Biomedical Engineering Reference
In-Depth Information
estimations of its potential are based wholly on preclinical and animal studies. Above all,
the patient must not be led to believe that the risks and benefits of the intervention are
not better understood than they in fact are. Another important point is to ensure that the
patient understands all of the options—not simply life or death, but also a life with severely
impaired quality. Although desperate circumstances may legitimate desperate actions, the
decision to take such actions must rest upon the informed and voluntary consent of the
patient, certainly for an especially vulnerable patient.
It is important here for a clinician involved in emergency use of an unapproved device to
recognize that these activities constitute a form of practice, albeit nonvalidated, and not
research. Hence, the primary obligation is to the well-being of the patient. The patient
enters into the relationship with the clinician with the same trust that accompanies any
normal clinical situation. Treating this sort of intervention as if it were an instance of research
and, thus, justified by its benefits to science and society would be an abuse of this trust.
2.13 ETHICAL ISSUES IN TREATMENT USE
The FDA has adopted regulations authorizing the use of investigational new drugs in
certain circumstances where a patient has not responded to approved therapies. This “treat-
ment use” of unapproved new drugs is not limited to life-threatening emergency situations
but is also available to treat “serious” diseases or conditions. The FDA has not approved
treatment use of unapproved medical devices, but it is possible that a manufacturer could
obtain such approval by establishing a specific protocol for this kind of use within the con-
text of an IDE.
The criteria for treatment use of unapproved medical devices would be similar to criteria
for treatment use of investigational drugs: (1) the device is intended to treat a serious or life-
threatening disease or condition; (2) there is no comparable or satisfactory alternative prod-
uct available to treat that condition; (3) the device is under an IDE or has received an IDE
exemption, or all clinical trials have been completed and the device is awaiting approval;
and (4) the sponsor is actively pursuing marketing approval of the investigational device.
The treatment use protocol would be submitted as part of the IDE and would describe
the intended use of the device, the rationale for use of the device, the available alternatives
and why the investigational product is preferable, the criteria for patient selection, the mea-
sures to monitor the use of the device and to minimize risk, and technical information that
is relevant to the safety and effectiveness of the device for the intended treatment purpose.
Were the FDA to approve treatment use of unapproved medical devices, what ethical
issues would be posed? First, because such use is premised on the failure of validated inter-
ventions to improve the patient's condition adequately, it is a form of practice rather than
research. Second, since the device involved in an instance of treatment use is unapproved,
such use would constitute nonvalidated practice. As such, like emergency use, it should be
subject to the FDA's requirement that prior preclinical tests and animal studies have been
conducted that provide substantial reason to believe that patient benefit will result. As with
emergency use, although this does not prevent assessment of the intervention's benefits and
risks from being highly speculative, it does prevent assessment from being totally specula-
tive. Here, too, although desperate circumstances can justify desperate action, they do not
