One month and counting: Some UDI resources you may have missed | GHX

Karen Conway

Executive Director, Industry Relations
Sunday, August 24, 2014

One month and counting: Some UDI resources you may have missed

Today, we are just one month away from the first official US FDA UDI deadline:  September, 24, 2014. That's when manufacturers of Class III devices must be in compliance with the US FDA rule. Over the years, GHX has been providing assistance to manufacturers to prepare for and now comply with the rule, not to mention making recommendations to hospitals and healthcare systems that ultimately must use the unique identifiers to achieve the vision of UDI.  Below, I have posted a link to many of those blog posts, videos and articles.  You can also find more at www.ghx.com/udi.  

Today, we are just one month away from the first official US FDA UDI deadline:  September, 24, 2014. That's when manufacturers of Class III devices must be in compliance with the US FDA rule. Over the years, GHX has been providing assistance to manufacturers to prepare for and now comply with the rule, not to mention making recommendations to hospitals and healthcare systems that ultimately must use the unique identifiers to achieve the vision of UDI.  Below, I have posted a link to many of those blog posts, videos and articles.  You can also find more at www.ghx.com/udi
Just last week, GHX successfully completed submission of Class III product data to the FDA’s Global UDI Database (GUDID). We leveraged our relationship with PTC to submit the data in the required Health Level 7 Structured Product Label format to the GUDID.
As we discussed in depth on last month’s GHX Global Data Standards Users Group call, regulatory data submissions present some unique challenges, which we have successfully overcome by:
1)       Ensuring the data (both device identifiers and attributes) met FDA  specifications
2)       Submitting the data to a staging environment to verify the data (and catch some    formatting issues upfront)
3)       Submitting the data to a test server at the FDA
4)       Addressing issues identified by the FDA
5)       Submitting the validated data to the FDA GUDID. 
Last month’s call also highlighted the added complexities faced by manufacturers who are simultaneously trying to meet increasing demands from customers to provide UDI-like data through the Global Data Synchronization Network (GDSN).  There are some important differences between the attributes in the GUDID and the GDSN and how they are populated.   For those who may have missed the call, here is a link to the recording.  Also, check out this blog post from Medical Design Technology.
As promised, here is a link to many of the resources we have produced over the years for providers and manufacturers alike:
Video
Part One:  History and Purpose of the UDI Rule
Part Two: What Manufacturers Need to Know and Do
Part Three: How Manufacturers Can Prepare
Part Four: The FDA’s Vision for UDI
Articles
Healthcare Purchasing News Standard Practices Columns
·      July 2014:  Standards: Can You Handle It?
·       April 2014:  UDI:  It Takes a Village
·       November 2013: UDI: The Big Picture
·       October 2013: What’s Behind a Bar Code?
·       September 2013: An Unstandard Standard Transition
Medical Design Technology:  UDI:  A Non-Standardized Test for Manufacturers, August 2014
Medical Design Technology: Complying with Product Data Sharing Requirements Under UDI,, February 2014
Orthoworld/BoneZone:  UDI:  It’s All About the Data, March 2013
Orthoworld/BoneZone: UDI: From Compliance to Value, October 2012
DotMed News, UDI Compliance is Just Around the Corner, February 2014
Blog Posts
March 11, 2013:  UDI:  the Human Standard
February 24, 2012: UDI: Not Meaningful Yet
Healthcare Matters
SearchHealthIT

 

Follow:
*
Contributors