This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Apr 2014.
Vivian E. Strong*, Kenneth A. Forde**, Bruce V. MacFadyen***, John D. Mellinger+, Peter F. Crookes++, Lelan F. Sillin#, and Phillip P. Shadduck+++ for the SAGES Ethics Liaison Group
*Memorial Sloan-Kettering Cancer Center, New York, NY
**Columbia University, New York, NY
***University of Texas, Houston, TX
+ Southern Illinois University, Springfield, IL
++ University of Southern California, Los Angeles, CA
# Lahey Hospital and Medical Center, Burlington, MA
+++Duke Regional Hospital and Duke University, Durham, NC
Vivian E. Strong, MD
Associate Attending Surgeon
Gastric and Mixed Tumor Service
Department of Surgery
1275 York Avenue, H-1217
New York, NY 10065
Phone: 212 639-5056
Fax: 212 717-3647
Ethics of New Technology in Surgery
Merriam-Webster defines technology as the “manner of accomplishing a task especially using technical processes, methods, or knowledge”. (1) For those who remember the rotary dial phone and cassette tapes, the changes in electronic, communication, computing, and other technologies have been staggering, and the rate of change seems to be rising exponentially. Advances in technology have been critical to and inseparable from advances in medicine and surgery. Yet, with the implementation of new surgical technologies and novel techniques come a host of ethical considerations.
In gastrointestinal and endoscopic surgery, the progress in devices and techniques over the last two decades has been unprecedented. It seems almost beyond belief now that Kurt Semm, the German gynecologist who performed the world’s first laparoscopic appendectomy in 1980, was criticized so harshly for this and his other early work in therapeutic laparoscopy. His colleagues at the University of Keil reportedly opined that “only a person with brain damage would perform laparoscopic surgery”, and they ordered him to undergo a brain scan (2, 3). Remarkably, only a decade after Semm’s laparoscopic appendectomy, laparoscopic cholecystectomy was rapidly adopted based on less pain, shorter hospital stay, and quicker recovery than open cholecystectomy, and the laparoscopic revolution in general surgery had begun.
However, not all was done well regarding the implementation of laparoscopic cholecystectomy. When large series and randomized clinical trials revealed a several fold higher rate of bile duct injury compared to the open technique, the surgical community and the public took note (4- 6). Marketing influences, weekend courses, and loosely structured implementation of new techniques were questioned, and lessons were learned. Notably, with the implementation of subsequent platforms for cholecystectomy (single incision, natural orifice, and robotic), as well as the implementation of other new devices and techniques, surgeons have been mindful of those lessons (7).
Ethical considerations relevant to the implementation of new surgical technologies and techniques include the following: (1) How is the safety of a new technology or technique ensured?; (2) What are the timing and process by which a new technology or technique is implemented at a hospital?; (3) How are patients informed before undergoing a new technology or technique?; (4) How are surgeons trained and credentialed in a new technology or technique?; (5) How are the outcomes of a new technology or technique tracked and evaluated?; and (6) How are the responsibilities to individual patients and society at large balanced? The following discussion is presented with the intent of encouraging thought and dialogue about ethical considerations relevant to the implementation of new technologies and new techniques in surgery.
Ensuring Safety of New Technologies and Techniques
The ability to sell new devices in the United States (US) is regulated by the Food and Drug Administration (FDA), with approval processes that are ever changing, politically sensitive, and increasingly stringent. While few would question the importance of promoting safety, there are negative tradeoffs that come with increasing regulatory efforts to ensure safety, including longer times for FDA approval, higher costs of pre- and post-market studies, and greater uncertainty of approval. All of these factors impede the ability of start-up companies to raise the venture capital necessary to bring new innovations to market. These factors also adversely affect the willingness of large medical device corporations to bring new products to the US market. Unless there is high confidence that a product in their development pipeline will both achieve US regulatory approval and generate sufficient revenue to cover the development expenses (estimated to be as much as $100-150 Million), the product may be abandoned during development, even if preclinical results are encouraging. More than 90% of devices in development never reach the US market. (8) Instead, medical device companies often market their new devices outside the US, where regulatory processes are widely believed to be more stable, less slow, and less expensive. While historically marketing outside the US has often been followed by an effort to achieve US FDA approval, there seems to be a trend developing whereby device corporations are now choosing to sell their products outside the US exclusively. (8)
Ensuring the safety of new techniques also has its challenges. The US FDA regulates diagnostics, drugs, and devices—it does not regulate new procedures. In a thought-provoking editorial, Steven Strasberg notes that “innovative procedures are not regulated in the same way as research on human subjects. Interestingly, the national commission whose recommendations formed the basis for the elaborate federal regulations that protect subjects of human research was concerned about innovative procedures. It recommended that significant innovations be incorporated into a research project at an early stage, so that patients are protected under the federal research regulations. However, this recommendation was actually outside the purview of the commission and was never made into a regulation.” (9, 10). The evaluation and implementation of new techniques is typically handled at a local, institutional level.
