[Cell salvage : Scientific evidence, clinical practice and legal framework]. / Maschinelle Autotransfusion : Wissenschaftliche Evidenz, klinische Praxis und rechtliche Rahmenbedingungen.

Cell salvage is an efficient method to reduce the transfusion of homologous banked blood, as documented by several meta-analyses detected in a systematic literature search. Cell salvage is widely used in orthopedics, trauma surgery, cardiovascular and abdominal transplantation surgery. The retransfusion of unwashed shed blood from wounds or drainage is not permitted according to German regulations. Following irradiation of wound blood, salvaged blood can also be used in tumor surgery. Cell salvage makes a valuable contribution to providing sufficient compatible blood for transfusions in cases of massive blood loss. Certain surgical procedures for Jehovah's Witnesses are only possible with the use of cell salvage. Another possible use is the washing of homologous banked blood, e. g. to prevent potassium-induced arrhythmia or sequestration of autologous platelets. Other advantages besides a good compatibility are the high vitality and functionality of the unstored autologous red blood cells. These have been declared a pharmaceutical product by the German transfusion task force in 2014, so that the autologous red blood cells are now under the control of the Pharmaceutical Products Act (AMG). The new hemotherapy guidelines, however, tolerate cell salvage only under strict rules, whereby the production of autologous blood during or after surgery is still possible without additional special permits. The new guidelines now require the introduction of a quality management system for cell salvage and regular quality controls. These quality controls include a control of the product hematocrit for every application, monthly controls of the protein and albumin elimination rates and the erythrocyte recovery rate for each cell salvage device. Testing for infection markers is not required. The application of cell salvage has to be reported to the appropriate authorities.

Circulating microRNAs as biomarkers for detection of autologous blood transfusion.

MicroRNAs (miRNAs) are small non-coding RNAs that regulate various biological processes. Cell-free miRNAs measured in blood plasma have emerged as specific and sensitive markers of physiological processes and disease. In this study, we investigated whether circulating miRNAs can serve as biomarkers for the detection of autologous blood transfusion, a major doping technique that is still undetectable. Plasma miRNA levels were analyzed using high-throughput quantitative real-time PCR. Plasma samples were obtained before and at several time points after autologous blood transfusion (blood bag storage time 42 days) in 10 healthy subjects and 10 controls without transfusion. Other serum markers of erythropoiesis were determined in the same samples. Our results revealed a distinct change in the pattern of circulating miRNAs. Ten miRNAs were upregulated in transfusion samples compared with control samples. Among these, miR-30b, miR-30c, and miR-26b increased significantly and showed a 3.9-, 4.0-, and 3.0-fold change, respectively. The origin of these miRNAs was related to pulmonary and liver tissues. Erythropoietin (EPO) concentration decreased after blood reinfusion. A combination of miRNAs and EPO measurement in a mathematical model enhanced the efficiency of autologous transfusion detection through miRNA analysis. Therefore, our results lay the foundation for the development of miRNAs as novel blood-based biomarkers to detect autologous transfusion.

Blood conservation strategies in major orthopaedic surgery: efficacy, safety and European regulations.

Several major orthopaedic surgical procedures may result in significant blood loss and the need for allogeneic blood transfusion (ABT). However, overall concerns about adverse effects of ABT have prompted the review of transfusion practice and the search for transfusion alternatives to decrease or avoid the use of ABT. These strategies include the correction of perioperative anaemia, pharmacological and non-pharmacologic measures to reduce blood loss, preoperative autologous blood donation and perioperative red blood cell salvage. We have reviewed the efficacy and safety of these strategies and where appropriate offer evidence-based recommendations on their use in orthopaedic surgery. We also reviewed the European regulations on ABT alternatives. Pharmacological alternatives need to be used with a total adherence to European regulations in their legal and off-label use. The administration and use of pharmacological agents to stimulate erythropoiesis or reduce blood loss needs to be within the context of attempting to use allogenic blood in a rational manner. As for autologous blood, European Directives cover preoperative autologous blood donation, but not its clinical use, and perioperative red blood cell salvage devices, but not the product yielded by them. Therefore, the development of quality standards and good practice guidelines for perioperative red blood cell salvage, as well as its inclusion in the haemovigilance programme, is urgently needed. Finally, it is noteworthy that some recommendations given for ABT alternatives are not supported by a high level of evidence and that the goal of performing major orthopaedic surgical procedures without the use of ABT may be better accomplished by combining several of these techniques within a defined algorithm.

[Autohemotherapy, state intervention and bioethics]. / Auto-hemoterapia, intervenção do estado e bioética.

