Section 75207 - Disinfectant Rinsing(a) If a disinfectant chemical other than formaldehyde is used, a process validation to assess and assure the safety and effectiveness of the disinfectant rinsing procedure shall be performed and the results submitted to the Department for approval prior to use as a disinfectant rinsing procedure for the reprocessing of dialyzers; otherwise, the remainder of the subsections contained in this section shall apply. Within 30 days of receipt of the request for approval of a rinsing procedure for an alternative disinfectant chemical, the Department shall inform the applicant, in writing, that the request is complete and accepted for consideration or that the request is deficient and what specific information is required. The Department shall approve or disapprove the request within 90 days of receipt.(b) Alternative procedures for the rinsing of disinfectant chemicals complying with Section 75206(b) may be used, if the following requirements are met: (1) The labeling of the disinfectant chemical(s) shall include procedures and adequate directions for use for disinfectant rinsing of dialyzers.(2) The maximum residual limit which defines the limit for patient safety given acute and long-term exposure to the disinfectant chemical shall be specified on the disinfectant chemical labeling.(3) A test method for detecting the residual limit shall be specified on the disinfectant chemical labeling and shall be used by the dialysis facility. No dialyzer shall be used when tests indicate an amount of disinfectant chemical residual greater than the minimum residual limit required under (2) above.(c) The dialyzer shall be released from storage and rinsed of disinfectant chemical upon scheduled order for patient treatment.(d) The blood compartment rinsing solution shall be sterile and nonpyrogenic, and shall not degrade the structure of the dialyzer.(e) If the disinfecting solution is formaldehyde, the dialyzer shall be subjected to a rinsing procedure until the disinfectant is no longer detectable as indicated by testing the blood compartment effluent of the dialyzer with a reagent capable of detecting at least three (3) ppm.(f) The result(s) of the disinfectant chemical residual test shall be recorded in the Device History Record. A positive test shall be an indication not to release the dialyzer for patient dialysis treatment, however it may be subjected again to the rinsing procedure and retested.(g) The reprocessing technician shall indicate on the dialyzer label and in the Device History Record by appropriate initials that the dialyzer is ready for patient treatment. The date of disinfectant rinsing shall also be logged in the Device History Record.(h) The rinsing solution in the blood compartment shall be purged from the dialyzer and refilled with a fresh solution immediately prior to the dialysis treatment except where the validation process has accounted for the time between disinfectant testing and patient treatment.Cal. Code Regs. Tit. 22, § 75207
1. New section filed 4-8-87; effective thirtieth day thereafter (Register 87, No. 16). Note: Authority cited: Sections 208(a), 417.10, 1225 and 1275, Health and Safety Code. Reference: Sections 417.10- 417.15, 1226 and 1276, Health and Safety Code and Section 15376, Government Code.
1. New section filed 4-8-87; effective thirtieth day thereafter (Register 87, No. 16).