3 Program organization
AAMI national standards and technical documents are developed by a consensus body (a technical committee or working group) assisted by staff and overseen by the AAMI Standards Board.
3.2 Technical Committees/Consensus bodies
Committees and working groups composed of volunteer technical experts are the heart of the AAMI standards program. Each AAMI committee has a defined scope of work and operates under established policies and procedures. An AAMI committee evaluates the need for standards and other technical publications within its area of competency. An AAMI committee also may assist staff in developing educational programs or may advise AAMI on responses to government initiatives and other public policy matters.
A committee may establish working groups to address particular technological areas within the scope of the parent committee.
AAMI standards are developed by a committee or working group acting as a consensus body. Consensus bodies provide the technical resources for developing, approving, and revising standards and TIRs.
Some committees, working groups, or subgroups not only serve as consensus bodies but also may act in an advisory, organizational, or oversight capacity in the standards process. The provisions given in this document governing organization, membership, participation, and operations of consensus bodies do not apply to groups when not acting as consensus bodies.
3.3 AAMI Standards Board
The Standards Board approves any revisions to the AAMI Standards Program Policies and Procedures and directs and supervises AAMI consensus body activities relating to the national standards program.
The members of the Standards Board are AAMI's Standards Program Head of Department (HOD) (nonvoting), and eight or more additional experts appointed at the discretion of the Standards Program HOD. The membership of the Standards Board should reflect balanced representation of interest groups and individuals should have preferably served at least one term as a consensus body cochair. Two individuals, preferably representing different interests, co-chair the Standards Board.
The chairs of the Standards Board serve three-year terms that are renewable at the discretion of the Standards Program HOD. Members serve three-year renewable terms. Under normal circumstances, members should serve on the Standards Board for no more than two consecutive terms, although additional terms may be approved by the Standards Program HOD.
Standards Board member and chair appointments may be terminated at any time by the Standards Program HOD should it become evident that the individual 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 individual will receive written notification that the appointment has been terminated.
The Standards Board determines whether AAMI policies and procedures have been followed in the development of standards and TIRs. The Standards Board’s responsibilities also include the following:
a) advising the AAMI Standards Program HOD on the appointment of consensus body chairs;
b) reviewing the progress of consensus body work;
c) authorizing new projects
d) authorizing the initiation and termination of consensus bodies and consensus body activities;
e) endorsing new or revised policies related to standards work (but are other than the AAMI Standards Policies and Procedures) for approval by the Board of Directors; and
f) hearing appeals of consensus body decisions.
3.3.5 Conduct of meetings
SB meetings are run by the chairs or standards staff. A quorum of 50% of voting members is required for a meeting. Voting members who are not able to attend a meeting for final action on a consensus document but wish to communicate an abstention or objection can do so in accordance with 6.7.4.
Meetings are conducted in accordance with general parliamentary principles and procedures, with some decisions made by motion and vote.
3.4 AAMI Board of Directors
The Board of Directors serves as the final AAMI appellate body for disputes concerning membership, procedures, standards or TIRs.
3.5 AAMI staff
AAMI staff manages the program on a day-to-day basis, advising consensus bodies on AAMI policies and procedures, scheduling meetings, maintaining records, preparing documentation, editing technical documents, administering ballots, overseeing public review, and coordinating consensus body and Standards Board activities.
3.6 AAMI Committee on Standards Strategy
The Committee on Standards Strategy (CSS) is a strategic committee whose primary goal is the development of safe and effective healthcare technology products, processes, and services. Membership is invitation only and limited to corporate members of AAMI. Other AAMI members may be appointed at AAMI’s discretion. The chair of the Standards Board may be invited to participate as a non-voting member. There is no term limit for membership.
The CSS chair is selected by the Standards Program HOD from among the committee membership and serves a three-year term, which may be renewed once.
CSS member and chair appointments may be terminated at any time by the Standards Program HOD should it become evident that the individual 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 individual will receive written notification that the appointment has been terminated.