Today, the United States Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act, a bill to give the FDA the tools needed to monitor and review medical products and prevent drug shortages. The bill included two provisions authored by Oregon's Senator Jeff Merkley to improve the safety of medical devices.
"Innovative medical devices help save and improve patients' lives every day," Merkley said. "However, the failure of medical devices, particularly those that are implanted or life-sustaining, can lead to death or significant long term disability and pain for patients. This bill will make sure that patients, doctors, and the FDA have the information and tools they need to improve patient safety."
The provisions inserted into the bill by Senator Merkley closely mirror the bipartisan Ensuring Medical Devices for Patients Act, which Senator Merkley introduced in March. It will require the FDA to implement a Unique Device Identifier system for high-risk and implantable devices, so that in the event of safety problems, affected doctors and patients can be notified. Merkley's provisions also add medical devices to the Sentinel Initiative, a national, integrated, electronic data system for tracking health outcomes associated with prescription drugs. This database will allow the FDA to spot trends and flag potential safety problems patients have experienced with medical devices.