Our patients who are
using a Philips BiLevel Positive Airway Pressure or
Continuous Positive Airway Pressure device for
treatment of a sleep disorder should have already
heard from Philips, who has issued a recall of
many of their CPAP
and BiLevel PAP devices and mechanical ventilators.
This is due to possible degradation of sound
abatement foam and exposure to chemical emissions
from the degraded foam material. High heat and
humidity as well as use of unapproved cleaning
methods, such as ozone (e.g. SoClean, PrimeClean),
may contribute to foam degradation.
Philips has excellent information on their web site
regarding their efforts to rectify the issue and as
well as answers
to questions. They offer a registration
process which allows patients to look up their
device serial number and begin a claim if the unit
is affected. We encourage anyone using a Philips
device to use the registration process.
We are following recommendations from the American
Academy of Sleep Medicine and the American Thoracic
Society with regard to use of the affected devices.
For patients using life-sustaining mechanical
ventilator devices, we would recommend that you do
not stop or alter prescribed therapy until
after talking to your physician. Appropriate
therapeutic decisions need to balance risks of
continuing therapy versus temporarily discontinuing
the device while awaiting a reasonable alternative.
For our patients on Bi-level PAP and CPAP devices
who have severe breathing difficulties or were very
sleepy during the daytime before treatment, have
chronic obstructive pulmonary disease (COPD),
cardiovascular or neurologic comorbidity, or who
work in safety-critical positions (e.g. professional
drivers, pilots, heavy equipment operators), we
would recommend that you not stop your prescribed
therapy until your unit is replaced or repaired.
Philips advises patients use an inline bacterial
filter with your unit in the meantime.
For our other patients using Bi-level PAP and CPAP
devices, contact your physician or DME provider to
determine the most appropriate option for continued
treatment. The determination will be based on the
severity of your sleep disorder, the availability of
an alternate device (durable medical equipment
suppliers, including Texas Pulmonary, have very
limited inventory), as well as other possible
treatment methods, such as positional therapy or
oral appliance therapy.
As noted above, if you need to continue use of an
affected device, do not use unapproved cleaning
methods and keep your device away from high heat and
Frequently Asked Questions:
(Also see the Questions
and Answers section of Philips' site.)
Q. What is the risk to the patient associated with
using a recalled device during one night for an
A. Based on the information currently available from
Philips, this risk is unknown.
Q. What is the risk to regular users of recalled PAP
A. Philips has reported that the complaint rate in
2020 was low (0.03%). However, it is unknown how
many cases may have been unreported.
Q. Should filters be used with a recalled device?
A. According to Philips, if physicians determine
that a patient must continue using a life-sustaining
mechanical ventilator device, patients are strongly
urged to use an approved bacterial filter per
Instructions for Use; it may reduce exposure to
degraded sound abatement foam particles, though
bacterial filters will not reduce exposure to
potential volatile organic compounds (VOCs). Contact
your DME supplier to identify the appropriate filter
for your device. Philips has made no public
recommendation for or against the use of filters
with recalled BiPAP and CPAP devices.
Q. I have an affected device and need to continue
using it. Where can I get an in-line bacterial
A. Texas Pulmonary does not have the in-line
bacterial filters available, but they can be
obtained from a number of online suppliers (Amazon,
Q. Do other PAP manufacturers use the same foam
found in the recalled Philips devices?
A. An online statement from ResMed indicates that,
“ResMed devices are not subject to this recall and
are safe for patients to use. ResMed devices use a
different material for sound reduction than the
material used by Philips.”
Q. How long will it take for Philips to repair and
replace the recalled devices?
A. At this time, Philips has not disclosed a
timeline to repair and replace recalled devices.
However, because the recall involves millions of PAP
devices, it may take some time before this process
is complete. Philips has stated that it will replace
the current sound abatement foam with a new material
after obtaining relevant regulatory clearances.
Philips also has indicated that they will address
all affected devices in the scope of this correction
as expeditiously as possible.
the Philips web site (https://www.usa.philips.com/healthcare/e/sleep/communications/src-update)
as well as this page for updates.