Why ECRI Institute Opposes the Single Medical Device Naming System

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

Benefits

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.
Concerns

ECRI Institute is concerned that FDA