SPECIAL FOCUS
filiated with larger organizations have just begun their journey with standards and that there is opportunity for more education on patient safety and efficiency on this issue, which can be more complex for this space. “Like manufacturers, healthcare provider
use of data standards runs the gamut from ‘A’ to ‘Incomplete,’” Black indicated. “The ‘A’ grades go to [those organizations] that are either in the process of implementing now or are investing in system changes at this time. There are a number of IDNs that are actively modifying their enter- prise resource planning (ERP), materials management information systems (MMIS), warehouse management systems (WMS), electronic health record (EHR) or other sys- tems to leverage the wealth of data available through data standards. I expect that com- pliant software will help them to turn the ‘Incompletes’ into value-added processes.” Joe Pleasant, former Vice President and
CIO, Premier Inc., who recently retired after 41 years with the organization but continues to serve in a consulting role, reflected somewhat favorably and fondly on industry progresss. “[I’m] not sure providing
Joe Pleasant
a grade at this point is use- ful since most all supply chain participants have been waiting for the final FDA ruling before starting their adoption and imple- mentation,” Pleasant said.
“Thus, given that most participants have taken a wait-to-see-the-FDA-rule position I would provide a grade of ‘C’ in actual adoption and implementation. “There are several large manufacturers
that made a decision to move forward with adoption and implementation prior to the final ruling, and these front runners are establishing the path for others and will be ahead of the field,” he continued. “I also believe they will achieve the benefits before others. If we look at involvement by the participants in assisting and pushing FDA toward the rule and the specifics associated with the [Global Unique Device Identifica- tion Database] (GUDID) system I would give provider and supplier participants an ‘A.’ There are many industry groups that have provided FDA excellent input and served as pilots to test the specifics of the FDA requirements in the final ruling.” Every hospital in America will implement
the UDI, Byer noted, but they struggle with competing priorities. “The hospitals face an enormous amount of obstacles, including funding, availability of resources and the absence of software that supports the UDI,” he said. “Many hospitals are so overloaded
with information and new requirements that they don’t know where to start. There are only a small percentage of hospitals who can afford to implement both the electronic health record and the UDI at the same time. Unless a hospital has the resources and the funding, full implementation of the UDI and realizing the benefits of the rule could take a decade or more. “The discussions in the press and in indus- try group meetings typically focus on the
cost of the UDI and the impact to medical device manufacturers, the stifling of inno- vation and the loss of jobs. There has to be more focus on the patients, the group that is ultimately going to pay for all of this and who will be most impacted,” he insisted. HPN
For the sidebars, “2013 GS1 Healthcare US highlights” and “What does GS1 Health- care US say?” visit
www.hpnonline.com/ inside/2014-03/
1403-SF-DataStandards.html.
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