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VII
Concluding Remarks
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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
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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.
Representative terms from entire chapter:
blood supply
