June 02, 2016

This Special General Memorandum (SGM) establishes Indian Health Service (IHS) policy on the minimum standards for medical equipment management, purchase, maintenance, and replacement to ensure quality care.

My expectations for IHS Headquarters, Area Offices, and Service Units are that they effectively manage the medical equipment program and take proactive steps to identify and mitigate risks.  Medical equipment is a vital component in the delivery of quality health care.  By proactively planning and managing medical equipment to Centers for Medicare and Medicaid Services (CMS) standards and other applicable accreditation standards, IHS will create a strong foundation for the delivery of high quality health care to the Native American community.

Medical Equipment Management and Maintenance

Direct management, repair, replacement, and procurement of medical equipment is accomplished at the Area Offices and Service Units.  The IHS will use 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 and maintenance.  This standard includes:

1. Maintaining an inventory of Service Unit medical equipment, including useful life timeframes.  In order to achieve this standard, the Area Offices and Service Units shall utilize WebTMA, the IHS-standardized computerized maintenance management system, for the medical equipment inventory.  However, WebTMA does not replace the Property Management Information System (PMIS), which is the official property system to track all accountable property in IHS.
2. Following manufacturers' maintenance recommendations, procedures, and frequencies (or approved alternative when allowed) for all medical equipment.
3. Maintaining and/or monitoring the credentials of all persons providing maintenance on medical equipment.

Medical Equipment Procurement and Replacement

Medical equipment should be replaced at the end of its useful life.  Equipment useful life tables, such as the American Hospital Association Estimated Useful Lives of Depreciable Hospital Assets, will be used as the IHS operating standard for when to replace medical equipment.

Area Offices and Service Units should also consider other factors which affect medical equipment useful life as outlined by the American Society for Healthcare Engineering:

1. Equipment no longer meets government or manufacturer safety standards.  If an item of equipment no longer meets the manufacturer's safety standards, it must immediately be removed from service.  This is especially relevant to medical devices that are used for direct patient care.
2. Maximum maintenance expenditure limits.  When an individual maintenance/repair cost exceeds 50 percent of the replacement cost it is typically more economically and operationally effective to replace the equipment.
3. Availability of repair parts.  The availability of repair parts meeting the manufacturer's specifications is essential in keeping equipment serviceable.  Even though a piece of equipment is relatively new, its life can be shortened if repair parts are no longer available.
4. Obsolescence that inhibits or prohibits modern medical practice.  Out-of-date medical equipment will need to be upgraded to remain at the leading edge of technology and clinical practice.
5. Reliability of equipment.  If an item of equipment has a high incidence of breakdowns affecting its availability, it should be considered for replacement.
6. Availability of new technology.  As medical technology is constantly advancing, the capacity for equipment to be upgraded must be considered.

Area Offices and Service Units shall use these factors when developing their medical equipment management plans and annual acquisition plans for new/replacement medical equipment.  Area Offices and Service Units shall ensure funds are prioritized for this purpose.  Appropriated funds, as well as, third-party reimbursement funds should be used for the purpose of ensuring equipment is well maintained and replaced in accordance with the guidelines noted above.  If Area Offices and/or Service Units are not able to comply with CMS standards and other applicable accreditation standards, the Director, Office of Environmental Health and Engineering (OEHE) at IHS Headquarters is to be notified.  The OEHE Director will ensure the IHS Director is notified.

When procuring medical equipment, Area Offices should standardize on single manufacturers where practical and consolidate purchases where feasible.  Using multiple different vendors for a type of medical equipment is not optimal.

Biomedical Equipment Governance Committee

Per the Indian Health Manual, Part 5, Chapter 14, "Clinical Engineering Program," dated September 23, 2015, Area Offices and Service Units are to establish Biomedical Equipment Governance Committees to oversee major medical equipment purchases, develop strategies to field new technologies and address health disparities, overcome delays/obstacles in fielding new/replacement equipment, evaluate infrastructure upgrades to support new equipment, etc.

The Area Biomedical Equipment Governance Committee will manage risks, priorities, and funding.  From these Area Biomedical Equipment Governance Committees, critical medical equipment issues and risks should flow to the IHS Headquarters leadership through OEHE to provide guidance and direction.

Area Offices are directed to hold an Area Biomedical Equipment Governance Committee meeting by June 30, 2016, and semi-annually thereafter.  For each Governance Committee meeting, Area staff will generate a report from the WebTMA equipment inventory that identifies new/replacement equipment needs for each Service Unit per the criteria outlined above.  A Governance Committee meeting report is to be provided to the Headquarters OEHE Director within 30 days that documents the decisions of the Governance Committee.  The report should include the planned equipment purchases and/or repairs, completion dates, any urgent/end of useful life equipment issues not addressed and a copy of the WebTMA equipment inventory.  A standard report format will be provided.

Effective Date

This SGM becomes effective on the date signed by the Principle Deputy Director, IHS.