The proposed FDA UDI rule requires the use of human readable and at least one AIDC technology to carry the new standardized identifier on all non-exempt devices and/or their packages. An AIDC technology is a way of Continue reading FDA Proposed UDI: AIDC Requirements→
Like so many others, I had been patiently awaiting the publication of the U.S. Food and Drug Administration’s (FDA’s) Unique Device Identification (UDI) proposed rules. Now that they are out I’ve been studying them and I think I will have enough to say about them that I will cover the topic in a multi-part series. Today I want to look at just one of the differences between the FDA’s proposed UDI rule for medical devices and their National Drug Code (NDC), the pharmaceutical unique identifier. The NDC structure was first conceived by the FDA back in 1969. For more about the history of the NDC see my essay “Anatomy Of The National Drug Code”.
The FDA is co-sponsoring an important two-day conference in Orlando on September 18th and 19th, 2012 that will cover their plans for medical device Unique Device Identification (UDI). Today is the last day to get their early-bird registration rate of $695 so act fast.
But I know a way to get another $100 off of the early, the advance and the standard registration fees. When you register, simply put the letters “RX” in the “Promotional Code” field of the registration form. That lets them know that you are a special RxTrace reader and deserve to pay less. Remember, it works on all registration levels.
The published guidance is not radically different from the draft guidance that the agency published under the same name in January of 2009. In fact, in my view, the only really important difference is how the Continue reading FDA Aligns with GS1 SGTIN For SNDC→
In April of last year VHA, a nationwide network of community-owned health care systems, published a viewpoint essay on their website called “The Track to Improving Health Care will be Built with IT Standards”. The posting was written by Mike Cummins, Chief Information Officer of VHA, Inc. In it, he draws a great analogy between the widespread adoption of a standard railroad gauge by railroad companies 150 years ago as part of the U.S. Transcontinental Railway (as set in motion by President Abraham Lincoln), and the potential benefits of widespread adoption of health care IT standards. Mike points out that some historians believe that the nationwide adoption of a single railway gauge accelerated the evolution of the greatness of the United States. It’s well worth reading.
I think the problem Mike sees is that there are so many incompatible IT standards in use in the healthcare industry, with different ones in use in different pockets of the industry. There are too many proprietary approaches in use, and too many standards in use in one segment of the industry that are incompatible with similar standards in use in another. In effect, it’s a patchwork, yet each user can claim to be using a standard. This was exactly the case with the railroads 150 years ago as Mike’s analogy implies. Each railroad company, or groups of companies, had their favorite “standard” gauge, but which standard was “the best”…the one worthy of becoming the national standard? I don’t know, but I do know they eventually figured it out and settled on a single gauge for the Transcontinental Railroad and that gauge become the defacto standard. That allowed the country to be connected and, as Mike points out, historians have dawn a direct line from that agreement to economic expansion and eventual greatness.
Mike makes several proposals that I interpret as ways to cut through the patchwork of standards and get the industry to settle, like the railroad companies, on a single standard for some key technologies like Electronic Medical Records (EMR), Health Identification Numbers and Personal Health Records (PHR). He calls for the broad, mandatory adoption of GS1barcodes, Global Location Numbers (GLN), Global Trade Item Numbers (GTIN) and accelerated plans by the FDA to mandate the usage of Unique Device Identification (UDI). He calls for the use of part of the federal economic stimulus money to be used for standards development. Continue reading “Why the rush for GS1 standards?”→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.