Eliana Ramirez was initially delighted when doctors switched her 2-year-old daughter, Lexi, to a new ventilator last year. The machine, a Trilogy Evo made by Philips Respironics, was more modern, lightweight and portable than the ventilator Lexi had used since birth because of a rare brain condition that causes her to stop breathing when she’s asleep or concentrating.
But the Fresno mom began to worry after a visit with Lexi’s pulmonologist in February. The ventilator Lexi uses every day has been recalled by the manufacturer, the doctor said. The physician recommended the family consider switching to a different machine because the manufacturer was discontinuing the ventilators and would eventually stop servicing them. Because Lexi relies on her ventilator to breathe, and doesn’t have a replacement, if it were to break and there were no parts to fix it, the toddler would have to go to the hospital to use a ventilator there. Her life would depend on it.
“It’s concerning because my daughter needs this,” said Ramirez. “It’s her way to live.”
Lexi’s ventilator is one of millions of breathing machines manufactured by Philips Respironics that have been recalled because of defects the federal Food and Drug Administration says may cause serious injury or death. In 2021, the company recalled about 5.6 million of its breathing machines due to concerns that a polyester-based foam used inside them could degrade and force users to breath in toxic particles and fumes, possibly causing cancer. Since then, regulators have raised other safety concerns, including about a new, silicone-based foam used as a replacement inside some recalled ventilators. In 2023, Philips also recalled the Trilogy Evo, which Lexi uses, and other Evo ventilator models after finding that dust and dirt could accumulate and block the devices’ air vents, potentially preventing patients from getting enough oxygen.
Some doctors and children’s advocates are asking federal officials to better track the health of patients exposed to the recalled ventilators, provide physicians with more information on how to assess patients for potential problems caused by the devices, and provide stronger oversight of medical devices in general.
The recalls have shaken parents whose children depend on ventilators due to health conditions that affect their breathing. Some are concerned that foam still inside the devices could be emitting toxic fumes and causing health problems, such as respiratory issues, or increasing their child’s risk of developing cancer in the long-term. An investigation by ProPublica and the Pittsburg Post-Gazette uncovered thousands of complaints about Philips Respironics breathing machines dating back as much as a decade before the recall, included reports of cancer, liver and kidney disease and respiratory problems. Many of these complaints centered around machines used by adults for conditions such as sleep apnea, and it’s not clear how many involved children.
Other parents, including Ramirez, as well as some doctors treating children who use the ventilators, are more worried about Philips’ decision to discontinue the devices and how it could affect the availability of replacement parts. The company has said it will stop servicing some portable ventilators as early as December 2025. The Trilogy Evo will no longer be serviced starting in January 2029. This could mean, some doctors and parents fear, that children who rely on these devices could have life-threatening breathing problems if their ventilators break.
Philips, which did not respond to a request for comment from the California Health Report, has said that “use of the sleep therapy devices is not expected to result in appreciable harm to health in patients,” although it is continuing to conduct tests. The company also maintains it has not identified any safety issues with the replacement, silicone foam. According to Philips’ website on the recall, the company has remediated 2.59 million sleep therapy devices as of March by either replacing the foam in them or replacing the entire device. It’s not clear if that number includes ventilators. The company has said it is working on a remediation plan for Trilogy 100 and Trilogy 200 ventilators, subject to the 2021 recall, with durable medical equipment suppliers, hospitals and other institutions. Parents and caregivers will be notified by their suppliers if and when they need to take any action, the company says.
Sheena Maharaj, a pediatric pulmonologist for Sutter Health in Sacramento, said she hasn’t seen any evidence in her practice of children getting sick from using the ventilators. She said she spoke with third-party ventilator suppliers after the first recall announcement and was reassured that the problems associated with foam inside the machines were linked to sleep therapy devices used by adults and cleaning products that could degrade the foam. The ventilators used by her pediatric patients don’t use these cleaning products and require regular servicing, as well as filter and tubing changes. Additionally, the Trilogy Evos are now supplied with an additional filter to prevent the air vent blockage problem.
Nevertheless, Dr. Maharaj said she’s encountering many parents who are worried about using the ventilators and have asked to switch. Their children are already immunocompromised and have respiratory problems, and they are more susceptible to health risks in the environment than other kids. Additionally, diseases that can be caused by exposure to toxins such as cancer can take years or decades to manifest, and parents want to limit their child’s risk of exposure.
