Biomedical Engineering Reference
In-Depth Information
one of the recommended drugs and conducts a dose regimen to determine the effectiveness of
the drug for the particular patient. During the treatment, blood tests are conducted to ascertain
the presence of drug toxicity, and other psychiatric measures obtained to determine if the drug
is having the desired effect.
As these data elements are entered, they are compared with standard expected outcomes, and
if the outcomes are outside the expected limits, an alert is sent to the physician indicating further
action needs to be taken.
In this situation:
1.
Who is liable for mistreatment—the clinician, the programmer, or the systems administrator?
2.
What constitutes mistreatment?
3.
What is the role of the designers of such a system; in other words, what constitutes a successful
design?
4.
How does the clinic evaluate the performance of a physician using the system, as well as the
system itself?
Thus, although the benefits and risks posed by use of the device are highly speculative,
they are not entirely speculative. Although the only way to validate a new technology is to
engage in research on humans at some point, not all nonvalidated technologies are equal.
Some will be largely uninvestigated, and assessment of their risks and benefits will be
wholly or almost wholly speculative. Others will at least have the support of preclinical
and animal tests. Although this is not sufficient support for incorporating use of a device
into regular clinical practice, it may, however, represent sufficient support to justify use
in the desperate circumstances at issue in emergency situations. Desperate circumstances
can justify desperate actions, but desperate actions are not the same as reckless actions,
hence the ethical soundness of the FDA's requirement that emergency use be supported
by solid results from preclinical and animal tests of the unapproved device.
A second requirement that the FDA imposes on the emergency use of unapproved
devices is the expectation that physicians “exercise reasonable foresight with respect to
potential emergencies and
make appropriate arrangements under the IDE procedures.”
Thus, a physician should not “create” an emergency in order to circumvent IRB review and
avoid requesting the sponsor's authorization of the unapproved use of a “device.” From a
Kantian point of view, which is concerned with protecting the dignity of people, this is a
particularly important requirement. To create an emergency in order to avoid FDA regula-
tions is to treat the patient as a mere resource whose value is reducible to service to the clin-
ician's goals. Hence, the FDA is quite correct to insist that emergencies are circumstances
that reasonable foresight would not anticipate.
Also especially important here is the nature of the patient's consent. Individuals facing
death are especially vulnerable to exploitation and deserve greater measures for their pro-
tection than might otherwise be necessary. One such measure would be to ensure that the
patient, or his legitimate proxy, knows the highly speculative nature of the intervention
being offered—that is, to ensure that it is clearly understood that the clinician's estimation
of the intervention's risks and benefits is far less solidly grounded than in the case of vali-
dated practices. The patient's consent must be based on an awareness that the device whose
use is contemplated has not undergone complete and rigorous testing on humans and that
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