A bipartisan group of U.S. senators is pushing a bill that supporters say will make medical devices safer, according to the Association for the Advancement of Medical Instrumentation (AAMI).
If approved, the Ensuring Safe Medical Devices for Patients Act would require the U.S. Food and Drug Administration (FDA) to release its long-awaited unique device identifier (UDI) rule this year. The FDA would also have to add devices to its Sentinel postmarketing surveillance initiative, which monitors prescription drug safety.
The legislation, introduced March 15, 2012, comes at a time when the medical device industry is pressing Congress to streamline the federal review process for new devices, saying it is slow and complicated, impeding innovation. Patient safety advocates, on the other hand, say the oversight process is not strict enough.
President Obama said during his State of the Union address in January that smart regulations could help prevent faulty medical devices from hitting the market. In a press release, one of the bills sponsors cited patient safety as motivation for the legislation.
When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldnt have to worry that the device that is supposed to improve their health could actually make them sicker, said Sen. Jeff Merkley, D-OR, who introduced the bill with Sens. Chuck Grassley, R-IA, Michael Bennett, D-CO, and Herb Kohl, D-WI. Strong postmarketing surveillance of medical devices will ensure those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market.
The agency has worked on the UDI rule since it became a requirement under the Food and Drug Administration Amendments Act of 2007. FDA officials have said that the draft rule is going through the Office of Management and Budgets approval process. Once finalized, manufacturers must put a UDI barcode on devices so they can be identified.
The legislation was endorsed by consumer advocacy organizations such as the National Research Center for Women and Families, Consumers Union, and the National Womens Health Network.
The Advanced Medical Technology Association (AdvaMed), a device trade association based in Washington, D.C., gave a measured response to the legislation.
The appropriate development and use of UDI and the postmarket risk identification and analysis system known as Sentinel should further enhance FDAs already robust postmarket authorities, said Stephen J. Ubl, AdvaMed president and chief executive officer, in a statement. We are reviewing the bill and look forward to working with Sen. Merkley and other members of Congress on these issues.
To read the press release from Merkley, CLICK HERE.
Source: Association for the Advancement of Medical Instrumentation (AAMI)