The process of clinical decision-making in chronic wound care: A scenario-based think-aloud study.

AIMS: To undertake a comprehensive investigation into both the process of information acquisition and the clinical decision-making process utilized by primary care nurses in the course of treating chronic wounds. DESIGN: Scenario-based think-aloud method, enriched by the integration of information processing theory. The study was conducted within the framework of home care nursing organizations situated in Flanders, the Flemish speaking part of Belgium. A cohort of primary care nurses (n = 10), each possessing a minimum of one year of nursing experience, was recruited through the collaboration of three home care nursing organizations. METHODS: Two real-life clinical practice scenarios were employed for the interviews, with the researcher adopting the roles of either the patient or another clinician to enhance the realism of the think-aloud process. Each think-aloud session was promptly succeeded by a subsequent follow-up interview. The Consolidated criteria for Reporting Qualitative research checklist was followed to guarantee a consistent and complete report of the study. RESULTS: Amidst noticeable variations, a discernible pattern surfaced, delineating three sequential concepts: 1. gathering overarching information, 2. collecting and documenting wound-specific data, and 3. interpreting information to formulate wound treatment strategies. These concepts encompassed collaborative discussions with stakeholders, while the refinement of wound treatment strategies was interwoven within both concepts 2 and 3. CONCLUSIONS: Evident variations were identified in chronic wound care clinical decision-making, regardless of educational background or experience. These insights hold the potential to inform the development of clinical decision support systems for chronic wound management and provide guidance to clinicians in their decision-making endeavours.

Preanalytical variables influencing the interpretation and reporting of biological tests on blood samples of living and deceased donors for human body materials.

With the present paper, the Working Group on Cells, Tissues and Organs and other experts of the Superior Health Council of Belgium aimed to provide stakeholders in material of human origin with advice on critical aspects of serological and nucleic acid test (NAT) testing, to improve virological safety of cell- and tissue and organ donation. The current paper focusses on a number of preanalytical variables which can be critical for any medical biology examination: (1) sampling related variables (type of samples, collection of the samples, volume of the sample, choice of specific tubes, identification of tubes), (2) variables related to transport, storage and processing of blood samples (transport, centrifugation and haemolysis, storage before and after centrifugation, use of serum versus plasma), (3) variables related to dilution (haemodilution, pooling of samples), and (4) test dependent variables (available tests and validation). Depending on the type of donor (deceased donor (heart-beating or non-heart beating) versus living donor (allogeneic, related, autologous), and the type of donated human material (cells, tissue or organs) additional factors can play a role: pre- and post-mortem sampling, conditions of sampling (e.g. morgue), haemodilution, possibility of retesting.

A Belgian student with black eschars.

BACKGROUND: Human cowpox virus infection is a rare zoonotic disease. Cowpox virus is a member of the Orthopoxvirus genus, like smallpox. Over the last years records of cowpox virus transmission from pet cats and pet rats to humans in Europe have increased. This observation may result from the loss of cross-immunity against orthopoxviruses after discontinuation of routine smallpox vaccination in the 1980s. CASE PRESENTATION: We report the first case of a human cowpox infection in an unvaccinated Belgian citizen. This 19-year-old student presented with multiple necrotic skin lesions on the chin, the scalp and the pubic region, and with cervical lymphadenopathy and flu-like symptoms. The diagnosis of human cowpox was based on electron microscopic findings and PCR examination performed on a skin biopsy of the pubic lesion. Close contact with cats (her domestic cats or cats from a local shelter) was probably the source of transmission. Spreading of the lesions was likely the result of autoinoculation. After six months all lesions spontaneously healed with atrophic scars. DISCUSSION: To enhance awareness of this rare viral zoonosis and to verify the suspected increase in incidence and symptom severity after cessation of smallpox vaccination, one could argue whether human cowpox should become a notifiable disease.

The measurement properties of assessment tools for chronic wounds: A systematic review.

