AG Tong urges FDA to speed up Philips CPAP replacement
Press release from the GA office:
October 9, 2021
Attorney General William Tong urged the U.S. Food and Drug Administration to step up monitoring of the Philips Respironics recall to ensure millions of affected patients can safely resume use of their CPAP devices, biPAPs and ventilators as soon as possible.
Philips Respironics launched a voluntary recall on June 14, 2021 of its E-30, Dream Station ASV, Dreams Station ST, AVAPS,, System One ASV4, C-Series ASV, C-Series S / T, AVAPS, Omnilab Advanced +, System One (Q series), Dream Station, Dream Station Go, Dorma 400, Dorma 500, REMStar SE Auto, Trilogy 100, Trilogy 200, A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40, and A-Series BiPAP A30, noting the potentially fatal problems associated with the degradation of polyester-based polyurethane (PE-PUR) noise-canceling foam. The particles released by the breakdown of PE-PUR foam in the airways of devices and the gassing of chemicals are toxic and potentially carcinogenic, posing a serious and unacceptable risk to patients. It is important to note that the individual registration of affected machines is the first step in the recall process.
Unfortunately, the notification issued by Philips Respironics to patients never explained how the company will repair or replace defective devices. Patients have reported that calls to the provided toll-free number do not connect callers with people aware of the recall, and requests for return phone calls are not being met.
Attorney General Tong asked the company to provide replacement machines, reimbursement, and repair advice. While Philips can and should take stronger action immediately to help patients, the recall is regulated by the FDA. Philips said the FDA has approved a corrective action plan, but neither the FDA nor the company has made the plan public, causing confusion and concern. Greater transparency is needed to ensure public confidence in the plan.
“It is quite clear to me that millions of people who depend on these devices are scared, upset and sorely lacking in understanding of what to do. The corrective action plan approved by your agency, to be followed by Philips has not been disclosed either by the FDA or Philips. This lack of transparency puts patients at risk, “Attorney General Tong said in his letter.
Janet Woodcock, MD
Food and drug administration
10903 New Hampshire Avenue
Silver spring, MD 20993
Re: Philips Respironics recall
Dear Commissioner Woodcock:
I am writing to urge the FDA to take more aggressive regulatory action regarding the voluntary recall by Philips Respironics of certain Continuous Positive Airway Pressure (“CPAP”), Dual Level Positive Airway Pressure (“BiPAP”) and ventilator devices, that contain foam that has been determined by the FDA to be potentially fatal.
I wrote to Philips directly on August 5, 2021 regarding its voluntary recall, at a time when it was unclear what corrective action Philips intended to take, if Philips intended to replace affected machines. and, if so, how long would this process take. The response I received was not reassuring. Philips responded that it will replace the devices, but the process will take up to 12 months. In the meantime, he has offered no interim measures to be taken to protect those who must use the machines while they are awaiting replacement as part of the recall.
It is quite clear to me that millions of people who depend on these devices are scared, upset and sorely lacking in understanding of what to do. The corrective action plan approved by your agency, to be followed by Philips, has not been disclosed by the FDA or Philips. This lack of transparency puts patients at risk. On the one hand, they do not want to be exposed by the continuous use of the machines concerned to particles and carcinogens released by the degrading foam. On the other hand, they need breathing assistance and are in many cases unable to locate or invest in alternative machines. To make matters worse, replacement machines would be scarce in light of the increased demand caused by the recall itself.
My office contacted James Nick Walker, deputy director of recalls and shortages at your agency’s CDRH by email on September 2, 2021 to open a discussion on the issues with the recall. My office received a promise from a government relations spokesperson that we will receive a response, but no substantive response or communication has taken place. We hoped to provide feedback to the FDA on issues relating to patient notification, short-term replacement strategies, and suggestions on comprehensive transparency actions that would enhance patient confidence in actions taken on their behalf.
My office suggested that Philips, through their outside counsel, consider the following:
• Pay off health plans that provide coverage for replacement machines before the end of the typical five-year coverage period required by many if not most plans.
• Consider whether filtration methods could be used to reduce the risk of exposure prior to replacement.
• Sponsor the issuance of loan machines through DME providers prior to replacement
• Reimburse patients who are able to replace machines at their expense before Philips can.
• Improve public awareness and patient notification through direct outreach to sleep centers and hospital systems where these devices are commonly used and recommended.
• Prioritize those in need by ensuring that the most medically compromised patients get their replacements sooner.
• Consider certified methods of local repair of affected machinery.
• Progress towards the goal of more transparent machinery replacement to the public by publishing bi-monthly reports containing, as a minimum, the number of machine records and the number of machines replaced, segmented by state.
This is by no means an exhaustive list of suggestions. Nonetheless, it is quite clear that while Philips has recognized these suggestions, it is really up to the regulator, i.e. the FDA, to select strategies that will shorten this crisis, protect vulnerable patients in the process. the interval and keep all concerned citizens informed of their rights and the progress of the corrective action plan. Please give this matter the urgent and focused attention it deserves.
This press release was produced by the office of the VG. The opinions expressed here are those of the author.