Devices being used to treat chronic conditions, COVID-19

Delaware Insurance Commissioner Trinidad Navarro has released a consumer alert for users of respiratory devices manufactured by Philips. An estimated 4 million Philips Continuous Positive Airway Pressure (CPAP) and Bi-Level Positive Airway Pressure (BiPAP or BiLevel PAP) devices, as well as mechanical ventilators manufactured before April 26, 2021 are being recalled due to potential health risks associated with the sound abatement foam in the devices that may degrade and be inhaled, and could contain cancer-causing chemicals.

The Delaware Department of Insurance is issuing this notice after the company’s recall notification and lack of communication to consumers and facilities has caused concern, particularly due to the necessity of devices in the treatment of both chronic conditions as well as facility-based usage. Recalled devices include those listed as providing respiratory treatment or support for COVID-19 patients.

While the recall notice urges immediate discontinuation of device use if possible, some individuals require the use of CPAP, BiPAP, and ventilator devices and may face serious medical issues, including the possibility of death, if they do not have access to a machine. Residents using these medically necessary devices should contact their physician to discuss the best path forward for their individual needs and register in the Philips recall system online or call 1-877-907-7508 to begin a claim for replacement or financial restitution. Users should not make any changes to their equipment or treatment plan without discussing with a physician. Doctors are encouraged to proactively communicate with their patients, and facilities should check all machines.

At this time, the company has not provided a replacement or repair timeline after issuing notice in June that the sound abatement foam in these devices may degrade, be ingested, and create additional respiratory problems, and could be releasing carcinogenic or otherwise hazardous chemicals into the air pathway. The Department of Insurance encourages insurers to assist policyholders in any way possible during this situation.

DOVER, Del. — About 1 in 6 Americans gets sick every year from foodborne illnesses. Under the Food Safety Modernization Act (FSMA), FDA and the USDA work closely to trace the cause and origin of these illnesses. Traceability is key so the origin is quickly detected, and a recall enacted, preventing others from becoming ill. Preparation and planning are necessary for produce growers and businesses in the supply chain to successfully navigate a product recall.

The Delaware Department of Agriculture’s Produce Safety Program will present the United Fresh Recall Ready Workshop on January 22, 2020 at Dover Downs from 8 a.m. to 5 p.m., registration and breakfast will begin at 7:30 a.m. Registration is required, but the event is free for registered attendees.

The Recall Ready Workshop is a one-day, hands-on training that will help producers and companies understand the fundamentals of a product recall. Attendees will gain an understanding of their rights and responsibilities, the role of FDA and/or state regulatory agencies, how to limit their liability, and how to manage customer expectations. During a crisis, effectively communicating to the industry, customers, consumers, and the media is vital. Developing a communications plan that incorporates key points and answers media questions, can make all the difference in minimizing the impact on the local business and economy.

Registration is available online at https://de.gov/producesafety or by emailing Anna Wicks at anna.wicks@delaware.gov. The workshop is limited to the first 56 registrants. Registration closes on January 10.

Funding for this workshop was made possible, in part, by the Food and Drug Administration through grant PAR-16-137. The views expressed in written materials or publications and by speakers and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.

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Media Contact: Stacey Hofmann, 302-698-4542, Stacey.Hofmann@delaware.gov