UDI Proposal Tacks on Standardized Dating
Published: September 25th, 2012
FDA’s proposed Unique Device Identification specifies more than just unique identifiers. It would also attempt to standardize date formats on medical device packaging and labeling, at least those intended for the U.S. market. The agency states “the rule would also contribute to improved identification of medical devices . . . by requiring dates on medical device labels to conform to a standard format. . . to ensure dates are unambiguous and clearly understood by device users.” FDA proposes that the date format be “Month Day, Year,” with the month shown as a three-letter abbreviation of the month (e.g., SEP 30, 2011). “This is the format most commonly used in the United States,” the agency writes.
The FDA-proposed format differs from ISO 8601-2004: Data elements and interchange formats—Information exchange—Representation of dates and times. This internationally accepted format expresses the year in four digits, the month in two digits, and the day in two digits (e.g., YYYY-MM-DD).
Medical device manufacturers and identification industry experts are questioning FDA’s approach. “It would make sense for FDA to attempt to lead standardization efforts to define a date format if an international standard didn’t already exist, but that is not the case. The ISO standard is already well adopted internationally,” says Peter Tomicki of Zimmer Holdings, Inc. Further, “manufacturers are attempting to drive efficiencies in the supply chain by creating labeling and packaging for multiple markets, leveraging internationally recognized standards such as ISO,” adds Tomicki. “Mutually exclusive requirements either impede this effort or add confusion, if both date formats are required for labeling and packaging. Education for those reading the printed dates or additional clarifications in line with the ISO standard, such as printing “YYYY-MM-DD” under the date, might arguably be effective in the United States and other markets where the ISO date format is less recognized.”
Adds George Wright IV, vice president, Product Identification & Processing Systems, (Port Chester, NY): “Quite simply, an all-numeric format eliminates language translation (and therefore potential multinational labeling) issues. The hyphenated YYYY-MM-DD format, which is explicitly called for in the ISO 8601 standard when the date is represented in plain text—and must be used when there is no day of the month given— should be readily recognized by caregivers and patients alike. It is the most universal and unambiguous. And it has the lowest implementation cost.”
Wright adds that “it is important to understand that the plain text date format does not have to be the same as either the date format encoded in an associated UDI bar code, for example, or the date format specified for the GUDID database. Of course they have to be equivalent; but not identical. Not everyone understands this distinction.”
FDA is considering international harmonization, but it only questions whether a different order—Day Month Year—would be more appropriate. The agency poses several date format related questions that stakeholders should address. Comments will be accepted through November 7.
Please visit www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdent....
»
- Login or register to post comments
-
- Email this page
Printer-friendly version
Seattle Seahawks cornerback
Seattle Seahawks cornerback Wholesale Snapback Hats Richard Sherman can shut down MLB Snapback Hats opposing wide receivers; however, opponents NFL Snapback Hats probably would rather he just shut up. Sherman NBA Snapback Hats and Washington Redskins left Obey Snapback Hats tackle Trent Williams got Ymcmb Snapback involved in a highly visible Beanie Hats kerfuffle after the Seahawks 24-14 road win. The NBA beanie Hats Seahawks corner later explained NFL beanie Hats the sequence that led to Supreme beanie Hats Williams' face push. "He came up NRL Snapback Hats and tapped me, 'What's up now? Supreme Snapback Hats I'll swing on you'," Sherman told USA Diamond Supply Co. Snapback Today Sports.
Sherman showed no fear The Hundreds Snapback Hats of the 6-foot-5, 325-pount lineman. "Swing!" he Philadelphia Eagles Snapback said provoking Williams New York Yankees Snapback in a daring tone. "He told Chicago Bulls Snapback me was going to swing, and he Miami Heat Snapback swung. That's what he did, and New York Knicks Snapback that's that. He thought I Oklahoma City Thunder Snapback was going to be scared. I'm not Orlando Magic Snapback scared." Williams later issued an Cleveland Browns Snapback apology.
