Frozen and Irradiated Human Tissue for Transplant
Storage REQUIREMENTS: Tissue is frozen and it is the end user clinician’s responsibility to maintain tissue in appropriate storage conditions prior to transplant. Store at < -20°C for up to one month and store at < -40°C for up to expiry date stated on the label. Do not allow frozen tissue to thaw. If thawing or partial thawing occurs, DO NOT RE-FREEZE. The tissue is not acceptable for use.
DONOR SELECTION: Donor screening following American Association of Tissue Banks (AATB), Tissue Banks International/International Federation of Eye and Tissue Banks (TBI/IFETB), European Association of Tissue Banks (EATB), Czech Transplant Law and Tissue Bank University Hospital Brno Donor Exclusion Criteria is performed via donor physical inspection, review of available medical record, and review of autopsy findings.
Individuals considered to be at high risk for AIDS or hepatitis as defined by the AATB and EATB are excluded from donorship.
A serum sample from the donor has passed a hemodilution review and was tested non-reactive for human immunodeficiency virus antibody and antigen HIV 1 and 2, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (anti-HBcore), hepatitis C antibody (anti-HCV), human T-lymphotrophic virus type I and II antibody (anti-HTLV-I and II), and for syphilis using test kits licensed in the EU and performed by a certified lab.
POSSIBLE CONTRAINDICATIONS: This allograft should not be implanted into sites with active or latent infection.
POSSIBLE ADVERSE REACTIONS: An allograft may not elicit proper response from the recipient (e.g. fusion/union with adjacent tissue). It is possible for a host site to become infected. The allograft may not provide mechanical support and collapse, or cause an inflammatory response. While efforts are made to ensure the safety of the tissue, current technologies may not preclude the transmission of disease, including hepatitis and HIV.
The surgeon is responsible for reporting all adverse reactions potentially attributable to the allograft to Tissue Bank of the University Hospital Brno, Jihlavská 20, 625 00 Brno, Czech Republic.PRECAUTIONS: Inspect the integrity of the package upon receipt and before use. DO NOT USE THIS ALLOGRAFT UNDER THE FOLLOWING CONDITIONS:
- The container in which the tissue is stored is damaged or the label has been removed or defaced.
- The allograft expiration date has passed.
- Recommended storage conditions have not been met.
WARNING:
- Unused allograft, whole, or partial, may not be repackaged, or resterilized.
- This allograft is intended for single patient use only.
- While every effort has been made to ensure the quality of this allograft, TB UHB makes no claims concerning its biologic or biomechanical properties. As with any allograft, despite strict screening/testing procedures, this allograft has the potential to transmit infectious agents to the recipient.
- The allograft may contain trace amounts of processing agents such as iodine or normal saline.
STERILITY CONTROL: The allograft has been subject to gamma irradiation at a target 20 kGy dose. Tissue from this donor has passed bacteriological quality control testing according to the Czech and European Pharmacopoea by a certified lab.
USAGE: This graft is intended for use in one patient on a single occasion by licensed physicians, dentists, and podiatrists. Use aseptic technique when unpackaging allografts. If the allograft is not to be used within approximately two hours of unpackaging, assure its continued sterility and hydration and keep at 2-8°C. Use thawed tissue within 24 hours or discard. DO NOT STERILIZE / RE-STERILIZE.
PREPARE ALOGRAFT FOR USE: Frozen, double-pouched allografts and associated paperwork are contained in non-sterile dust covers.
1. Remove double pouched allograft and paperwork from dust cover (ITEMS IN DUST COVER ARE NOT STERILE).
2. Examine outer allograft pouch for package integrity. Do not use if there is evidence that the outer pouch is damaged or sterility has been compromised.
3. Open the outer pouch and aseptically present the inner pouch containing the allograft to the sterile field.
4. Thaw using one of these two methods:
a. Aseptically remove allograft from inner pouch and immerse in isotonic sterile saline at room temperature. Allow large allografts with cortical bone to thaw in saline for no less than three hours. Allografts with soft tissue should remain in saline until the soft tissue is pliable.
b. Thaw overnight (for up to 12 hours) by placing the allograft in original, unopened packaging into a refrigerator at 2 to 8°C. After thawing, aseptically transfer the allograft to a sterile basin and immerse in sterile saline.
5. We recommend that you obtain a swab culture of the allograft and submit it to your microbiological laboratory for aerobic and anaerobic testing. If the surgeon desires, antibiotics may be added to the allograft in the preparation basin prior to use.
6. If the allograft is not to be used within approximately two hours of unpackaging/thawing, assure its continued sterility and hydration in isotonic saline and keep at 2 to 8°C. Use thawed tissue within 24 hours or discard.
TISSUE TRACING: It is the responsibility of the user surgeon to complete the recipient records for the purpose of tracing tissue post transplant. Complete the enclosed ALLOGRAFT RETURN CARD IN DETAIL AND RETURN AS INDICATED.
Revised: 1th May 2006
