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The Marburg bone bank system for thermal disinfection of femoral head allografts from living donors has been validated for head diameters up to 56 mm. The system

•    inactivates HIV 1, HIV 1/0, HIV 2 viruses
•    inactivates HTLV, CMV viruses
•    inactivates CPV (model virus for HPV B19/ hepatitis B) and BVDV (model virus for 
      hepatitis C)
•    inactivates syphilis 
•    inactivates vegetative infectious agents
•    reduces the graft’s fat content 
•    broadly preserves the biomechanical and biological valence of the graft 
•    permits easy intraoperative use
•    minimizes the recontamination risk, using a closed system
•    takes 94 minutes for the process (minimum temperature of 82.5 º C within the
     center of the femoral head for at least 15 minutes)

In the German Federal Gazette (no 84, 04 May 1994) the German Federal Health Authority and the Paul-Ehrlich Institute, Federal Agency for Sera and Vaccines, published the requirements on validation studies designed to provide evidence on the virus safety of medicinal products from human blood or plasma:

“According to current knowledge, at least the following viruses are to be tested:

•    HIV
•    Model virus for hepatitis C virus (e.g. BVDV)
•    Enveloped DNA-Virus (e.g. herpes virus PSR)
•    Non-enveloped virus (e.g. HAV, reo virus or SV 40)”

In the United States of America, the AATB and the FDA require the exclusion of any transfer risk of:

•    HIV 1
•    HIV 2
•    HBV
•    HCV

Furthermore, the American Red Cross requires additional aerobic and anaerobic blood culture tests. The EATB and the EAMST extend the statement of requirements by syphilis (VDRL) and CMV tests, the Dutch Orthopaedic Society recommends a supplementary HTLV-1 test.
The revised German bone banking guidelines (“Richtlinien zum Führen einer Knochenbank”, published in the German peer journal ”Deutsches Ärzteblatt”, on 13 April 2001) state the parameters set forth for laboratory tests:

•    Parameter                 Requirements
•    Anti-HIV ½ antibodies         negative
•    Anti-HCV antibodies             negative
•    Anti-HBc antibodies             negative
•    HBs – antigen                 negative
•    Syphilis screening (e.g. TPHA)       negative
•    ALT (GPT)
•    Optimized method 1972 (+25°C٭٭)
•    IFCC method  (+37°C)    women < 45 U/L  men < 68 U/L   women < 89 U/L  men < 135 U/L

 
In the event of a positive anti-HBc test and a negative HbsAg test, further examinations need to be carried out to exclude an HBV infection.

•    HBV-DNA test must be negative, based on a detection limit of <50 WHO units/ml,
      respectively 250 genomic equivalents
•    IgM anti-HBc must be negative
•    A possibly known, previous acute hepatitis B must date back more than 5 years and be
      fully resolved
•    Anti-HBs must be > 100 I.E./l
•    ALT must be within the normal range

Provided all these requirements are met, the explant can be released for use. In case of doubt a virologist is to be consulted.
٭٭Measurements at 37 °C require respective value conversion.

 

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Updated: 02.04.2015