4 Consensus body membership and structure
4.1 Definition of consensus body
A consensus body is a “group that approves the content of a standard and whose vote demonstrates evidence of consensus” (ANSI Essential Requirements).
When a committee or working group is actively developing and approving AAMI standards or TIRs, that group is acting as a consensus body.
4.2 Consensus body leadership (chairs)
4.2.1 General
Most AAMI consensus bodies have two chairs—one representing industry (see 4.5.2.1) interests and one representing non-industry interests (user, regulatory, general, or other interests). If suitable candidates from disparate interests cannot be found, two chairs from the same interest category may serve or the consensus body may be chaired by a single member.
4.2.2 Selection of chairs
The Standards Program HOD appoints consensus body chairs with appropriate consultation with the AAMI Standards Board and AAMI staff.
In the event that a consensus body has no chair and there is pressing business before the group, the Standards Program HOD may appoint an interim chair.
If a chair is not able to attend a meeting, an acting chair may be appointed by staff to lead the meeting.
4.2.3 Terms of chairs
The term of a consensus body chair appointment is for three years, renewable for a second three- year term. Additional terms may be approved by the Standards Program HOD in consultation with the Standards Board. All terms end either June 30 or December 31, whichever date occurs first following three years from start of term.
4.2.4 Qualifications of chairs
Consensus body chairs should be experts in the technology covered in the scope of the group. The industry chair of a consensus body shall be a representative of an AAMI corporate member, unless this requirement is waived by the Standards Program HOD. For non-industry chairs, preference is given to individual AAMI members and representatives of AAMI institutional members.
4.2.5 Responsibilities of chairs
Specifically, chairs are responsible for:
a) conducting committee meetings;
b) implementing the policies, objectives, and priorities of AAMI;
c) efficiently managing consensus body activities to ensure timely completion of work;
d) advising staff, when requested, on membership matters;
e) appointing task group members or other consensus body officers;
f) advising staff on technical and administrative matters relevant to the consensus body's work;
g) documenting consensus body meetings in the absence of AAMI staff; and
h) representing the consensus body at public meetings or hearings when requested by AAMI or appropriate standards department staff.
Unless authorized by appropriate standards department staff, consensus body chairs may not speak officially for AAMI.
4.2.6 Termination of chair appointments
A chair appointment may be terminated at any time by the Standards Program HOD should it become evident that the chair has insufficient time or resources to fulfill the responsibilities of the position, is not properly executing AAMI's policies and procedures, or is not abiding by AAMI policies. In such a case, the chair will receive written notification that the appointment has been terminated.
4.3 Consensus body size
There is no restriction on the size of consensus bodies.
4.4 Members of consensus bodies
4.4.1 Member qualifications
A consensus body member should have a direct and material interest in the work of the consensus body, either as an individual or through association with an organization. Members who do not have a direct and material interest also may serve as voting
members, subject to AAMI approval, provided that they are knowledgeable about the subject of the consensus body's work or possess needed expertise. A consensus body member also must have sufficient time and resources to fulfill the responsibilities
of membership and is required to review and vote on all balloted documents or proposals.
Consensus body members need not be individual members of AAMI or represent institutional or corporate members of AAMI; however, AAMI may impose cost-reimbursement fees on for-profit companies that are not corporate members of AAMI or on not-for-profit
institutions (including associations, societies, government agencies and the like) that are not institutional members of AAMI.
Consensus body members also must provide adequate contact information. Because consensus body communications and documents are normally distributed electronically, members must have access to the Internet and a functioning e-mail address.
4.4.2 Representative members and alternates
A representative member is anyone who meets one or more of the following criteria:
a) The individual receives remuneration or expense reimbursement from an organization (a company or institution) to support, or in exchange for, participation in an AAMI consensus body.
b) The individual is expected to vote for or speak for an organization with respect to standards under development by the consensus body.
c) The individual is compensated to be an information source for an organization with respect to the activity of a consensus body.