BACKGROUND: Chronic wounds are an increasing problem in the aging population, patients experience a lower health-related quality of life and the care for these patients is associated with high costs. Thorough wound assessments facilitate objective monitoring of wound status and progress. A wound assessment tool can guide clinicians in these wound assessments and in recording wound progress or deterioration. OBJECTIVE: Systematically identify assessment tools for chronic wounds, investigate their measurement properties, and summarize the data per assessment tool. DESIGN: Systematic review METHODS: The databases Medline (PubMed interface), Embase, CINAHL, and CENTRAL were systematically searched until May 2020 (updated in February 2021). Studies reporting the development and/or the evaluation of measurement properties of assessment tools for chronic wounds were included. The "Consensus-based Standards for the selection of health Measurement Instruments" risk of Bias checklist was applied to evaluate the methodological quality of the included studies. Each reported measurement property was rated against criteria for good measurement properties. The evidence was summarized and the quality of the evidence was graded using a modified Grades of Recommendation, Assessment, Development, and Evaluation approach. Study selection, data extraction and quality appraisal were conducted independently by two reviewers and double-checked by a third reviewer. RESULTS: Twenty-seven studies describing the measurement properties of fourteen assessment tools for chronic wounds were included. None of the studies reported a content validity evaluation by a relevance study or a comprehensiveness study in professionals. Six articles reported the development or revision of an existing assessment tool. The reported measurement properties included: structural validity (5 studies), reliability (18 studies), hypotheses testing for construct validity (18 studies) and responsiveness (7 studies). Internal consistency, cross-cultural validity / measurement invariance and measurement error were not reported. If criterion validity was assessed, the results were allocated to hypotheses testing for construct validity as no 'gold standard' is available. CONCLUSIONS: Fourteen assessment tools for chronic wounds were identified. Construct validity (by hypotheses testing) and responsiveness of the Pressure Ulcer Scale for Healing version 3.0 were supported by sufficient ratings based on moderate to high level quality of evidence. Reliability of the (Revised) Photographic Wound Assessment Tool had a sufficient rating based on moderate quality of evidence. The ratings of the measurement properties of the other wound assessment tools were either insufficient or indeterminate, or a sufficient result was supported by low to very low quality of evidence. Registration number in PROSPERO: CRD42020183920 Tweetable abstract: A systematic review giving a clear overview of the measurement properties of available assessment tools for chronic wounds.

A prospective randomized controlled clinical investigation comparing two post-operative wound dressings used after elective hip and knee replacement; Mepilex® Border Post-Op versus Aquacel® surgical.

BACKGROUND: Post-operative wound complications, including blistering and surgical site infections, can increase recovery times, costs associated with hospital stay and morbidity. AIM: To compare two post-operative wound dressings (Mepilex Border Post-Op and Aquacel Surgical), in patients undergoing elective hip or knee arthroplasty. METHODS: International, open-label, prospective, superiority, multicentre, randomised, parallel-group, controlled trial. Primary outcome was dressing failure, a composite endpoint assessing four factors weighted from highest to lowest in relation to the risk of surgical site infection. RESULTS: Mepilex Border Post-Op was comparable or superior to Aquacel® Surgical in all parameters investigated. Dressing failure rates, skin redness, itching under the dressing, pain during dressing removal and number of patients requiring a dressing change were low in both groups. Mepilex® Border Post-Op outperformed Aquacel Surgical for ease of application (p<0.0001) and removal (p<0.0001), ability to handle blood (p<0.0001), prevention of dressing residuals (p=0.0167), patient satisfaction of wearing the dressing during rehabilitation training (p=0.0037) and patients' overall experience with the dressing (P=0.0025). CONCLUSION: Both dressings performed well in terms of minimizing post-operative wound complications. However, in relation to clinician satisfaction, minimization of pain and facilitation of patient comfort, Mepilex® Border Post-Op outperformed Aquacel Surgical.

Delphi procedure in core outcome set development: rating scale and consensus criteria determined outcome selection.

OBJECTIVE: The objective of this study was to compare two different rating scales within one Delphi study for defining consensus in core outcome set development and to explore the influence of consensus criteria on the outcome selection. STUDY DESIGN AND SETTING: Randomized controlled parallel group trial with 1:1 allocation within the first Delphi round of the Core Outcome Set in the Incontinence-Associated Dermatitis project. Outcomes were rated on a three-point or nine-point Likert scale. Decisions about which outcomes to retain were determined by commonly used consensus criteria (i.e., [combinations of] proportions with restricted ranges, central tendency within a specific range, and decrease in variance). RESULTS: Fifty-seven participants (group 1 = 28, group 2 = 29) rated 58 outcomes. The use of the nine-point scale resulted in almost twice as many outcomes being rated as "critical" compared with the three-point scale (24 vs. 13). Stricter criteria and combining criteria led to less outcomes being identified as "critical". CONCLUSION: The format of rating scales in Delphi studies for core outcome set development and the definition of the consensus criteria influence outcome selection. The use of the nine-point scale might be recommended to inform the consensus process for a subsequent rating or face-to-face meeting. The three-point scale might be preferred when determining final consensus.

