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Bill calls for UDIs on medical devices

by Brendon Nafziger, DOTmed News Associate Editor | March 16, 2012
Jeff Merkley
A bill introduced into the Senate Thursday appears to be aimed at pressuring the Office of Management and Budget to speed up its review of a plan to better track medical devices.

The bill, Ensuring Safe Medical Devices for Patients Act, or S. 2193, calls for devices to carry a unique tracking number and to be included in a post-market surveillance system currently used only for drugs. Both measures could help regulators keep better tabs on the safety of devices once they hit the market, according to the legislation's backers, Sens. Jeff Merkley (D-Ore.), Chuck Grassley (R-Iowa), Michael Bennet (D-Colo.) and Herb Kohl (D-Wis.). The bill also comes with the support of a number of consumer watchdog groups and group purchasing organizations.

"When seniors undergo hip replacement surgery or heart patients need a cardiac stent, they shouldn't have to worry that the device that is supposed to improve their health could actually make them sicker," Merkley said in a statement.

The legislation has two parts: one part would require devices to be enrolled in the so-called Sentinel post-market surveillance system, instituted four years ago by the Food and Drug Administration for tracking drugs that are on the market. The bill asks for priority to be given to riskier Class II and Class III items.

The other part of the bill calls for the Food and Drug Administration to issue a final rule establishing a code for tracking devices through the supply chain, called a Unique Device Identifier, by the end of the year.

However, UDIs have already been mandated by legislation passed in 2007. And on July 11, the Food and Drug Administration actually already submitted a rule on how to implement such a scheme.

Currently, though, that rule is sitting with the Office of Management and Budget, awaiting final approval. According to an outstanding executive order, OMB has 90 days to make a decision or request an extension, but the OMB has taken more than six months to act on the UDI rule. The office's website currently says "pending review" for the UDI rule. In fact, in February, two of the current bill's backers, Grassley and Kohl, along with Sen. Richard Blumenthal, sent a letter to the OMB demanding to know why it has taken the office so long to make a decision. The senators asked for answers by "no later than close of business March 1, 2012," a recently elapsed deadline that might help explain the timing of the new bill.

"We haven’t got anything back from [the OMB] yet," a spokesman from Sen. Kohl's office told DOTmed News. "The bill is basically to get things moving."

The new bill's supporters, by the way, include Public Citizen, National Research Center for Women and Families and the Health Care Supply Chain Association, a lobby of GPO groups. Interestingly, though, in a statement, AdvaMed, a trade lobby for device makers, was in principle cautiously behind at least part of the proposed legislation.

"America's medical device manufacturers have long-supported the appropriate implementation and use of a UDI system and believe it can play an important role in advancing patient safety," said the group's president and CEO Stephen J. Ubl, who also said his group would continue to review the bill.

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