The UDI/Standards Adoption Network (USAN) - An Introduction

Kevin Stout, Executive Director
Medical Device Supply Chain Council

By now most Supply Chain professionals in the Medical Device Industry are familiar with the pending legislation from the FDA that will force the industry to go to a Unique Device Identification scheme for all products across the healthcare supply chain. In addition, there is a move toward industry-wide use of data standards globally as the foundation to provide improved information for decision making across the industry.

It is important to clarify that there are a number of different data standards that that will provide compliance with the pending FDA legislation. The US regulation will in fact state that Companies can choose which standard they wish to use. Similar initiatives are going on around the world, and other regulatory bodies are moving toward requiring the use of a single data standard. Based on the current state of global UDI regulation, nearly every country supporting a single standard is moving toward the GS1 system of global data standards. The GTIN (Global Trade Item Number) is the product identifier, along with a number of product attributes that will meet UDI requirements. There are other data standards in the GS1 suite that, while not required for UDI compliance, will provide benefits across the supply chain. While the Medical Device Supply Chain Council does not advocate specific standards, it is clear that GS1 is becoming the global data standard for healthcare. The Medical Device Supply Chain Council is a strong supporter of the broad adoption of these data standards and the benefits that they will provide to all players in the healthcare supply chain.

To this end, on behalf of the members and sponsors of the Medical Device Supply Chain Council, we are pleased to announce the launch of the UDI/Standards Adoption Network ("the Network"). The mission of the Network will be focused on increasing adoption of data standards across the global universe of medical device manufacturers. This includes the ability to articulate, identify and capture the business value from adoption.

• We will focus exclusively on Medical Device manufacturer adoption. We understand that true industry adoption will not be achieved without standards use by healthcare providers, GPO's, distributors and other relevant organizations. We will NOT focus on driving adoption by these other supply chain participants. We will work closely with other companies and industry groups in support of adoption by all participants in the healthcare supply chain.
• We will focus on adoption and implementation activities, providing support for those individuals who have responsibility within their respective organizations for implementation of data standards.
• We WILL NOT get involved in setting standards - we leave this to GS1 and their member companies. We will provide input to these organizations where appropriate and as requested.

The focus of the Network will initially be on the following areas:

• Providing a forum for individuals from Medical Device manufacturers who have responsibility for standards implementation to stay up to date on the current state of GLOBAL standards. This includes providing access to subject matter experts and industry leaders so that the industry can benefit from the efforts of the leaders in this area and not "reinvent the wheel."
• Communicating to the broadest audience possible - the adoption message must be communicated to all medical device manufacturers. Standards cannot be effective unless there is broad industry adoption and use.
• Providing easier access to the information and tools available to facilitate adoption and implementation.

Participation in the UDI/Standards Adoption Network will be open to all Medical Device manufacturers and relevant third parties. This will not be a sales forum for third parties, so their participation will be limited and controlled. This effort will be driven by the industry and supported by third parties based on industry needs. We will use subject matter experts and thought leaders as an "Editorial Board." This group will provide guidance regarding the collection and dissemination of information.

• AMR Announcement of the UDI/Standards Adoption Network
• USAN Charter
• USAN Participating Companies