Correction to: Biological tests carried out on serum/plasma samples from donors of human body material for transplantation: Belgian experience and practical recommendations.

The article Biological tests carried out on serum/plasma samples from donors of human body material for transplantation: Belgian experience and practical recommendations.

Biological tests carried out on serum/plasma samples from donors of human body material for transplantation: Belgian experience and practical recommendations.

This paper on the biological tests carried out on serum/plasma samples from donors of human body material (HBM) is the result of a project of the working Group of Superior Health Council of Belgium formed with experts in the field of HBM and infectious serology. Indeed, uncertainty about the interpretation of biological test results currently leads to the sometimes unjustified cancelling of planned donations or the rejection of harvested HBM, whilst more sophisticated diagnostic algorithms would still allow the use of organs or HBM that would otherwise have been rejected. NAT tests will not be discussed in this publication. In the first part some general aspects as the need for a formal agreement between the Tissue Establishment l and the laboratory responsible for the biological testing, but also some specifications regarding testing material, the choice of additional biological tests, and some general aspects concerning interpretation and reporting are discussed. In a second part, detailed information and recommendations concerning the interpretation are presented for each of the mandatory tests (human immunodeficiency virus, hepatitis B virus, hepatitis C virus and syphilis) is presented. A number of not mandatory, but regularly used optional serological tests (e.g. for the detection of antibodies to Toxoplasma gondii, Epstein-Barr virus, human T cell leukemia virus and cytomegalovirus) are also extensively discussed. Although the project was meant to provide clarification and recommendations concerning the Belgian legislation, the majority of recommendations are also applicable to testing of donors of tissues and cells in other (European) countries.

Core outcome domains in incontinence-associated dermatitis research.

AIM: To report the development of a core set of outcome domains for clinical research involving adults with incontinence-associated dermatitis or at risk, independently from any geographical location or skin colour. BACKGROUND: The management of incontinence-associated dermatitis is important in caring for incontinent patients. The lack of comparability of clinical trial outcomes is a major challenge in the field of evidence-based incontinence-associated dermatitis prevention and treatment. Core outcome sets may therefore be helpful to improve the value of clinical incontinence-associated dermatitis research. DESIGN: Systematic literature review, patient interviews and consensus study using Delphi procedure. METHODS: A list of outcome domains was generated through a systematic literature review (no date restrictions-April 2016), consultation of an international steering committee and three patient interviews. The project team reviewed and refined the outcome domains prior to starting a three-round Delphi procedure conducted between April-September 2017. The panellists, including healthcare providers, researchers and industry were invited to rate the importance of the outcome domains. RESULTS: We extracted 1,852 outcomes from 244 articles. Experts proposed 56 and patients 32 outcome domains. After refinement, 57 panellists from 17 countries rated a list of 58 outcome domains. The final list of outcome domains includes erythema, erosion, maceration, IAD-related pain and patient satisfaction. CONCLUSION: Erythema, erosion, maceration, incontinence-associated dermatitis -related pain and patient satisfaction are the most important outcome domains to be measured in incontinence-associated dermatitis trials. Based on this international consensus on what to measure, the question of how to measure these domains now requires consideration. Registration: This project has been registered in the Core Outcome Measures in Effectiveness Trials (COMET Initiative) database and is part of the Cochrane Skin Group-Core Outcomes Set Initiative (CSG-COUSIN).

Incontinence-Associated Dermatitis: Pathogenesis, Contributing Factors, Prevention and Management Options.

Incontinence-associated dermatitis (IAD) is a common type of irritant contact dermatitis, seen in patients with urinary or faecal incontinence. Mechanical factors such as traumata and friction may aggravate the lesions. The fragile skin in elderly patients is more prone to developing IAD. The clinical picture of IAD consists of persistent redness on the one hand and skin loss on the other. Both categories may be associated with clinical signs of major colonisation or infection. It is important to distinguish IAD from pressure ulcers and other dermatoses in the genital region. Due to the lack of well-established clinical trials, recommendations about prevention and treatment are based on expert opinion and best practice. Gentle cleansing, use of hydrating topical agents and application of barrier products are the main elements in the prevention and treatment of IAD. It is important to translate these recommendations and general guidelines into ready-to-use protocols that can be implemented for each specific clinical manifestation of IAD.

