Devices

Legislation Introduced to Improve Device Recalls

U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) have introduced bicameral legislation to improve the medical device recall process. Their Medical Device Recall Improvement Act would require FDA to establish an electronic format for medical device recall notifications to streamline communication between device manufacturers, FDA, hospitals, and health 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,” they say in a news release.

The lawmakers say that currently device makers report recall information to FDA and healthcare 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,” they say. “It also extends the amount of time it takes hospital coordinators to track and pull recalled medical devices from inventories. As a result, patients are often the last informed about a recall—if ever.”

Specifically, their legislation would:

Require FDA to establish an electronic format for medical device recall notifications;
Require device manufacturers to use the electronic format to contact FDA and healthcare providers; and
Require manufacturers to include information in recall notifications about the risks of the recalled device, and instruct hospitals and healthcare providers to distribute the information to patients.

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