WATERLOO, Iowa (July 27, 2021)— VGM & Associates has sent a letter to the FDA urging the agency to quickly approve Philips repair and replacement program for CPAP and noninvasive ventilators that were affected in a recent recall.
Philips Respironics announced a recall of nearly 4 million CPAP and noninvasive ventilator devices on June 14, 2021. The devices have a sound abatement foam that can degrade and present a cancer risk. The recalled machines will either be replaced with a new or refurbished unit, or repaired with a new sound abatement material.
The United States’ Food and Drug Administration (FDA) must issue approval on the repair/replace process and sound abatement material before repairs can proceed.
The letter from VGM highlighted the difficulty patients and home medical equipment providers are facing due to supply chain issues and the sheer size of the recall.
“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,” the letter reads. “Swift action is needed to protect access to these products and avoid a device shortage that would further burden an already stressed health care system. … We ask that the FDA expedite this approval process to make these devices available to consumers who rely on them as quickly as possible.”
The letter also acknowledged the FDA’s role in keeping consumers safe. “We are not in any way asking for anything to be done that would jeopardize consumer safety,” said the letter.
VGM Government Relations also noted that providers can contact the FDA as well.
- Use the FDA’s reporting portal
- Contact the Division of Industry and Consumer Education at dice@fda.hhs.gov.
- Send a letter to their FDA recall Coordinators based on their state, which they can find on this link.
