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The Unintended Consequences of FDA’s Proposed UDI Rule

Why ECRI Institute opposes the single medical device
naming system approach

Read here the official comment of ECRI Institute to the U.S. Food and Drug Administration regarding Unique Device Identification for Medical Devices Docket No. FDA-2011–N–0090

The final rule on Unique Device Identification (UDI) is scheduled for release in May 2013. ECRI Institute believes that UDI is a good idea and although we fully support its intent, we are concerned about some unintended and costly consequences that could affect everyone involved with health care facilities and the supply chain.

If implemented correctly, UDI should help healthcare organizations do a better job of tracking and managing their inventories of medical devices. This can help control costs, achieve better standardization, and identify product safety concerns. Patient safety and product development researchers should be able to better identify trends in device problems and develop early safety warnings and product design improvements.
However, in order for UDI to achieve its expected benefits, it needs to be based on solid, sustainable, and accessible naming conventions and database design structures.

ECRI Institute is concerned that FDA’s UDI design will not achieve these goals because the rule is based on a single medical device naming convention—one which has not been publicly available for general review and commentary. More importantly, it has been used by only a very small number of healthcare organizations and medical device manufacturers in the United States, and does not have a publicly available model for how it will be technically and financially maintained and updated over time.
Thank you very much for your support and consideration.

UDI Resources

  • View FDA's proposed rule (website)
  • View the public comments posted to the FDA (website)
  • View ECRI Institute's submitted comments (PDF)
  • ECRI Institute's Universal Medical Device Nomenclature System (learn more)