A medical device-focused scientific advocacy group is calling on the US Food and Drug Administration (FDA) to make changes to a recently proposed regulation set to make big changes to the way medical devices are tracked after being introduced to the market.
In a statement on 11 October, the Emergency Care Research (ECRI) Institute said it is "concerned" about FDA's Unique Device Identification (UDI), set to come into effect within the next year. The rule-long delayed by the Office of Management and Budget (OMB)-sets in place a system through which FDA can track medical devices through a standardized, alpha-numeric system of identifying elements. Those elements would be maintained in an FDA database, and regulators said the system will be particularly useful for evaluating adverse events and identifying medical device problems.
The rule has been more than five years in the making. It was originally required by the FDA Amendments Act (FDAAA) of 2007, but the law did not require a specific date for the rule to be implemented or prescribe any penalties if the rule was not implemented.
Has FDA Been Transparent Enough?
But if the agency has had ample time to regulate, ECRI is concerned it hasn't used that time to consult with the public on some important aspects of the rule. In a statement, ECRI said it believes the UDI rule is overly reliant upon a single medical device naming convention which ECRI notes has not been available for public review or commentary.
"More importantly, it has been used by only a very small number or healthcare organizations and medical device manufacturers in the US, and does not have a publicly available model for how it will be technically and financially maintained and updated over time," the group explained.
The system, called the Global Medical Device Nomenclature (GMDN), would stand in competition to two other standards, one of which is maintained by ECRI: the Universal Medical Device Nomenclature System (UMDNS), maintained by ECRI, and the Standard Products and Services Code (SPSC), maintained by the United Nations.
ECRI said it was concerned that unlike its standard and that of the UN, the GMDN is maintained by a group which does not presently allow for free access. Though plans are in place to eventually allow for free access, no guarantees existed.
ECRI said it is requesting that any UDI system be designed to accommodate multiple naming convention systems, including the UMDNS and UNSPSC.
"This is particularly important when considering GS1's GTIN (Global Trade Item Number) and the Global Data Synchronisation Network (GDSN) which already incorporates UNSPSC as a naming convention and allows the inclusion of UMDNS," the group wrote.
ECRI also argued that at a minimum, the public should "be able to access the information this will be based on … to vet the standards and have the opportunity to use them on a trial basis before they are formally adopted nationwide."
FDA's UDI proposal
is accepting comments until 7 November.