Barcode Risk is Business Risk: Medical Devices

Packaging a medical device is the final step in a long process. The device’s form factor, dimensions, and marketing are considerations in packaging, but FDA regulations do not simply require that devices be packaged. They say that packaging is integral to the device’s design controls and quality system.  This is an important distinction.

Getting a medical device to that point is complicated, lengthy, and all-consuming (not to mention expensive).  It is not unusual for packaging to be an afterthought, and that’s where critical mistakes can be made.

Why Packaging?

A brief step back: why are we talking about packaging when the focus of this article is barcode risk? The answer is simple: the FDA requires medical devices to be barcoded, and packaging carries the barcode.

Barcodes are not a primary focus of the initial FDA Approval for a medical device, but are part of the submission. Once cleared or approved, compliance with separate Unique Device Identification (UDI) barcode regulations takes effect before commercial distribution is permitted

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The barcode is important! You’ve spent $ (fill in the blank) over (fill in the blank) months researching, inventing, developing, and building a brilliant new breakthrough medical device. The package will cost $ (fill in the blank), and the barcode, amortized over several thousand packages, will be almost free. However, if there are any issues with it, the project release will be delayed. It can take weeks or months.

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What could go wrong?

Here’s what:

• Device information must be submitted to the Global UDI Database (GUDID)
• The label must include the UDI information in both human-readable form and in machine-readable barcode format
• Some data elements are required to be shown only in the human-readable form but not encoded in the barcode
• Barcode data formats must comply with the technical standards of an FDA-recognized issuing agency (GS1, HIBCC, ICCBBA, or IFA).
• Barcodes must meet print quality standards for ISO/IEC 15416 for linear barcodes, or ISO/IEC 15415 for 2D barcodes.

FDA can block the release of a medical device if the UDI barcode is missing or incorrectly parsed, if it is not scannable, if the GUDID information has not been submitted, is incomplete or inaccurate, or if compliance deadlines are not met.

Why is this so stringent? It is not to prevent new medical devices from entering the market, or to protect/prevent competition. Why is this so complicated?

It is stringent for the following reasons:

• Barcodes protect patients. They prevent medication errors, surgical implant errors, and allergic reactions to drugs.
• Barcodes provide traceability down to the batch and lot level, including manufacturing date, expiration date, and manufacturing location.
• Barcodes provide visibility into product movement across the supply chain, preventing counterfeit infiltration and detecting theft.
• Barcodes improve product recall accuracy, reduce chargebacks, and prevent waste from destroyed inventory.

Packaging is Compliance

Medical device packaging isn’t optional—and it isn’t generic. The package must effectively protect the medical device and, if necessary, maintain sterility. Furthermore, the package is the carrier of required label information, including the UDI. This means that barcode quality is a compliance issue. A non-scannable barcode violates the labelling requirement, which is a regulatory violation.

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