1. (a) All equipment used by a facility, including backup equipment, shall be approved by the United States Food and Drug Administration (FDA), operated in accordance with the manufacturer's direction for use, and maintained free of defects that could be a potential hazard to patients, staff, or visitors. Qualified staff or contract personnel shall perform maintenance and repair of all equipment.

   1. (1) Staff shall be able to identify malfunctioning equipment and immediately report such equipment to the appropriate staff for repair.
   2. (2) Staff shall clearly and immediately label medical equipment that malfunctions and promptly remove the equipment from service until the facility ensures identification and correction of the malfunction.
   3. (3) A facility shall maintain a record of all maintenance and repairs.
   4. (4) After the facility ensures necessary repair or alteration to any equipment or system, the facility shall thoroughly test the equipment or system for proper operation and disinfect the equipment or system before returning the equipment or system to service.
   5. (5) A facility shall comply with the Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §360i(b) (relating to Records and Reports on Devices), concerning reporting when a medical device, as defined in 21 USC §321(h) (relating to Definitions; Generally), has or may have caused or contributed to the injury or death of a patient of the facility.
   6. (6) A facility shall document completion of the requirements listed in paragraphs (1) - (5) of this subsection on the facility's equipment or system repair log (electronic or paper).
2. (b) A facility shall develop, implement, and enforce a written preventive maintenance program to ensure patient care related equipment used in the facility, or provided by the facility for use by a patient in the patient's home, receives electrical safety inspections, when appropriate, and maintenance at least annually, or more frequently in accordance with the manufacturer's direction for use. Facility staff or contract personnel may provide the preventive maintenance.
3. (c) At least one complete dialysis machine shall be available on site as backup for every 10 machines in use. At least one of these backup machines shall be completely operational during hours of treatment. Machines not in use during a patient shift may be counted as backup except at the time of an initial or an expansion survey.
4. (d) A facility shall annually inspect equipment with internal transducer protectors to ensure the equipment is not contaminated. If the transducer protector is wetted or fluid or blood is visible, the facility must follow instructions as described in §507.36 of this subchapter (relating to Infection Control).
5. (e) If a facility treats pediatric patients, the facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.
6. (f) All equipment and appliances shall be properly grounded in accordance with the National Fire Protection Association (NFPA 99), Standard for Health Care Facilities, §4.3.2.2.2, 2002 Edition.

7. (g) A facility shall have emergency equipment and supplies immediately accessible in the treatment area.

   1. (1) At a minimum, the emergency equipment and supplies shall include:

      1. (A) oxygen;
      2. (B) ventilatory assistance equipment, to include airways, manual breathing bag, and mask;
      3. (C) suction equipment;
      4. (D) supplies specified by the medical director; and
      5. (E) automated external defibrillator.
   2. (2) If a facility treats pediatric patients, the facility shall have the appropriate type and size emergency equipment and supplies listed in paragraph (1) of this subsection for this special population.
   3. (3) A facility shall establish, implement, and enforce a policy for periodic testing and maintenance of the emergency equipment. Staff shall properly maintain and test the emergency equipment and supplies and document the testing and maintenance.

Source Note:The provisions of this §507.31 adopted to be effective December 23, 2025, 50 TexReg 8289.