National Academies Press: OpenBook

Blood and Blood Products: Safety and Risk (1996)

Chapter: 7: Concluding Remarks

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Suggested Citation:"7: Concluding Remarks." Institute of Medicine. 1996. Blood and Blood Products: Safety and Risk. Washington, DC: The National Academies Press. doi: 10.17226/5395.
Page 175
Suggested Citation:"7: Concluding Remarks." Institute of Medicine. 1996. Blood and Blood Products: Safety and Risk. Washington, DC: The National Academies Press. doi: 10.17226/5395.
Page 176
Suggested Citation:"7: Concluding Remarks." Institute of Medicine. 1996. Blood and Blood Products: Safety and Risk. Washington, DC: The National Academies Press. doi: 10.17226/5395.
Page 177
Suggested Citation:"7: Concluding Remarks." Institute of Medicine. 1996. Blood and Blood Products: Safety and Risk. Washington, DC: The National Academies Press. doi: 10.17226/5395.
Page 178

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VII Concluding Remarks

Henrik H. Bendixen Chair, Forum on Blood Safety and Blood Availahilif;y As we review the risks of transfusion, as well as the perception of risk expressed by recipients and the public at large, we should examine all data and all issues in the context of health care and society at large. Since World War II the growth in knowledge and technology has been amazing, leading to substantial advances in safety, including the safety of the blood supply. One important development is the growing importance of computers and information systems. These increasingly drive the way we do research, teach, and train, as well as every aspect of health care practice. During the same period of time, public attitudes have changed from the acceptance of a tragic mishap as an act of God to today's unwillingness to accept anything other than a perfect result. We do not know all the reasons why this change is taking place, but attitudes certainly have changed, irreversibly, and we see this change in attitude reflected in everything from legislation and regulation to accreditation requirements, lawsuits, and the media. Returning to the advances in the safety of the blood supply, we must observe that a finite risk remains, a risk that may or may not be acceptable. What are the factors that influence the degree of acceptability or lack of acceptability of a given risk? First, there is informed consent. Granger Morgan's presentation on risk communication stressed how informed consent converts an involuntary risk into a voluntarily acceptable risk, provided the consent is competently obtained. In Nelson's study of patients undergoing open heart surgery, the patients gave infonned consent not only to the surgery but also to receiving multiple blood transfusions. The risk of multiple transfusions was not trivial, yet it was acceptable, being relatively small compared with the risks of surgery, anesthesia, and the heart disease itself. Sometimes informed consent cannot be obtained, such as in major trauma, and while the risk of transfusion may still be modest compared with the total risk, it is still an involuntary risk. Finally, when transfusion of blood or a blood product stands alone as the only intervention, that is when the risk is least 177

178 BLOOD AND BLOOD PRODUCTS: SAFETY AND RISK acceptable, particularly when it is unknown and therefore not voluntarily accepted. Moreno recommended that we err on the side of hyperinforming in obtaining informed consent. He presented a tiered process, starting with a relatively concise explanation and moving on to an explicit invitation to the patient to ask questions. A second tier would be to respond to any questions that are asked, while a third tier might be to provide written material or references. The conflict between individual rights, placing autonomy first, and the needs and financial concerns of society at large will always be with us. Fiscal realities will drive us to find rationales within our liberal framework to explain where we draw the limits on the share of common resources that the individual can claim. We are groping toward an adaptation of public philosophy to real- world constraints. The Oregon experience of having panels of experts rank treatments and procedures according to both benefit and cost is an intriguing program. Community groups then did their independent ranking, which, at least in part, was different from that of the experts, but the result was a plan that had community support. The result of involving the community as decision makers was building trust. The concept of informed consent goes beyond the specific consent obtained for a specific procedure to the acceptance of patients' right to know and to be active decision makers about their own health or illness. The loss of trust referred to by Chess could have been avoided or mitigated had those at greatest risk been active participants in the decision-making process during the early days of the HIV problem. The vice chairman of the National Hemophilia Foundation reminded the Forum of the importance of trust and its enhancement by open communication. Many factors have contributed to improved blood safety, including new concepts, good research, ever better technology, and computer-based quality control. Also contributing have been the introduction of guidelines and standards by professional groups, as well as the influence of the press, consumer groups, special interest groups, and even lawsuits. Regulations by federal or state agencies have played a special role. Advances in safety, however, do not logically argue for deregulation, but in a modern industrial society, one important facilitator is "predictability." There must be some rules of the game, and one can accept even tough rules, as long as they are well known and equitably administered. Much has been learned from more than 10 years of dealing with HIV in the blood supply, and much progress has been made. All of that knowledge should help us in preparing for the defense against the next new illness to descend upon us.

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This volume explores the safety and availability of the nation's supply of blood and blood components. It discusses the risks of disease transmission, methods of guarding the blood supply, new ideas on safety and monitoring, risk tolerance, risk communication, and no-fault insurance.

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