As ECRI points out, manufacturers of medical devices rarely have direct communication with patients who use their devices at home, and healthcare providers may not proactively contact patients about recalls.
As a result, patients who use medical devices in the home may learn about a recall—and the steps needed to ensure safe use of the device—long after it was issued, and potentially from an unreliable source, such as a television commercial for a class-action lawsuit or through social media, ECRI noted.
Even if patients do receive a recall notification, the language may be full of industry jargon that the average layperson doesn’t understand.
“Without a clear understanding of the risks, patients may be harmed by continuing to use an unsafe device—or by inappropriately stopping use of a device whose benefits outweigh the risks,” according to the report.
The ongoing recall impacting millions of continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP) machines manufactured by Philips is a prime example of how real this danger is. Although Philips' recall was initiated in June 2021 and affected 5.5 million devices, several months elapsed before some patients became aware of the recall. The language in the recall notice also confused patients about whether to continue to use the device and what actions needed to be taken, ECRI noted.
In the Top 10 Health Tech Hazards for 2023 report, ECRI challenges manufacturers of medical devices that can be used outside the hospital environment to implement measures such as: providing users with easy-to-follow device registration instructions, writing simply worded recall notices, maintaining up-to-date databases of device distribution, and designating staff to ensuring that recalls reach home users.