Schakowsky, Durbin Introduce Legislation to Improve the Medical Device Recall Process

WASHINGTON - Today, U.S. Representative Jan Schakowsky (IL-09) and U.S. Senate Democratic Whip Dick Durbin (D-IL) reintroduced legislation to improve the medical device recall process in order to protect patients. The Medical Device Recall Improvement Act would require the 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.

"Americans deserve to know that the medical devices they depend on for their health and wellbeing are safe and effective," said Congresswoman Jan Schakowsky. "That's why I'm proud to work with Senator Dick Durbin on the Medical Device Recall Improvement Act. Our bill ensures that all medical device recall information is sent to the Food and Drug Administration electronically, rather than through physical mail, so providers and patients can receive critical updates faster. With more than 1,000 recalls issued each year affecting millions of devices, timely communication saves lives. This important legislation makes sure patients get the information they need when they need it."

"Millions of Americans rely on a medical device to stay healthy. But if their medical device is recalled, patients have the right to know as soon as possible so that they can understand the risks and consult with their health care provider," said Senator Dick Durbin. "The Medical Device Recall Improvement Act is an obvious solution to ensure that medical device manufacturers, FDA, and health providers can quickly share up-to-date information with patients."

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.

FDA oversees the regulation of almost 200,000 medical devices in the U.S., from contact lenses and contraceptive devices to prosthetics and pacemakers. According to the American Medical Association, more than 32 million Americans have an implanted medical device, and countless others use them throughout their lives. These devices improve and save lives. However, medical devices that are recalled for safety issues or manufacturing defects can cause severe harm to patients.

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. As a result, patients are often the last informed about a recall-if ever. According to Consumer Reports, most Americans are not aware of recalls for their products, including medical devices.

The Medical Device Recall Improvement Act has earned endorsements from Public Citizen; National Center for Health Research; Device Events; and UCSF Team for High Value Care.

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