Physicians are trying to find replacements for the expanding number of individuals who use them after a widespread recall of Philips (PHG.AS) respiration machines in 2021 due to a risk of serious damage.
The 5.5 million gadgets, which include manual ventilators and non-invasive breathing devices intended to treat sleep apnea, a disorder characterised by brief pauses in breathing while sleeping, are being replaced, according to Philips, who stated last week that it is almost halfway done. Roy Jakobs, a newly appointed chief executive, will guide the business through the recall.
Dr. Raj Dasgupta, a sleep specialist at the University of Southern California, estimates that more than 30 million Americans have sleep apnea, but that only a small percentage of them are receiving treatment.
Obesity is a significant risk factor, and the number of people requiring continuous positive airway pressure (CPAP) devices, which push air through a facial mask and hose to guarantee regular breathing, has increased globally along with obesity rates.
As per market research agency Fortune Business Insights, the global market for therapies was $8 billion in 2017 and is predicted to reach $13 billion in 2028.
During sleep, the muscles in the rear of the throat in many people with sleep apnea relax, obstructing the airway and resulting in a temporary stop in breathing. The stress hormone adrenaline makes people rouse and gasp for air as blood oxygen levels fall.
Dr. Indira Gurubhagavatula, a sleep medicine expert at the University of Pennsylvania Sleep Clinic in Philadelphia, said that for some people, this occurs hundreds of times per night.
Chronic oxygen deprivation can result in high blood pressure, irregular heartbeat, heart attacks, and heart failure in addition to depression, memory loss, and difficulty concentrating.
Lack of sleep is another concern.
Additionally, there is concern over auto accidents. There are worries about accidents at work due to extreme sleepiness, according to Dasgupta.
Philips, a Dutch manufacturer of medical equipment, started the recalls in June 2021 for 3 million to 4 million devices. On August 17, it raised that figure to 5.5 million devices.
Devices employing PE-PUR sound absorption foam, which the manufacturer claimed could break down into particles and be consumed or inhaled by the user, were subject to the recall. Volatile organic compounds may also be released from the foam.
The company has begun using silicone foam to replace the insulation on affected products, and it hopes to be finished by the end of 2022.
The U.S. Food and Drug Administration (FDA) reported receiving more than 69,000 complaints of failures or injuries connected to the breakdown, or suspected breakdown, of PE-PUR foam since April 2021, including 168 fatalities. The FDA uses the reports to monitor possible issues, not to establish that the devices are to blame for injuries or fatalities.
Many medical professionals claimed they got minimal information about the recall or instructions on how to continue using possibly defective equipment for patients until a replacement was available. Calls from patients concerned that their use of breathing apparatuses was increasing their risk of developing cancer flooded their offices.
It has been really difficult to find a way out of this mess, Gurubhagavatula said, adding that rival ResMed Inc (RMD.N) has had trouble keeping up with the surge in demand.
Dr. Justin Fiala, a sleep medicine specialist at Chicago-based Northwestern University’s Feinberg School of Medicine, revealed that information on cancer risk is scarce.
He and other medical professionals have advised their most vulnerable patients to continue using their CPAP machines while they wait for a replacement.
Alternatives for patients with less serious conditions include the advice to quit drinking alcohol, the use of special pillows to prevent people from resting on their backs, and over-the-counter nasal patches to maintain the healthy gap of the airways.
