[ST-18] Statement on Emerging Surgical Technologies and the
Evaluation of Credentials
[by the American College of Surgeons]
The development and rapid dissemination of minimally invasive
surgical procedures has brought into focus the need for a balanced
assessment of the safety, efficacy, and costs of potentially
important new technology. It is essential that the process of
evaluation not impede the timely development or use of the new
treatment, but it is equally essential that the value and safety
of the procedure be established before it is widely used on patients.
The basic principles of this process are outlined in the "Statement
on Emerging Surgical Technologies," which was recently developed
by the College's Committee on Emerging Surgical Technology and
Education and approved by the Board of Regents.
As the new technology is introduced into the clinical armamentarium,
it is essential that surgeons using the technology be appropriately
educated and their skills assessed. Therefore, the following
"Guidelines for Evaluation of Credentials of Individuals
for the Purpose of Awarding Surgical Privileges in New Technologies"
were also developed by the committee and endorsed by the Board
of Regents.
The final step in the process will be to establish the
value of the new technology in day-to-day practice. Therefore,
technology assessment is more than a determination of safety
and efficacy. It must also include assessment of the procedure
through analysis of the outcome of the procedure in clinical
practice. Outcomes research, a new and difficult tool, must be
developed from a background of each surgeon's clinical experience
to determine if the new technology is of value to society. These
studies, yet to come, may be the most important aspect of the
process of evaluating emerging technologies.
Statement on Emerging Surgical Technologies
New surgical technologies are the combined product of basic
and applied surgical research. The introduction and application
of any new technology should proceed through a series of steps
intended to ensure its safety, appropriateness, and cost-effectiveness.
1. The development of a new technology must be accompanied
by a scientific assessment of safety, efficacy, and need. Both
the rigor and scope of an assessment will depend, to some extent,
on the novelty and complexity of the technology. The assessment
process may range from carefully monitored observational studies
with evaluation to controlled clinical trials.
2. Diffusion into clinical practice requires appropriate
education of surgeons and evaluation of their use of the new
technology. An in-depth knowledge of the relevant disease process
and its management, gained through formal training and clinical
experience, is a prerequisite. Acquisition of new technical skills
and the development of appropriate support facilities must follow,
and must be subject to initial assessment and periodic monitoring
of outcomes.
3. Widespread application of new technologies must
be continuously assessed and compared with alternative therapies
to ensure appropriateness and cost-effectiveness through outcome
studies.
The introduction of new technology to surgeons and the public
must be done in an ethical manner with the Statement on Principles
of the American College of Surgeons.
Guidelines for Evaluation of Credentials of Individuals
for the Purpose of Awarding Surgical Privileges in New Technologies
1. The surgeon must be a member in good standing of
the department or service from which privileges are to be recommended.
2. A defined educational program in the technology,
including didactic and practical elements, must be completed
and documented either as a postresidency course of instruction
or as a component of an approved residency program.
3. The surgeon must be qualified, experienced, and
knowledgeable in the management of the diseases for which the
technology is applied--for example, laparoscopic instrumentation
would be applied by surgeons with abdominal or pelvic surgical
experience and credentials.
4. The qualifications of the surgeon to apply the new
technology must be assessed by a surgeon who is qualified and
experienced in the technology and should result in a written
recommendation to the department or service head. In the case
of a resident trained in the technology during residency, recommendation
by the program director is acceptable.
5. Maintenance of skills should be documented through
periodic outcomes assessment and evaluation, in association with
the regular renewal of surgical privileges.
Statements
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Reprinted from The Bulletin of the American College
of Surgeons
Vol. 79, No. 6, Pages 40-41, June 1994.
