19)
The Impact of Rising COVID-19 Hospitalizations
Adding to the supply and demand issue is the rapid rise in hospital admissions across the United States, as hospitalization in the U.S. for COVID-19 have more than doubled in the past month. According to the CDC, during the week of August 23rd more than 500 people with COVID-19 in the U.S. were admitted to hospitals each hour on average.
The American Hospital Association stated that it has “reactivated a program to help distribute ventilators and supplies to regions where the delta variant had hit hardest," according to spokesman Thomas Jordan in the article for the New York Times. (Brockman, New York Times, 8/17)
While a rise in COVID-19 hospitalizations has thereby impacted those affected by the recent Philips recall due to supply issues, the FDA isn’t aware of the recall having a reverse impact (shortage) for hospitalized patients.
Doctors and Patients in Crisis
For physicians treating patients with recalled home breathing machines, accurately quantifying health risks for these patients would be possible if they knew how much time it would take for replacements, but Philips has yet to provide that information.
Patients with obstructive sleep apnea (OSA) may stop breathing many times an hour while they sleep. CPAP machines force air into the patient’s nose, triggering breathing to continue. Without the aid of CPAP machines, patients are at risk of cardiac and neurological events as well as a more serious case of COVID-19. And without new units or repair kits, OSA patients must continue to use the recalled units despite the risks.
Not surprisingly, this situation has given rise to class action litigation against Philips claiming, in addition to the continued contamination exposure of machine users, that Philips was aware of the defect long before the recall was announced, leaving physicians to weigh the risks and benefits of using these defective machines on a crisis basis. Patients are ultimately the ones left making the final decision to use a breathing machine that possesses potentially fatal harm or not having one at all for the unforeseeable future.
As this situation continues to unfold, look for more information and what to do if you or someone you know might be impacted by visiting the Philips Respironics recall website directly, or the FDA communications page for commonly asked questions and updates.
Author: With over 11 years as a published journalist, editor, and writer Genni Burkhart’s career has spanned politics, healthcare, law, business, finance, and news. She resides on the western shores of the Puget Sound where she works as the Editor in Chief at DOCS Education out of Seattle, WA.