Dive Brief:
- Another Philips respiratory recall has been designated as a Class I event by the Food and Drug Administration, which warned the device may fail suddenly.
- Philips told customers about another problem with some of its bi-level positive airway pressure (BiPAP) machines last month after learning that they may contain a plastic contaminated with a non-compatible material.
- Should the plastic cause the machine to stop working suddenly, it could lead to serious injury or death, the regulator said, adding it hasn’t had any reports of serious injuries or deaths linked to the contaminated plastic.
Dive Insight:
The latest Class I recall notice describes an issue that is unrelated to the sound abatement foam fault at the center of Philips’ recall of millions of respiratory devices. Still, the contaminated plastic issue affects a subset of devices covered by the larger sound abatement foam recall.
The overlap between the two events means some of the 386 devices in the U.S. that are covered by the contaminated plastic recall may already be off the market.
If the BiPAP devices, which are used in clinical and home care settings, have already been corrected or replaced through the larger foam-related recall, no action is needed, the FDA said in a recall notice posted Friday. The contaminated plastic will have been replaced as part of the other changes.
If a device hasn’t been corrected or replaced, Philips is advising healthcare providers, patients and caregivers to discuss whether the care and treatment plan should change in light of the risks posed by the contaminated plastic.
The plastic may release volatile organic compounds if it’s in the device motor, leading to symptoms such as headache, dizziness and nausea. The FDA also lists “toxic and cancer-causing effects” among the risks of inhaling the compounds. The more immediate risk is that the plastic may cause the machine to fail and stop suddenly, potentially leading to serious injury or death, according to the agency.
