Bennet, Merkley Applaud Implementation of New Safety Provision for Medical Devices

Today, U.S. Senators Michael Bennet (D-CO) and Jeff Merkley (D-OR) applauded the Food and Drug Administration (FDA) for finalizing proposed rules to create a unique device identification (UDI) system for medical devices. This key safety advance was championed by Bennet and Merkley in last year’s FDA Safety and Innovation Act, and will allow medical devices to be recalled much more quickly and accurately when safety problems are identified.

“Patients deserve to know that the medical devices they use to stay healthy or treat their ailment are safe and effective.  And they should have comfort in knowing that if something is defective, they’ll be alerted quickly and efficiently,” Bennet said. “This is a sensible step that will improve patient safety and ensure that medical devices are reliable for everyone.”

“When medical devices turn out to be flawed or dangerous, it is critical that we are able to find and inform affected patients quickly,” said Merkley. “This is a smart step forward that will help protect medical consumers.”

In recent years, safety problems and recalls of certain medical devices, including metal-on-metal hips, surgical mesh, and implantable programmable infusion pumps called into question whether the FDA and its Center for Devices and Radiologic Health (CDRH) had the tools needed to protect patients and keep harmful devices off the market. An average of 700 different medical devices has been recalled every year since 2005, but without a UDI system, it is difficult to find and inform patients about recalls so they can take action to protect their health. Harmful or defective devices were associated with the death of almost 5,000 Americans in 2009 alone.

The UDI system will also help to better track the effectiveness and safety of medical devices, making it easier for bad devices to be identified in the first place.