VGM Asks FDA to Expedite Approval of New Foam for Philips Devices

VGM & Associates sends a letter underscoring the urgency to take action to ensure patient access to devices; offers resources to help providers share their concerns with FDA, as well.

• By David Kopf
• Jul 22, 2021

VGM & Associates has sent a letter to the Food and Drug Administration urging the agency to hasten its approval of Philips repair and replacement program and new foam material that will go into PAP therapy and non-invasive ventilators that were covered by the recall the company announced last month.

On Jun 14, Philips issued a recall notification for the United States for specific Philips bi-level positive airway pressure (Bi-PAP), continuous positive airway pressure (CPAP), and mechanical ventilator devices to address potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam used in these devices.

The recall itself is a repair/replacement program, in which Philips will either replace affected devices with a new or refurbished unit that incorporates the new sound abatement material that is not affected by this issue or will repair them to replace the sound abatement foam. The new material will also replace the current sound abatement foam in future products.

However, to do that, Philips Respironics receives approval from the FDA (Food and Drug Administration) on the process for the repair/replacement recall, as well as the replacement sound abatement material. Given that the volume of sleep and respiratory patients impacted by this recall is so large and that it is impacting the supply chain for those care continuums as a whole, VGM’s letter stressed the need for the FDA to take fast action.

“Swift action is needed to protect access to these products and avoid a device shortage that would further burden an already stressed healthcare system,” the letter reads. “We ask that the FDA expedite this approval process to make these devices available to consumers who rely on them as quickly as possible.”

At the same time, VGM’s letter emphasized that it understands and supports the FDA’s safety role.

“We are not in any way asking for anything to be done that would jeopardize consumer safety,” it reads. “We are simply asking that you consider this situation to be a critical one and prioritize it accordingly.”

If providers wish to contact the FDA regarding the Philips Recall, as well, VGM Government Relations noted they can:

• Use the FDA’s reporting portal
• Contact the Division of Industry and Consumer Education at [email protected].
• Send a letter to their FDA recall Coordinators based on their state, which they can find on this link.