Imagine a world in which medical devices had a kind of tracking code that allowed a big database to keep track of them. The FDA thinks it's a good idea, and so does Congress. However, a proposal to create such a system has been stuck at the Office of Management and Budget for review since July--without any explanation for the delay.
In 2004, the FDA published a final rule requiring bar codes on certain drugs and biologics. Medical device stakeholders have pushed for a similar system. Having such a system would allow health officials to find devices that have been recalled. Currently, the device recall process is infuriatingly slow. "We can recall tainted dog food faster than a pacemaker," said Amanda Forster, a senior communications director at Premier, as quoted by Politico. "It's just shocking."
And hospital groups aren't the only ones up in arms about the OMB's delay. Sen. Herb Kohl (D-WI) plans to take the OMB to task, too. "For every day that we wait on putting UDIs in place, a significant number of patients are placed at risk," Kohl told Politico in a statement.
The delay could have far-reaching consequences, according to AdvaMed's Jeff Secunda, as other countries might consider installing incompatible systems of their own. "If the FDA were to publish their proposed rule tomorrow, other countries would know what they had to work with," he said, Politico notes.
The FDA itself has faced criticism over its oversight of medical device recalls. Last summer, a GAO report maintained that the agency hasn't routinely analyzed data to determine whether there are systemic problems underlying trends in device recalls. While the agency has used data to monitor individual recalls and target companies for inspections, it has failed to routinely analyze this data and only reacts to individual recalls as they occur. It therefore misses out on chances to use the information to address risks presented by unsafe devices, according to the report.
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