Bar code grading, is it really necessary?

In the pharmaceutical industry, bar codes have become an instrumental tool for controlling product inventories, reordering and through the use of bar code serialization, product tracking. All of these features, in turn, provide strong anti-counterfeit measures through the supply chain.

However, if a bar code can be read, does it really need to be graded? In short, bar code grading ensures that someone down the line will be able to accurately read and/or scan the bar code with any type of reader. Therefore, bar code grading acts as a precautionary measure since not being able to obtain the information from the bar code, basically renders the bar code useless.

Unit-Dose Foil

How necessary are bar codes? The FDA has designated bar codes as essential and required tools to decrease medication errors in facilities such as hospitals. According to the Bar Code Label Requirements’ Final Rule:

This makes the consistent, accurate reading of bar codes absolutely essential.

To accommodate the required information, the FDA has proposed the use of Reduced Space Symbology (RSS), which includes a linear bar code that is readable by standard linear laser devices, and a stackable 2-dimensional code that is readable by high end readers or camera systems. Each product’s bar code needs to be verified and graded before it leaves the facility since there is no way of knowing the quality of reading or scanning devices medical personnel down the line will be using to read the bar code.

Currently on the market there are four different types of bar code readers:

• Pen readers (bar code wands)
• Laser scanners
• CCD readers
• Camera-based readers.

Considering the financial constraint of many health care facilities, it is safe to say that lower quality readers are the most common readers used. Therefore, to ensure that bar codes are correctly read or decoded on a consistent basis, bar codes must be constantly printed in the best quality possible. To guarantee this quality, bar codes must be efficiently inspected and tested, (ie., graded), before entering the supply chain.

According to the FDA’s Guidance for Industry, Bar Code Label Requirements Questions and Answers, June 2005 draft guidance, the FDA has no intention of issuing any guidance regarding bar code quality, such as size, symbol quality, symbol grade and reflectance. They also stated that the reason for this was that “we believe there are sufficient documents and standards issued by third parties to address such bar code quality and standard matters”. Therefore, the full responsibility for ensuring that only quality bar codes leave a company’s facilities lies with each company.

However, finding a bar code grading solution is far easier said than done; this is evident through the available products currently on the market. Most companies that offer bar code grading solutions, offer solutions that are off-line. This means that the most they can offer is only random verification of bar codes. Then there are the companies which state that they have on-line grading, but they do not offer grading that is according to ISO/IEC standards since they don’t grade all of the required parameters.

There is yet another group of companies that offer on-line linear grading, but they don’t have the technology to carry out 2-D bar code grading. And finally, there is Optel Vision, which provides linear and 2-D, on-line bar code grading tools that comply to ISO/IEC standards. Furthermore, the Optel Vision bar code grading tools are calibrated according to the NIST standards, which further ensures that all bar codes that pass inspection are of the highest quality.

In the end, bar code grading is an essential element in ensuring that your product’s bar code information will be consistently and correctly read at any point down supply chain. However, when looking for the technology to carry out this task, it is clear that not all solutions are created equal and in this case, you really get what you pay for.

¹ FDA, Bar Code Label Requirements for Human Drug Products and Biological Products, February 25, 2004.
http://www.fda.gov/OHRMS/DOCKETS/98fr/04-4249.htm