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Microprocessor-Based
"Intelligent" Machines in Patient Care
National Institutes of Health
Consensus Development Conference Statement
October 17-19, 1979
This statement is more
than five years old and is provided solely for historical purposes. Due to
the cumulative nature of medical research, new knowledge has inevitably
accumulated in this subject area in the time since the statement was
initially prepared. Thus some of the material is likely to be out of date,
and at worst simply wrong. For reliable, current information on this and
other health topics, we recommend consulting the National Institutes of
Health's MedlinePlus http://www.nlm.nih.gov/medlineplus/.
This statement was originally published as: Microprocessor-Based "Intelligent"
Machines in Patient Care. NIH Consens Statement 1979 Oct
17-19;2(10):59-62.
For making bibliographic reference to the
statement in the electronic form displayed here, it is recommended that
the following format be used: Microprocessor-Based "Intelligent"
Machines in Patient Care. NIH Consens Statement Online 1979 Oct 17-19
[cited year month day];2(10):59-62.
Introduction
An NIH Consensus Development Conference on
"The Use of Microprocessor-Based, 'Intelligent' Machines in Patient
Care" was held in Silver Spring, Maryland on October 17-19, 1979.
The NIH consensus development program
brings together practicing physicians, biomedical research scientists,
consumers, and others in an effort to reach general agreement on the
safety and efficacy of a medical technology, whether it be a drug, device,
or procedure.
Progressive improvements in the art of
manufacturing integrated circuits have shrunk the size and cost of many
electronics devices. Tens of thousands of transistors and related
components now routinely fit on silicon chips only 1/4 inch square.
Nowhere, perhaps, have these engineering achievements had more pronounced
effects than in the development of very small and inexpensive computers.
Some specially designed microcomputers are small enough to fit within
other devices or to be implanted biologically. The relative
inexpensiveness and miniaturization of microcomputers have already led to
the development of many new medical technologies.
Among the most interesting technologies may
be those resulting from the incorporation of microcomputers into familiar
medical devices. Microcomputer-based intensive care monitors, for example,
might soon be capable of making medical judgments about patients and,
where time is critical, autonomously modifying the patients' treatments in
response to changes in their needs. The use of such devices--intended to
improve patient care--would, however, raise both technological and
sociological questions:
- Would these devices truly be more
reliable or cost-effective than manual methods? Would they lead to
improved patient outcomes?
- What ethical-legal issues can arise in
their development, testing, and marketing?
- What might be their long-term, adverse
consequences? How could these ill-effects be avoided?
- How might one verify that the devices
perform those functions--and only those--which their designers
intended?
The NIH consensus conference on medical
uses of microprocessors* was convened to allow
practitioners, researchers, and others to attempt to seek agreement on
these issues. By meeting during a formative stage in the technology's
development they might thus be able to guide its development along lines
which are most responsive to society's needs.
* Microprocessors are large-scale integrated circuits
which serve as the central processing units of microcomputers. As such
they are key components controlling the interpretation and execution of
machine instructions.
The conference began with nine invited
papers on technical and social aspects of the subject--including six on
recent applications. There then followed separate consensus panels which
discussed the issues above in regard to use of the technology in (1)
medical history taking, physical examinations, laboratory testing, and
special procedures; (2) diagnosis and decision making; and (3) treatment
and monitoring.
(Note: During the summer of 1978, the
Biomedical Engineering and Instrumentation Branch, DRS, of the National
Institutes of Health conducted a series of four workshops on "The Use
of Microprocessor- Based, 'Intelligent' Machines in Patient Care" in
preparation for the NIH consensus development conference. Fifteen
panelists from the research and practicing communities participated by
discussing: (1) the technology's state of the art, (2) its prospects for
future development, and (3) some of its potential legal, ethical, social,
political, medical, and economic implications. Copies of its report, NIH
Pub. No. 79-1852, are available from Henry S. Eden, M.D., Assistant to the
Chief, Biomedical Engineering and Instrumentation Branch, DRS, Building
13, Room 3W-13, NIH, Bethesda, Maryland 20205.)
What follows is a brief summary of some of
the points raised by the audience and panels.
- Most panel members felt that so basic a
development as small, inexpensive computers could potentially affect
society in more fundamental ways then just through applications in
medical settings. (As an example, microprocessor-based assembly line
automation could displace workers.)
- Panel members stressed that although the
electronic components of microcomputer-based systems were often
inexpensive, total costs for such systems could be high, due to the
expense of software development and regulatory compliance.
- Panel 1 felt that there was a medical
role for microcomputers in the physician's office. They considered it
desirable in some cases to have the results of certain tests (e.g.,
phonocardiograms, pulmonary function, blood chemistry profiles)
available prior to the patient's examination. It was suggested that
computerized, office-based instruments could make it possible for
allied health personnel to acquire such data easily, quickly and
precisely.
