Mayo Clinic Project Charter
Project Name:
UDI (PCOR Database)
Brief Project Description :
What is UDI (unique device identification)? The Unique Device Identification (UDI) System is intended to
assign a unique identifier to medical devices within the United States. It was signed into law on September 27,
2007, as part of the Food and Drug Administration Amendments Act of 2007. This act includes language related
to the establishment of a Unique Device Identification System.
When implemented, the new system will require:
 The label of a device to bear a unique identifier
 The unique identifier to be able to identify the device through distribution and use
 The unique identifier to include the lot or serial number if specified by FDA
The FDA is mainly interested in establishing a reliable infrastructure as well as clear and achievable meaningful
use of UDI. Their main interest at this time is safety and recall. As a result the FDA has issued a minimally
funded RFP to develop effective use of UDI (Unique Device Identifiers) and Mercy has been awarded this
contract. Mercy has now approached Mayo Clinic with an opportunity to work together to research, develop and
advise in the area of using UDI and correlating supplies to outcomes (directly related to this RFP).
What is PCOR (patient-centered outcomes research)? It is research that is informed by the perspectives, interests
and values of patients throughout the research process, from the selection of research questions to the
dissemination of research results. Patient-centered outcomes research (PCOR) is intended to be practically
relevant. Its real-world impact on patients is known and included in decisions about prevention, diagnosis and
treatment.
Both Mercy and Mayo Clinic feel that marrying PCOR to UDI will serve FDA and long-term industry needs. To
accomplish this Mercy will provide IT resources to build the database while both parties (as well as others as
needed) will provide both clinical and supply chain expertise as well as standardized de-identified data.
If Mayo Clinic were to decide not to participate in a co-development effort, Mercy would seek another partner. It
is possible that Mayo Clinic could participate from an advisory only perspective. This is not desirable as it would
advance others (lead adopters) and leave Mayo at a disadvantage pertaining to our ability to capitalize on Supply
Market opportunities. Innovation such as this project will be needed to meet the expense challenges currently
being discussed at SEMC (Supply and Expense Management Committtee).
Business Need (Problem or Opportunity Statement / Background of Need)
Goal/Aim Statement
1) Participate in putting together the necessary project organizational structure.
 Recruit the 3rd health system to participate in the demonstrations.
 Enlist the participation of the professional organizations (ACC, SCAI, HRS)
 Co-lead HTG efforts to enlist industry participation.
 Co-lead all related committee meetings (expert panel, etc.)
2) Participate in demonstration projects as a full participant.
 Enable internal systems to retrieve UDI data for stents and ICDs from industry-wide data bases and
Version 1.0
1 of 4
incorporate them into the EHR.
3) Develop the required data sets containing EHR and UDI data.
 Participate in the Steering Committee of the coronary stent demonstration.
 Define the data elements to be contained in the data sets.
 Design the network through which the data will be shared among researchers at participating systems, the
FDA, and the national registries.
 Oversee the evaluation of data quality in the demonstrations.
4) Develop an investigative strategy with Mercy.
 Establish a robust post-market, UDI-enabled surveillance system for Class III implantable devices
 Enable a research agenda using device and clinical data (EHR and registry) for doing Patient Centered
Outcomes Research/Comparative Effectiveness Research (CER).
5) Fill in holes in the UDI system that are not currently being addressed by the FDA.
 Move the pilots into “production” establishing a working database for UDI attributes.
 Participate with Mercy in seeking funding to support this work.
Project Value– Quantitative and Qualitative Metrics of Success
Objective
Metrics/Measurements
The primary value to Mayo Clinic would be to
advance our analytics by correlating outcomes and
products (at a granular level; i.e. specific device).
This is going to be necessary in the years to come to
continue to drive cost out of the system (primarily around
price, utilization and new technology decisions).
While it would be possible to do this internally we can
get there faster working in a collaborative and the
solution will be more viable if it is more comprehensive
(beyond Mayo Clinic).
