Equipment Maintenance Fact Sheet 2017-12-20T16:15:23+00:00

Equipment Maintenance Fact Sheet

Definition of Medical Equipment

Medical equipment is defined as any patient-related equipment that is facility owned, borrowed, leased, consigned or equipment used for demonstration purposes and data collection (i.e. oxygen equipment, sensors, bands, oximeters, thermistors, beds, PAP equipment and biophysiologic equipment).

Purpose of Equipment Maintenance

A routine schedule for the inspection and maintenance of all patient-related equipment helps ensure the safety of patients and personnel as well as accurate and uninterrupted operation.

Components of Equipment Maintenance

  • A routine visual inspection for apparent defects must be completed by staff at least monthly. Inspection includes the following:
    • Inspection of the physical condition of equipment for flaws, cracks deformities, tears or any other visually apparent defects.
    • Inspection for loose knobs or switches, frayed or cracked power cords, loose or broken plug pin, loose power plug or any medical equipment with a two-pronged plug.
    • Ensure that equipment is labeled with a current electrical safety inspection sticker.
    • Complete performance test checking for appropriate lights or tones when unit is operated. If any problems are noted, remove equipment, tag appropriately and send for repair by an authorized technician. A plan for preventing future failures must be documented.
    • Procedures for infection control including sterilization and high-level disinfection that is consistent with manufacture’s recommendation.
    • Separation of clean and dirty devices in compliance with the infection control plan.
  • Electrical safety testing by a certified technician or biomedical engineer needs to be conducted at least annually or more frequently to adhere to manufacturer’s recommendations.
  • A written plan that includes specific instructions regarding documentation of compliance in an Equipment Maintenance Log must be kept. Documentation of compliance on the Maintenance Log will include:
    • Each piece of equipment.
    • Frequency of inspection.
    • Procedure for inspection.
    • Who performs inspection, and where monthly reports are filed.
    • Annual report signed by certified electrician or biomedical engineer which includes all patient related equipment.

Applicable Accreditation Standards

The facility must have a written plan for monitoring of all 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; and annual electrical safety testing by a certified electrician or biomedical engineer.

  1. The facility must have a written procedure for infection control including cleaning and inspecting 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 test (e.g. no data, inadequate data, or corrupt data) must be removed from service and tested for proper function prior to next use.
  3. 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.
  4. The facility must physically separate clean and dirty devices in compliance with its infection control plan.

Key Things to Keep In Mind

  • Routine visual inspection of all patient-related equipment needs to be performed at least monthly.
    • A policy should address the role of the sleep technician, or indicate who performs visual inspection.
  • Electrical and mechanical inspection by a certified electrician or biomedical engineer needs to be performed yearly.
  • Equipment should be tested for proper function; failures categorized and analyzed for cause to prevent future failures.
  • Remove equipment that may be faulty and send for repairs by an authorized technician.
  • Both monthly inspection and annual inspection needs to be documented for compliance.
  • Documentation of in-service on any new equipment or equipment upgrades must be completed prior to use on patients.