Case for 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
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
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.
Initial activities for the Network
will include the following:
Useful Links, Documents, and Articles
- Establish an on-going Communication Forum for
participants. These communications will be through
meetings, webcasts and ad-hoc information distribution.
- Create a Network Information Repository that
will be a "one-stop shop" for Standards information.
The site will include content and will leverage
information available on other relevant sites.
This site will serve as that the Repository. It
is assumed that this site will continue to grow
and evolve based on content availability and the
needs of Network participants.