Barcode Quality in the Healthcare Industry
The guest author for this article is George Wright IV, Vice President, Consulting and Business Development at Product Identification and Processing Systems, Inc.He is the vice-chairman of AIM’s Unique Device Identification Committee and editor of the recently revised “HDMA Guidelines for Bar Coding in the Pharmaceutical Products Supply Chain.”
In the broadest of terms, the healthcare products industry is made up to two major areas: medical devices and pharmaceuticals. Standardized product identification and barcode marking (and scanning) are essential tools in both areas, but there are significant differences. Volumes of discussion and hype notwithstanding, pharmaceutical product serialization for track and trace doesn’t exist yet and so a discussion about measuring and reporting barcode quality in that application will be saved for later.
In most respects, the barcode quality on medical device packaging is not regulated, at least no more or less that any other information printed on the package. However, there is now an FDA proposed rule for Unique Device Identification (UDI) that is directed specifically at establishing standardized product identification (“coding”) and use of automatic identification technology (“marking”) on medical devices and/or their packaging. Barcode will undoubtedly be the primary technology used in this application, at least for most products and for many years to come.
As with other markets, anything that could go wrong with barcode quality on a medical device package probably will: substrate to ink mismatching, over-inking, “bad” barcode art, bad plate. It’s not much better with thermal transfer printing for medical devices: X dimension too small, the ribbon is not matched (or incorrectly matched) to the substrate, the print head is dirty or (worse yet) pixel(s) are burned out, the head temperature is set too low or too high, or the transport speed is set too high.
The good news about barcoding in the healthcare industry is the very definite trend away from proprietary barcodes. There is a mass movement toward either HIBCC or, even more pronounced, GS1 barcoding (and the standardized item identification and symbologies upon which both of these systems are predicated), and this is a very good thing. But poorly performing barcodes are still a major concern, especially in medical device packaging.
A recent survey of medical and surgical packaging at a leading Midwest hospital system attributes the barcode quality problems to several factors, the most often mentioned being the wider variety of device packaging materials. But there are other factors at work here.
Barcode quality on healthcare packaging: You get what you enforce
Barcode quality on all prescription and many over the counter (OTC) drug primary product “labels” (which also includes the folding cartons they may be packaged in and unit-dose packaging, including cups, blisters, etc., where offered) has been covered by FDA regulations since 2004. This same regulation stipulates the use of a standardized product identification coding and marking standard, either GS1 or HIBCC (with GS1 being by far the predominant standard in this supply chain). With a minimum bar code quality grade of “C” required by both HIBCC and GS1 (and incorporated by reference in the FDA “bar code rule”), pharmaceutical manufacturers have to take barcode quality seriously. In principle, a drug package with less than a “C” grade barcode can be declared “mislabeled” and be subject to recall. For this reason pharmaceutical packagers pay pretty strict attention to barcode quality. This is a perfect example of the principle, ‘You get what you enforce.’
On the medical device side, the situation is different. Until the FDA’s Unique Device Identification proposed rule actually becomes a final rule and is put into effect (in whatever its final form turns out to be), medical device manufacturers to not have the same incentive to print high quality, readily-scannable symbols, even if they have moved away from proprietary coding and have adopted one of the main product identification standards, such as HIBCC or GS1.
Barcode quality is unregulated in Medical Devices until the FDA’s proposed rule is adopted
But “enforcement” is not strictly a regulatory matter. In fact, in most supply chains it is the customer that enforces strict conformance with product coding and marking standards. Just ask any consumer goods manufacturer that sells to Wal-Mart, or Woolworths in Australia, or many other major retailers around the globe. It’s the cost of charge-backs imposed by the retailer (customer) that makes the supplier learn about and achieve compliance with standardized item identification and barcode quality requirements.
Barcode quality in healthcare is not strictly a regulatory matter
So far, however, the U.S. healthcare products supply chain has not been subject to such strict “vendor compliance” mandates in the same way consumer goods manufacturers have been. That may be beginning to change, especially at the distributor level. But whether that changes or not, the FDA Unique Device identification rule is likely to have the same positive effect on medical device item identification standardization and barcode quality that the FDA “pharmaceutical bar code rule” did on drug labels. And for that we should all be thankful because, for a broad segment of products (though certainly not all), the current state of today’s medical device bar code printing is dismal. Thankfully, education, training and a commitment to quality can readily rectify the problem. HIBCC and GS1 system healthcare barcode specialists are standing by to assist.
George Wright IV is Vice-president, Consulting and Business Development at Product Identification & Processing Systems, Inc. (PIPS) a 34-year old New York firm with a wide range of AIDC offerings that specializes in bar code print quality verification solutions featuring the best global brands of ISO/IEC-compliant verifiers. He is vice-chairman of AIM’s Unique Device Identification Committee, editor of the recently revised “HDMA Guidelines for Bar Coding in the Pharmaceutical Products Supply Chain” and an active member of several GS1, GS1-US, ISO and other technical committees. Certified as a Bar Code Consultant in the GS1-US Solution Partner program, George serves as an educator and consultant to numerous corporate clients, particularly in the FDA-regulated pharmaceutical and medical device supply chain. He is a frequent author of technical articles on bar code standards. Pharmaceutical & Medical Packaging News and principal inventor of four U.S. patents covering bar code printing and verification.