For the third year running, the supply-chain standards organization GS1 Healthcare US held a small roundtable discussion dinner for media, healthcare supply-chain professionals and suppliers during the annual Association for Healthcare Resource & Materials Management conference. This year's event occurred on the second evening of AHRMM's four-day conference, held this month in Denver.
Reporter's notebook: Tracking at a crossroads
The discussion had me thinking about the ongoing effort to implement a universal tracking system. GS1 has been politicking for several years to become top dog in the medical-products tracking standards arena, but healthcare reform has created a new sense of urgency to close the deal among proponents of the standards. Additionally, more than a few of the proponents are concerned that federal regulators aren't moving fast enough to develop rules and guidance that will ensure that standards for tracking the use of medical devices and products are appropriately linked to electronic health-record systems and useful to healthcare providers and patients.
Joe Pleasant, senior vice president and chief information officer of the group purchasing organization Premier, said during the dinner that his organization has been pushing for Food and Drug Administration and HHS officials to get involved in the adoption of universal tracking standards so that providers, suppliers and health IT software developers can move forward on sure footing with standards implementation. According to Pleasant and others at the dinner, the electronic health records system will be incomplete and severely disadvantaged if doctors and patients don't have a system for tracking devices that are used on patients back to their manufacturing sources.
"The driving force for us is the safety of patients and also the ability to be able to inform the clinician on the performance of devices and drugs," Pleasant said. Supporters of supply-chain standards have been promoting to David Blumenthal, national coordinator for health information technology for HHS, the importance of incorporating supply-chain tracking information into the rollout of health IT activity, he added.
Mary Beth Lang, senior vice president of business intelligence for the GPO Amerinet, echoed Pleasant's sentiment about the need for a push from federal officials in the adoption of universal tracking standards. Until such a nudge comes, Lang says, software developers are going to be hard-pressed to invest money in designing new systems that enable the use of certain types of product identification and tracking standards. "It's much easier to justify the financial resources when there's a government mandate,” Lang said.
Still, even in the face of a letter-writing campaign, which has found some GPOs, suppliers and other stakeholders supporting the adoption of GS1 standards, the FDA and other federal agencies have been reluctant to endorse a specific organization's standards. They point out—correctly—that GS1 is not the only healthcare supply-chain standards group and say that it is ultimately the industry's responsibility to adopt a single standard or choose multiple standards that are capable of working together to track products throughout the supply chain.
Such arguments suggest the healthcare industry is at an interesting and precarious juncture when it comes to navigating the roles of private and public entities in the shaping of a new and, one hopes, improved healthcare system. It will certainly be interesting to see next year whether and how supply-chain officials address that conundrum.
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