Medical Device Labeling: New ISO 15223-1 & FDA Guidance Recommend UDI Symbol Use
By Roger Peterson, manager of global labeling systems, Arthrex
When encountering multiple bar codes on a medical device label at the point of care, healthcare practitioners have historically found it to be challenging to rapidly identify and scan a bar code containing a medical device UDI (unique device identifier). It is often the case that when multiple bar codes are encountered on a medical device label, bar-coded data carriers will contain very different elements of information, both UDI and non-UDI.
Bar code scanning is one of the most crucial steps in capturing medical device UDI data to ensure that the core UDI-DI and UDI-PI attributes populate an electronic patient health record (ePHR). Accurate UDI scanning is equally important to ensure improvements in electronic medical device adverse event reporting, recall tracking, and efficient charge capture and billing.
The Association for Health Care Resource & Materials Management (AHRMM) Learning UDI Community (LUC) working group conducted a Point of Care survey in August 2018 with the Association of periOperative Registered Nurses (AORN) as well as a number of group purchasing organizations (GPOs) to garner a deeper understanding of issues related to point of care bar code scanning.
One of the many aspects of the survey regarding improving the point of use bar code scanning was the importance of quickly identifying the primary UDI within a bar code. The healthcare participants were asked whether it would be helpful for manufacturers to “identify” the primary UDI bar code by simply printing the word “UDI” next to the critical data carrier. The majority of respondents (86 percent) agreed that this would be extremely useful in quickly identifying the correct bar code at the point of use.
Illustrative example of a medical device label containing multiple bar codes.
The UDI Symbol In ISO 15223-1:2021
As a means to address the quandary of multiple bar codes appearing on a medical device label, the ISO committee responsible for medical device graphical symbol development (ISO Technical Committee 210 Working Group 3) initiated a strategy in 2019 to develop, validate, and implement a new UDI graphical symbol for the medical device industry, with the intended purpose of aiding healthcare practitioners to quickly identify which bar code or data carrier contains the required UDI information. ISO TC 210 WG 3 took the AHRMM survey results into consideration in its development and validation of the UDI graphical symbol. The validation effort was expansive, soliciting point of care practitioner feedback across multiple verticals within the medical device industry (e.g., orthopedic, cardiology, renal care, etc.) to garner a superior level of symbol comprehensibility. The UDI graphical symbol was officially published within the international standard ISO 15223-1 this past July. Of all the new medical device graphical symbols that were introduced as part of the recently published ISO 15223-1 fourth edition revision, the UDI symbol is intended to address the inherent usability shortcomings when a medical device label must bear multiple bar codes.
New ISO 15223-1 Fourth Edition Unique Device Identifier symbol.
As the newly published standard informatively reveals, the use of the graphical symbol is optional, but the various practitioner advocacy organizations are encouraging manufacturers to implement use of the UDI graphical symbol to identify the UDI information when multiple bar codes are present on a medical device label.
The informative Annex A of ISO 15223-1 provides some illustrative examples as to where it is best to place the new UDI symbol relative to the bar code containing the UDI information. These examples, in general, illustratively provide placement recommendations to the left of the bar code that contains a medical device UDI. In general, manufacturers should apply the new UDI graphical symbol to the left or upper left of the bar code symbol while considering minimum quiet space between the graphical and data carrier symbols.
Example of the UDI symbol applied to a linear bar code.
Example of the UDI symbol applied to a 2D DataMatrix bar code symbol.
The FDA’s Guidance Document On The UDI Symbol
Also to help encourage further consideration in using the newly published UDI symbol, the FDA recently issued the much-anticipated final guidance document: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI). The guidance details the FDA’s recommendations for the form and content of the UDI bar code that must appear on devices according to the now well-established UDI Rule. The guidance includes a prescriptive statement that in context explains that if the AIDC (automated information data capture) technology form used to convey the UDI is not immediately evident upon visual examination of the label or medical device package, the medical device label or package must disclose the presence of the AIDC (bar code) technology containing the UDI. The guidance further states that the FDA does not require a specific type of symbol to disclose the presence of AIDC technology containing the UDI that is otherwise not obvious upon visual examination by the end user. However, the guidance provides a recommendation that labelers consider using symbols that are internationally recognized via a standards development organization and that the use of such symbols is very much consistent with 21 CFR 801.15, Medical devices; prominence of required label statements; use of symbols in labeling. This being said, the newly published UDI graphical symbol contained within ISO 15223-1 is indeed internationally recognized.
Practitioner advocacy organizations encourage manufacturers to use the UDI graphical symbol when they cannot avoid including multiple bar codes on a medical device label that they provide. Ultimately, proper use of the UDI symbol reduces inherent risks associated with scanning incorrect information as well as greatly improving user efficiency while enhancing the overall customer experience with the respective medical device.
About The Author:
Roger Peterson, MSc, is manager of global labeling systems at Arthrex Incorporated. His expertise is in development, validation, and implementation of labeling for Class I, II, and III active and non-active medical device applications. He has led implementation of GS1/UDI standards commensurate with FDA compliance milestone dates and EUDAMED data exchange strategy planning. He is active in AAMI, ISO technical committee 210 Working Group 3: Graphic Symbols & Nomenclature, the MedTech Europe labeling ad hoc working group, and other industry groups.