Guidance Document - American Association of Tissue Banks

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manufacturer, a description of the tissue and the graft expiration date. The storagetemperature, appropriate warnings, and adequate instructions for use when relatedto the prevention of the introduction, transmission, or spread of communicabledisease must also be provided on the label or on a package insert.Q22. Is a tissue establishment required to “validate/verify” the tracking methodprocess when adopting a distinct identification code assigned by anotherestablishment engaged in manufacturing, to insure distinct identificationcodes are used by the second tissue establishment?A22. The establishment must ensure the tracking method is effective both forward andbackward. It is advisable to utilize validation and/or verification techniques todemonstrate that the tracking system is effective.Q23. Is the term “medical record number” analogous to the donor number(distinct identifier) assigned at the tissue bank, or is it a reference to thepatient’s medical record number that may be obtained prior to donation?Accession/donor numbers assigned at the time of receipt at the tissue bankmay be used to track the donor records internally, and may be usedthroughout the processing and distribution of tissues.A23. Except in the case of autologous or directed donations, the donor’s hospitalmedical record number is never the tissue distinct identification assigned by thetissue bank. Regulations provide flexibility regarding how an establishmentassigns a distinct identifier. It is up to the establishment to define the system andensure it meets the requirements for tracking and traceability.Q24.To what extent are tissue banks responsible for tracking of the releasedallograft for transplant?A24. The tissue establishment needs to assure that tissue tracking can be made to thefacility or person (consignee) to which it distributed tissue. This is typicallyaccomplished through maintaining accurate distribution records. Further trackingmethods are provided by way of written notification from the distributingestablishment to the consignee that describes that the consignee must maintainthe required records traceable to the recipient. In this case, the traceability processshould be verified by the establishment as being effective. If the end user is ahospital, JCAHO Standards apply and tracing to the recipient is required by themand return of graft implant cards is supported by their Tissue Storage and IssuanceStandards that became effective on July 1, 2005 in updates to five manuals:Laboratories, Hospitals, Critical Access Hospitals, Ambulatory Care, and OfficeBased Surgery Practices. At or before the time of distribution of a tissue to aconsignee, you must inform the consignee in writing of the requirements of thetracking system that you have established and are maintaining to comply withthese requirements. An example of a labeling statement that would comply withthis requirement is: ‘‘IMPORTANT NOTICE TO END-USER: Please record thisPage 30 of 44
distinct identification code in your records and in the patient’s file.’’ Expectations tocomplete and return graft disposition information can also be included in theseinstructions.Q25. Since tissue grafts are not medical devices, the instructions for use of thegraft may be followed by the surgeon or could be used in an alternativefashion. How does a tissue bank satisfy the CGTPs in this case regarding“instructions for use”?A25. There is a distinction between “instructions” and “indications” for use. “Instructionsfor use” means the graft handling requirements to be used during the surgicalprocedure. Examples of this would be: thawing the allograft or re-hydration of itprior to use; removing the outer layer of packaging prior to introduction to thesterile field, etc. Instructions for use should be followed. “Indications for use”dictate the surgical procedures or clinical use the graft shall be limited to for therepair, replacement, reconstruction or supplementation of the patient. The actualuse or application is up to the discretion of the licensed physician.Q26. To what degree are symbols allowed on tissue labels such as those used formedical devices?A26.Standardized symbols such as those used to depict sterilization methods,expiration dates, etc., are acceptable provided they are defined within theinstructions for use.Q27. How do the “instructions for use” relate to allograft claims? Will the use ofterms such as “in order to achieve optimal result” be restricted?A27. Any claim is required to be fully verified or validated. It is up to the establishmentto determine their claims and degree of verification/validation required todemonstrate that the claim is true and accurate.Q28. What is considered “misleading” with respect to label claims? For example,if the phrase “graft sterilized” is used without documented validation of aterminal sterilization process, could this be considered misleading to the enduser regarding the sterility of the final graft?A28. Labeling statements must be truthful, accurate and not misleading. It’s advisableto consult FDA guidance documents for labeling, use industry standards, and usestandardized symbols.Q29. Will negative claims be held to the same scrutiny? For example, ifpromotional materials contain the statement that implies that an alternativeprocessing method may be detrimental, will there be requirements tosubstantiate such a claim?Page 31 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 14 and 15: eagents meet established specificat
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 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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