Biomedical Engineering Reference
In-Depth Information
justify reckless action. Unlike emergency use, the circumstances of treatment use involve
serious impairment of health rather than the threat of premature death. Hence, an issue that
must be considered is how serious such impairment must be to justify resorting to an inter-
vention whose risks and benefits have not been solidly established.
In cases of emergency use, the FDA requires that physicians not create an exception to an
IDE to avoid requirements that would otherwise be in place. As with emergency use of
unapproved devices, the patients involved in treatment uses would be particularly vulner-
able patients. Although they are not dying, they are facing serious medical conditions and
are thereby likely to be less able to avoid exploitation than patients under less desperate
circumstances. Consequently, here too it is especially important that patients be informed
of the speculative nature of the intervention and of the possibility that treatment may result
in little to no benefit to them.
2.14 THE ROLE OF THE BIOMEDICAL ENGINEER IN
THE FDA PROCESS
(Public Law 101-629) went
into effect. This regulation requires a wide range of health care institutions, including hos-
pitals, ambulatory-surgical facilities, nursing homes, and outpatient treatment facilities, to
report information that “reasonably suggests” the likelihood that the death, serious injury,
or serious illness of a patient at that facility was caused or contributed to by a medical
device. When a death is device-related, a report must be made directly to the FDA and to
the manufacturer of the device. When a serious illness or injury is device-related, a report
must be made to the manufacturer or to the FDA in cases where the manufacturer is not
known. In addition, summaries of previously submitted reports must be submitted to the
FDA on a semiannual basis. Prior to this regulation, such reporting was wholly voluntary.
This new regulation was designed to enhance the FDA's ability to learn quickly about
problems related to medical devices and supplements the medical device reporting (MDR)
regulations promulgated in 1984. MDR regulations require that manufacturers and importers
submit reports of device-related deaths and serious injuries to the FDA. The new law extends
this requirement to users of medical devices along with manufacturers and importers. This
act gives the FDA authority over device-user facilities.
The FDA regulations are ethically significant because by attempting to increase the
FDA's awareness of medical device-related problems, it attempts to increase that agency's
ability to protect the welfare of patients. The main controversy over the FDA's regulation
policies is essentially utilitarian in nature. Skeptics of the law are dubious about its ability
to provide the FDA with much useful information. They worry that much of the informa-
tion generated by this new law will simply duplicate information already provided under
MDR regulations. If this were the case, little or no benefit to patients would accrue from
compliance with the regulation. Furthermore, these regulations, according to the skeptics,
are likely to increase lawsuits filed against hospitals and manufacturers and will require
device-user facilities to implement formal systems for reporting device-related problems
and to provide personnel to operate those systems. This would, of course, add to the costs
of health care and thereby exacerbate the problem of access to care, a situation that many
On November 28, 1991, the
Safe Medical Devices Act of 1990