A representative membership in a consensus body is held by the organization represented rather than the individual serving as a representative.
Organizations may appoint one voting representative per consensus body.
NOTE 1 A parent corporation and its divisions or subsidiaries are usually considered one organization for purposes of voting representation.
Organizations may appoint one alternate representative. An alternate’s vote is counted only if the principal representative fails to vote.
Organizations also may appoint up to six non-voting representatives to a consensus body who can participate in the consensus body’s work but do not have voting rights.
NOTE 2 With appropriate standards staff approval, additional non-voting representatives from a single organization may be permitted.
An organization or its representative can appoint a temporary alternate as a proxy representative to participate in specific meetings if the organization’s primary and alternate representatives are unable to attend.
A single individual participating in AAMI consensus standards development may only represent a single organization.
4.4.3 Independent expert members
Qualified individuals who do not meet the criteria of representative members may serve on consensus bodies and vote on matters as independent expert members.
4.4.4 AAMI Consensus Body Member Code of Conduct
All participants in AAMI consensus bodies shall comply with the AAMI Consensus Body Member Code of Conduct (Annex A).
4.5 Interest categories (stakeholders)
4.5.1 General information
4.5.1.1 Classification scheme
Every consensus body member (stakeholder) shall be classified by interest category. AAMI recognizes five different interest categories: Industry, User, Regulatory, General and Other. Consensus bodies should strive for participation from all affected interest categories. Members are classified by their overall interest (or the overall interest of the organization they represent) in the AAMI Standards Program’s body of work rather than by their interest relative to the work of a specific consensus body or document.4.5.1.2 Declaration of interest and disclosure of potential conflicts of interests
Consensus body members must declare the interest they represent on AAMI standards committees and must disclose all potential conflicts of interests. In cases where a consensus body member receives funding from AAMI or other entities, that information shall be disclosed to AAMI to determine if it will impact the member’s interest classification. Consensus body members also shall comply with any applicable conflict of interest policies set by the AAMI Standards Board or the AAMI Board of Directors.
4.5.2 Stakeholder category definitions
4.5.2.1 Industry Interest category
A member of a consensus body who, as an individual or organizational representative, is involved in the commercial production, promotion, sale, use or distribution of materials, products, systems, or services covered in the scope of technical documents
developed by AAMI shall be classified as an Industry Interest stakeholder. Individuals in this interest category include manufacturers, those involved in supply chains, employees of test labs or commercial labs, industry consultants, etc.
4.5.2.2 User Interest category
A member of a consensus body who, as an individual or organizational representative, purchases, utilizes or receives the materials, products, systems, or services covered in the scope of technical documents developed by AAMI in the delivery of healthcare shall be classified as a User Interest stakeholder. Individuals in this interest category include clinicians, employees or representatives of Healthcare Delivery Organizations, clinical consultants, patients, etc.
4.5.2.3 Regulatory Interest category
A member of a consensus body who, as an individual or organizational representative, is involved in the regulation of the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI shall be classified as a Regulatory Interest stakeholder. Individuals in this interest category would include those representing federal, state, local, foreign, or other government entities.
4.5.2.4 General Interest category
A member of a consensus body who, as an individual or organizational representative, has a general direct and material interest in the materials, products, systems, or services covered in the scope of the technical documents developed by AAMI and who does not fit into any of the preceding categories shall be classified as a General Interest stakeholder. Individuals in this category would include noncommercial academicians, noncommercial researchers, patient or consumer advocates, representatives of accrediting organizations, representatives of other organizations, etc.
4.5.2.5 Other Interest category
A member who does not fit into any of the preceding interest categories but who still has an identifiable material interest in, or specialized knowledge of the materials, products, systems, or services covered in the scope of technical documents
developed by AAMI in the delivery of healthcare shall be classified as an Other Interest stakeholder. The particular interest shall be declared and documented.
4.5.3 Categorization of membership associations
A membership association (e.g., trade association, professional society) shall be categorized according to the appropriate interest category of its members.
