This book includes a plain text version that is designed for high accessibility. To use this version please follow this link.
● Tactical Operations Facing the music

Why the supply chain must take the lead with UDI/GUDID. By Jason Free, Features Editor


n 2007, I was asked to serve as a lead facilita- tor at T e Global Forum at Canadian Music Week, an invitation-only event designed to explore the current and future landscape of

the international music industry. At the time, music executives felt powerless to

act as the reach of the Internet, the mp3 and digital piracy were growing at seemingly exponential rates. Within this hostile environment, they were treading water in a tsunami of new data. T ey had no idea how to survive the crushing wave of information. T e idea of having your wits and resources directed at studying the situation with the hopes of developing a predictive tool for future best practices seemed impossible. Does this sound familiar to anyone in healthcare? A month or so after Canadian Music Week, I shared an el-

evator with Ray Cooper, former President of Virgin Records. He had worked at a separate discussion table for the confer- ence, and I asked him about his impressions of the event. “T ey just don’t get it, Jason,” he said. A bell rang, and the doors opened. “It isn’t technology that dictates our future,” he said as

he exited. I remained in the elevator to continue the ride to the

lobby. He turned back to speak to me with his hand hold- ing the door. “It’s the supply chain,” he said in a tone as if he were stat- ing the punch line to a joke. “No matter what comes your way, respect what the supply chain has to say, and you’ll be fi ne. We haven’t done that for a while now, and we are pay- ing the price for it.” Before I could ask him to elaborate, a woman politely tapped Cooper’s shoulder, hoping to enter the elevator. He held the door just long enough for her to enter, and we quickly agreed to speak again just before the doors closed and my ride continued. Fast forward to the HIMSS14 preconference symposium entitled, “Linking Technology and Supply Chain: Cost, Qual- ity and Outcomes,” where the speakers and attendees dis-

14 April 2014

cussed how the supply

chain data can help healthcare organizations give higher quality care at lower costs. T ey were very passionate about moving directly forward into the numerous, eminent sea changes facing the industry. (T ey were so passionate that most of the symposium attendees met again for a 7 am breakfast two days later for another round of dialogue and debate). One major point of discussion involved unique device identifi cation (UDI). As part of the Food and Drug Administration (FDA) Act of 2007, the UDI system requires a unique identifi er for medical devices in the United States. Under this rule, medical devices will be required to have certain information clearly listed on their labels and packaging. Some of the informa- tion required includes the device’s manufacturer and model, production lot number, serial number, expiration data and date of manufacture. In addition to new label and packag- ing requirements, the FDA also called for the creation of the Global Unique Device Identifi cation Database (GUDID) that will contain a standard set of basic identifying elements for each device with a UDI. T e basic intent of this rule, along with additional rules such as the FDA Safety and Innovation Act of 2012, is to re- duce obstacles to the identifi cation of medical devices used in the United States. T e system is also aimed at reducing medi- cal errors, simplifying device information in data systems, hastening reports relative to adverse events and facilitating


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28