Physical examination of potential tissue donors: results of a risk management procedure to identify the critical elements of the physical examination.

To identify critical elements of physical examination (PE) of potential tissue donors that could help to improve the safety of tissue transplantation. Physical signs were identified that can indicate the presence of a contraindication mentioned in EU Directive 2006/17/EC and that can theoretically be detected at PE. A risk assessment was designed, according to the Failure Mode and Effects Analysis model. Signs were scored on several aspects, taking into account various control measures, either required in the EU Directive or additional non-required measures. 106 signs associated with general and tissue-specific contraindications were identified. Signs of advanced infection with HIV, hepatitis B/C and syphilis (n = 13, 12.3%) can be omitted, since these contraindications will be detected by the required serological testing. With the required control measures, risk priorities are unacceptably "high" for 17.3% of the signs. For 64.5% of the signs, additional control measures are possible, which result in acceptable risk priorities for all signs. This risk management procedure identified the minimal necessary content of PE in potential tissue donors. Furthermore, risks associated with tissue donation were elucidated and possible risk control measures were identified as well as their impact on the safety of tissue transplantation.

Physical examination of the potential tissue donor, what do European tissue banks do?

According to the EU Directive 2006/17/EC, European tissue banks are required to perform a physical examination on every potential tissue donor. The directive itself, however, does not specify the content of this examination. The aim of this study was to investigate the current practice of physical examination in European tissue banks. A questionnaire was drawn up and sent to the members of the European Association of Tissue Banks and the European Eye Bank Association. Information was gathered on the type of procurement; the personnel involved (number, educational background and training); the content of physical examination; the problems encountered; and the outcome of the performed physical examinations. Completed questionnaires were received from 32 European tissue banks (response rate of 35%). Of these tissue banks, 73% perform a physical examination. The most frequently encountered problems are the inability to open the mouth due to rigor mortis, the inability to examine the total body surface and the incapacity to palpate the lymph nodes. Tissue banks reject potential donors, based on the results of the physical examination in 5% of cases (median rejection rate). Twenty-seven percent of the responding tissue banks do not perform a physical examination. This was most often due to a lack of adequate educational background and/or a lack of appropriate training.

Physical examination of the potential tissue donor, what does literature tell us?

European Tissue Banks should carry out a physical examination as a part of the donor selection procedure. This is one of the obligations concerning donation and procurement mentioned in the European Commission directives on tissue banking. As the directives do not give any further specification on the content or on the procedure of the physical examination, a search of literature was done in order to find more information. Although data in literature generally remain quite vague, it was possible to set up a list of items which should be looked at during physical examination. This list can be used temporarily until further information is gathered from an international survey and from a risk assessment analysis.

EATB Donor Case Workshop 2007.

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the programme of the EATB annual Congress since 2003. This workshop has been used to discuss clinical donor cases with peer review of practice. It was agreed in advance that the experience of the 2007 workshop should be shared by publication as an example of participative learning which can be extended to other fields within tissue banking and which may be applicable in other disciplines. The EATB Congress in 2008 will extend the idea of participative open workshops with two additional workshops, one on Quality System cases and another on heart valve cases.