The Food and Drug Administration has classified the recall as Class I, which is used to designate situations in which there is a reasonable probability that the product could cause serious health consequences or death.
Philips advises users to stop using ozone-based cleaners, which break down the foam faster. It also instructs users to stop using non-life-sustaining machines, but Bisogno doesn’t feel he can do that.
“The only guidance I’ve been given was from the manufacturer who told me to stop using it, which I would equate to somebody telling a diabetic to stop using their insulin without actually giving them a solution,” said Bisogno. “It’s not an option.”
Without the BiPap, Bisogno said, he is exhausted, cranky and sore, and he needs coffee to get through the workday. Because he drives a lot as part of his job in sales and marketing for a beer wholesaler, Bisogno sees his sleep apnea machine not only as a device that’s important for his personal health, but for the health and safety of others on the road as well.
Temple Health’s Dr. Fred Jaffe, who works in sleep medicine and pulmonology, said users of the recalled devices should talk to their physicians before they stop using them. He said his office has been fielding 15 to 20 calls a day from patients asking for advice.
For some, the symptoms are severe enough that the benefits outweigh the potential dangers, Jaffe said, and they should continue using their machines.
“I wouldn’t suggest somebody saying, ‘Well, I’m going to not use my machine. I’m going to register my machine, and I’ll wait for a replacement.’ Because depending on their symptoms and the severity, they could be putting their health at risk,” he said.
For others, depending on the severity of their symptoms, there may be treatments such as dental and positional devices their doctors can recommend while the patients wait for new machines.