Compilation of Rules and Regulations of the State of Georgia › Department 111 - RULES OF DEPARTMENT OF COMMUNITY HEALTH › Chapter 111-8 - HEALTHCARE FACILITY REGULATION › Subject 111-8-22 - END STAGE RENAL DISEASE FACILITIES › Rule 111-8-22-.13 - Hemodialyzer Reuse

Current through Rules and Regulations filed through June 27, 2024
(a) Facilities processing dialyzers for reuse
				shall adhere to the current American National Standard, Reuse of Hemodialyzers,
				published by the Association for the Advancement of Medical Instrumentation
				(AAMI), which are incorporated herein by reference.
(2) The facility practicing reuse shall
				provide each patient with information regarding the reuse practice at the
				facility and an opportunity to ask questions regarding the reprocessing of
				dialyzers, and shall obtain written informed consent from the patient, or the
				patient's representative, if applicable, for the use of a reprocessed dialyzer
				for the patient's hemodialysis.
(3)
				The facility shall develop and implement policies and procedures for dialyzer
				reprocessing which include but are not limited to criteria for determining the
				safe and useful life of a dialyzer, procedures for documenting the reprocessing
				history of each dialyzer, and procedures for documenting maintenance and
				monitoring of the functioning of the reprocessing equipment. If the facility
				uses an offsite reprocessing service, the facility shall have policies and
				procedures regarding the coordination of this service with the handling of
				dialyzers within the facility, to ensure adequate documentation of the storage
				and transport of the dialyzers from the time they are re- moved from the
				dialysis machine to the time they are returned to the facility.
(4) The facility shall limit access to the
				reprocessing room to authorized personnel.
(5) The reprocessing room shall have a
				ventilation system, which is connected to an exhaust system vented to the
				outside, with a fan at the outside end to direct discharge of air outward. The
				exhaust outlet shall be arranged to minimize recirculation of the exhausted air
				into the building.
(6) The system
				providing water for reprocessing must meet all the requirements for pressure,
				flow rate, bacteriological and pyrogenic contamination, and other requirements
				for operating the reprocessing equipment under minimal and peak load
				conditions.
(7) If a facility
				utilizes an off-site reprocessing service, the facility shall be responsible
				and accountable for the safety and effectiveness of the reprocessing of the
				dialyzers. Such arrangements must be by written contract requiring that:
(a) The reprocessing services comply with the
				American National Standard, Reuse of Hemodialyzers, published by the
				Association for the Advancement of Medical Instrumentation (AAMI), in its
				current edition:
(b) The
				individuals performing the reprocessing meet training and competency standards
				equivalent to or exceeding those required for reuse technicians at the end
				stage renal disease facility;
(c)
				The service implements a continuous quality improvement program to monitor the
				effectiveness and safety of reprocessing procedures;
(d) There are provisions for transport of the
				dialyzers to and from the reprocessing site which are adequate to prevent
				contamination or deterioration; and
(e) The off-site reprocessing location shall
				be available during regular business hours for inspection of reprocessing
				procedures by representatives of the Department.