CHICAGO, Aug 21 (Reuters) – Massive recall of Philips breathing devices (PHG.AS) in 2021 Due to the risk of potential injury, it has caused doctors to seek alternatives to the growing number of people who use them.
Philips said last week that it has already replaced 5.5 million devices, including mechanical fans, as well as non-invasive breathing devices used to treat sleep apnea, a condition characterized by brief pauses in breathing during sleep. The company recently appointed a new CEO, Roy Jakobs, to guide it through the recall. read more
Here is a summary of the impact of the recall.
Table of Contents
HOW COMMON IS SLEEP APNEA?
More than 30 million people in the United States suffer from sleep apnea, but only a small fraction get treated, Dr. Raj Dasgupta, sleep expert at the University of Southern California.
One of the major risk factors is obesity, and as obesity rates rise worldwide, the number of people who need Continuous Positive Airway Pressure (CPAP) devices that pump air through a face mask and hose to ensure normal breathing is increasing.
According to the research firm Fortune Business Insights, the global treatment market was $ 8 billion last year and is expected to reach $ 13 billion in 2028.
In many patients with sleep apnea, the muscles in the back of the throat relax during sleep, blocking the airways and pausing breathing briefly. When blood oxygen levels drop, the stress hormone adrenaline causes people to wake up and gasp.
For some, it happens hundreds of times a night, Dr. Indira Gurubhagavatula, specialist in sleep medicine at the University of Pennsylvania Sleep Center in Philadelphia.
Recurrent drops in oxygen can cause high blood pressure, heart rhythm problems, heart attacks and heart failure, as well as depression, memory loss, and trouble concentrating.
Lack of sleep is also a threat.
“We are concerned about car accidents, we are worried about work-related injuries due to excessive sleepiness,” said Dasgupta.
The Dutch medical equipment company Philips initiated the recall in June 2021 for around 3 to 4 million devices. He increased that number to 5.5 million devices in August. 17. read more
The recall concerned devices using a sound-absorbing foam called PE-PUR, which the company said could disintegrate into particles and be ingested or inhaled by the user. The foam can also be volatile organic chemicals derived from waste gas.
The company is replacing the insulation of the recalled appliances with silicone foam and expects to do so by December 2022.
As of April 2021, the US Food and Drug Administration (FDA) reported that it had received more than 69,000 reports of crashes or injuries related to PE-PUR foam decay or suspected accidents, including 168 deaths. Reports do not prove that the devices are directly responsible for injuries or deaths, but are used by the FDA to track down potential problems.
EVERYTHING FOR TREATMENT OF SLEEP APNEA
Several doctors said they had received little warning of a recall or guidance on keeping patients on a potentially defective device until a replacement was available. Their practices were inundated with phone calls from patients who feared their breathing apparatus was putting them at risk of cancer.
“Digging our way out of it all was an incredible challenge,” said Gurubhagavatula, noting competitor ResMed Inc (RMD.N) struggling to meet the surge in demand.
Information on cancer risk is limited, said Dr. Justin Fiala, sleep medicine expert at the Feinberg School of Medicine in Chicago.
He and other physicians have advised his most critical patients to continue using CPAP devices pending replacement.
Alternatives for less critical patients include the use of special pillows to stay awake on the back, over-the-counter nasal strips to maintain the airway, and a recommendation to stop drinking alcohol.
Register Reporting by Julie Steenhuysen in Chicago; Additional reports by Ahmed Aboulenein in Washington; Edited by Josie Kao
Source: Reuters Trust Principles.