US Senator Dick Durbin (D-IL), who recently addressed concerns about the high-profile Philips Respironics’ CPAP and ventilator recall in a ProPublica article, and US Representative Jan Schakowsky (D-IL-09) have introduced bicameral legislation to improve the medical device recall process in order to protect patients.
The legislation, the Medical Device Recall Improvement Act, would require the US Food and Drug Administration (FDA) to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and health care professionals.
It also would require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and instruct hospitals and health care professionals to provide that information to patients. The legislation was inspired by Illinois constituents who had shared their personal stories about medical harms and other concerns related to recalled devices.
FDA oversees the regulation of almost 200,000 medical devices in the US.
Medical device manufacturers communicate recall information to FDA and health care professionals through letter and email. This extends the amount of time it takes FDA to review recall information, determine a recall classification, and communicate the recall to the public. It also extends the amount of time it takes hospital coordinators to track and pull recalled medical devices from inventories, according to a release from Durbin and Schakowsky. As a result, patients are often the last informed about a recall. The politicians note in the release that, per Consumer Reports, most Americans are not aware of recalls for their products, including medical devices.
“Americans deserve to know that the medical devices they rely on for their health and wellbeing are safe,” says Schakowsky in the release. “I am proud to partner with Senator Dick Durbin to introduce the Medical Device Recall Improvement Act, which will require all medical device recall information to be disseminated to the Food and Drug Administration in an electronic format, as opposed to physical mail, to reach health providers and patients quicker. Medical device companies initiate over 1,000 annual recalls, which impact millions of medical device units. Recalls save lives. We must ensure patients get this information in a timely manner, and our bill does just that.”
In the ProPublica article, which alleges Philips kept CPAP machine complaints secret long before initiating its recall in June 2021, Durbin “lambasted Philips for ‘allowing consumers to breathe in harmful particles from their CPAP machines.’”
“It’s deeply disturbing that Phillips would sit on this information as Americans became sicker and sicker,” Durbin told ProPublica.
Specifically, the Medical Device Recall Improvement Act would:
- Require FDA to establish an electronic format for medical device recall notifications;
- Require medical device manufacturers to use the electronic format to contact FDA and hospitals and health providers; and
- Require medical device manufacturers to include information in recall notifications about the risks of the recalled device, and instruct hospitals and health providers to distribute the information to patients.
The Medical Device Recall Improvement Act has earned endorsements from Consumer Reports, Public Citizen, National Center for Health Research, Device Events, Breast Implant Safety Alliance, Medical Device Problems, Patient Safety Action Network, USA Patient Network, and UCSF Team for High-Value Care.