Ingrid Tischer needs a machine to sleep. For nearly 30 years, she’s been using BiPAP devices, which push pressurized air into her lungs so she gets enough oxygen through the night. In June, a friend texted to tell her that Philips Respironics, one of the world’s biggest producers of respiratory devices, had recalled many of its ventilators, CPAPs, and BiPAPs. Her machine was on the list.
The realization was terrifying. “I’d gotten through the wildfires, the pandemic, and then suddenly, it’s like, oh, the monster is not dead yet,” says Tischer. “But it feels like the call is coming from inside the house. It’s not out there. It’s in my home and on my face every night.”
During its earnings report in late April, Philips noted concerns about the sound dampening foam in several of its machines. The foam could break down, sending debris and potentially toxic chemicals through the device’s airway that can then be swallowed or inhaled by the user. The degradation of the foam is exacerbated by high heat and humidity, worsening the risks for people in areas impacted by wildfires and record heatwaves.
On June 14th, the company issued a recall notice for over a dozen of its ventilators and BiPAP and CPAP machines, which are used by millions of people at home, in hospitals, and in care facilities across the country. One model, the E30 ventilator, was on the list of ventilators granted Emergency Use Authorizations by the FDA during the pandemic.
The FDA gave the recall a Class I designation, the most serious type. The classification means there’s a reasonable probability that use of a recalled product “will cause serious adverse health consequences or death.”
Philips estimates that 3 to 4 million devices are in use globally, around half of which are in the US. “We fully understand the impact that this is having on patients,” says Philips. “Our priority is to replace the foam in all the affected devices either by repair or replacement with like devices with the new foam.”
Yet over a month after the recall, people who rely on these devices to breathe are still scrambling to figure out what to do. Philips recommends that people register their devices and follow the advice of their doctors when deciding whether to continue using them. But most people who use these devices can’t go without them, even temporarily. Just one night without a BiPAP is detrimental to Tischer’s health, and other people need their ventilators around the clock.
“Respiratory equipment is not like a car that’s faulty,” says Tischer. “You can stop driving the car, but you can’t just postpone breathing. So we were given a really ridiculous thing that they called a choice, which was use it or don’t.”
Tischer was able to get a replacement after several calls with her medical equipment provider, insurance company, and doctor, but others haven’t been so lucky. Alice Wong, a disabled activist who uses two of the recalled ventilators, hasn’t gotten very far in her search for replacements. She received bacterial filters from her equipment provider, but the FDA hasn’t fully evaluated how effective such filters are for dealing with the degraded foam.
The existence of the recall has been poorly communicated. Wong found out about it through a Facebook group for people with neuromuscular disabilities, not through her doctor or Philips. She tweeted a thread to spread the word and started the hashtag #SuckYouPhilips to collect people’s stories. Several people have described a frustrating loop of conversations with doctors, less than sympathetic medical equipment suppliers, and insurers, while often being unable to reach Philips through its hotline. “Many people are getting the runaround while a few were able to get a replacement machine from another manufacturer immediately,” says Wong.
Philips says it is “working to address this issue as expeditiously as possible,” and has increased the production capacity of repair kits and replacements. The company couldn’t offer a timeline, but says it is “in discussions with the relevant regulatory authorities to obtain authorization to start deploying the repair kits and replacement devices that we are already producing in large quantities.” Philips also says it has stopped taking orders for sleep therapy devices for new patients while production capacity is focused on repair and replacement efforts.
The slow and convoluted process hasn’t been enough. “Disabled people have always been considered disposable by society,” says Wong, “and this is another ugly example of it.” She and others are calling on Philips to be more transparent about its plans for repairs and replacements. She says the company should pay for comparable machines from other manufacturers, reimburse people who purchased additional equipment out of pocket, and staff its phone line with people who have thorough information and resources.
But even that wouldn’t address the larger problems at play. A small number of companies produce the majority of durable medical equipment like ventilators, and patients have little choice which machines they end up with based on their insurance. When one of those companies announces its products have dangerous defects, there’s not much of a contingency plan for the people who rely on them.
Wong is exhausted from living through a pandemic as a ventilator user, and the recall of devices she needs to live is another massive source of stress. “I have to breathe,” she says, “but breathing from a machine pumping carcinogenic particles into my lungs is my only option?”