MOU 225-17-003
MEMORANDUM OF UNDERSTANDING
BETWEEN THE ASSOCIATION FOR HEALTHCARE
RESOURCES & MATERIALS MANAGEMENT
AND THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
I. Purpose
The United States Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) land the Association of Healthcare Resource & Materials Management (AHRMM) have a shared interest in facilitating the successful adoption of Unique Device Identifiers (UDIs) across the healthcare device ecosystem especially with regard to the initial capture of UDI in supply chain and clinical health information technology (IT) systems. Both FDA and AHRMM are referred to individually as a “Party” and collectively as the “Parties.” This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote shared interests.
II. Parties
A. FDA
FDA is authorized to enforce the Federal food, Drug, and Cosmetic Act (“the Act”) (21 U.S.C. section 301 et seq.) In fulfilling its responsibilities under the Act, FDA is responsible for among other things, protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
B. AHRMM
AHRMM represents healthcare supply chain professionals and is affiliated with the American Hospital Association. AHRMM has more than 4,300 members representing the entire healthcare supply chain, including hospitals, manufacturers, distributors, group purchasing organizations and health technology vendors. AHRMM also has active relationships with other associations and academic institutions focused on the healthcare supply chain. As a result, AHRMM is positioned to convene an array of thought leader and experts from across the entire healthcare community.
III. Background
Section 519(e) of the Act (21 U.S.C. sec. 360i(f)) directs FDA to issue regulations establishing a UDI system. On September 24, 2013, FDA published regulations establishing a UDI system to adequately identify medical devices through their distribution and use. When the UDI becomes fully implemented, the label of most devices will include a UDI in human- and machine-readable form. FDA expects that the fully-implemented UDI system will have a number of benefits, land that some of those benefits depend on the successful adoption of UDI by stakeholders and other labelers subject to FDA’s UDI regulatory requirements.
AHRMM supports and promotes the adoption of the UDI system within the provider community. It believes that UDI should be the single unifying way to track medical devices across the entire healthcare value chain, from point of manufacture through, use, and, in the case of implantable devices, through the lifecycle of that product. Potential benefits to the provider and the patient include:
· Efficiencies in supply chain transactions, inventory and recall management;
· Insight into real world product performance and variations in clinical practice; and
· The ability to conduct comparative effectiveness research and decision analytics to drive better sourcing decisions.
Thus, FDA and AHRMM have a mutual interest in promoting a more organized and coordinated collaboration of members of the healthcare community to help facilitate UDI adoption. To date, UDI education for stakeholders other than labelers subject to UDI regulatory requirements has been ad hoc and uncoordinated.
To address the healthcare community’s need to learn more about UDI adoption, AHRMM will organize and host the listening UDI Community (LUC), which is a coalition comprised of a broad-base of affected stakeholders such as industry representatives, supply chain service providers, standards groups, and healthcare leaders that will focus on identifying issues that impact UDI adoption within the healthcare community. The intent of forming the LUC is to provide an open and coordinated public forum where the affected stakeholders can collaborate to facilitate the adoption of UDI, and explore barriers to adoption that occurs throughout the supply chain and among relevant stakeholders. /the LUC will convene a Learning UDI Community Steering /Committee (LUCSC) which establishes a process and criterial whereby UDI-related issues can be vetted and assigned to ad hoc work groups that will research and report on adoption barriers for stakeholders. The materials developed by the ad hoc work groups would be aproved by the LUCSC. These materials can then be used to facilitate UDI adoption throughout the supply chain and in the healthcare community. The LUC, the LUCSC, and the work groups are intended to foster and exchange of ideas and information about UDI adoption in the healthcare community. They are not intended to provide advice or recommendations to the FDA.
IV. Substance of the Understanding
This MOU forms the basis for collaboration between FDA and AHRMM in support of the LUC. All activities undertaken pursuant to the MOU are subject to the availability of personnel, resources, and funds and, if necessary, the execution of separate supplemental agreements governing the proposed activities.
· FDA will provide the LUC with technical assistance and FDA’s perspective on issues affecting IUD adoption.
· AHRMM will be responsible for selecting the members of the LUCSC.
