Why standards for checking barcode quality are essential

A view from Martin Morrison, Managing Director, Axicon Auto ID Ltd

The use of automatic identification and data capture (AIDC) systems is only the starting point for an effective patient care management system, with an equally vital element being the use of electronic information about all the real-world entities that have been identified. GS1 summarises this approach as ‘identify, capture, share’, and it is one we support by enabling users to measure the quality of the linear or two-dimensional barcodes they are producing or scanning.

As the use of GS1 DataMatrix codes to mark pharmaceuticals, medical devices, patient wristbands, and documents increases, we have to find simple and straightforward ways of measuring the quality of these symbols, so that their production can be monitored and any errors corrected before they cause problems further on in the healthcare supply chain.

In the US, the FDA’s ruling on unique device identification (UDI) cannot be explained in any great detail here, but we see that direct part marking will be one area where the verification of symbols will be especially important. Any medical device intended for more than one use and intended to be reprocessed before each use will need to be marked with a unique identifier. These devices are intended to be used over a long period of time and they will inevitably be separated from their original labels or packaging. Each device will need its own device identifier that corresponds to its brand and version or model (in GS1 terms, a global trade item number or GTIN) and a production identifier that relates to each instance of the item (again in GS1 terms, a production date, an expiry date, a batch number and a serial number).

The FDA allows other issuing agencies as well as GS1 to provide unique UDIs, but the GS1 specification is as follows:

Example: (01) 05012345678900 (11)151231 (17)160707 (10)A213B1 (21)1234 Note: maximum symbol size is 76 alphanumeric characters

The other agencies are HIBCC (Health Industry Business Communications Council), and ICCBBA (International Council for Commonality in Blood Banking Automation) and all three systems for UDI are designed so that there will be no confusion between them.

In many healthcare settings, reusable medical devices, such as surgical instruments may be directly part marked locally, and scanned locally, so any problems with readability are rapidly detected and corrected, but as more of these devices are source-marked by the manufacturer it becomes more important to check that they will function as intended. There are two international approaches that should be followed, and if a verifier does not conform to ISO/IEC 15415 or the DPM Quality Guideline (ISO/IEC TR 29158) it will not be able to guarantee that GS1 DataMatrix symbols used for this marking will be readable. The first standard mentioned here also applies to any GS1 DataMatrix symbol used anywhere in the healthcare world, and this use of the ISO/IEC protocol means that any users can be reassured about the accuracy and reliability of the results of their tests.

The use of GS1 DataMatrix symbols to encode standardised data sets that enable the accurate start of the identify, capture and share processes for healthcare is fundamentally important, and their readability has to be safeguarded.