CAN CSA Z900.2.2:2017 pdf download.Tissues for transplantation
14.3.2.2.2 tion of surgical preparation for skin recovery, samples for microbial testing shall be taken before the tissue is exposed to any antibiotics, disinfecting chemicals, or sterilizing agents unless the suitability of the testing method(s) have been validated to account for inhibitory effect.
14.3.2.2.3 For tissues having positive testing results obtained before the tissue is exposed to any antibiotic-containing preparations, it is acceptable for transplantation if a suitable and validated protocol for disinfection is in place. The organisms found shall be identified to the genus level and the tissue shall be disinfected. Disinfection shall take place either during preparation or as part of a terminal sterilization event before transplantation. For skin tissue, the presence of normal skin flora before or after disinfection is acceptable for release.
The SOPs shall list the micro-organisms that, if found, would necessitate discard of the tissue, unless tissue will be subsequently sterilized with a process validated to eliminate the infectivity of the micro-organism. The list shall be based upon not only the type of tissue but also the method by which the tissue was prepared (e.g., cryopreserved tissues that cannot be sterilized and can only be disinfected).
Note: Programs that disinfect tissues with antibiotics and/or antifungals should validate the rinsing process to ensure there are no inhibitory effects of carryover antimicrobials present in the sample tested that could impact the detection of pathogenic bacteria or fungi.
14.3.2.5.1 The medical director or designate shall review the results of all cultures for each tissue. Evaluation of the safety of that tissue shall be determined before the tissue is released for transplantation. The medical director or designate shall document the suitability of a tissue donor before tissues are released.
14.3.2.5.2 Tissues failing to meet the suitability criteria outlined in the SOP manual shall not be used. Suitability criteria shall include a list of unacceptable micro-organisms if identified pre-, post-, or in-processing. The SOPs shall list the micro-organisms that, if detected, would render the tissue not suitable for release. The list should be based upon the type of tissue and the method by which the tissue was prepared (e.g.,cryopreserved tissues that cannot be sterilized and can only be disinfected).
14.3.2.6.1 For each preparation step in which tissue is unwrapped and rewrapped, microbial testing should be performed to rule out contamination during the procedure, unless the tissue is processed using a validated sterilization method or appropriate final packaging sterility testing is performed. Any occurrence of contamination shall be documented in the donor record.CAN CSA Z900.2.2 pdf download.