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.
- 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.
- 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.
- 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
- The surgeon must be a member in good standing of the department or service from which privileges are to be recommended.
- 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.
- 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.
- 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.
- Maintenance of skills should be documented through periodic outcomes assessment and evaluation, in association with the regular renewal of surgical privileges.
Reprinted from The Bulletin of the American College of Surgeons
Vol. 79, No. 6, Pages 40-41, June 1994.
