Guidance Document - American Association of Tissue Banks

Q10. Does the sterilizer that is used to perform final sterilization of tissue recoveryinstruments need to be "validated"? Are manufacturer recommendations forpreventive maintenance/servicing/calibration 'enough'?A10. No, validation of the sterilization process would not be required under theregulations as "Process Validation" applies to processing, not recovery operations.As the sterilizer is used specifically for preventing contamination and crosscontamination during recovery of tissue by rendering the recovery instrumentssterile, you would have to ensure that the sterilizer is performing its intendedfunction. A common practice that offers a level of assurance and verification that aset of instruments has been adequately sterilized during a cycle is the use ofchemical indicator strips. These can be strategically placed in a challenged area ofpenetration of the set as well as superficially as an external indicator (sterilityindicator tape). Upon opening the sterilized set of instruments at recovery, thechange to the indicator tape and/or strip are observed and documented to verifythat the set met expectations for sterilization. Another method to verify sterilizationcycle operations is the use of biological indicators that are used in eachsterilization load or other acceptable schedule (e.g. schedules which may be usedby a hospital sterile processing department suggested by standards-settingorganizations or other accrediting entities with oversight of such sterilizationoperations).Q11. If a tissue recovery agency cleans and disinfects their tissue recoveryinstruments, there are published, established standards that can befollowed. Is it acceptable to clean and disinfect tissue recovery instrumentsets together that were used for recovery of tissues from different donors?Examples are eye recovery instruments (which are small) or just two sets ofheart or bone recovery instruments.A11. No, it is not a requirement, however, it may be prudent to separately clean anddisinfect instruments used for different tissue types (e.g., segregate those used fortissues considered a prion risk). Cleaning and disinfection (sanitizing) steps wouldnot require validation if not part of processing.Q12. If the recovery instruments are (ideally) cleaned and disinfected as separatesets, does that also mean that the there can be no re-use of thecleaning/detergent baths and soaking solutions that are used to clean anddisinfect instruments? By manufacturers' instructions for product use ofsuch solutions, re-use is acceptable and change of solutions varies by oncea day to once a week or until visually unsuitable.A12. No, following the manufacturer’s instructions for solution re-use/changing isacceptable.Page 12 of 44