Speeding Compliance with Imminent UDI Labeling Mandates: A Proven Methodology

There has never been a better or more urgent time for manufacturers of healthcare products to make a close examination of their product labeling systems. Why? Because in most cases, existing solutions were developed over time, usually organically and often departmentally, individually and separately by each manufacturing entity to a labeling standard of their own choice. This approach has mostly worked, albeit at great expense, with much inefficiency, and at the tremendous risk of error, manufacturing interruptions, counterfeit labels and a host of other problems. But in addition to these well-known limitations, there is one additional major reason why now is a good time to explore labeling solution alternatives. New labeling mandates

UDI Compliance – Part 3: What do Supply Chain Professionals think?

What Do The Most Important Experts – Supply Chain Professionals – Think?
While important associations and provider organizations have rallied in support of a GS1-driven solution, the most important evidence of the inevitability of the standard must include a review of the current perception among healthcare supply chain and logistics executives toward this solution. To that point, recent independent university-driven research provides an illuminating look at today’s prevailing attitudes… and current as well as planned actions — among the people most critical to the adoption cycle.

Specifically, in November 2008, the Center for Innovation in Healthcare Logistics at the University of Arkansas in conjunction with the Association for Healthcare Resource & Materials Management (AHRMM) administered an industry wide survey

Healthcare and Compliance Label Concerns

If you are responsible for business labeling at any medical device or diagnostic firm, whether in a family of manufacturing companies, distribution centers and regional franchises or a medium-sized business, you are facing some immediate GS1 and GTIN label compliance, regulatory, and global issues in 2010. How you respond to these legal and regulatory requirements will determine

UDI Compliance – Part 1: In the beginning…

Over many years, the inevitability of a global system of standards for the unique identification of medical devices and products didn’t begin nor end in Washington, DC. on a late September day in 2007. Yes, that was the day, on September 27th, that the U.S. Food and Drug Administration’s (FDA) Amendments Act was signed into law. Included in that Act, as everyone now knows, was language related to the eventual establishment, for the first time in the history of healthcare products and medical device regulation, of a Unique Device Identification standard.

But for years in advance of this Act, healthcare manufacturers, suppliers, and providers have been constantly analyzing opportunities