In the end we will be required to submit robust data that
will be used by the FDA and academic research and
Mayo Clinic has an opportunity to work proactively
would be best served if we were influencing decisions as
with FDA and shape the future as it pertains to supply apposed to watching.
based regulation.
The value to our patients would be a safer and more
innovative environment for Healthcare as a whole.
Project Scope (elements that are in & out of scope)
In Scope:





Out of Scope:
Project Structure and Governance.
Stent and ICD Demonstration Projects.
Data Specifications.
Investigative Strategy for Utilization of the Data.
Identify Gaps in FDA strategies.

GS1 Implementations already underway.
Project Team
Project Governance
Role
Executive/Physician Owner(s):
Administrative Sponsor(s):
Oversight Group(s):
Version 1.0
Name(s)
A
David S. Loeb, MD and Robert F. Rea, MD
Jim Francis
SEMC
X
R
C
I
V
D
X
X
X
X
X
2 of 4
Project Management Team
Role
Name(s)
Team Leader:
Local Coach:
Team Members:
A
X
Joe Dudas
N/A
Tom Stewart, Physicians to be named
R
C
I
V
D
X
X
Initial Business Partners and Resource Requirements Estimate
Internal/External Partner
Resource Skill Set Needed
FTE needed
(e.g. IT, S&P, QMS, Communications,
Finance, EPMO)
(e.g. Project Mgr, Business Analyst, Software Architect,
Analyst/Programmer)
(for Planning Phase Only)
Physician Research
SCM Analytics
IT
Provide expertise in patient care and outcomes
information and research.
Provide expertise in supply analytics and information
management and analytics.
Extract information as needed by the project to feed the
data base.
.25
.25
Requests to be
submitted and
prioritized as per
normal SOP.
Initial Timeline Estimate
Record your high level milestones, which will be in your high WBS and may include phases from any one of the following methodologies:
DMAIC: Define, Measure, Analyze, Improve, Control
Project Phase:
Define
Measure
Analyze
Implement
Control
Target Start Date:
Target End Date:
1Q2012
2Q2012
2Q2012
3Q2012
3Q2012
4Q2012
4Q2012
1Q2013
1Q2013
2Q2013
Initial Risks/Barriers and Opportunities
Co-development is not something SCM can do behind the scenes so it will be imperative that all parties impacted
are in agreement and supportive.
The data that is needed is not owned or stewarded by one particular group so these issues too will need to be
resolved and require support for success.
This project is incremental to current GS1/HTG efforts to support Sunrise 2010 (GLN) and 2012 (GTIN).
Assumptions
IT requirements are not well understood at this time. Request will be made as requirements are defined. It is not
anticipated at this time that needs are significant (Lawson, SIMS, and MICS/Cerner likely contain the needed
information).
Quality is assumed. Rank in order of priority with 1 being least flexible for change and 3 is the most flexible for change; ; there may only be one item ranked
as 1)
Scope Priority: 1
Schedule Priority: 2
Budget Priority: 3
Estimated Organizational Change Impact (Stakeholders)
Types of Change: (List all of the following that apply: Organization / Governance, integration & Standardization, Process & Procedures, Policies,
Practice Models)
Staff / Groups Affected by the Change
Version 1.0
Impact (H, M, L)
Impact Description
3 of 4
Project Interdependencies and Interrelationships
Sunrise 2010 (GLN) and Sunrise 2012 (GTIN)
Ongoing Operational Owner(s)
SEMC, Supply Chain Management and Physician Departments
Links to Relevant Documents (Optional)
Document Name
Document Location/Hyperlink
(e.g. Stakeholder Analysis, Communication Plan)
Project Charter Approvals
Approval Groups
SCM LT
SEMC
Description
Approval Date
Supply Chain Leadership Team
Supply and Expense Management Committee
Charter Revision History
Date
October 2011
Version 1.0
Version
1.0
Synopsis of Change
Original DRAFT
4 of 4