Premier Comments on FDA’s UDI Rule

November 2, 2012
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The Premier Healthcare Alliance, a Charlotte-based for-profit organization of provider groups, has submitted comments to the Food and Drug Administration (FDA) about the proposed Unique Device Identification (UDI) rule. According to Premier, it supports the implementation of a UDI system and says it is the “missing link to protect patient safety.”

“Enabling healthcare providers to track medical devices electronically in the supply chain will improve the speed and accuracy of product recalls, as well as adverse event reporting. In addition, automating the now manual process of tracking of medical devices is projected to save the healthcare industry approximately $16 billion each year from greatly improved efficiencies,” Premier said in its comments. Public comments to the FDA are due Nov. 7.

Premier says it believes the proposed seven-year implementation timeframe is too long, because there has been a five-year wait for UDI.  Premier’s comments mentioned that the recently enacted FDA Safety and Innovation Act shows there is congressional interest in seeing relatively prompt implementation of UDI requirements.

Another highlight of Premier’s comments include the fact it believes providers need to be excluded from UDI labeler requirements. It says hospitals, healthcare systems, and other entities that repackage devices, assemble kits, or reprocess single-use devices for internal use should not be subject to UDI-related requirements, even when the repackaged products, assembled kits, or reprocessed devices must cross state lines in the process.

Here is a complete look at Premier’s comments.  

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