How the Philips recall is raising scrutiny of at-home medical devices

Philips’ CPAP recall has placed a spotlight on serious communication gaps involving home-use medical devices.

Nonprofit safety organization ECRI recently released its annual Top 10 Health Technology Hazards report. The report said the No. 1 health technology safety issue for 2023 involves communications over medical devices in the home.

The trend of more healthcare services moving to the home is accelerating, according to ECRI. Officials at the group worry that home patients may not receive safety notices that warn of dangerous problems with the medical devices they are using.

ECRI claims that medical device manufacturers seldom directly communicate with people using their devices at home. Worse, healthcare providers may not proactively contact patients about recalls. As a result, people using affected products may learn about a recall long after its issuance and from potentially unreliable sources.

“Even if patients do receive notifications, the language may be jargon-heavy and perplexing, and patients may have difficulty determining whether their device is affected or what to do about it,” ECRI CEO Dr. Marcus Schabacker said in a news release. “Without clear, understandable information about a product recall, patients cannot accurately assess the health risks and may harm themselves by continuing to use an unsafe device, or by inappropriately stopping use of a device.”

Philips’ respiratory devices recall is an example

In mid-2021, Philips kicked off a recall that now involves 5.5 million CPAP and BiPAP ventilators and other respiratory devices. The devices — used for sleep apnea therapy and more — have sound abatement foam that could potentially degrade and get into the airways.

By March 2022, FDA was informing Philips that its communications over the recall were inadequate. The company is presently in consent decree talks with the U.S. Department of Justice and the FDA over its handling of the recall. The FDA has received 90,000 reports of problems, including 260 mentioning deaths.

(Here is a full timeline of the Philips recall.) 

Another home medical device with serious problems is Medtronic’s HVAD. The medtech giant stopped selling the device in 2021, but it continues to announce serious recalls that affect people who still have the heart pumps implanted inside their bodies.