This AAMI Recommended Practice applies to any entity responsible for the management of medical equipment used as part of the routine care of patients, including health care organizations as a whole divisions and departments within health care organizations, and outside vendors such as medical equipment manufacturers, shared service providers, and independent service organizations.
This AAMI Recommended Practice specifies required characteristics for a management program designed to minimize certain risks associated with equipment that is used in a health care organization during routine care of patients. The document addresses the structure of such a program, the documentation that must be produced by the program, program staffing, and resources that should be allocated to those responsible for maintaining medical equipment. Definitions of terms and normative references are also included, as are notes and rationale that expand the provisions of the document.
This AAMI Recommended Practice does not cover training needs of equipment users, nor does it cover competency assessment of the users of equipment included in the equipment management program. Rationale: This recommended practice focuses on medical equipment acquisition and maintenance, but consideration of other aspects of equipment management is also a requisite for a complete program. In most health care organizations, however, clinical engineers and biomedical equipment technicians are directly involved in equipment acquisition and maintenance, while the responsibility for other activities, such as training in the use of equipment, is delegated to others within the health care organization.
The expertise of the members of the AAMI Equipment Management Committee was primarily in the acquisition and maintenance of medical equipment. While some members had much broader experience, the Committee as a whole did not feel comfortable identifying requirements for other aspects of a complete equipment management program.