Barcode Quality: Medical Devices

The current issue of Quality Magazine has an excellent article titled A Pulse on Quality 4.0 for Medical Device Manufacturing.* Because our interest in quality is so specific, I read the article with great interest. I came away with renewed respect for the complexity of many medical devices and the challenges these highly specialized companies face and overcome.

The article, which makes no mention of packaging and barcodes, also reminded me of the essential role that barcodes play; how often they are an after-thought in getting a medical device to market. Like other steps in the process, that seemingly small, neglected step can cause the most stress and lost sleep. And possibly financial pain.

Barcodes are often an After-Thought

Barcodes are a step in the process of taking a medical device to market. They are also more than that. Barcodes are also a vital tool in tracking the medical device through its life cycle; documenting installation date, periodic maintenance, routine updates and upgrades and planning for end-of-life replacement. Barcodes can also provide distinguish recalled medical devices by batch or lot number, minimizing disruption.

The article highlights the improvements that the Quality 4.0 initiative brings. In healthcare  these improvements connect people and data through technologies like IoT, AR and robotics. Barcodes identify individual medical devices, distinguishing them from substantially identical items in the Internet of Things. Barcodes can also assist robots in confirming that the correct item or subassembly is being selected in a manufacturing process. And barcodes make traceability possible, both in manufacturing, supply chain and asset life-cycle.

Quality 4.0 depends on barcodes

The promised advancements in Quality 4.0 depend on barcodes; it is essential that they work right. Barcode quality means barcodes that are legible to a scanner and contain the correct data, correctly prefixed and parsed.

Barcodes are an essential component of FDA compliance. Print quality is an ISO standard. Data format is industry-specific. GS1 is a global standard data format in the medical device industry. HIBC is another. Trading partners in a supply chain determine which data format is utilized. When in doubt, consult your customer.

Barcode quality is achieved and maintained several ways. Whether they are printing the barcode in-house or using a packaging vendor, many medical device manufacturers use a barcode testing lab to verify barcode quality. This is a common starting point. Eventually, buying a barcode verifier makes sense for some medical device manufacturers.

Insist on Barcode Quality

When using a label or packaging vendor, a good practice is to insist that the vendor verify the barcodes they are printing—and prove that they did by providing a verification report with each order.

Liability for poorly scanning, mis-reading or non-working barcodes accrues to the brand owner. Bad barcodes are a serious medical device FDA compliance problem. Significant penalties can be imposed. Life-threatening (or worse) injuries can be caused by bad barcodes.

Quality 4.0 is the next step for improved operational efficiency. Barcodes that work right keep make it all possible, from manufacturing resource planning and assembly, to packaging, distribution and end user usage.

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*Thanks to author Scott Reedy for his excellent article, available here.