Philips recall: VGM asks FDA to speed up approval
By HME News Staff
Updated 12:47 PM CDT, Thu July 22, 2021
WASHINGTON – VGM has asked the U.S. Food and Drug Administration to expedite its approval process for a replacement foam for respiratory devices affected by the Philips recall.
“We are requesting accelerated approval from the FDA for this critical replacement component for approved technicians to rapidly start the process of replacing/repairing all recalled units,” states VGM in a letter to the agency.
Philips on June 14 announced a voluntary recall of certain Bi-Level CPAP, CPAP and mechanical ventilator devices to address identified potential health risks related to the polyester-based polyurethane sound abatement foam component in these devices.
VGM points out in the letter that the recall has exacerbated an existing product shortage related to ongoing supply chain issues.
“Currently there is a shortage of manufacturers of these devices with inventory constraints to adequately increase production to absorb the demand for these devices typically provided by Philips Respironics,” it states. “Swift action is needed to protect access to these products and avoid a device shortage that would further burden an already stressed healthcare system.”
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