AASM guidance in response to Philips recall of PAP devices


On June 14, 2021, Philips initiated a voluntary remember notification within the U.S. (and an international subject safety word) for particular Philips Respironics fashions of non-stop tremendous airway strain (CPAP), bilevel fantastic airway stress (BPAP), and mechanical ventilator devices, mentioning that the recollect is to “make certain patient protection in session with regulatory companies.” The consider is to address ability health risks associated with the polyester-based totally polyurethane (PE-PUR) sound abatement foam utilized in certain devices. Philips reviews that the froth-related complaint fee in 2020 became low (zero.03%). Read the AASM precis of the Philips statement for extra info and confer with the Philips internet site for ongoing updates and complete statistics.

Submitting PAP Device Prescriptions (August 2022 Update)
In its “Sleep and respiration care bulletin #7,” published in August 2022, Philips reviews that many patients have registered to get hold of their remediated CPAP or BiPAP tool, however the method to acquire the substitute tool is unable to take vicinity as they no longer have a DME to confirm the prescription and remedy settings. Philips will ask these patients to touch their medical doctor and request a script be sent to Philips Respironics. Philips might also touch some sufferers via cellphone and ask for their doctor’s contact statistics, after which Philips will touch the doctor without delay so that the prescription can be despatched to the contact records underneath:

The AASM is imparting the subsequent facts to help sleep facilities and sleep medicine experts understand their alternatives. Members ought to take into account discussing these options with their hazard control team or recommend. This steerage record does no longer constitute felony recommendation and isn’t always intended to substitute bipap machine for the scientific or clinical judgment of our clinicians or contributors. Additional records, including responses to regularly asked questions, could be made available by means of the AASM as quickly as feasible. Call Philips at 877-907-7508 for extra assist and guide.

Philips updated its guidance to align with FDA’s suggestions in connection with the recollect. Philips now advises that patients the usage of recalled BPAP and CPAP gadgets need to consult with their health practitioner on a suitable remedy plan. For patients the usage of BPAP and CPAP devices, Philips advises that they communicate to a health care issuer to decide on a suitable treatment for clinical conditions, which might also consist of:

Stopping use of an affected tool
Using any other similar tool that is not part of the do not forget
Continuing to use an affected tool, if a affected person’s health care company determines that the blessings outweigh the dangers recognized inside the keep in mind notification.
Using opportunity remedies for sleep apnea.
The AASM indicates that the medical company prescribe for their patient a PAP device that isn’t always stricken by the take into account. However, within the case that this isn’t always an alternative, or another device is unavailable, then it’s miles the AASM point of view that scientific elements along with comorbidities, severity of symptoms, dangers associated with PAP discontinuation, and protection-sensitive roles need to inform the selection to maintain or discontinue therapy. This choice should be made in concert among the affected person and their scientific company. The remaining judgment regarding any unique care should be made through the treating clinician and the affected person, taking into account the character circumstances of the patient, available treatment alternatives, and sources. The AASM advises that sufferers touch their scientific provider as quickly as possible to speak about whether or not to keep or discontinue remedy.


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