In 2004, FDA published a final rule on bar code label requirements for drug and biological products. It subsequently began considering whether to expand that concept to medical device labeling. Over the past few years, FDA has held several meetings on unique device identification (UDI) to collect input from the device industry. It is expected that the agency will issue a draft guidance on the topic in the near future. The basis for these actions is FDA’s mandate to protect the consumer, in this case, patients. Evidence of significant medical errors related to product identification have made clear the need for regulatory initiatives.

Product identification, whether by traditional bar codes, newer two-dimensional symbols, or radio-frequency identification, is increasingly being used to locate and remove devices that are found to be the source of problems after they have entered the supply chain, or worse, have been used in medical procedures. The use of product identification as a resource in medical practice, as opposed to just a tool to manage inventory and warehouse logistics, is creating an entirely new paradigm. A UDI system based on universal product numbers (UPNs) would be a safe and efficient way to accommodate both hospital and warehouse needs.

The History of UPNs

Ironically, standards that uniquely identify medical products and meet FDA requirements have not only been in place for more than 25 years, but are already present on the vast majority of medical devices. Although widely used, UPNs have not been mandated by FDA, are often not placed on single-use packaging levels, and are frequently ignored in medical-delivery and hospital settings that lack the technology to capture the UPN information.

A primary component of the UPN is the health industry bar code (HIBC). It is maintained by the Health Industry Business Communications Council (HIBCC), which was created in 1983 by major healthcare associations at the behest of the American Hospital Association. HIBCC was specifically tasked with developing standards that met the unique needs of the healthcare supply chain. Traceability was a key concern for HIBCC; therefore, its standards permit manufacturers to directly encode product IDs in their labels, create consistency for packaging at all levels, and provide serialization and lot and batch information for track-and-trace purposes.

HIBC standards were also designed to coexist with generic retail and pharmaceutical standards known as GS1 codes. The codes work well in cash-register and warehouse environments, but are less suitable for medical applications in which safety and error minimization are crucial. Because HIBC standards are alphanumeric and GS1 codes are limited to numbers only, the two can coexist without being confused.

Adoption of UPN Standards

It is logical for FDA to adopt the UPN standards for UDI because they are based on existing, internationally recognized standards and leverage the significant progress that has already been made by the medical device industry in product identification. These standards meet the requirements for track and trace and, if fully implemented, can help reduce medical errors.

The most important aspect of HIBC UPNs, in terms of patient safety, is that they enable device manufacturers to directly encode their existing alphanumeric product identifiers into their labels. This avoids the unsafe practice of changing or cross-referencing them to meet arbitrary new or numbers-only requirements. In short, it would be counterproductive for FDA to add new risk by imposing new standards.

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