Part II: The Discrepancies in the GUDID Causing Concern Among Clinicians, the Supply Chain, and the FDA
Some of the parties involved include the AHRMM LUC (Association for Healthcare Resource Materials Managers) (Learning UDI Committee) and the FDA.
In 2016 AHRMM/FDA created the Learning UDI Community (www.ahrmm.org/luc) to bring together all users of the UDI. This included the NIH, AORN, IAHCSMM, AHA, AMA, registries, physicians, clinicians, researchers, data miners, and anyone who was interested in supporting the adoption of the UDI.
The GUDID is a great tool that we should all get accustomed to using. The development of the tool incorporated suggestions of manufacturers, FDA, healthcare providers, IT, and many individuals. The group worked diligently to create a flawless database. What they found by using the GUDID was how missing information may limit the use of the data to its fullest extent. In order to make changes to the required data in the GUDID, the request would require a change to the Regulation, thus approval by Congress. The Learning UDI Committee (LUC) is working together to determine what changes need to be made and why. Then they can request, as a community, that the GUDID be populated with additional information.
The team formed workgroups to address specific concerns and develop tools or protocols, case studies, any supporting information for the adoption of the UDI. Here are a few examples:
Supply Chain uses the catalog number as the identifier to match/interface to the ordering information systems such as People Soft, Lawson, etc., and clinical systems such as Cerner, EPIC, Interventional Radiology, etc. The catalog number is not a required field in the GUDID, so many of the manufacturers did not enter this information. As previously mentioned, the data from the GUDID can be pulled into a spreadsheet to be used to update the Item Master – all of the products being purchased that are on contract. The catalog number would have been the connecting information between the items master and the GUDID data. As that information was missing for most products, it was extremely difficult and time-intensive to match the data.
Clinically Relevant Size
This workgroup was led by physicians because this information impacts their ability to understand the size of a product. Often the size information exceeds the number of characters allowed for in the item master and clinical documentation, and is therefore missing. The physicians need not only the outside diameter but the inside diameter and the thickness of the product, in addition to the length and incremental lengths. The manufacturers may have provided some of this information but not all, often due to limitations in the size of the field to be populated. The workgroup studied the issues and developed a plan to present to stakeholders: manufacturers, software providers, the government, and others to provide the option to obtain all of the size information about a product.
This group was also led by physicians. If you consider the overall category of orthopedic implants, you will find multiple subcategories: hip, knee, ankle, shoulder, trauma, and spine. Cardiac products may also be divided into multiple subcategories.
Today, there are multiple categorizations in use. Group Purchasing Organizations (GPO) have their categories. Another, the UNSCPSC (United Nations Standard Products and Services Code), is used by many hospitals to categorize the products. This is just an example of the many that are in use.
The FDA partnered with a company GMDN (Global Medical Device Nomenclature) for all manufacturers to utilize their categories and descriptions. Then there is SNOMEDCT (Systematized Nomenclature of Medicine – Clinical Terms) used by the National Institute of Medicine which is the most comprehensive clinical healthcare terminology in the world and is expected to be used in electronic health records. The GMDN and SNOMEDCT are not a direct match, requiring linkage tables to translate and connect the two. As the FDA requires the manufacturers to use the GMDN, healthcare providers should consider the use of the GMDN/SNOMEDCT as well, for consistency.
The FDA wrote into the regulation that high-risk implants would be identified as such, and patient medical records would contain this information. After months of discussions with manufacturers, clinicians, and physicians, AORN formed a task force. which concluded that getting all to agree on the definition of a critical implant is not possible. The FDA definition of an implantable device is anything that stays in the body for longer than 30 days, which would include sutures.
Multiple Device Identifiers
As manufacturers are working to update their systems and labels to meet the FDA requirements, they have a problem with products having labels with more than one identifier/barcode. The clinicians do not know which one to scan. There is a gap between what the manufacturers need to accomplish, and what the clinicians need to capture the information. Bridging this gap is essential to the successful use of the UDI. There was a lot of discussion on how to mitigate the issue as the transition occurs so that the manufacturers understood the implication for the clinicians, and everyone was committed to the need to complete the labeling transition as soon as possible.
One of the roadblocks to adoption was the need for funding to update multiple systems, and purchase bar code scanners, printers, software, and hardware. The first question asked was: “How much will this cost?” The response that this is a patient safety issue that needs to be implemented doesn’t answer the question. With that reality, this workgroup developed methods to determine the costs to implement capturing of the UDI. Each facility is going to be different, based on the systems already in place and the need to update; the hardware in use or needed to be purchased; time, and resources.
How is the information communicated from the manufacturer to the healthcare user? The Charter goals for this workgroup are to:
- “Analyze current communication processes and their implications on all stakeholders related to changes to the UDI-DI”
- “Gain a clear understanding how these changes are documented in affected software systems”
- “Identify gaps between current and desired state and develop recommended practices to improve the process for all stakeholders”
As stated above, the changes to the label include changes to the GUDID. There is no trigger to a healthcare provider that updates have been made to the GUDID. From the time a product is manufactured to the time it is in the clinician’s hand ranges from 10 days to 4 months. Timing of the changes, as well as the communication are crucial.
This is one critical topic as we realize how many patients may have been harmed by a product that has been recalled, because no one knew who the product was used on. Scanning devices to a patient will tell us what recalled devices were used on which patients. However, until we scan this information into the patient’s medical record, patients may still suffer needlessly.
There are many registries that are eager to capture this information. One is the Vascular Quality Initiative; another, the American Academy of Orthopedic Surgeons. Here is an example of the importance of these registries:
A patient has a total hip replacement in Tampa. Ten years later on a Sunday morning, she is traveling in Boston and has an issue requiring a revision to her hip. Does she have her card with her that states what type of implant(s) she has and its serial number? Likely not. How does the hospital in Boston determine what device is needed to complete the revision? Who calls the hospital in Tampa to ask for information? If this is not a 24-hour 365-day facility, there may not be anyone in medical records or the OR to look for the information. Therefore, the physician orders three types of devices. SPD has to sterilize trays of instruments and implantables in order for the physician to have what is needed when the patient is on the operating table. In our best-case scenario, the clinician signs in to the registry look for this patient, and finds the type of device used in the original procedure. An order is placed for the one device and applicable instrumentation, creating much less work and less cost for all. The patient is not left suffering for extended periods of time without that information.
Barcode scanning began in the 1970s in grocery stores. It took years to achieve a solid dependable baseline with ongoing process improvement. It is the purpose of this article is to help you understand the importance of the UDI to patient safety. Healthcare is slow to adopt, so it may take some time unless you and others in your organization are able to convince senior management of the many reasons for the adoption of the UDI.
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