Sherman said he was Dallas Cowboys Snapback just trying to shake Williams hand Denver Broncos Snapback after the game, but the post-scuffle Detroit Lions Snapback taunting is an example of just New England Patriots Snapback how skilled the cornerback New Orleans Saints Snapback has become at burrowing underneath Chicago Blackhawks Snapback Hats an adversary's skin. The 2013 NFL Detroit Red Wings Snapback Hats draft is a huge topic of Los Angeles Kings Snapback Hats discussion for the teams with Atlanta Braves Snapback nothing to play for in the Boston Red Sox Snapback postseason, but every organization Chicago White Sox Snapback is trying to find that first-round Los Angeles Dodgers Snapback sleeper pick that turns into a full-blown star.
Standard dating is most
Standard dating is most important concept and it will help to view easily on every medicine.I have seen most of the drugs with too less size of date.it is not making sense to check the expiry date.
copper jumper
Before a few day back,I have
Before a few day back,I have seen news about child dead because of expiry of medicine and mother did not know the information about expiry medicine so this is better way to display in that format.
web based hrms software
Quality articles is the
Quality articles is the important to attract the people to pay a visit the website, that�s what this web site is providing. Wintertime
Write more, thats all I have
Write more, thats all I have to say. Literally, it seems as though you relied on the video to make your point. You clearly know what youre talking about, why waste your intelligence on just posting videos to your blog when you could be giving us something enlightening to read?
tech herbs
technology
cresent technology
Thanks for sharing this
Thanks for sharing this information. I always search new and different blogs and your article is mind catching. www.justshoppingcenter.com
Hi! This is my first time
Hi! This is my first time viewing of http://www.questions4sure.com/70-458.htm your site! I appreciate your sharing, I always enjoy reading quality articles by an author who is obviously knowledgeable on their selected subject. Iâll be following this thread with great interest. I am liking your weblog, and am 70-458 questions a regular follower.
You need not be worried of
You need not be worried of your certification exams when you have an easy access to 70-465 exam We provide perfect guidelines for all your
70-465 practice test requirements.The variety of products offered by Killtests are designed and produced according to your real needs and
requirements. Hence they are the guarantee killtest 70-465 of a brilliant success in the minimum period of time.
We're a gaggle of volunteers
We're a gaggle of volunteers and starting a new scheme in our community. This is such a great resource that you are providing and you give it away for free. I love seeing blog that understand the value. Im glad to have found this post as its such an interesting one! I am always on the lookout for quality posts and articles so i suppose im lucky to have found this! I hope you will be adding more in the future...read more
Proposal for standardize
Proposal for standardize dating is eligible to maintain product information and expiry so easy to identify its end date.
pest spraying
I am really impressed by this
I am really impressed by this blog!Very clear explanation of issues is given and it is open to everyone.It contains true and fair information. Your website is very useful.
read more
Such decisions changed the
Such decisions changed the overall issues and also work with efficiency and maintain quality and rules.
Humidity temperature transmitter
his will helpful for every
his will helpful for every one reahis will helpful for every one read date and medicine eligible or nd date and medicine eligible or n limo service survey
the date is represented in
the date is represented in plain text—and must be used when there is no day of the month given— should be readily recognized by caregivers and patients alike. It is the most universal and unambiguous. And it has the lowest implementation cost.” black friday mattress deals
I am in the middle of working
I am in the middle of working on a school report on this topic and your post has helped me with the information I needed to complete it. ThanksFat Burning Furnace
Classic, sleek, and chic are
Classic, sleek, and chic are the right words to describe the elegant Michael Kors Sachtels. Even if you aren’t fashion forward, I would assume you would be instantly more interested in Kors and his line.michael kors outlet online
I love reading through your
I love reading through your blog, I wanted to leave a little comment to support you and wish you a good continuation. Wishing you the best of luck for all your blogging efforts.electric adjustable bed frame
packaging and labeling are
packaging and labeling are very important because it will show the expiration and manufacture date and the company name so it can quickly identified.
http://www.promos10.com
This will helpful for every
This will helpful for every one read date and medicine eligible or not..
http://www.moviebricks.blogspot.com