The following statement on issues surrounding the introduction of new surgical technology was developed by the Committee on Emerging Surgical Technology and Education of the American College of Surgeons and approved by the College's Board of Regents at its June 1995 meeting.
As major new biomedical technology is developed and made available for use, its worth is measured on the basis of the value and safety it confers for patients. Part of this process of evaluation should include a comparison with existing and proven technologies that deal with similar clinical problems. Indications for application of the technology should be carefully defined and patients selected using clear criteria. The qualifications of those who propose to use the new technology must be carefully assessed, verifying that the individual has had comprehensive education and experience in the management of the disease process for which the technology is applied, has acquired the necessary technical skills, and is competent to recognize and manage any complications resulting from use of the new technology. Questions that might be raised by surgeons and health care institutions as a new technology is introduced include the following:
1. Has the new technology been adequately tested for safety and efficacy?
In consideration of this question, data are developed based on careful, controlled clinical trials and observations. It may be that the initial evaluation of complex and novel technologies would be best accomplished in a few specialized centers where expertise and support facilities are available. The results of the trials should be published in peer-reviewed scientific literature so that the medical community at large has the benefit of studying the trial in detail before deciding to adopt and use the new technology.
2. Is the new technology at least as safe and effective as existing, proven techniques?
There is enormous public pressure brought to bear to reduce the extent of invasive surgical procedures in favor of the use of minimal access techniques. When assessing the new technology, safety becomes a major consideration. Although attractive to patients, some minimal access procedures may carry risks greater than the established counterpart, even the risk of sudden death or disability as, for example, might occur during performance of endovascular procedures in major arteries. Newer procedures may be less effective than their standard counterpart, and sometimes the early benefits of lessened hospital stay or reduced postoperative pain are outweighed by earlier recurrence of the disease process. Only with careful clinical trials and published observations can a conclusion be reached that the new technology is an acceptable and effective substitute for an established alternative.
3. Is the individual proposing to perform the new procedure fully qualified to do so?
Many skills are highly specialized. The mere acquisition of a skill is not the only criterion by which to measure qualifications. In order to determine and apply proper indications for a procedure and to select the appropriate patients for application of the technology, comprehensive knowledge of the disease process and experience in management of patients with the disease is essential. Prompt recognition and management of complications can only be achieved when the individual or team member is fully qualified in all aspects of treatment of the disease.
4. Is the new technology cost-effective?
"Cost-effectiveness" is a product of many factors: the costs of developing and testing the new technology; the actual costs of the equipment associated with the new technology; the costs of the support services needed to safely provide the service; the costs of educating health care professionals in the use of the technique; the benefits of lessened hospital stay and period of disability; and the likelihood of a good long-term outcome and lower long-term health care costs. Each of these factors must be taken into account when making a determination that the new technology offers cost benefits when compared with alternatives, either established treatments or nonsurgical options. It becomes necessary to establish and maintain a database in which outcome measures will include cost analyses.
Reprinted from Bulletin of the American College of Surgeons
Vol. 80, No. 9, Pages 46-47, September 1995
