New White Paper!
Compliance with 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 from the FDA – now expected to be imposed no later than September, 2013 – are going to require all healthcare products manufacturers in the United States to adhere to a uniform set of Unique Device Identification (UDI) labeling standards. This means that proprietary labels and any labels that are not part of a universally-accessible database for common use by all other manufacturers and at all checkpoints in any supply chain will, virtually overnight, be a thing of the past in the United States. In fact, it is likely the FDA initiative will further drive the global effort occurring at this time to effect this same kind of UDI solution worldwide.
New White Paper!
Unique Device Identification and GS1:
Defining Elements in the Future of Global Healthcare Logistics
In defense of forward thinking supply chain executives in the healthcare industry... 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 for improving, streamlining, and bringing more efficiency to the healthcare supply chain, both independently and collaboratively. What the Amendments Act did signal, however, were two very important milestones: One, for the first time, it was seen that the implications to patient safety of a UDI standard – of chief interest to the FDA –could potentially align, co–exist and fuel supply chain efficiencies as well. And two, the FDA’s decision vanquished one of the biggest and longest-standing concerns among manufacturers to the adoption of any would-be standard: whether or not enough manufacturers – eventually all manufacturers everywhere – would adopt the same standard solution. After all, for a standard to be effective, it has to be in standard use. For it to be useful, it has to have common currency in the supply chain from end–to–end and across and among trading partners. The 2007 Amendments Act set aside the possibility of purely voluntary adoption and upon closer examination began to be seen as a way forward that promises significant logistics benefits and safety features.
Other factors leading up to 2007, and gaining momentum since, have also increased the inevitability of a UDI standard. These include significant consumer and mainstream media interest in patient safety, medical device recall effectiveness, and overall healthcare reform with particular emphasis on lower costs (i.e., more efficiency in the system). This means even if the FDA were not moving to impose new safety standards on medical products and devices, consumer tolerance for the status quo is diminishing rapidly, making change a foregone conclusion. But perhaps the most significant turn of events, which may have been only peripherally noticed by some domestic healthcare products manufacturers prior to 2007, occurred when a global, long–established, standards–driven and non–profit product marking movement by the name of GS1 turned its sights for the first time on the healthcare supply chain.
