Rule 111-8-22-.13 - Hemodialyzer Reuse(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.Ga. Comp. R. & Regs. R. 111-8-22-.13
O.C.G.A. § 31-44-3.
Original Rule entitled "Hemodialyzer Reuse" adopted. F. Feb. 20, 2013; eff. Mar. 12, 2013.