- The majority of Panel 2 felt that a
proper goal for the development of systems for diagnosis and decision
making should be "to exceed physician capability, not just
emulate it." It was further felt that many commonly encountered
medical decisions are neither difficult, nor do they require
computerization. (One panelist further felt that some work in the area
of "artificial intelligence" for medicine was predicated
upon a false assumption--a shortage of physicians to make medical
decisions.) The group listed the following technologically feasible,
if not essential, applications of computers for diagnosis and decision
making:
- use in auditing simple, routine
decisions.
- assisting with a limited number of
selected, complex decisions.
- providing improved access to medical
information, and
- communicating information more
quickly (e.g., from a clinical laboratory to an office).
As a caveat, the group recalled early and
somewhat unrealized expectations for automated systems in diagnosis
and decision making. They cited the fuzzy and multidimensional nature
of many medical decision processes as causes of difficulty in
converting physicians' thought processes to machine-usable routines.
- Members of Panel 3 observed that the
characteristics of microprocessors--significant computing power in
small, inexpensive packages--offer tremendous advantages to designers
of instruments for patient therapy and monitoring. The panel noted
promising developments underway in the form of implantable wearable,
and bedside devices which were programmable through the use of
microcomputers. Although the panel felt that the technical
sophistication of microcomputers, per se, was fairly advanced, it
noted a lack of ways to make miniaturized sensors and effectors
capable of working in vivo for extended periods. This knowledge gap
was felt to be inhibiting the development of effective closed-loop
systems.
- Ethical and legal questions surrounding
the use of microcomputers in medicine were not felt to be unique.
There have, for example, been ethical and legal precedents for most
issues, involving larger traditional computers and
non-microprocessor-based wearable and implantable devices. It was
felt, however, that debate on some of the issues--such as informed
consent--may be given new life when the number and diversity of
computer applications in medicine increase due to the availability of
small, inexpensive computers.
- There was general discussion on whether
computers used to acquire patient histories would depersonalize the
doctor-patient encounter. The panels suggested that computers could be
used effectively to ascertain the patient's "data base", but
that the patient's "problem history"-- with its emotional
overlays--could still be best acquired directly by the physician.
- The panels saw a need for effective
standards for microprocessor-based medical instruments, particularly
standards developed by professional medical and engineering societies.
They drew a distinction, however, between "standards" and
"standardization", the latter being too prone to inhibit
further innovation. Panel 3 particularly commented that "the
innovation process is a delicate one and probably needs more
cultivation than control". At the same time, the panels
acknowledged the existence of multiple and conflicting standards which
have occasionally made device interconnection difficult.
- Potential problems with the
documentation and evaluation of software were also acknowledged.
Unanswered questions which the panels identified were: When users
modify the software of a device, is a new device created? Who then is
responsible for certifying that the modified device is safe and
effective? Who will repair such devices? How can there best be a
resolution of the conflicting needs of manufacturers--who wish to keep
their software proprietary--and the needs of physicians--who wish to
fully understand the algorithms used in devices serving patients under
their care.
- The members of Panel 3 called for
greater efforts to develop methods of assessing medical technologies
and selectively encouraging the dissemination of those which are most
cost-effective. It was observed that in many areas of the health care
system the normal feedback mechanisms of the marketplace do not
effectively select out the most appropriate uses of technology. The
panelists felt that greater efforts are needed to prepare physicians
to play this role, both in rejecting ineffective technologies and
accepting and using those that are effective.
- Most panelists cited a need for better
mechanisms for transferring recently developed technologies a) between
institutions and b) from academia to the commercial sector. It was
felt that this role could be played in part by federal seed monies
which would assist in technology transfer.
Consensus Development Panel 1
Use in Medical History Taking, Physical
Examination, Laboratory Testing and Special Procedures:
Cesar A. Caceres, M.D. (Chairman)
Mark S. Frankel, Ph.D. (Rapporteur)
Daniel Scott Janick, M.D., M.P.H.
Elwin Marg, Ph.D.
Roger G. Mark, M.D., Ph.D.
Helmuth F. Orthner, Ph.D.
Chariklia T. Spiegel, M.D.
Consensus Development Panel 2
Use in Diagnosis and Decision Making:
Morris F. Collen, M.D. (Chairman)
William A. Hymen, Ph.D. (Rapporteur)
J. Barclay Adams, M.D., Ph.D.
Thomas G. Field, Jr.. J.D.
Stanton Glantz, Ph.D.
Albert H. Tech, Ph.D.
Kenneth E. Warner, Ph.D.
Consensus Development Panel 3
Use in Treatment and Monitoring:
Ronald S. Newbower, Ph.D. (Chairman)
Victor Klig (Rapporteur)
Roy Branson, Ph.D
Ernest G. Cravalho, Ph.D.
Nicholas DeClaris, Sc. D.
Robert E. Fischell
Daniel Graupe, Ph.D.
Byron McLees, M.D.
Willis J. Tompkins, Ph.D.
Conference Sponsors
NIH Division of Research Services
Biomedical Engineering and Instrumentation Branch
Office of Medical Applications of Research
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