FDA: CPAP, BiPAP Machines Recalled due to Potential Health Risks
The United States Food and Drug Administration has announced that a recall has been issued for several BiPAP machines, CPAP machines, and respirators.
According to the post, a foam contained in some units marketed by Philips may become dislodged from the unit which could, in turn, cause them to be inhaled or swallowed by the user of the device. When this happens, the foam could release harmful chemicals into the user's body.
The foam is polyurethane and is used to absorb sound and vibration when the breathing machines are in use.
The FDA has posted a list of the recalled units on its website. Units affected include Continuous Positive Airway Pressure units, Bi-Level Positive Airway Pressure units, and ventilators.
RECALLED PHILIPS CPAP and BiPAP List
DreamStation ST, AVAPS
C-Series S/T and AVAPS
E30 (Emergency Use Authorization)
REMstar SE Auto
RECALLED PHILIPS Ventilator List
A-Series BiPAP A40
A-Series BiPAP A30
A-Series BiPAP Hybrid A30 (not marketed in US)
A-Series BiPAP V30 Auto
Garbin Plus, Aeris, LifeVent
IF YOU USE ONE OF THESE RECALLED BiPAP/CPAP DEVICES
If you use one of the recalled BiPAP/CPAP devices, here is what the FDA recommends:
- Talk to your health care provider to decide on a suitable treatment for your condition, which may include:
- Stopping use of your device
- Using another similar device that is not part of the recall
- Using alternative treatments for sleep apnea, such as positional therapy or oral appliances, which fit like a sports mouth guard or an orthodontic retainer.
- Initiating long term therapies for sleep apnea, such as losing weight, avoiding alcohol, stopping smoking, or, for moderate to severe sleep apnea, considering surgical options.
- Continuing to use your affected device, if your health care provider determines that the benefits outweigh the risks identified in the recall notification.
IF YOU USE ONE OF THESE RECALLED VENTILATOR DEVICES
If you use one of these recalled ventilators, here is what the FDA recommends:
- Do not stop or change ventilator use until you have talked to your health care provider.
- Alternate ventilator options for therapy may not exist or may be severely limited for patients who require a ventilator for life-sustaining therapy, or in cases where therapy disruption is unacceptable. In these situations, and in the judgment of the treating clinical team, the benefit of continued usage of these ventilator devices may outweigh the potential risks identified in the recall notification.
- Talk to your health care provider about using an inline bacterial filter, which may help to filter out particles of foam, as indicated in the Philips recall notification. At this time, the FDA does not have evidence of the safety and effectiveness of a filter for mitigating the foam risks, and the FDA’s evaluation is ongoing. It is important to note the following considerations:
- Filters will not help to reduce exposure to certain chemicals that may be released from the PE-PUR foam.
- Filters may affect ventilator performance because they may increase resistance of air flow through the device.
- You should closely monitor for possible accumulation of foam debris on the filter or resistance-related problems in the breathing circuit after filter placement.
For more information, visit the United States Food and Drug Administration's website or the Philips website.
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