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.
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.
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.
you very much for your support and consideration.