SIOUX CITY, Iowa (KCAU) — After a massive recall from a manufacturer of CPAP and BPAP devices, patients in some areas of the nation have 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 start randomly.
Philips, a manufacturer recalled 4 to 5 million CPAP and BPAP devices. The company provided an update on April 26, regarding efforts to address an identified issue with a component in products of their Sleep & Respiratory Care portfolio.
After an ongoing analysis following the announcement, the company issued a voluntary recall notification and field safety notice for specific affected devices on June 14.
Health risks of using Philips recalled devices include exposure to degraded sound abatement foam, which could be ingested or inhaled by the user and the foam may off-gas 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 as best as they can as they continue to work around the shortage of devices for their patients.
UnityPoint Health St. Lukes said in a statement that they use Philips Respironics PAP devices and are working to notify customers. They also said they are working to obtain supplies and they ask patients to talk to their doctors. Read the statement below:
“UnityPoint Health takes seriously its responsibility to protect the health and well-being of the people and families we serve. We’re aware of the recent voluntary recall on Philips Respironics PAP devices, and we’re working with Philips, a global supplier of these devices, to notify our impacted patients and better understand when new Philips devices will be available. We realize this recall is frustrating for impacted patients and their families. Please know we’re contacting other vendors to help obtain as much additional supply as possible given industrywide supply constraints. We strongly encourage affected patients to contact their primary care provider as soon as possible to determine what option is best for them.”
In light of the recall, manufacturing competitor ResMed announced they will be increasing the manufacturing of their CPAP devices. ResMed CEO Mick Farrell said they use different materials than Philips, so their devices were not affected by the recall.
“We rigorously test our devices against applicable standards before we launch a new product. We reevaluate our testing when other device makers raise concerns. The information we’ve reviewed from Philips’ recall of its devices and our detailed analysis of our products’ test results confirm that ResMed devices are safe to use.”
Katy Tritz, manager of MercyOne Home Medical Equipment, said they responded quickly to the recall and sent out letters to their patients to highlight that they needed to contact their doctor before seeking CPAP devices.
“It’s not affecting us as much as it’s affecting others because we stopped [using] Philips Respironics a couple years ago,” Tritz said, “We are only getting a certain allotment at a time; however, we are prioritizing kind of by a first-come-first-serve, but also noting that some patients might need a CPAP more than others and we no qualms about being able to continue to service our patients.”
The MercyOne lab is still able to conduct home sleep tests and diagnostic studies at the hospital. They are unable to do a titration, which is what is needed to test whether a patient needs a CPAP. According to Tritz, they have ordered the necessary equipment and should arrive soon.
According to Philips, they have received a limited number of reports of patient impact due to foam degradation, and no reports regarding patient impact related to chemical emissions or death.
The potential risks of particulate exposure include headache, irritation, inflammation, respiratory issues, and possible toxic and carcinogenic effects. The potential risks of chemical exposure due to off-gassing include headache, irritation, hypersensitivity, nausea/vomiting, and possible toxic carcinogenic effects.
“We deeply regret any concern and inconvenience that patients using the affected devices will experience because 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 the updated devices. Patient safety is at the heart of everything we do at Philips.”
To see additional information about the Philips voluntary recall, visit their website or click here.
To view the statement from Mick Farrell, CEO of ResMed, visit their website or click here.