“Every little thing that happens to their kid now it’s, what, is this the ventilator?” Dr. Maharaj said. “They’re fixating on the ventilator and what they see in the media about it, even though their child’s had no problems.”
Transitioning every child who uses a ventilator to a new one isn’t practical, Dr. Maharaj said. That’s partly because medical supply companies are unlikely to have enough alternative ventilators available to make that possible. It’s also because switching to a new ventilator is a time-consuming process that often requires an overnight stay or multiple days in the hospital.
But because of Philips’ plans to stop servicing machines, she and other doctors are transitioning some patients to new ventilators, especially if they will require breathing support long term. That transition can be very stressful for families, said Susan Gage, a pediatric pulmonologist at Children’s Hospital Orange County.
“For many of these families they have (children with) complex (medical-needs) with a lot of other things going on and it certainly is just one more burden, and it’s difficult to come in and switch ventilators,” Dr. Gage said. “We’ve definitely had delays from families saying, you know what, I don’t want to do it right now, I’m fine with the way it is.”
Kim Lockwood is one of those parents. His teenage daughter uses a Trilogy 100 ventilator, which was subject to the original recall in 2021. Lockwood, who requested that his daughter’s name be omitted from the story for privacy reasons, said he tried switching her to a different brand after her pulmonologist recommended it. She spent a night in the hospital to try it out, but had trouble syncing her breath to the machine. They decided to stick with the Trilogy device. Lockwood said he’d heard about the potential foam problem, but hasn’t seen any evidence that it’s impacted his daughter’s machine.
“If it works, why fix it, why change it?” he said.
Many parents don’t even know their child’s ventilator could be a risk, said Jennifer McLelland, a disability rights advocate and columnist for the California Health Report. The FDA and others have criticized Philips for not proactively alerting individual patients about the recall and leaving it to suppliers to inform their clients. In March 2022, the FDA ordered Philips to adequately notify all patients, clinicians and supply chain intermediaries affected by the recall. Yet, McLelland said she regularly sees parents post in online support groups that they only just found out about the recalls.
That raises ethical concerns, she said.
“Medical decisions are supposed to be based on informed consent,” McLelland said. Yet many parents “haven’t gotten the information that makes it possible to give informed consent to continue using a recalled ventilator.”
Parents who are concerned about their child’s ventilator should talk to their child’s doctor and care team, Dr. Maharaj said. Families can also contact their durable medical equipment supplier to ask whether their child’s ventilator is subject to a recall and if it’s been remediated. Additionally, Philips Respironics has detailed information about the recalls available on its website, although the company advises parents and caregivers to contact their medical equipment supplier if they have questions.
Doctors and advocates are calling on the FDA to provide better oversight of medical devices and do more to track whether patients who have used the recalled Philips machines have gotten sick. In an editorial published in the American Journal of Respiratory and Critical Care Medicine, four doctors called for health care practices to create clinical assessments that providers can use to see if patients have been affected by exposure, and for more research to assess possible health impacts more broadly. Similarly, three doctors who authored another editorial published in JAMA Internal Medicine said the FDA should require Philips to study the impact of ventilator exposure.
McLelland agreed that Philips should be required to do more, including directly contacting patients who use ventilators, finding out whether they’ve experienced health problems, and keeping them informed. An option on Philips website allows patients to type in the serial number for their ventilator to find out if it’s subject to a recall, and also to find out whether they may benefit from a recent monetary settlement. McLelland said this is complicated for most families whose children are ventilator dependent because they rent the devices from a durable medical equipment company, and typically receive multiple different ventilators over time and therefor the serial numbers change. People who are able to obtain and register the serial numbers for recalled devices they are using or have used in the past, including those from a rental company, may be eligible for up to $1,552 per device, according to Philips’ settlement page .
To help durable medical equipment companies switch to non-Philips ventilators the disability rights advocate also called on California legislators to increase Medi-Cal reimbursement rates for ventilators so that these firms can afford to buy new ones.
Meanwhile, Ramirez has decided to hold tight and hope that the company that supplies her daughter’s ventilator comes up with a plan to buy new ventilators or obtain replacement parts. She said she’s doing what she can to keep Lexi’s ventilator clean and in good condition by replacing the filters regularly.
The recall “is like a little stone in your shoe that bothers you, but you just kind of keep going,” she said. “It’s there but there’s not much I can do at the moment.”
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