Medical Equipment

Refer to: OEHE

1. PURPOSE.  This circular establishes the Indian Health Service (IHS) policy on the minimum standards for medical equipment management, maintenance, and procurement to ensure quality care.  The IHS Area Offices and Service Units will effectively manage medical equipment programs and take proactive steps to identify and mitigate risks for safe and effective health care delivery.  By proactively planning and managing medical equipment to Centers for Medicare & Medicaid Services (CMS) standards and other applicable accreditation standards, the IHS will create a strong foundation for delivering high-quality health care to American Indians and Alaska Natives.
2. MEDICAL EQUIPMENT MANAGEMENT AND MAINTENANCE.  Area Offices and Service Units shall accomplish the direct management, maintenance, and procurement of medical equipment by:
   1. Utilizing IHS-standardized Computerized Maintenance Management System (IHS CMMS) and the Center for Clinical Standards and Quality/Survey & Certification (S&C) Group, CMS Standard S&C 14-07 - Hospital, Hospital Equipment Maintenance Requirements, for medical equipment management, maintenance, and inventory.  The IHS CMMS does not replace the Property Management Information System, which is the official property tracking system for accountable property that is IHS-owned.  The IHS CMMS inventory of medical equipment must include the IHS mandatory fields indicated in Circular Exhibit 24-05-A.
   2. Following manufacturers’ maintenance recommendations, procedures, and frequencies (or approved alternative).
   3. Maintaining and/or monitoring the credentials of all persons providing maintenance on medical equipment.
   4. Ensuring IHS CMMS user access is limited to the least required privilege by roles and responsibilities.
   5. Coordinating the migration of new and existing medical devices by utilizing network connectivity into specialized medical device Virtual Local Area Networks with the least required network access as part of network segmentation efforts.
   6. Ensuring service contracts are in place for newly leased or purchased medical devices that require vendor support as per applicable legislative or regulatory requirements, Federal Executive Orders, binding operational directives, emergency directives, and Office of Management and Budget memorandums and cybersecurity requirements.
   The IHS CMMS Coordinator assists Area Offices and Service Units in conjunction with the IHS Headquarters and Area Clinical Engineering Program lead personnel, in maintaining the integrity and validity of the IHS CMMS medical equipment inventory.
3. MEDICAL EQUIPMENT PROCUREMENT AND REPLACEMENT.  It is important to emphasize the application of new technologies and medical devices to enhance the delivery of health care.  New technologies and medical devices improve patient experiences, increase productivity, reduce costs, enhance supply chain management and inventory control, improve detection of illnesses, and also help patients better understand their condition, treatment options, and likely outcomes.

   The procurement process must focus on replacing medical equipment at the end of useful life.  The IHS uses the American Hospital Association Estimated Useful Lives of Depreciable Hospital Assets publication as the IHS standard for calculating approximate “end of useful life” dates.  The IHS Area Offices and Service Units should also consider other factors that affect the useful life of medical equipment as outlined by the American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI EQ56:2013) Recommended Practice for a Medical Equipment Management Program:

   “The health care organization shall develop equipment replacement plans when it becomes difficult to find suitable replacement parts in a timely manner.  An “End of Support” or “End of Life” letter from the manufacturer does not automatically signal that a shortage of replacement parts is imminent, but it should trigger a careful evaluation of parts and technical support availability in the future.

   The health care organization may include other criteria when deciding whether to replace or retire equipment, such as the dependability of the equipment, the cost of ownership, and compatibility (i.e., sterilization modalities, interface with information systems, etc.).”

   When procuring medical equipment, Area Offices should standardize on single manufacturers where practical and consolidate purchases where feasible.

   Area Offices and Service Units shall use this guidance to develop their medical equipment management plans and annual acquisition plans for new and replacement medical equipment.  The IHS Clinical Engineering program has a copy of the above guidance available for use by the Area Offices and Service Units.  The IHS Facilities Appropriation sub-budget activity for medical equipment, IHS Services Appropriation, and collections funding may be available – subject to appropriations restrictions – to ensure equipment is well maintained, replaced in accordance with the guidelines noted above, and for the application of new medical equipment technologies.

   Administrative provisions in the annual IHS Appropriation authorizes the use of both IHS Services Appropriation and IHS Facilities Appropriation for the purchase of medical equipment.  The primary source of medical equipment funding is the IHS Facilities Appropriation equipment funding.  However, IHS Service Units can use Services funding or collections if their Facilities Appropriation equipment funding is already obligated or expensed.  The IHS Area Directors and IHS Service Unit Chief Executive Officers should consider using available funding sources to purchase medical equipment for healthcare services to help ensure the highest possible level of health care can be provided.

   The IHS Area Offices or Service Units should notify the Director, Office of Environmental Health and Engineering (OEHE), at IHS Headquarters if they are not able to comply with applicable accreditation standards for the provision of health care.  The OEHE Director will raise these concerns through IHS leadership as appropriate.

4. BIOMEDICAL EQUIPMENT GOVERNANCE COMMITTEE.  The IHS Area Offices are required to hold, at a minimum, two Area Biomedical Equipment Governance Committee meetings per year.

   Per the Indian Health Manual (IHM), Part 5, Chapter 14, “Clinical Engineering Program,” Biomedical Equipment Governance Committees oversee medical equipment purchases, develop strategies to field new technologies to address health disparities, overcome delays/obstacles in fielding new/replacement equipment, and evaluate infrastructure upgrades to support new equipment, etc.  The Area and Service Unit Biomedical Equipment Governance Committees manage risks and prioritize medical equipment purchases.

   For each meeting, the Governance Committee will review Service Units’ medical equipment acquisition requests to generate a report that identifies their medical equipment needs and documents Governance Committee decisions.  The report should include the planned equipment purchases, projected completion dates, and urgent equipment issues.  Area staff shall provide the report to the Headquarters OEHE Director within 30 days of the meeting.

   For Area Offices with IHS-operated health care facilities, by October 31 of each year, the Area Director will submit a Certification Statement, Circular Exhibit 24-05-B, to the Headquarters OEHE Director to ensure compliance with this Circular.

5. SUPERSEDURE.  This IHS Circular supersedes Special General Memorandum 16-02, Medical Equipment, dated June 2, 2016.
6. EFFECTIVE DATE.  This IHS Circular is effective upon the date of signature.

Distribution: IHS-wide
Date: 03/27/2024