Chapter 14 - Biomedical Engineering

5-14.1 PURPOSE

This issuance establishes policy, objectives, authority, responsibilities and program elements for the Indian Health Service (IHS) Biomedical Engineering Program.

It is Indian Health Service policy that a functional Biomedical Engineering Program, as defined in this issuance, shall be maintained at all IHS Program levels to:

1. Support direct patient care through application of biomedical engineering technology in the health care environment.
2. Provide professional/technical consultation related to biomedical engineering technology and biomedical equipment.
3. Develop and manage resources available to the Biomedical Engineering Program.

1. Biomedical Engineer: Person with training and expertise, analogous to that of a professional engineer, in at least one engineering discipline and with specific training in the life sciences, physiology, medical terminology, medical electronics, biomedical equipment and clinical patient care.
2. Biomedical Engineering Program: The practice of professional engineering applied to the health sciences; specifically, the practice of engineering applied to health care environments, clinical practices and procedures, and biomedical equipment used to provide direct patient care.
3. Biomedical Engineering Technician (BMET): Person with training and experience in biomedical engineering technology who implements Biomedical Engineering Program activities.
4. Biomedical Equipment: Property intended exclusively for USE by health care professionals and paraprofessionals, in health care environments , to provide direct patient care.

1. Director, Indian Health Service, shall:
   1. Direct the establishment and implementation of an IHS Biomedical Engineering Program.
   2. Ensure that an equitable portion of the funds appropriated to the IHS be allocated for the 1HS Biomedical Engineering Program.
   3. Ensure that Area Directors identify resources and provide support for Biomedical Engineering Program implementation at- a11 program levels.
2. Associate Director, Office of Environmental Health and Engineering (OEHE), shall:
   1. Ensure that the Director, Division of Facilities Management (DFM) has management flexibility/support and resources necessary to develop and implement the IHS Biomedical Engineering Program.
   2. Ensure the formulation and submission of a Biomedical Engineering Program budget for annual budget cycles.
3. Director, Division of Facilities Management (DFM), shall:
   1. Ensure that an IHS Biomedical Engineering Program is developed, implemented .and effectively administered.
   2. Submit an annual IHS Biomedical Engineering Program budget to Associate Director, OEHE.
   3. Ensure that the Biomedical Engineer, IHS, has management flexibility and support necessary to implement the IHS Biomedical Engineering Program.
4. Biomedical Engineer, IHS shall:
   1. Develop, implement, coordinate, manage, and evaluate I he IHS Biomedical Engineering Program.
   2. Provide guidance and assistance to each Area to establish and implement an effective Biomedical Engineering Program in compliance with IHS Biomedical Engineering Program policy.
   3. Develop technical handbooks and standardized documentation systems to assist Area implementation of the Biomedical Engineering Program elements.
   4. Review each Area Biomedical Engineering Program to evaluate compliance with IHS Biomedical Engineering Program policy.
   5. Prepare and submit an annual IHS Biomedical Engineering budget justification to the Director, DFM.
   6. Participate with IHS Headquarters components in development of program related policies/funding mechanisms such as resource modules (i.e., RRM, ARAM/SURAM, etc.), automated management information systems and facilities/equipment planning methodologies.
   7. Be the principal technical consultant to IHS staff on laws, policies, regulations, standards, codes, etc. pertaining to biomedical equipment, systems, and technology.
   8. Develop, review and recommend changes to IHS policies, guide1ines, and methodologies that affect the Biomedical Engineering Program.
5. Area Director shall:
   1. Establish an operational Area Biomedical Engineering Program with a designated Chief.
   2. Establish recurring funding mechanisms for the Biomedical Engineering Program.
   3. Ensure that Service Unit Directors and Public Law 93-638 Project Officers identify resources and provide support for Biomedical Engineering Program implementation.
6. Area Chief, Biomedical Engineering Program, shall:
   1. Implement a functional Area Biomedical Engineering Program and develop procedures consistent with IHS Biomedical Engineering Program policy.
   2. Provide technical supervision to all Biomedical Engineering personnel within the Area.
   3. Review each Service Unit Biomedical Engineering Program to evaluate compliance with the IHS and Area policy and procedures.
   4. Serve as principal technical consultant to Area and Service Unit staff on matters relating to the Biomedical Engineering Program.
   5. Serve as Project Officer on all biomedical equipment service contracts within the Area.
   6. Review and recommend approval on requests for acquisition of biomedical equipment within the Area.
   7. Review and approve design modifications to existing biomedical equipment.
   8. Have authority to remove defective biomedical equipment from service.

Program elements outline the minimum functions to be performed at all Program levels to comply with the IHS policy to:

1. Support direct patient care through application of biomedical engineering technology in the health care environment. This is accomplished by:
   1. Equipment Control
      1. Equipment inventory
      2. Incoming inspection
      3. Preventive maintenance programs
      4. Electrical safety inspection
      5. Repairs
      6. Hazard alert/recall reporting system
      7. Quality assurance
      8. Parts inventory
      9. Equipment labeling
      10. Equipment service/operators manuals
      11. Vendor service
      12. Life-expectancies
      13. Condition coding
      14. Replacement
      15. Documentation systems
          1. Historical records
          2. Work orders
          3. Written preventive maintenance plan
          4. Cost accounting
   2. Operator Education and In-Service Training
      1. Employee orientation
      2. New equipment operation/functions/care
      3. Existing equipment operation/functions/care
      4. Equipment electrical safety
      5. Recommended Training Modes
         1. Formal classes
         2. Informal demonstrations
         3. Audio/Visual programs
         4. User/Operator instruction manuals
         5. Abbreviated operation instructions, troubleshooting procedures
         6. Vendors
   3. Biomedical Equipment Acquisition
      1. Planning
         1. Annual, biennial, 5-year plan
         2. Replacement equipment
         3. Additional equipment
         4. Equipment committee participation
      2. Prepurchase evaluations
      3. Review and approval recommendations
         1. Requisitions
         2. Specifications
         3. Bids
2. Provide professional/technical consultation related to biomedical engineering technology and biomedical equipment.
   1. Accreditation
   2. Laws, codes, and standards
   3. Equipment modifications
   4. Facilities construction/renovation plans
   5. Service contracts
   6. Safety
   7. Infection control
   8. Supplies/disposables
   9. Quality Assurance
3. Develop and manage resources available to the Biomedical Engineering Program.
   1. Budget
      1. Planning
      2. Distribution
      3. Utilization
   2. Staffing/positions
   3. Space
   4. Test equipment and devices
   5. Training
      1. Proficiency
      2. Career development
   6. Technical library