Equipment Maintenance Fact Sheet

Applicable Accreditation Standards

Labs must have a written plan for monitoring all in-lab patient-related equipment for electrical and mechanical safety. The written plan must include specific instructions regarding documentation of compliance in an equipment maintenance log. The plan must address monthly visual inspection of equipment by staff for apparent defects adhering to manufacturer’s recommendations for monitoring and maintenance of recording equipment; reported or detected failures of devices, sensors or processes must be categorized and analyzed for cause and a plan for preventing future failures must be documented; and annual electrical safety testing must be conducted by a certified electrician or biomedical engineer.  

Labs must have a written procedure for infection control including cleaning and inspecting all patient-related equipment; this includes sterilization, high-level disinfection, or the application of germicidal agents after each use that is consistent with the manufacturers’ recommendations, federal and state health policy regulations, and institutional standards. 

There must be a written plan for monitoring of all HSAT patient-related equipment for electrical and mechanical safety.

  1. The service location must have a written procedure for infection control including cleaning and inspecting all patient-related equipment; this includes sterilization, high-level disinfection, or the application of germicidal agents after each use that is consistent with the manufacturers’ recommendations, federal and state health policy regulations, and institutional standards. 
  2. All devices and sensors associated with a failed HSAT (e.g., no data, or corrupt data) must be tested for proper function prior to next use.
  3. Reported or detected failures of HSATs, sensors or processes must be categorized and analyzed for cause and a plan for preventing future failures must be documented.
  4. The service location must physically separate clean and dirty devices in compliance with its infection control plan.
  5. Specific instructions must exist for HSATs and sensor packing, shipping, and storage.
  6. Entities must have a policy in place that documents the procedure(s) used to delete all PHI and physiologic data from an HSAT following each use of the device. 

Each service location is to maintain a written policy describing all equipment maintenance procedures for both in-center and HSAT service, including infection control procedures. 

Definition of Medical Equipment

Medical equipment is defined as any patient-related equipment that is owned, borrowed, leased, consigned or equipment used for demonstration purposes and data collection (i.e. oxygen equipment, sensors, bands, oximeters, thermistors, beds, PAP equipment, emergency equipment (AED), HSAT equipment and biophysiological equipment, computers and equipment in the control room). 

Purpose of Equipment Maintenance

To ensure safety of patients and personnel as well as accurate and uninterrupted operation of all patient related equipment through routine inspection, ongoing maintenance and infection control procedures.  

Components of the Lab Equipment Maintenance Plan 

  • Lab staff must conduct a monthly visual inspection for defects, including:
    • Inspecting equipment for physical flaws (cracks, deformities, etc.) loose parts, damaged cords, or two-pronged plugs.
    • Conducting performance test to ensure proper lights, or tones during operation.
    • Documenting and removing faulty equipment for repair.
    • Logging failures for categorization and analysis for cause and creating a plan to prevent future issues. 
  • Annual electrical safety inspections are required for all patient-related equipment, conducted by a certified electrician or biomedical engineer.
  • All routine and annual inspections must be documented using an Equipment Maintenance Log, detailing:
    • Equipment details, inspection frequency, procedures, responsible staff member.
    • Location for maintaining monthly reports.
    • Annual reports must be signed by the certified electrician or biomedical engineer covering all patient-related equipment.
  • Procedure for infection control that include:
    • Cleaning and storage (e.g., clean vs dirty area)
    • Sterilization, high-level disinfection, or application of germicidal agents after each use, per manufacturer recommendations, OSHA or hospital guidelines. 

Components of an HSAT Equipment Maintenance Plan

The HSAT location must have a written plan for electrical and mechanical safety, including:

  • Reporting and documenting all devices and sensors linked to a failed HSAT. 
  • Logging failed devices (e.g.no data or corrupt data) on an Equipment Failure log.
  • Categorizing and analyzing detected failures to identify causes.
  • Documenting plans to prevent future failures 
  • Testing failed devices/sensors before their next use.
  • Infection control procedures, such as sterilization, disinfection or germicidal treatment, per manufacturer guidelines, OSHA or hospital guidelines.
  • Clear separation of clean and dirty devices.
  • Instructions for packing and shipping HSAT devices.
  • Procedures for deleting PHI and physiological data after each use.

Key Things to Keep In Mind

  • A single equipment maintenance plan covering procedures for both in-center and HSAT is acceptable.
  • The equipment maintenance plan should outline the roles and responsibilities of sleep staff in routine inspections.
    • Monthly inspection logs must list each piece of equipment individually and document the room assignment for each item; grouping equipment is not permitted.
    • Any faulty equipment should be removed and sent for repair by an authorized technician.
    • Reported or detected failures should be recorded on the failure log, categorized and analyzed to prevent future issues, and tested before the next use.
  • All patient-related equipment must receive an annual electrical safety inspection by a biomedical engineer or certified electrician. If manufacturer guidelines do not require electrical safety testing for specific equipment, the annual inspection must, at a minimum, document completion of a visual and functional assessment.
  • Both monthly and annual inspections must be documented on an equipment log to demonstrate compliance.
  • The service location should maintain at least two logs: a monthly visual inspection log and a failure log.
  • The procedure for deleting PHI may be included in the HSAT protocol.
  • Documentation of in-service training on any new equipment or upgrades must be completed before use on patients.