Interventions for preventing and treating incontinence-associated dermatitis in adults.

BACKGROUND: Incontinence-associated dermatitis (IAD) is one of the most common skin problems in adults who are incontinent for urine, stool, or both. In practice, products and procedures are the same for both prevention and treatment of IAD. OBJECTIVES: The objective of this review was to assess the effectiveness of various products and procedures to preventand treat incontinence-associated dermatitis in adults. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Trials Register, which contains trials identified from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE In-Process, MEDLINE Epub Ahead of Print, CINAHL, ClinicalTrials.gov, WHO ICTRP and handsearching of journals and conference proceedings (searched 28 September 2016). Additionally we searched other electronic databases: CENTRAL(2015, Issue 4), MEDLINE (January 1946 to May Week 3 2015), MEDLINE In-Process (inception to 26 May 2015), CINAHL(December 1981 to 28 May 2015), Web of Science (WoS; inception to 28 May 2015) and handsearched conference proceedings (to June 2015) and the reference lists of relevant articles, and contacted authors and experts in the field. SELECTION CRITERIA: We selected randomised controlled trials (RCTs) and quasi-RCTs, performed in any healthcare setting, with included participants over 18 years of age, with or without IAD. We included trials comparing the (cost) effectiveness of topical skin care products such as skin cleansers, moisturisers, and skin protectants of different compositions and skin care procedures aiming to prevent and treat IAD. DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles, abstracts and full-texts, extracted data, and assessed the risk of bias of the included trials. MAIN RESULTS: We included 13 trials with 1295 participants in a qualitative synthesis. Participants were incontinent for urine, stool, or both, and were residents in a nursing home or were hospitalised.Eleven trials had a small sample size and short follow-up periods. .The overall risk of bias in the included studies was high. The data were not suitable for meta-analysis due to heterogeneity in participant population, skin care products, skin care procedures, outcomes, and measurement tools.Nine trials compared different topical skin care products, including a combination of products. Two trials tested a structured skin care procedure. One trial compared topical skin care products alongside frequencies of application. One trial compared frequencies of application of topical skin care products.We found evidence in two trials, being of low and moderate quality, that soap and water performed poorly in the prevention and treatment of IAD (primary outcomes of this review). The first trial indicated that the use of a skin cleanser might be more effective than the use of soap and water (risk ratio (RR) 0.39, 95% confidence interval (CI) 0.17 to 0.87; low quality evidence). The second trial indicated that a structured skin care procedure, being a washcloth with cleansing, moisturising, and protecting properties, might be more effective than soap and water (RR 0.31, 95% CI 0.12 to 0.79; moderate quality evidence). Findings from the other trials, all being of low to very low quality, suggest that applying a leave-on product (moisturiser, skin protectant, or a combination) might be more effective than not applying a leave-on product. No trial reported on the third primary outcome 'number of participants not satisfied with treatment' or on adverse effects. AUTHORS' CONCLUSIONS: Little evidence, of very low to moderate quality, exists on the effects of interventions for preventing and treating IAD in adults. Soap and water performed poorly in the prevention and treatment of IAD. Application of leave-on products (moisturisers, skin protectants, or a combination) and avoiding soap seems to be more effective than withholding these products. The performance of leave-on products depends on the combination of ingredients, the overall formulation and the usage (e.g. amount applied). High quality confirmatory trials using standardised, and comparable prevention and treatment regimens in different settings/regions are required. Furthermore, to increase the comparability of trial results, we recommend the development of a core outcome set, including validated measurement tools. The evidence in this review is current up to 28 September 2016.

Report of the clinical donor case workshop of the European Association of Tissue Banks annual meeting 2014.

