FDA Update on Recalled Philips CPAP and BiPap Sleep Apnea Machines

The Food and Drug Administration (FDA) recently provided an update on recalled Philips CPAP and BiPap sleep apnea machines regarding its June 2021 recall of some Philips Respironics breathing continuous positive airway pressure (CPAP) machines as well as bilevel positive airway pressure (BiPAP) machines.

Quick Facts About the Phillips Recall

Some of the important details to understand about the Philips recall include the following:

• The recall impacts devices manufactured between 2009 and 2021. Some of the machines recalled include certain kinds of A-Series BiPAP machines, C-Series machines, DreamStations, Dormas, SystemOnes, and Trilogy ventilators.
• You should make sure to follow Philips’ instructions for cleaning your CPAP machine.
• Never utilize ozone or ultraviolet light cleaners on Philip machines.
• Under no circumstance should you stop or change the use of a ventilator until you have talked to your medical provider about doing so.

The FDA’s Goal in Dealing With the Recall

The director for the FDA’s Center for Devices and Radiological Health has commented that making sure patients, as well as providers, have the most up-to-date details involving their care is one of the agency’s top priorities. The director also commented that the agency acknowledges that the people who count on these devices are closely monitoring the company’s activity to make sure that issues are resolved as timely as possible for patients. Additionally, the director emphasized the agency’s ongoing commitment to routinely updating the public about the status of the recall including any new suggestions concerning Philips Respironics’ devices.

The Beginnings of the Recall

Earlier in 2021, Philips Respironics recalled some CPAPS, BiPAPs, and ventilators manufactured by the company as the result of potential threats to user health presented by polyester-based polyurethane sound abatement foam that was placed in this medical equipment. The foam can break down and its decomposed particles can result in serious injuries that necessitate medical care to prevent permanent injury.

The FDA’s Inspection of the Philips Plants

In the wake of the recall, the federal government examined Philips Respironics’ facilities where the medical equipment was manufactured to assess what may have led to or contributed to the use of the hazardous foam and assess adherence to the FDA’s requirements involving quality manufacturing. FDA inspections were created to include the review as well as evaluation of things like operations, the production of medical equipment, quality assurance programs, staff training, and record evaluation. During an inspection of the plant, the FDA’s investigator logged several observations that are contained in a report referred to as FDA Form 483. The investigator from the FDA who conducted this examination provided its observations to Philips. While an FDA investigator’s list does not represent a final decision about whether any condition violates the Food, Drug, and Cosmetic Act or any of its associated regulations. The FDA then reviews the company’s response as well as the totality of details that can be obtained by the agency.

Philips’ Response to the CPAP Recall

Following the first recall, Philips created a strategy to repair the company’s polyester-based polyurethane foam in recalled BiPAP and CPAP devices with a different type of silicone foam. The FDA approved Philips’ plan at first. While inspecting the manufacturing facility, however, the FDA received new information that had not been previously available to the agency. This new information concerned the silicone foam used in similar devices marketed outside the United States which failed one safety test that looked for the release of certain chemicals known as volatile organic compounds. Similar testing on devices authorized for marketing in the United States given by Philips to the FDA had demonstrated acceptable results. The FDA subsequently requested that Philips keep an independent laboratory to conduct testing to assess whether any safety risks were presented to patients from foam produced with a silicone base.

Continued Testing by the FDA of the Philips CPAP and BiPap Machines

The FDA knows that many people have already received devices with silicone foam as part of the program to repair and replace this equipment. Currently, the FDA lacks sufficient details on which to determine whether the foam being utilized in repaired devices presents a risk to patients.

While testing on devices is currently underway, the FDA does not advise individuals who have participated in the replacement program to stop using their products. The FDA decided on this approach following an assessment of the associated benefits and risks.

The FDA has also determined that ceasing use of this medical equipment might present more harm to a patient’s well-being than the risk of continuing to use one of the devices. Results from independently conducted tests are necessary to assess whether the foam manufactured from silicone that is used in repaired devices presents any significant risk to patients.

The FDA will then relay this data to users as well as the general public as soon as possible. Currently, patients who have concerns about the dangers presented by Philips products should make sure to speak with their medical provider about their approach to getting the care they need.

The FDA also suggests that patients who have concerns about the device should acquire another, safe type of breathing machine if possible instead of discontinuing using a machine altogether.

The Future of the Philips Recall

The FDA acknowledges that many people who are impacted by the recall will have concerns about what these details mean in regards to the safety of the recalled devices.

Patients facing medical conditions have worked with the FDA as well as other health care professional organizations to respond to the situation. Some of the agencies with which the FDA has worked include the American Sleep Apnea Association, the COPD Foundation, Mended Heads Inc., and the American Academy of Sleep Medicine. The FDA has also been providing updates about the recall in the Frequently Asked Questions section on its webpage about the Philips recall.

Contact an Experienced Defective Product Attorney Regarding the Philips CPAP Lawsuit

If you or a loved one has been impacted by the Philips recall, you should not hesitate to speak with a knowledgeable lawyer. Contact the Law Office of Cohen & Jaffe LLP today to schedule a free case evaluation.

For a free legal consultation, call 516-358-6900