The increasingly frequent practice of autohemotherapy entails a potential risk to the health of individuals since it is scientifically unproven. There are practically no clinical studies showing the efficacy and safety of this procedure; only experimental research with questionable results from studies on human beings and animals. Over the last years, the sanitary surveillance area has expanded its preventive and risk control actions based upon a precautionary philosophy in the private as well as the public sphere. By observing the theoretical and practical reference points of the "four Ps" (prevention, protection, precaution and prudence), in accordance with the epistemology developed within Intervention Bioethics, sanitary surveillance actions are based upon legal administrative policing powers. These powers are understood to be the Public Administration's competence to set conditions on and restrict the use and benefit of goods, activities and individual rights, on behalf of the common well being of people or the State itself. The Brazilian State, through its sanitary surveillance policing powers at the three levels of government, has intervened in the practice of autohemotherapy. Considering the responsible State intervention in situations of collective interest, vulnerability and susceptibility, the present study proposed to analyze the practice of autohemotherapy in the light of sanitary surveillance actions and their relationship with the "four Ps" of Intervention Bioethics.

Auto-hemoterapia, intervenção do estado e bioética / Autohemoteraphy, state intervention and bioethics

A auto-hemoterapia é uma prática de uso clínico crescente, mas com potencial risco à saúde dos indivíduos, uma vez que se trata de procedimento terapêutico sem comprovação científica. Até o momento não existem estudos clínicos que comprovem a eficácia e a segurança deste procedimento; apenas pesquisas experimentais com resultados questionáveis, tanto em seres humanos quanto em animais. Nos últimos anos, a área de Vigilância Sanitária (VS) do Ministério da Saúde ampliou suas ações preventivas e de controle de riscos tanto no âmbito privado como coletivo. As ações da VS têm, muitas vezes, como base o poder legal de polícia administrativa que a legislação lhe confere. Esse poder é entendido como a faculdade que dispõe a Administração Pública para condicionar e restringir o uso e gozo de bens, atividades e direitos individuais, em benefício da coletividade ou do próprio Estado. Recentemente, o Estado, por meio do poder de polícia da VS, interveio na prática da auto-hemoterapia no Brasil. O presente estudo analisa e defende a ação interventiva da VS na prática clínica da auto-hemoterapia no país, tendo como base de sustentação argumentativa os "Quatro Pês" desenvolvidos pela chamada "Bioética de Intervenção" - prevenção, proteção, precaução e prudência.

The increasingly frequent practice of autohemotherapy entails a potential risk to the health of individuals since it is scientifically unproven. There are practically no clinical studies showing the efficacy and safety of this procedure; only experimental research with questionable results from studies on human beings and animals. Over the last years, the sanitary surveillance area has expanded its preventive and risk control actions based upon a precautionary philosophy in the private as well as the public sphere. By observing the theoretical and practical reference points of the "four Ps" (prevention, protection, precaution and prudence), in accordance with the epistemology developed within Intervention Bioethics, sanitary surveillance actions are based upon legal administrative policing powers. These powers are understood to be the Public Administration's competence to set conditions on and restrict the use and benefit of goods, activities and individual rights, on behalf of the common well being of people or the State itself. The Brazilian State, through its sanitary surveillance policing powers at the three levels of government, has intervened in the practice of autohemotherapy. Considering the responsible State intervention in situations of collective interest, vulnerability and susceptibility, the present study proposed to analyze the practice of autohemotherapy in the light of sanitary surveillance actions and their relationship with the "four Ps" of Intervention Bioethics.

Legal and ethical considerations in the transfusion of infected or untested autologous blood.

Autologous blood transfusion grew in popularity in response to the recognition of transfusion-transmitted HIV and a lack of effective screening. Laboratory screening and donor deferrals have decreased the need for autologous transfusion. The issue of banking blood that has not been tested or has been tested and found positive for serious infectious diseases raises ethical and legal issues that must be addressed by transfusion services, transfusion committees, physicians, and administrators. This article provides a summary of pertinent federal and state laws regarding autologous blood transfusion and a framework to assess the ethical implications of various strategies.

Marco legal del uso de sangre autóloga y otras alternativas a la transfusión alogénica / Legal framework for the use of autologous blood and other alternatives to allogenic transfusion

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[Legal aspects of preparation and handling of concentrated red cells derived from placental blood in Germany]. / Juristische Aspekte bei der Herstellung und Verwendung von Plazentablut-Erythrozytenkonzentraten in Deutschland.

Legal aspects of collection, preparation and storage of autologous red cells derived from cord blood according to German law are presented and discussed.

[Autologous blood transfusion]. / Transfusion sanguine autologue.

Autologous blood transfusion techniques are the principal means of reducing allogeneic blood exposure. Those techniques were developed in order to prevent the risk of contamination by viruses, mainly HVB, HCV and HIV. However that risk has become so small that all studies show an exorbitant cost/efficiency ratio. Autologous blood transfusion would therefore be of no interest in terms of public health but a recent experimental study suggested a possible transmission of the BSE agent through blood. Until the matter is settled, the precaution principle means we should prefer alternative techniques to allogeneic blood whenever possible, hence a renewed interest in autologous transfusion.