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Cancelous bone crushed, freeze-dried irradiated

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U N I V E R S I T Y   H O S P I T A L   B R N O
Jihlavská 20, 625 00 Brno
TISSUE BANK                                                          Location Bohunice
TEL. +420 5 3223 3997, 2989,3308                                Jihlavská 20
FAX.+420 5 3223 2372                                                    625 00 Bnro
e-mail.tissue                                      Czech Republic

Cancellous bone crushed, freeze-dried irradiated

DEFINITION: Cancellous bone is obtained from human donors. 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 being at high risk for AIDS or hepatitis as defined by the AATB and EATB are excluded from donor ship.

A serum sample from the donor has passed a hemodilution review and was tested non-reactive for human immunodeficiency virus antigen and antibody (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.

Cancellous bone was purified, frozen, freeze-dried, crashed. The allograft has been subject to gamma irradiation.  Tissue from this donor has passed bacteriological quality control testing according to the Czech and European Pharmacopoea by a certified lab.

Composition: Cancellous bone, crushed, freeze – dried irradiated allografts in Petri dish pouched and associated paperwork are contained in non-sterile dust covers.

WARNING:               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.

Transport: in room temperature; short time below zero is acceptable (for example airway transport).

Storage requirementsin room temperature at dry place for up to expiry date stated on the label.

Indication: bone defect reconstruction (cysts, benign bone tumors etc.), bone augmentation, dental implantology.         

PREPARE ALOGRAFT FOR USE:

1.        Remove pouched allograft and paperwork from dust cover

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.        Aseptically add isotonic sterile saline at room temperature to allograft in Petri dish for 10 – 15 minutes.

4.        You can add patient own venous blood or antibiotic solution (tetracyklin) and chemotherapeutic solution (metranidazol)

5.        If the allograft is not to be used within approximately two hours of unpackaging, assure its continued sterility and hydration in isotonic saline and keep at 2 to 8°C.  Use wetted 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.

Allografts are prepared and distributed by Tissue Bank of the University Hospital Brno, Jihlavská 20, 625 00 Brno, Czech Republic

                                                                                                Adresa: Tkáňová banka FN Brno
Jihlavská 20
625 00  Brno, Česká republika
Telefon: +420 5 3223 3997, Fax: +420 5 3223 2372

Informace o pohotovosti v Brně a Jihomoravském kraji