Ingrid Tischer needs a machine to sleep. For nearly 30 years, he has been using BiPAP devices that push compressed air into his lungs to get him enough oxygen during the night. In June, a friend sent me a text message to tell him that Philips Respironics, one of the world’s largest ventilator manufacturers, had reminded many of its ventilators, CPAP and BiPAP devices. His machine was on the list.
The insight was scary. “I had survived wildfires, a pandemic, and then suddenly it’s like the monster isn’t dead yet,” Tischer says. “But it feels like the call is coming from inside the house. It’s not there. It’s at home and on my face every night.”
During that time earnings report at the end of April, Philips noticed concerns about sound-absorbing foam on several of its machines. The foam can break down and send debris and potentially toxic chemicals through the device’s airways, which can then be swallowed or inhaled by the user. Foam decomposition is exacerbated by high heat and humidity, which exacerbates the risks to humans from forest fires and record heat waves.
The company released on June 14th return notice more than a dozen of its ventilators, as well as BiPAP and CPAP machines, used by millions of people at home, in hospitals, and in health care facilities across the country. One model, the E30 fan, was on the fan list emergency licenses During the FDA pandemic.
FDA gave the reminder a Class I designation, the most serious type. Classification means that there is a reasonable likelihood that use of the returned product will “cause serious adverse health effects or death.”
Philips estimates that 3-4 million devices are used worldwide, about half of which are in the United States. “We fully understand its impact on patients,” Philips says. “Our primary goal is to replace the foam in all of the equipment in question, either by repairing or replacing similar equipment with new foam.”
Yet more than a month after the recall, people who rely on these devices to breathe continue to try to think about what to do. Philips recommends that people register your device and follow the advice of doctors when deciding to continue using them. But most people who use these devices cannot go without them even temporarily. Just one night without a BiPAP device will damage Tischer’s health, and other people will need their breathing equipment around the clock.
“Respirators are not like a faulty car,” Tischer says. “You can stop driving, but you can’t just delay breathing. So we were given a really ridiculous thing they called a choice, either to use it or not to use it. “
Tischer managed to get a replacement after several calls with a medical equipment provider, insurance company and doctor, but others have not been so lucky. Alice Wong, a disabled activist who uses two recalled fans, has not come very far in her search for replacements. He received bacterial filters from his equipment manufacturer, but the FDA has not fully evaluated how effective such filters are in treating degradable foam.
The existence of a refund has been poorly communicated. Wong found out about it through a Facebook group for people with neuromuscular disorders, not through a doctor or Philips. He tweeted the thread spread the word and started the hashtag #SuckYouPhilips to collect people’s stories. Several people have described the frustrating conversation with doctors, less than sympathetic medical device suppliers and insurance companies, even though they often don’t reach Philips through its hotline. “Many people get a detour, while a few immediately got a replacement machine from another manufacturer,” Wong says.
Philips says it is “working to resolve this issue as quickly as possible,” and has increased the capacity of repair kits and their replacement. The company could not provide a timetable, but says it is “negotiating with the relevant regulators to get permission to start deploying the repair kits and replacement equipment we already manufacture in large quantities”. Philips also says it has stopped receiving orders for new patient sleep therapy devices, while production capacity is focused on repair and replacement work.
The slow and confusing process has not been enough. “Society has always considered people with disabilities to be disposable,” Wong says, “and this is another ugly example of that.” He and others are urging Philips to be more open about their repair and replacement plans. He says the company should pay for similar machines from other manufacturers, replace accessories from people who have bought pockets and provide its phone lines to people with in-depth knowledge and resources.
But that, too, would not eliminate the bigger problems. A small number of companies produce most of the durable medical devices, such as respirators, and patients have little choice in which machines they end up with based on their insurance. When one of these companies reports dangerous defects in their products, there is not much contingency plan for those prepared for them.
Wong is exhausted live through a pandemic as a respirator userand restoring the equipment needed to live is another massive source of stress. “I have to breathe,” he says, “but breathing from a machine that pumps cancer-causing particles into my lungs is the only option?”