· AHRMM will ensure that the materials approved by the LUSCS are shared with the LUC and the healthcare community at large and accessible through a common repository
accessible by any interested party.
· AHRMM will ensure that the LUC is open to all interested parties. Any LUC meetings, including LUCSC and ad hoc working group meetings, will be open to the public to the fullest
extent practicable.
· The LUC will focus on issues that affect multi-stakeholder groups. Issues that affect only specific entity such as a healthcare or medical device organization or a specific partnership
between organizations will not be addressed by the LUC.
Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest, and as needed develop separate, written agreements (supplemental agreements) with designated work groups for each collaboration that will outlie each Party's financial commitments (if any) to the collaboration and the terms to govern the collaboration. Where applicable, the supplemental agreements shall incorporate by reference the terms of this MOU. Additional agreements with additional partners may also be executed to support the LUC. /the terms and conditions of any supplemental agreements will be in accordance with applicable federal law and regulations, and shall be negotiated and executed by appropriate representatives of AHRMM and the FDA. The Parties will not enter into agreements and collaborations described in this paragraph for the purpose of providing advice or recommendations to the FDA.
V. General Provisions
A. Data Sharing Guidelines: FDA will comply with all applicable disclosure states and regulations with respect to sharing confidential information, trade secrets, or personal privacy information with AHRMM or the LUC. See e.g., 21 U.S.C. section 331(j), 21 U.S.C. section 360(c), 18 U.S.C. section 1905, 21 CFR section 20.61 and 20.63.
B. Intellectual Property: “Invention” refers to any subject matter or discovery patentable under Title 35 of the United States Code and conceived or first reduced to practice under the activities of Supplemental Agreements to the MOU. “Intellectual Property” refers to patents, patent applications, know-how, trade secrets, copyrights and computer programs either used or developed under the activities of Supplemental Agreements to the MOU. Ownership of and rights to inventions or intellectual Property developed under a Supplemental Agreement will be addressed in the Supplemental Agreement. Inventions made under the /Federal research and development grant or contract will be subject to the Bah-Dole Act. No Party, by virtue of their participation in activities under the MOU, will be required to disclose or license intellectual property to the other Party. Neither Party shall use the name, logos, trademarks, service marks, trade names, seals, insignia, symbols or decorative designs of the other Party or any derivatives thereof without the prior written permission of the other Party.
C. Representation of Views: At FDA’s request the LUC will include a disclaimer on any work product to indicate that it does not represent the official views of FDA.
VI. Resource Obligations
This MOU represents the broad outline of the FDA and AHRMM’s intent to collaborate in areas of mutual interest. It does not create binding or enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to the availability of personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.
VII. Liaison Officers
For CDRH:
Terrie L. Reed, MSI
Senior Advisor for UDI Adoption
10903 New Hampshire Avenue
White Oak Building 66, Room 332A
Silver Spring, MD 20993
301-796-6130
For AHRMM
Debbie Sprindzunas
Executive Director, AHRMM
155 N. Wacker Dr.
Suite 400
Chicago, IL 60606
Michael Schiller
Senior Director of Supply Chain, AHRMM
155 N. Wacker Dr.
Suite 400
Chicago, IL 60606
Each Party may designate new liaisons at any time by notifying the other Party’s administrative liaison in writing. If at any time, an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within two weeks and notify the other Party through the designated administrative liaison.
VIII. Term, Termination, and Modification
This MOU become effective upon acceptance by both parties and will continue in effect for (5) years from the date of the last signature. It may be renewed by mutual written agreement of both Parties. It may be modified at any time by mutual agreement of both Parties. It may be terminated by either Party upon 60-day advance notice to the other.
IX. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA and AHRMM operate.
IN WITNESS WHEREOF, the Parties, by their undersigned representatives, have caused this MOU to be executed. This MOU may be executed in counterparts and each counterpart shall be deemed an original.
APPROVED AND ACCEPTED FOR AHRMM
Deborah Sprindznas
Executive Director, AHRMM
October 12, 2016
APPROVED AND ACCEPTED FOR FDA/CDRH
Jeffrey Shuren, M.D., J.D.
Director
Center for Devices and Radiological Health
October 21, 2016