Journal Title
Title of Journal: Cell Tissue Bank
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Abbravation: Cell and Tissue Banking
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Publisher
Springer Netherlands
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Authors: John B Kowalski Karen Merritt David Gocke Joel Osborne
Publish Date: 2012/02/11
Volume: 13, Issue: 3, Pages: 431-439
Abstract
A quantitative method was developed and validated to assess bioburden on tissue from human donors and to compare bioburden determination results to swab culture results from the same donor An initial study with allograft tissue from 101 donors showed a wide range of bioburden levels values from no colonyforming units CFU detected to 28000 CFU were observed Tissues from donors that had swab cultures negative for objectionable microorganisms generally had lower bioburden than tissues from donors where objectionable microorganisms were recovered by swab culturing In a followup study with 1445 donors a wide range of bioburden levels was again observed on tissues from donors that were swab culture negative for objectionable microorganisms Tissues from 885 61 of these donors had no recoverable bioburden 2 CFU Importantly tissues from 560 39 of the donors had recoverable bioburden which ranged from 1 to 24000 CFU Identification of bioburden isolates showed a diversity of genera and species In compliance with the recent revision of the American Association of Tissue Banks K2210 Standard the quantitative bioburden determination method was validated with a composite tissue sample that contains bone and soft tissue sections tested together in one extraction vessel A recovery efficiency of 68 was validated and the composite sample was shown to be representative of all of the tissues recovered from a donor The use of the composite sample in conjunction with the quantitative bioburden determination method will facilitate an accurate assessment of the numbers and types of contaminating microorganisms on allografts prior to disinfection/sterilization This information will ensure that disinfection/sterilization processes are properly validated and the capability of the overall allograft process is understood on a donor by donor basis
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