HTG gets to the point (of care)

The Healthcare Transformation Group, formed in 2010 by Geisinger Health System, Intermountain Healthcare, Kaiser Permanente, Mayo Clinic, and Mercy, held its 8th annual summit in September. In addition to the founding members, the summit was attended by several other healthcare systems, along with manufacturers, distributors, technology companies, GS1 US, and the Food and Drug Administration (FDA). The two-day agenda was packed with updates by hospitals, manufacturers and the FDA on a wide variety of topics, but many of the conversations came back to a fundamental need — the ability of hospitals to be able to capture data on the products used at the point of care. Joe Drozda, MD, who leads outcomes research at Mercy, described just a few of the things that would be possible with unique device identifiers (UDIs) to capture data on products used on specific patients. These include (but are not limited to) the ability to better design care for individual patients and those with similar healthcare profiles, automating replenishment, and providing applications for patients to better understand and report on their experiences with particular medical devices.

One of the challenges is the ability of providers to successfully scan product barcodes. In some cases, there are multiple barcodes on the same product package, and nurses (who are often responsible for recording product usage) do not always know which one to scan. If they try scanning and are unsuccessful, they may move on to other tasks required in the course of patient care. In other cases, the nurse may scan the right barcode but still not be able to capture the data needed. There could be multiple reasons, including but not limited to: the scanner unable to read the barcode format, the scanner not properly programmed, or the barcode itself is not scannable or does not yield the required information. All of these issues assume hospitals have scanning capability at the point of care, while many still do not.

Karen Dean, supply chain operations program director for Kaiser Permanente, co-leads the HTG’s Point of Use and Consumption workgroup, which conducted a study to quantify the level of scan failures and seek the root cause. Between February and July of this year, they attempted more than 10,000 scans, nearly one third of which were unsuccessful. One of the primary reasons for the unsuccessful scans is that the product scanned was not found in the FDA’s Global UDI Database (GUDID) or the product information was not presented in the way the hospitals expected. Under the FDA’s UDI regulation, manufacturers must provide data on their products in the GUDID, while hospitals must share the UDIs for their patients’ implantable devices and electronic health record technology needs to hold specified data from the GUDID for those implanted devices.

The FDA, working with the National Library of Medicine, has developed application programming interfaces (APIs) that make it easier for hospitals and others to pull data from the GUDID. But as Dean reported at the HTG meeting, hospitals will likely still need crosswalks to map the GUDID data to their specific manufacturers and for the products they want to load into their item masters. The bigger issue is making sure the data in the GUDID provided by manufacturers is both usable and relevant for providers.

The value of meetings like the HTG Summit is the ability for providers, manufacturers and others to better understand each other’s needs and associated challenges. For example, Dean says many manufacturers do not have well-established processes or functions to handle UDI-related questions from their customers. BD, which has tried to comply with the UDI regulation in a manner that makes it easier for customers to do business with the company, has suggested providers communicate these challenges directly to manufacturers. Dean says when they tried, the manufacturer thought the problem was a defective product and not a barcode scanning issue. This is a good example of why successful implementation and use of the UDIs and related information requires process and systems changes by multiple parties.

At the meeting, the FDA outlined steps it has taken to make it easier for manufacturers to update data on their products in the GUDID and for providers and other users of the data to track when changes are made. In some cases, manufacturers have published data to the GUDID in a manner that is compliant with the regulation but not necessarily to the extent that providers need. For example, the catalog number field is optional under the UDI regulation, but providers have expressed the need to be able to link the proprietary numbers with the standardized device identifiers in the GUDID. Some manufacturers are responding by adding this data field, even though it is not required.

One of the most rewarding aspects of the HTG meeting was the spirit of cooperation and collaboration among the parties, even when there was disagreement on a particular topic. The final hours of the Summit were focused on how to further support such collaboration, specifically through future HTG workstreams and in conjunction with other groups like the AHRMM Learning UDI Community. We will continue to monitor the work of these groups and that of the other organizations attending the summit and report on their progress in future issues of Standard Practices.