4.6 Selection of consensus body members
4.6.1 General
Members of a consensus body are selected by application or by invitation.
4.6.2 Terms
There is no set term for consensus body membership.
4.6.3 Application process
Any person wishing to join an AAMI consensus body must apply for consensus body membership. A completed application should be submitted to the AAMI Standards Department for review and approval by staff. Industry stakeholders shall disclose any corporate parent/subsidiary relationships and any financial relationships with concerned commercial entities. User, General, Regulatory, or Other Interest stakeholders shall disclose any potential conflicts of interest (e.g., consulting arrangements with manufacturers, service on a corporate board).
A potential conflict of interest does not necessarily disqualify an applicant from independent voting status on a consensus body.
If an applicant (or the organization represented by the applicant) clearly has a direct and material interest in the health technology products, processes and/or associated services covered in documents under development by the consensus body, the application may be approved by authorized AAMI staff.4.6.4 Refusal of membership
Consensus body membership may be refused for one or more of the following reasons:
a) The applicant (or organization represented) does not have a direct and material interest in the health technology products, processes and/or associated services covered by the consensus body.
b) The work of the consensus body is nearing completion.
c) The organization the applicant would represent already is fully represented on the consensus body.
d) For User, General, Regulatory, or Other Interest stakeholders, the applicant has a substantial relationship or conflict of interest that precludes granting independent voting status.
e) For Industry Interest representatives, the sponsoring firm is neither a corporate nor an institutional member of AAMI and is not willing to pay any required cost reimbursement fee.
f) The applicant refuses to complete the application fully or to disclose relevant financial relationships or possible conflicts of interest or provides incomplete or erroneous information in the application.
g) The applicant is not in compliance with or has previously violated the terms of the AAMI Consensus Body Member Code of Conduct, the AAMI Antitrust Policy, or the AAMI Patent Policy, these procedures, or other AAMI policies.
An applicant has the right to appeal if membership is denied. All the correspondences shall be directed to Standards Program HOD.
4.6.5 Responsibilities
Consensus body members shall actively participate in all consensus body business. In particular, they shall respond to all consensus body ballots in a timely manner. Regular attendance at meetings is desirable but is not required.
Consensus body members are responsible for notifying AAMI of changes in e-mail address or affiliation, and organizations represented on consensus bodies are responsible for advising AAMI of desired changes in representation.
4.6.6 Change of interest category or representation
To ensure lack of dominance, balance, and due process, the membership of any individual on a consensus body terminates when that individual’s interest category or representation changes. Such a change shall be disclosed, and continued participation in the consensus body by that individual requires that the individual reapply in his or her new capacity.
4.6.7 Temporary designation of alternate
A consensus body member who cannot attend a meeting may designate a proxy for that meeting by notifying AAMI in writing in advance.
4.6.8 Non-voting representatives
Non-voting representatives to technical committees are representatives of an organization who receive all committee documentation but who cannot vote.
Standards staff approve Non-voting representatives and can deny or discontinue their membership for cause.
4.7 Termination of consensus body membership for cause
AAMI staff or the AAMI Standards Board may terminate an individual’s or an organization’s consensus body membership for lack of participation or interest, especially for failure to record a vote or abstention on two consecutive letter ballots. Substantive violation of AAMI policies, including violation of the AAMI Consensus Body Member Code of Conduct, the AAMI Antitrust Policy, or the ANSI Patent Policy, also is cause for termination of membership.
Failure to disclose a change in interest category or representation or to disclose a conflict of interest is grounds for termination of membership.
Membership in a consensus body also may be terminated if it is determined that the individual or company's continued membership or actions may be detrimental to the work of the consensus body, to the interests of AAMI, or to the public good.
Persons, institutions, or corporations whose voting representation on a committee has been terminated for any of the above reasons will be notified in writing and will retain all other rights afforded them by due process.
If AAMI is not able to contact a member or if a member cannot provide a working e-mail address, that individual’s membership may be terminated without further notice.