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With this analysis we would like to raise some issues that emerge as a result of recent evolutions in the burgeoning field of human cells, tissues, and cellular and tissue-based product (HCT/P) transplantation, and this in the light of the current EU regulatory framework. This paper is intended as an open letter addressed to the EU policy makers, who will be charged with the review and revision of the current legislation. We propose some urgent corrections or additions to cope with the rapid advances in biomedical science, an extensive commercialization of HCT/Ps, and the growing expectation of the general public regarding the ethical use of altruistically donated cells and tissues. Without a sound wake-up call, the diverging interests of this newly established 'healthcare' industry and the wellbeing of humanity will likely lead to totally unacceptable situations, like some of which we are reporting here.

Bone and tissue allografts are widely used in transplantation. The increasing demand for safe allografts must be met, while minimizing disease transmission. We analysed the incidence and potential risk factors of allograft contamination and the effectiveness of disinfection, by reviewing 22 years of tissue bank activity and 474 donor procurements. We also compared different disinfection procedures used over the 22 years. The overall contamination rate was 10.1%. Risk factors were related to the donor or procurement method. Immediate culture at the tissue recovery site diminished the rate of false positives by reducing later sample manipulation. High-virulence allograft contamination was mainly related to donor factors, while low-virulence contamination was related to procurement methods. Analysis of donor-related risk factors showed no statistical differences for age, sex, or cause of death. An intensive care unit stay was associated with less contamination with high-virulence microbes. Procurement in a setting other than an operating theatre was associated with higher contamination rate. Team experience reduced contamination. Pelvic and tendon allografts were most frequently contaminated. Proper disinfection considerably reduced the contamination rate to 3.6%. We conclude that procurement must be performed under aseptic conditions, with short delays, and by trained personnel. Grafts should be disinfected and packed as soon as possible.

Freeze-drying and irradiation are common process used by tissue banks to preserve and sterilize bone allografts. Freeze dried irradiated bone is known to be more brittle. Whether bone brittleness is due to irradiation alone, temperature during irradiation or to a synergetic effect of the freeze-drying-irradiation process was not yet assessed. Using a left-right femoral head symmetry model, 822 compression tests were performed to assess the influence of sequences of a 25 kGy irradiation with and without freeze-drying compared to the unprocessed counterpart. Irradiation of frozen bone did not cause any significant reduction in ultimate strength, stiffness and work to failure. The addition of the freeze-drying process before or after irradiation resulted in a mean drop of 35 and 31% in ultimate strength, 14 and 37% in stiffness and 46 and 37% in work to failure. Unlike irradiation at room temperature, irradiation under dry ice of solvent-detergent treated bone seemed to have no detrimental effect on mechanical properties of cancellous bone. Freeze-drying bone without irradiation had no influence on mechanical parameters, but the addition of irradiation to the freeze-drying step or the reverse sequence showed a detrimental effect and supports the idea of a negative synergetic effect of both procedures. These findings may have important implications for bone banking.

The use of massive bone allografts is increasing year by year and selection method remains unchanged. Superposition of patient's radiograph over allograft image and comparison of distances is the gold standard. Experiment was led to test selection procedure of a major european tissue bank. Four observers were asked to select an allograft for 10 fictive recipients. Nine allografts were provided. To simulate a perfect allograft, recipient himself was inserted in the pool of allografts (trap graft). The 10 potential bone transplants were classified in four categories (from adequate to unacceptable). In addition, observers were asked to choose the three best grafts for a given recipient. Quadratic kappa measuring agreement on classification between two observers ranged between 0.74 (substantial) and 0.47 (moderate). Trap graft was quoted by observers as adequate four times (10%) and was cited eight times (20%) among the three best matching allografts. None of the observers discovered that recipient was among allograft panel. This study demonstrates that current selection method is inaccurate for hemipelvic allograft selection. New methods should be developed and tested to assist tissue banks in bone allograft selection.