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communication with the FDA, Centers of Disease Control and Prevention (CDC), Centers for Medicare & Medicaid Service (CMS) and other industry organizations. On Sept. 24, 2013, the FDA issued its UDI System Fi-


nal Rule that outlines key compliance dates. T e labels and packages of implantable, life-supporting and life-sustaining devices must bear a UDI no later than Sept. 24, 2015. Other medical devices have subsequent compliance dates based upon their FDA classifi cation. All medical devices, regardless of classifi cation, must bear a UDI no later than Sept. 24, 2020. With these new rules in place, the opportunity to gather,


analyze, synthesize and share tremendous amounts of critical data is staggering. But who can eff ectively perform these tasks? T at’s right: the supply chain. It all sounds simple and logical, however, after speaking


with various members in the fi eld, it’s obvious that, much like with the upcoming mandate relative to ICD-10, the healthcare industry is not ready for the full impacts of UDI/ GUDID. T at’s not to say that most do not see the value in an organized eff ort to identify medical devices, or how such a system can cultivate new policies and practices at every level of the industry. T e problem is that few can work past the silo mentality that dominates so many in healthcare, or countless other sectors for that matter. Many feel the results of their eff orts to harness any new data while trying to implement the UDI/GUDID rules would be similar in nature to their attempts to push back the ocean with a broom. Ray Cooper and I had many follow-up conversations about the power of the supply chain. From his perspective, when it comes to achieving collaboration and standardiza- tion within an industry, the supply should take the lead and everyone else should “keep their mouths shut until they can all speak the same language.” He saw the benefi t of this philosophy during the 1980s when the International Electrotechnical Commission (IEC) adopted Compact Disc Digital Audio (CDDA) as the standard for all compact discs. Prior to the adoption of CDDA, the music industry was earning huge profi ts from their latest replacement for the vinyl record format: the cassette tape. When the compact disc fi rst entered the market, the industry violently rejected it as being unnecessary, expensive and logistically problematic for its distribution, marketing and sales eff orts. However, being well positioned within the industry, the supply chain was able to gather real, not perceived, new data needed to assist artists, distributors, promoters, administrators, store owners, press, etc. Unlike with cassettes, with the new CDDA audio and


identifi cation standards in place, the supply chain was more easily able to source and retrieve information at every location a compact disc “lived.” New insights were gained by track- ing the compact disc within manufacturing plants, trucking routes, warehouses, sales fl oors, display cases, concert facili- ties, press kits, promotional giveaways, etc. T e supply chain


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leveraged their fi ndings to create new models of business within each of these areas, and not just for themselves, but for their working partners as well. Had it not been for the music business supply chain’s enormous infl uence over other areas of the industry, infl uence that was earned from over 40 years of constant interactions with most every constituent in the business, the compact disc would have gone the way of the LaserDisc of the 1970s. Instead, manufacturers, distributors, promoters, store owners, venue owners, sponsors, artists and executives incorporated the supply chain’s lessons into their own processes, and the industry went on to generate record profi ts for nearly 20 years. (It was not until the consumeriza- tion of the Internet and the entertainment executives’ failure to accept that the new digital formats required modifi cations to their practices, modifi cations that the supply chain recom- mended but were ignored, that the compact disc began to lose its power as a viable product.) I know, on the surface, my comparison of the music indus-


try supply chain’s infl uence on the success of the compact disc with that of the healthcare supply chain and the mandated move toward UDI/GUDID may seem like a bit of a stretch in logic. But if you look deeper, the connections are rooted in the same basic principle: the backbone of any industry is its supply chain. To prove my point, let’s examine some of the impacts UDI/GUDID is meant to achieve relative to how medical devices are to be handled in the future. In terms of post-market surveillance, UDI/GUDID will


provide a standard for data entry into clinical registries which, in turn, will provide better, more complete information needed during adverse event reporting. On a similar note, it will establish standard device identifi ers in data sets used for research. It will also serve as a means to link data on medical devices between FDA data systems. T e new data opportunities in this stage of life for a medi- cal device are important to consider, but they are in a poor position to be used to make comprehensive evaluations and recommendations for other parts of the industry. T at’s not to say that post-market surveillance issues do not impact clinical care or the supply chain, it’s just that they are limited in their capacity to develop far-reaching improvements outside their own sphere of operations. In terms of clinical care, UDI/GUDID will create stan-


dards to facilitate medical device use at the point of care, such as at a patient’s bedside, in an operating room or cath- eterization laboratory. It will create a standard to document medical devices used on, or implanted in, a patient and, in turn, it will facilitate recalls. T e new data generated from tracking UDIs in this area will undoubtedly impact the quality of care and health costs in positive manners. It should also improve post-market surveillance and supply chain practices. However, given the heterogonous nature of healthcare organizations, it will be very diffi cult to create new, uniform practices that will


HEALTH MANAGEMENT TECHNOLOGY April 2014 15


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