As I have written on numerous occasions, we can expect the FDA to issue its final rule on unique device identification later this year. To comply with the rule, manufacturers of medical products will need to assign a unique code provided by one of the authorized issuing agencies that comply with the ISO 15459 series of standards. We have offered each of those agencies an opportunity to discuss how their standards can help manufacturers comply with the pending regulation.
The first guest blog is from Siobhan O’Bara with GS1 US.
Contamination of consumer products and their subsequent and successful recall efforts can provide valuable lessons on safety and integrity for the healthcare supply chain. Last fall’s recall of dog food (Sept. 2012), down to the product code, and the fall 2011 voluntary recall on a specific peanut butter brand, serve as a real-life examples of the importance of synchronized data. Because of the product information manufacturers and retailers were able to access, they were able to take action quickly so that consumers across America (and their pets) could be protected. Every time I prepare PB&J [and feed my pets], I think about how efficient these recalls were compared to those that take place for healthcare products.
In the healthcare setting, tracking a recalled medical device throughout our supply chain could take weeks. As an industry, we know that using product and location data standards can greatly increase patient safety by improving our ability to follow a product through manufacture to use, and with the recent release of the draft UDI regulation, it’s clear that the FDA agrees.
Having the ability to identify and locate a specific product after it leaves the manufacturing plant is paramount to patient safety. As supply chain practitioners, we focus a lot of our time and energy on many activities involved in four materials management processes that drive efficiency and cost-savings in the supply chain, including the order-to-cash cycle, account-to-report, procure-to-pay, and managing demand to inventory. I would venture we now have a FIFTH process we must focus on, one that is even more directly tied into patient care – “product to patient.” The fifth process completes the cycle of data as it brings consumer information into the supply chain by capturing product information in the patient record, which important during and post-care. These processes benefit from clean, accurate master data and the use of consistent, global standards in the business process.
The GS1 Global Trade Item Number® (GTIN®) is one of the tools suppliers and providers are using to enable the supply chain to follow the product from manufacture, through distribution and ultimately, to use on the patient in the clinical care setting. The Global Location Number (GLN) is used to uniquely and consistently identify a delivery location, so that St. Mary’s in one city is not confused with St. Mary’s in another city. The Global Data Synchronization Network™ (GDSN®) provides a centralized source for sharing healthcare data so that all constituents will have access to the same, uniform set of product information. Together, these standards provide the capability needed to streamline many of the communications processes that take place in the day in and day out of the supply chain.
The industry has been working for several years to establish a way to use current, accurate product and location data in our supply chain to not only drive efficiency improvements and reduce costs, but as a means to ensure the safety of those who put their care in the hands of our healthcare system. Focusing on the “product to patient” cycle makes it clear how important and necessary data standards are to ensure the right product gets to the right place at the right time, every time. Linking this information to the patient record (the EHR or the EMR) can establish an historical reference for the patient and also for post-care events that may occur. This is especially important in the event of a recall, so that the industry has a way to link a particular product to a specific universe of patients.
This product-to-patient cycle improves the ability to effect or support any recall effort – so that products can be tracked and traced down to the patient-use level like in other industries.
Now, with the FDA’s proposed UDI regulation, there is a catalyst for marrying standards to patient safety. There is no valid reason for the healthcare industry to not take action. GS1 standards can support product-to-patient and other processes. It’s no longer a question of “if” or even “when” it should happen – the time is now.