The European Association of Tissue Banks (EATB) donor case workshop is a forum held within the program of the EATB annual congress. The workshop offers an opportunity to discuss and evaluate possible approaches taken to challenging situations regarding donor selection. Donor case workshops actively engage participants with diverging background and experience in an informal, secure and enjoyable setting. The resulting discussion with peers promotes consensus development in deciding tissue donor acceptability, especially when donor health issues are not conclusively addressed in standards and regulations. Finally the workshop serves to strengthen the professional tissue banking networks across Europe and beyond. This report reflects some of the discussion at the workshop during the annual congress in Lund, Sweden, in 2014. The cases presented demonstrate that the implications of various donor illnesses, physical findings and behaviours on the safety of tissue transplantation, may be interpreted in a different way by medical directors and other professionals of different tissue facilities. This will also result in diverging preventive measures and decisions taken by the tissue facilities. Some of the donor cases illustrate varied responses from participants and demonstrate that operating procedures, regulations and standards cannot comprehensively cover all tissue donor illnesses, medical histories and circumstances surrounding the cause of death. For many of the issues raised, there is a lack of published scientific evidence. In those cases, tissue bank medical director judgement is critical to guarantee transplantation safety. This judgement should be based on a proper and documented risk assessment case by case. Conditions or parameters taken into account for risk assessment are amongst others, the type of tissue, the type of processing, the characteristics of the final product, and the availability of an adequate sterilisation methodology. By publishing these difficult donor suitability cases, and the resulting discussions, we provide information for future similar cases and we identify needs for future literature review and scientific research. In this way the donor case workshops play a role in optimizing the quality and security of tissue donation.

The risk of transmitting cutaneous malignancy through skin transplantation: a literature-based risk assessment.

According to the European Union Tissues and Cells Directives donation of tissue is contraindicated in the presence of or a previous history of malignant disease, with the exception of cutaneous basal cell carcinoma. Skin cancer is the most common cancer. Due to ultraviolet light exposure and increasing life expectancy an increasing prevalence of malignant or premalignant skin lesions is observed, which may result in a decline of the availability of skin for transplantation. A risk assessment based on published studies and expert opinion was performed in order to investigate the risk of transmitting malignant or premalignant skin lesions through tissue transplantation, and more particular through skin transplantation. The scarcity of data concerning cancer transmission in tissue transplantation was challenging. Circumstantial evidence, available for organ transplantation, was used to develop the following policy proposal for skin transplantation and cutaneous tumours. Malignant melanoma is an absolute contraindication for the donation of skin and also of other tissues, whereas, non-lesional skin and other tissues of a donor with non-melanoma skin cancer (basal cell and squamous cell carcinoma) or with a premalignant skin lesion can be considered for transplantation. The above mentioned protocol proposal might serve as a prototype for analogous protocols for non-cutaneous malignancies.

Report of the clinical donor case workshop of the European Association of Tissue Banks Annual Congress 2013.

The European Association of Tissue Banks (EATB) Donor Case Workshop is a forum held within the program of the EATB Annual Congress. The workshop offers an opportunity to discuss and evaluate approaches taken to challenging donor selection and donation ethics, and it strengthens networking between tissue banking professionals. The workshops actively engage participants from a wide array of international expertise, in an informal, secure and enjoyable setting in which learning from peers and finding potential solutions for submitted cases are facilitated. This report reflects some of the discussion at the Donor Case Workshop during the EATB Annual Congress in Brussels in 2013. The presented cases demonstrate that the findings, their interpretation, the resulting actions and preventive measures in the different tissue facilities are not always predictable. The varied responses from participants and lack of consensus corroborate this and clearly indicate that operating procedures do not comprehensively cover or prepare for all eventualities. For many of the issues raised there is no relevant information in the published literature. By publication of a summary of the discussions we hope to reach a wider audience, to provide information gathered at the workshop and to stimulate individuals and institutions to undertake further literature reviews or to undertake research in order to gather evidence concerning the discussed topics.

Implementation of a quality improvement initiative in Belgian diabetic foot clinics: feasibility and initial results.

BACKGROUND: This article aims to describe the implementation and initial results of an audit-feedback quality improvement initiative in Belgian diabetic foot clinics. METHODS: Using self-developed software and questionnaires, diabetic foot clinics collected data in 2005, 2008 and 2011, covering characteristics, history and ulcer severity, management and outcome of the first 52 patients presenting with a Wagner grade ≥ 2 diabetic foot ulcer or acute neuropathic osteoarthropathy that year. Quality improvement was encouraged by meetings and by anonymous benchmarking of diabetic foot clinics. RESULTS: The first audit-feedback cycle was a pilot study. Subsequent audits, with a modified methodology, had increasing rates of participation and data completeness. Over 85% of diabetic foot clinics participated and 3372 unique patients were sampled between 2005 and 2011 (3312 with a diabetic foot ulcer and 111 with acute neuropathic osteoarthropathy). Median age was 70 years, median diabetes duration was 14 years and 64% were men. Of all diabetic foot ulcers, 51% were plantar and 29% were both ischaemic and deeply infected. Ulcer healing rate at 6 months significantly increased from 49% to 54% between 2008 and 2011. Management of diabetic foot ulcers varied between diabetic foot clinics: 88% of plantar mid-foot ulcers were off-loaded (P10-P90: 64-100%), and 42% of ischaemic limbs were revascularized (P10-P90: 22-69%) in 2011. CONCLUSIONS: A unique, nationwide quality improvement initiative was established among diabetic foot clinics, covering ulcer healing, lower limb amputation and many other aspects of diabetic foot care. Data completeness increased, thanks in part to questionnaire revision. Benchmarking remains challenging, given the many possible indicators and limited sample size. The optimized questionnaire allows future quality of care monitoring in diabetic foot clinics.

