QUALITY ASSURANCE

Quality and safety are priorities for the TMH Tissue Bank, and a number of measures have been taken to fulfil these objectives.

Our quality systems are ISO 9001:2000 certified thereby guaranteeing the implementation of our quality policy and standard operating procedures which are designed to ensure that our grafts are reliable and free from transmissible disease. Some of the steps we take to ensure this high quality are:

  • Screening of potential donors on the basis of their medical history.
  • Serological testing of blood to exclude AIDS, Hepatitis B and C and Syphilis.
  • Microbiological analysis of the donated tissue in the case of deceased donors.
  • Cleaning and processing of all tissue.
  • Irradiation of the processed tissue at ISOMED, the Government of India Radiation Plant with ISO 9002 certified processes.
  • Extensive documentation to monitor the tissue from retrieval, through processing and sterilisation to transplantation.
  • Follow up with surgeons using the grafts.

The Bank itself is well equipped and its layout and design permit the separation of various procedures enabling the control of environmental contamination. The tissues are processed using aseptic techniques, and the environment of the Bank is regularly monitored. Processed tissues are packaged under laminar airflow and sterilised by gamma radiation. Sterility tests are conducted periodically to check the validity of the irradiation process.
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