AIM North America (AIM NA), the Association for Automatic Identification and Mobility in North America, reports the following new committee leaders for 2013:
These industry experts have been elected chair of their respective committees for one year.
The agency’s proposal would require most medical devices distributed in the United States to bear UDI, and in certain instances UDI would need to be marked directly on the device. These include devices that would remain in use for extended periods of time and would be likely to become separated from their labeling, the draft reads.
No national requirement for pharmaceutical track and trace has materialized to supersede California’s 2015 law, and Unique Device Identification has just been proposed in draft form.
With U.S. mandates slowly emerging, pharmaceutical and medical device companies should consider business needs as they prepare for unique product coding, GS1 representatives urge. The identification standards organization promotes its systems for standardizing product identification throughout the supply chain.
Speakers at GS1 Connect in June shared several business reasons to standardize product identification. Health systems representatives spoke of efficiencies that standardized identification could bring in product and patient identification and tracking as well as improvements in billing, ordering, and inventory. Many spoke of the need for standards, such as the GS1 family of standards.
FDA clarifies its proposed mandate, but still has 35 questions for stakeholders.
AIM North America has formed a new committee to address FDA’s forthcoming Unique Device Identification (UDI) proposed rule. The AIM-NA UDI committee will offer recommendations for a final rule as well as implementation models that are sensible and address the need for interoperability with other national and international unique device and unique item identification requirements.