Somewhere between those courses, I assembled a few salient observations about the ongoing effort to implement a universal tracking system. First off, while GS1 has been politicking for several years to become top dog in the medical-products tracking standards arena, healthcare reform has created a sense of urgency to close the deal among proponents of the standards. Second, more than a few of those proponents are concerned that federal regulators aren't moving fast enough to develop rules and guidance that will ensure product-tracking standards are appropriately linked to electronic health records and useful to healthcare providers and patients.
Joe Pleasant, vice president and chief information officer of the group purchasing organization Premier, said during the dinner that his organization has been pushing for the involvement of Food and Drug Administration and HHS officials in the adoption of universal tracking standards so that providers, suppliers and health IT software developers can move forward on sure footing with 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. According to Pleasant, supply chain standards advocates have been promoting to David Blumenthal, national coordinator of health information technology for HHS, the importance of incorporating supply-chain tracking information into the rollout of health IT activity.
Mary Beth Lang, senior vice president of business intelligence for the GPO Amerinet, echoed Pleasant's concern about a needed 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 press to invest money in designing new systems that enable the use of certain types 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 certain 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 correctly point out that GS1 is not the only healthcare supply-chain standards group and say that it ultimately is 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 hopefully improved, healthcare system. It will certainly be interesting to hear next year whether and how supply chain officials have addressed that conundrum.
Reporter Shawn Rhea, based in New York, covers health technology issues.