Siouxlanders in need of CPAP machines continue to wait amid a massive shortage.
SIOUX CITY, Iowa (KCAU) – After a massive recall from a manufacturer of CPAP and BPAP devices, patients in some parts of the country are having to wait for supplies, including those in Siouxland.
Continuous Positive Airway Pressure (CPAP) devices provide uninterrupted airflow to patients throughout the night while they sleep. These devices are used to treat patients with sleep apnea, a sleep disorder that causes breathing to stop and restart at random.
Philips, a manufacturer, has recalled 4 million to 5 million CPAP and BPAP devices. The company provided an update on April 26 regarding efforts to address an identified issue with a product component of its sleep and breathing care portfolio.
After continued analysis after the announcement, the company issued a voluntary recall notice and field safety notice for specific affected devices on June 14.
Health risks associated with the use of devices recalled by Philips include exposure to degraded sound absorbing foam, which could be ingested or inhaled by the user and the foam may give off certain chemicals.
According to the FDA, they had a low complaint rate of 0.03%, but Philips determined that the possible health complications were not the risk.
Local hospitals continue to provide care to the best of their ability while continuing to bypass the shortage of devices for their patients.
UnityPoint Health St. Lukes said in a statement that they use Philips Respironics PAP devices and make an effort to educate customers. They also said they were working to get supplies and asking patients to speak to their doctors. Read the statement below:
“UnityPoint Health takes seriously its responsibility to protect the health and well-being of the individuals and families we serve. We are aware of the recent voluntary recall of Philips Respironics PAP devices, and we are working with Philips, a global supplier of these devices, to inform our affected patients and better understand when new Philips devices will become available. We realize this recall is frustrating for affected patients and their families. Please note that we are reaching out to other suppliers to help you secure as much additional supply as possible given industry-wide supply constraints. We strongly encourage affected patients to contact their primary care provider as soon as possible to determine which option is best for them. ”
In light of the recall, competing manufacturer ResMed has announced that it will increase manufacturing of its CPAP devices. ResMed CEO Mick Farrell said they were using different materials than Philips, so their devices were not affected by the recall.
“We rigorously test our devices against applicable standards before launching a new product. We re-evaluate our tests when other device manufacturers raise concerns. The information we have reviewed from the recall of its devices by Philips and our detailed analysis of the test results of our products confirms that ResMed devices are safe to use.
Katy Tritz, head of MercyOne Home Medical Equipment, said she responded quickly to the recall and sent letters to their patients stressing that they should contact their doctor before looking for CPAP machines.
“It doesn’t affect us as much as the others because we stopped [using] Philips Respironics a few years ago, ”said Tritz,“ we only get a certain allowance at a time; However, we sort of prioritize first come, first served, but also note that some patients might need a CPAP more than others and we have no qualms about being able to continue serving our patients.
The MercyOne lab is still able to perform home sleep tests and hospital diagnostic studies. They are unable to do a titration, which is necessary to test whether a patient needs a CPAP. According to Tritz, they have ordered the necessary materials and should arrive soon.
According to Philips, they have received a limited number of patient impact reports due to foam degradation, and no patient impact reports related to chemical emissions or death.
Potential risks of exposure to particulate matter include headache, irritation, inflammation, respiratory problems, and possible toxic and carcinogenic effects. Potential risks of chemical exposure from off-gas include headache, irritation, hypersensitivity, nausea / vomiting, and possible toxic carcinogenic effects.
“We deeply regret any concerns and inconvenience that patients using the affected devices will experience as a result of the proactive measures we are announcing today to ensure patient safety,” said Frans van Houten, CEO of Royal Philips, “In consultation With the relevant regulatory agencies and in close collaboration with our customers and partners, we are working hard towards a resolution, which includes the deployment of updated devices. Patient safety is at the heart of everything we do at Philips.
To view additional information on Philips’ voluntary recall, visit their website or click here.
To view the statement by Mick Farrell, CEO of ResMed, visit their website or click here.