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 The medical equipment company recalled some breathing devices and
ventilators in June because of a silicone-based foam part that might
degrade and become toxic, potentially causing cancer.
The FDA noted, in a so-called form 483, that between April 2016 and
January 2021, Philips was aware of 14 instances of issues related to
potential foam degradation with its different sleep and respiratory
devices.
Philips, which in September said it will repair and replace the 15
million devices recalled globally, did not immediately respond to a
request for comment.
The company has not sufficiently demonstrated that other devices
containing this foam should not also be recalled, and its risk
analysis was inadequate, the agency said in the form.
The Form 483 lists observations of issues that could lead to
potential FDA rule violations.
The agency said the procedures for design change were not adequately
established and the design validation did not ensure that the device
conforms to defined user needs and intended uses.
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 The FDA had initially approved
https://www.fda.gov/news-events/press-announcements/fda-provides-update-recall-certain-philips-respironics-breathing-assistance-machines
a plan that Philips developed, to repair the
foam in the recalled devices with a different
silicone-based foam.
But that was before the agency found new
information during its manufacturing facility
inspection, which showed that the silicone-based
foam used in a singular, similar device marketed
outside the United States had failed a safety
test for the release of certain chemicals of
concern, called volatile organic compounds (VOCs).
The FDA has requested that Philips retain an
independent laboratory to perform additional
testing to determine what, if any, potential
safety risks may be posed to patients by the
silicone-based foam.
(Reporting by Mrinalika Roy in Bengaluru;
Editing by Devika Syamnath)
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