In
a piece published yesterday by The
Journal of Healthcare Contracting, HSCA President Curtis Rooney elaborated
on the organization’s support for the FDA’s proposed unique device
identification (“UDI”) system for medical devices. In the article, Rooney
reaffirms the organization’s recently submitted
comments to the U.S. Office of Management and Budget (OMB):
“[A]
UDI system, properly aligned with the GS1 standards so widely recognized
worldwide, will not only achieve the numerous health benefits sought by the FDA
in its proposal and its preliminary regulatory impact analysis, but will also
yield huge savings to the healthcare system that will far outweigh any costs
incurred by manufacturers, suppliers, or providers.”
Rooney
continued: “As products pass among manufacturers, distributors, suppliers, and
healthcare providers, a UDI system would make tracking those products easier.
Product tracking helps ensure that the right products are delivered to the
right purchaser at the right time. Efficient tracking can also help prevent
products from being lost or misplaced along the supply chain, and would protect
against counterfeit devices that pose significant patient safety concerns.”
To
read the complete article at The Journal of Healthcare Contracting, click here.