Public Health Law Map - Beta 5 - Medical and Public Health Law Site

oxygen saturation. When saturation falls below a certain threshold, an alarm is
sounded, unambiguously signaling that the patient needs more oxygen or that the
instrument has become detached or dysfunctional. In either case, definitive action
can be taken at once. These factors make oximetry an ideal safety technology. It
helps prevent injuries while not otherwise affecting record- keeping or staffing
practices. This is not entirely due to special virtues of oximetry.
It is rare that the patient is left completely alone in the operating room. The genius
of oximetry is that it is an easily understandable monitor. When the alarm goes off,
the surgeon can call for help if the anesthesiologist has drifted away. It can be
assumed that oximetry used as a remote-sensing, continuous- recording technology
will pose the same documentation and staffing problems as fetal heart monitors.
These may be outweighed by the clear intervention signal provided by oximetry. If,
however, hospitals use recording-remote oximeters in situations where this clear
signal is ignored, they will suddenly find oximetry to be a fertile source of
litigation.
2. Lessons for Technology Assessment
Continuous-recording instruments are invaluable research tools. If there is a central
criticism of fetal heart monitor usage, it is that the monitors were adopted for routine
use without the research background necessary to understand their limitations. Fetal
heart monitors illustrate that data, as opposed to information, increase the risk of
litigation. This happens because plaintiffs’ attorneys thrive on ambiguity. If a patient
is injured, the plaintiff’s attorney will comb the records for anything that cannot be
clearly explained to portray as the cause of the injury. This is countered to some
extent by the highly filtered nature of traditional medical records. Continuously
recorded streams of ambiguous instrument output, in contrast, provide a gold mine of
exploitable ambiguity.
It is critical that new instruments be evaluated for the reliability of their intrinsic
measurements and for the clinical significance of those measurements. Do the data
resolve clinical questions or merely complicate them? This question becomes more
interesting as hospitals purchase clinical information systems that feed the outputs of
various monitors into a computer-based continuous- recording system. The
assumption is that since these instruments are already in place, their output must be
useful. It is possible, however, that many existing measurements are useful only in
the larger context of patient care. Like a fetal heart rate observed without the context
of the mother, their readings may be much less valuable as retrospective records.
Given that efficacy testing is a recent innovation for medical devices, it is also
possible that some existing measurements are clinically irrelevant. This means that
their outputs will be randomly related to the patient’s condition, creating that
ambiguity so valuable to plaintiffs’ attorneys.
Clinical instruments provide data, not necessarily information that aids in clinical
decision making. The data create noise that can obscure significant clinical
information while providing clear hindsight to those who would second- guess the
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