Report of the clinical donor case workshop of the European Association of Tissue Banks annual meeting 2012.

The European Association of Tissue Banks (EATB) donor case workshop is a forum held within the program of the EATB annual congress. The workshop offers an opportunity to discuss and evaluate approaches taken to challenging situations regarding donor selection, it promotes consensus development in deciding tissue donor acceptability when donor health issues are not addressed in standards and regulations, and serves to strengthen the professional tissue banking networks across Europe and beyond. This report reflects some of the discussion at the workshop during the annual congress in Vienna in 2012. The cases presented dealt with problems encountered by tissue bank facilities concerning idiopathic thrombocytopenia and auto-immune disorders, hemodilution and blood sample identification, premalignant and malignant lesions, and Huntington's disease. The discussions during the workshop demonstrate that the implications on the safety of tissue transplantation of various tissue donor illnesses, physical findings and behaviours, and the preventive measures taken by tissue facilities, may not always be agreed by tissue facility medical directors and other professionals. Moreover, they reveal that operating procedures, regulations and standards cannot comprehensively cover all tissue donor findings, medical histories and circumstances surrounding the cause of death. For many of the issues raised, there is a need for scientific research to provide a better evidence base for future deliberations about the suitability and eligibility of tissue allograft donors.

The 22nd annual meeting of the European Tissue Repair Society (ETRS) in Athens, Greece.

The 22nd Annual Meeting of the European Tissue Repair Society, Athens, Greece, October 4 to 5, 2012 informed about pathophysiological mechanisms in tissue repair and on the development of clinical treatments of chronic wounds, fibrosis, and cancer, considering recent advances in molecular biology and biotechnology.

Keratinocytes in the treatment of severe burn injury: an update.

Burns are among the most life-threatening physical injuries, in which fast wound closure is crucial. The surgical burn care has evolved considerably throughout the past decennia resulting in a shift of therapeutic goals. Therapies aiming to provide coverage of the burn have been replaced by treatments that have both functional as aesthetic outcomes. The standard in treating severe burns is still early excision followed by skin grafting. The use of cultured keratinocytes to cover extensive burn wounds appeared very promising at first, but the technique still has several limitations of which the long time to culture, the major costs, the risk of infection and the need for an adequate dermal layer limit clinical application. The introduction of dermal substitutes, composite grafts, tissue engineering based on stem cell application have been advocated. The aim of this review is to assess the use of cultured keratinocytes in terms of technical aspects, clinical application, limitations and future perspectives. Cultured keratinocytes are expected to keep playing a role in wound healing, especially in the field of chronic wounds. In severe burns, despite its limitations, keratinocytes can be beneficial if implemented as one of the elements in a broader wound management.

Results of the clinical donor case and quality system case workshops of the European Association of Tissue Banks annual meeting 2009.

The European Association of Tissue Banks (EATB) Donor Case Workshop and Quality System Case workshop are forums held within the program of the EATB Annual Congress. These workshops offer an opportunity to discuss and evaluate approaches taken to challenging situations, regarding donor selection and quality issues, and strengthen the professional tissue banking and regulatory networks across Europe. This report reflects some of the discussion at the congress workshops and also subsequent correspondence between the various individuals who submitted cases for discussion. The cases presented to the workshops demonstrate that the findings, their interpretation, deducted actions and preventive measures in tissue banks are not predictable. The varied responses and lack of consensus corroborate this and clearly indicate that operating procedures cannot comprehensively cover or prepare for all eventualities. For many of the issues raised there is a lack of information in the published literature. The workshops actively engage participants, representing a wide array of international expertise, in an informal, secure and enjoyable setting, which facilitates learning from peers and provides potential solutions to those submitting cases. By publishing a summary of the discussions, we hope to reach a wider audience and to stimulate individuals to undertake full literature reviews or research on some of the discussed subjects.

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.