Guidance Document - American Association of Tissue Banks

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eagents meet established specifications. Additionally, the recovery agency muststore, maintain, and utilize these supplies and/or reagents in accordance with thevendor, manufacturer, or processor requirements. In the case of supplies and/orreagents assembled or produced by the recovery agency, it is the responsibility ofthe recovery agency to verify that these supplies have been selected because theylend to preventing the introduction, transmission or spread of relevantcommunicable disease agents or diseases (e.g., instruments, wraps, containersand/or reagents (e.g., solutions,) meet specifications you determine such as:instruments are surgical grade; solutions are sterile, or fall within a specific pHrange/contain pH change indicators; etc.). Specification sheets, certificates ofanalysis, and manufacturer’s package inserts describing the reagent or supply canbe referenced to verify suitability. The processor may require that specific suppliesand reagents must be used by the recovery agency so the processor bears theburden of reagent/supply verification but communicates this information toestablishments with whom they hold recovery agreements. For example, suppliesused to wrap/package the individual tissues at recovery should be designed toprevent leakage that can cause contamination, cross-contamination, or mix-ups,and should be able to perform in this capacity when subjected to expected storagetemperatures for that tissue type. Shipping containers used to transport tissuesfrom the recovery site to storage or to the processor, and/or from storage to theprocessor, should be qualified/verified to maintain the expected storageenvironment relative to controlling contamination. The storage and/or shippingprocess (utilizing the procedure and supplies together) would require validation ofthe processes and/or documented verification of expectations each time theseprocesses are performed (fully verifiable).Q17. What should a recovery agency do to ensure that the recovered tissues andrelated donor specimens are properly identified to avoid mix-ups?A17. Tissues must be traceable by using a distinct identifier code and must indicate thattissues are quarantined during storage or shipment that occurs prior to thedetermination of donor eligibility. A distinct identification code assigned by anotherestablishment engaged in the manufacturing process can be used, or a new codecan be assigned. If a new code is assigned, there must be procedures establishedand maintained for relating the new code to the old code. To prevent mix-ups,identification methods should be used and recorded which verify that distinctidentifier codes and dates are properly documented and indicated on recoveredtissues and related donor specimens and on all forms that will be used asmanufacturing records. This can be accomplished by verification methods (doublechecks)involving more than one person or, if not possible, accuracy and contentcan be verified by one person using a procedure that reduces the chance foridentification errors (e.g., clerical errors). Copies of relevant medical records sentwith the recovered tissue, or on a subsequent date, shall contain either the donorname or an assigned distinct identifier code.Page 14 of 44
Q18. In recovery operations, pre-printed labels are usually not generated, butrather, information can be handwritten directly on the wrap/packaging orcontainer, as needed. Is it appropriate or adequate to have anotheremployee verify that the information is correct or are other controlsrequired?A18. Proper identification of tissues to include accurate, legible, and indelibledocumentation is expected at any step of manufacturing. Specific prescriptions formeeting the new rule are not published. It’s up to the establishment to define themethods of controls for complying with the regulation. Procedures used that verifyidentification and documentation accuracy of tissues at recovery are required. Oneacceptable method would be to follow SOPs that suggest using multiple personnelfor verifying labeling, if more than one person is present, like the example used inthis question. Other verification methods may also be acceptable.Q19. Is a consent/authorization document considered to be part of “donoridentification documents” or “relevant medical records” that would need tobe records that must be in English, if the consent/authorization documentwas in a non-English language?A19. No. There are no federal regulations regarding informed consent for tissuesregulated as “361 products”. If an inspector from FDA should ask to specificallyreview a consent document or listen to a tape of the consent process (if it is doneby telephone), the firm could question this (and have the investigator contactCBER for clarification), because there is no federal authority in the area of consentregarding 361 tissues.Page 15 of 44
Page 5 and 6: purpose of this Guidance Document i
Page 8 and 9: periodic reviews of the performance
Page 12 and 13: Q10. Does the sterilizer that is us
Page 16 and 17: Section III.Donor Screening and Don
Page 18 and 19: enforcement. If a tissue establishm
Page 20 and 21: contractor has necessary elements o
Page 22 and 23: A17. No. Tissue processing-related
Page 24 and 25: IV. PACKAGINGQ1. Does the immediate
Page 26 and 27: V. LABELINGQ1. Given that new infec
Page 28: Q11. Must labeling operations, such
Page 31 and 32: distinct identification code in you
Page 33 and 34: Section VI.DistributionPage 33 of 4
Page 35 and 36: Q5. Is shipping container qualifica
Page 37 and 38: esponsible for notifying the tissue
Page 39 and 40: Section VII.ProcessingPage 39 of 44
Page 41 and 42: • Surface Monitoring - taking int
Page 43 and 44: Section VIII.StoragePage 43 of 44

Guidance Document - American Association of Tissue Banks

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