Compliance News: Manufacturer's Maintenance Recommendations - Alternatives Accepted by CMS

By Dean Samet, CHSP


The Joint Commission accredited hospitals, critical access hospitals, and ambulatory care programs can breathe a sigh of relief.  As reported in the December 2010 The Joint Commission Perspectives®, TJC engaged the Centers for Medicare & Medicaid Services (CMS) in a collaborative exchange to explain its viewpoint on why it is important to allow health care organizations to continue to employ TJC standards’ three criteria for scheduled maintenance activities for medical equipment and for utility systems.


The criteria consist of manufacturer’s recommendations, risk levels associated with the equipment, as well as hospital experience (see applicable TJC standards and elements of performance below along with yet to be revised CMS Interpretive Guidelines).  According to the Perspectives article, CMS agreed!


EC.02.04.01, EP4: The hospital identifies, in writing, frequencies for inspecting, testing, and maintaining medical equipment on the inventory based on criteria such as manufacturer’s recommendations, risk levels, or current hospital experience. 


EC.02.05.01, EP4: The hospital identifies, in writing, intervals for inspecting, testing, and maintaining all operating components of the utility systems on the inventory, based on criteria such as manufacturer’s recommendations, risk levels, or hospital experience.


CMS State Operations Manual, Appendix A - Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, Transmittal 37, Date: October 17, 2008:


§482.41(c)(2)-Facilities, supplies, and equipment must be maintained to ensure an acceptable level of safety and quality.


Interpretive Guidelines §482.41(c)(2)-Equipment includes both facility equipment (e.g., elevators, generators, air handlers, medical gas systems, air compressors and vacuum systems, etc.) and medical equipment (e.g., biomedical equipment, radiological equipment, patient beds, stretchers, IV infusion equipment, ventilators, laboratory equipment, etc.).


There must be a regular periodical maintenance and testing program for medical devices and equipment. A qualified individual, such as a clinical or biomedical engineer or other qualified maintenance person, must monitor, test, calibrate and maintain the equipment periodically in accordance with the manufacturer’s recommendations and Federal and State laws and regulations.  Equipment maintenance may be conducted using hospital staff, contracts or through a combination of hospital staff and contracted services.


TJC’s equipment management process is comprised of three parts:


1. Create and manage an accurate inventory.


2. Evaluate what maintenance strategy is most beneficial, such as predictive maintenance, reliability-centered maintenance, interval-based inspections, corrective maintenance, or metered maintenance.


3. Establish maintenance activities based on the manufacturer’s recommendations, risk levels of the equipment, and hospital experience.


TJC’s successful argument and reasoning was that “Occasionally manufacturer’s recommendations are labor and parts excessive with little or no recognized benefit to the patients’ care or safety.” TJC claims that its “process is much more cost-effective, reasonable, and relies on the expertise of the maintainers and users in managing both clinical equipment and facilities equipment.”