SECTION 117.31. Equipment

(a) All equipment used by a facility, including backup equipment, shall be FDA approved, operated in accordance with the manufacturer's direction for use, and maintained free of defects which could be a potential hazard to patients, staff, or visitors. Maintenance and repair of all equipment shall be performed by qualified staff or contract personnel.

(1) Staff shall be able to identify malfunctioning equipment and report such equipment to the appropriate staff for immediate repair.

(2) Medical equipment that malfunctions shall be clearly labeled and immediately removed from service until the malfunction is identified and corrected.

(3) A record of all maintenance and repairs shall be maintained.

(4) After repairs or alterations are made to any equipment or system, the equipment or system shall be thoroughly tested for proper operation and disinfected before returning to service.

(5) A facility shall comply with the Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC), §360i(b), concerning reporting when a medical device as defined in 21 USC §321(h) has or may have caused or contributed to the injury or death of a patient of the facility.

(6) Completion of the requirements listed in paragraphs (1) - (5) of this subsection shall be documented on the facility's equipment or system repair log.

(b) A facility shall develop, implement, and enforce a written preventive maintenance program to ensure patient care related equipment used in a facility or provided by a facility for use by the patient in the patient's home receives electrical safety inspections, if appropriate, and maintenance at least annually or more frequently in accordance with the manufacturer's direction for use. The preventive maintenance may be provided by facility staff or by contract personnel.

(c) At least one complete dialysis machine shall be available on site as backup for every ten dialysis 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.

(d) If pediatric patients are treated, a facility shall use equipment and supplies, to include blood pressure cuffs, dialyzers, and blood tubing, appropriate for this special population.

(e) All equipment and appliances shall be properly grounded in accordance with the National Fire Protection Association 99, Standard for Health Care Facilities, §4.3.2.2.2, 2002 Edition (NFPA 99), published by the NFPA. All documents published by the NFPA as referenced in this section may be obtained by writing or calling the NFPA at the following address and telephone number: National Fire Protection Association, 1 Batterymarch Park, Quincy, Massachusetts 02269-9101 or [phone].

(f) An ESRD facility shall have emergency equipment and supplies immediately accessible in the treatment area.

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

(A) oxygen;

(B) ventilatory assistance equipment, to include airways, manual breathing bag, and mask;

(C) suction equipment;

(D) supplies specified by the medical director; and

(E) automated external defibrillator.

(2) If pediatric patients are treated, 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) A facility shall establish, implement, and enforce a policy for the 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 §117.31 adopted to be effective July 6, 2010, 35 TexReg 5835