FDA UDI implementation is upon us and also the new European Medical Device Regulations have taken concrete shape. Many medical device manufacturers and labelers are rushing to understand and meet the compliance timelines and requirements.
How do I know that my decoded data matches what I intended?
One essential part needed for compliance is a verification solution that ensures symbol and mark integrity. How can you for example check data structure for your company-specific Global Trade Item Number (GTIN) in the GS1 General Specifications?
We know that GS1 General Specification Application Standards require that the date must be encoded in the symbol as YYMMDD. A verifier can identify obviously incorrect data such as a month value of “15”, and the software will communicate that the structure is improper and the data is invalid. However, if you have data such as a month value of “09” (September) but you intended for it to be “03” (March), the verifier cannot know your intentions unless you specify the intended data.
Omron Microscan LVS verification systems offer tools that work within the software, allowing you to configure the system to verify that the data in the symbol being decoded matches what is defined as the intended data.
Entering user-defined data and product descriptions: Product Lookup
Product Lookup is a feature of Omron Microscan LVS-95XX Software available to all users on the Setup tab, where entries can be added manually or by import. For example, all of your company’s Global Trade Item Numbers can be imported as a .csv file, populating all the information at once. If the data is entered and “Fail codes without a matching lookup entry” is selected, decoded data that does not match one of your allowed GTIN entries will fail with an error stating that the value is not found in the product lookup.
If the decoded text matches the user defined entered data, now not only do we know that it is an allowed Global Trade Item Number, but we also note on the grading tab the particular item description that this particular data belongs to. This will also be included in the archived reports.
What about expiration dates and batch numbers?
GS1 symbology structure involves FNC1 characters and Application Identifiers that are required in the embedded data to be proper GS1 symbology. AIs (Application Identifiers) define information encoded in a symbol.
Example: If you are creating a GS1 barcode that requires an expiration date, you would embed AI 17, followed by a 6-digit expiration date. The AI 17 is giving a sign to a scanner or verifier to communicate that the next 6 digits represent the expiration date.
There is an Optional Feature within the verification software that can be purchased as an additional data check, but is only available for GS1 General Specification data. If purchased, an Enhanced Application Identifier Verification (EAIV) activation code is provided to activate the feature in the software. The EAIV feature will do a ‘spell check’ and ensure that your embedded data is what you intended.
Once you have confirmed that the embedded data is correct and formatted as intended, you can then set up EAIV to test the data for accuracy. In the software, there is a training session provided with the feature activation to ensure that users understand how to program the EAIV properly. If the data is entered as intended, but the decoded text does not match, the symbol will fail.
What about data match to the human-readable?
While an off-line system performs the data structure and applies the rules for the application standard that has been selected on the Setup tab, the print quality is checked with an in-line system that grades the label during the printing process.
Verification of labels is most critical in regulated healthcare to accommodate the requirements of the UDI guidelines and the new European Medical Device Regulations, but is also used in other industries to ensure standards compliance and quality.
Each UDI must be provided in a plain-text form (readable to humans) and in a form that can be interpreted by automatic identification and data capture (AIDC) technology (readable to machines) on labels.
Omron Microscan LVS-75XX in-line systems include the following features:
- Barcode validation (deading of 1D and 2D codes);
- Barcode verification (grading of 1D and 2D codes to ISO/IEC standards);
- Master-to-label comparison (blemish detection);
- Optical character recognition (OCR);
- Optical character verification (OCV);
- Number validation;
- Data and code matching.
How will I know if my barcode is compliant?
Barcode readers or scanners cannot be used for verification or validation of your encoded data. While the symbol may be decodable, a scanner or reader will only report what is decoded. Verification is an objective, well-documented measurement of the quality of a barcode. It is a predictor of how readily-decodable a barcode will be throughout its lifecycle, and a method of analyzing a code against a published specification to determine whether the barcode is compliant to specifications (within spec) and will decode properly. Omron Microscan verifiers ensure compliance and can also determine defects in codes that may affect their readability.
To learn more about ‘Label Compliance with the New European Medical Device Regulations’, watch our joint webinar with USDM and NiceLabel on demand.
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