The Healthcare Hub
One month and counting: Some UDI resources you may have missed
-
Karen Conway, Vice President, Healthcare Value
Sunday, August 24, 2014
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.
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.
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, 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:
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
· March 2014: Making UDIs Meaningful: It’s More than Just Talk
· February 2014: The FDA UDI Database – A Good Idea for Good IDs
· January 2014: UDI at the Intersection of Cost, Quality, and Outcomes
· November 2013: UDI: The Big Picture
· October 2013: What’s Behind a Bar Code?
· September 2013: An Unstandard Standard Transition
· July 2013: Putting Auto ID technology to work in healthcare
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
MassDevice, FDA drops long-awaited Unique Device Identifier proposal, July 2012
DotMed News, UDI Compliance is Just Around the Corner, February 2014
DOTMed News, Get Ready: UDI rule could affect providers, too, July 2012
FierceHealthIT, FDA issues proposed rule for unique device identifiers, July 2012
Becker’s ASC Review, 8 Ways the FDA Unique Device Identifier System Will Impact Surgery Centers, July 2012
MedCity News, FDA’s unique device identifier proposal can have benefits beyond patient safety, July 2012
Blog Posts
February 25, 2014: Anyone for a game of connect the dots? WSJ, FDA and ONC
February 22, 2014: What a Difference a Decade Makes: Supply Chain Technology Drives EHR Vision
September 20, 2013: “Soon” is Soon Enough for UDI Conference, but Too Soon for Some Manufacturers
September 14, 2013: UDI and Health IT: Getting Closer?
June 22, 2013: Healthcare Data Standards Need a Matchmaker
March 11, 2013: UDI: the Human Standard
January 28, 2013: Pet Food, Peanut Butter and Patient Safety
December 7, 2012: For Cook, Standards Just Make Sense
November 19, 2012: UDI Update: Comment Now on Devices on Accelerated Compliance Schedule
September 27, 2012: Europe moves forward on Unique Device Identification, and then some
September 19, 2012: Down to Details at the UDI Conference
September 7, 2012: FDA Approach to Strengthening Post Market Surveillance - Value of Shared Data, Shared Technology
August 2, 2012: UDI: Can Healthcare Get it Together?
July 17, 2012: Getting Ready for UDI: What’s a Provider to Do?
July 12, 2012: When It Comes to UDI, Suppliers Need a Champion
July 11, 2012: Getting Ready for UDI: The Clock is Ticking
July 6, 2012: Getting Ready for UDI: What Suppliers and Providers Need to Know (Part 2)
July 3, 2012: BREAKING NEWS: The Proposed UDI Rule is Out!
July 2, 2012: Getting Ready for UDI: What Suppliers and Providers Need to Know (Part 1)
June 25, 2012: Lawmakers put UDI on a deadline
February 24, 2012: UDI: Not Meaningful Yet
Healthcare Matters
July 12, 2012: More on FDA’s UDI Ruling: Timetable for Action Getting Set.
July 5, 2012: Embracing FDA UDI Ruling as a Strategic Opportunity
SearchHealthIT
Karen Conway
Vice President, Healthcare Value
categories:
Categories
Subscribe