The FDA announced its plan to require unique barcodes on all medical devices starting by the end of the year, and while one purchaser group hailed the move, the device industry remains cautious.
Novation, a supplier of medical devices to hospitals, said in a statement that the unique device identifier program would cut down on healthcare costs by making the device-procurement process more efficient. "A robust UDI system will significantly enhance product identification, improve the device-recall process...and most importantly, advance and improve patient safety," Senior Vice President Daniel Sweeney said.
But some in the device industry aren't convinced the FDA's plan will amount to more than murky regulations and a lengthier approval process.
As AdvaMed Vice President Janet Trunzo told Reuters, the organization is still poring over the agency's guidance before making a definitive ruling. "We will be paying particular attention to whether the proposed rule follows a risk-based and least burdensome approach to implementing the UDI system, as we believe such an approach is essential given the huge diversity of medical devices and the cost and complexity of implementation," she said.
The program would create a searchable database of reported adverse events, and the FDA estimates it will cost the industry about $550 million over 10 years. The agency is giving devicemakers, watchdogs and doctors 120 days to comment on the proposal, and it will have 6 months to make a final ruling after that, Reuters reports.
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