Implementing New Technologies and Techniques – Timing and Process
Dr Ajit Sachdeva and Dr Thomas Russell of the American College of Surgeons (ACS) concisely articulated competing concerns regarding the timing of new technology/procedure introduction: “introduction of a new procedure or an emerging technology should be timed carefully and strike a balance between waiting for sufficient data to support its use and the health care needs of patients while data are being collected. Late introduction of a new modality may deprive the patients of adequate or state-of-the-art care”. (11) How to best strike this balance in timing varies depending on practice setting and other factors.
The actual process for implementing new procedures also varies. No US FDA template exists in this regard, and any effort to develop a single set of guidelines for universal application would surely be difficult. Professional medical associations (PMA) have therefore stepped up and taken a leading role, providing thoughtful guidance in this area. For gastrointestinal and endoscopic surgery, SAGES has published a number of guidelines. (12) In 2012, SAGES also developed a Technology Assessment and Value Assessment Committee (TAVAC). The SAGES TAVAC recently completed its first assessment, which will be reported later this year.
In their manuscript discussing safe introduction of new procedures, Sachdeva and Russell state that “although national organizations may provide guidance regarding credentialing standards, granting of privileges to perform a procedure or use a technology remains the prerogative of the local institution. Each institution is responsible for…overseeing practitioners; maintaining safe and adequate facilities…and formulating, adopting and enforcing rules and policies to ensure delivery of quality care to the patients. Neglect of these responsibilities may expose the institution to risk of liability.” (11). At the local institution level, the process for implementing new procedures may include input from academic department chairs and division chiefs, medical staff leadership, hospital C-suite leadership, and others. While clinical care, research and teaching, marketing, and financial return on investment considerations are typically addressed, the process for doing so varies. One approach is to bring the clinical/academic, administrative, financial, and other decision makers together into a multidisciplinary “New Technology Committee” (NTC). Some institutions do this in a formal committee structure (probably less common), others in a more ad hoc format (probably more common). Either way, these medical staff and hospital leadership teams are responsible for reviewing new devices and procedures, determining which ones to approve for introduction at that institution, providing uniform credentialing standards for physicians (including physicians from different disciplines, a potential source of conflict), and providing review of early outcomes, all in an effort to ensure quality care.
NTC (or their equivalents) are separate in purpose and structure from Institutional Review Boards (IRB), which maintain oversight of clinical research. Appropriate introduction of a new technology can, and in some cases should, also include IRB oversight. IRB review should be considered when significant clinical research questions are being addressed by the new device application and when research products such as scientific presentation or publication are intended. Depending on local needs, NTC may also be asked to participate in other institutional functions (e.g. assuring stabilization of techniques, coordinating efforts with patient safety staff, managing potential conflicts of interest, and reviewing the impact on institutional resources).
Informing Patients about New Technologies and Techniques
The role of the patient in the clinical application of new devices and techniques is paramount, and their welfare and interests must be protected. Patients present to surgeons with a wide variety of educational and cultural backgrounds, and at times they present with limited, scientifically imperfect, information received from enthusiastic proponents in industry, the media, and the internet. The resulting informed consent discussion may be even further challenged by a limited collective experience with the new technology/approach, including a limited ability to predict long-term results. While discussing with patients the potential benefits and risks of any procedure can be challenging, the challenges may be magnified with new procedures or technologies. Nevertheless, conducting these discussions well is an area of great scientific, ethical, and public interest. Surgeons must be as forthright and balanced in the presentation of information as possible. PMA guidelines and position statements may be helpful, and NTC input may also be helpful by providing an informed consent process or document, developed by the multidisciplinary team. This may serve not only to protect patients, but also to protect surgeons and their institutions by moving some of this process to the purview of physician peers and leadership.
Finally, before leaving the topic of “informed consent”, a word about semantics may be helpful. (13,14) It has been customary to refer to the process of discussing treatment risks, benefits, and alternatives with patients as the “op consent process”, the paper that is signed as the “op permit”, and obtaining patient signature on the paper as “getting consent”. Using these terms devalues this critical interaction and misleads regarding the dynamic. The discussion between the surgeon and the patient (and family) is a process of listening, understanding, educating, building trust, and advising. Patients should not consent or permit physicians to do things to them. They should request physicians to do things for them, after the patients have been well informed and empowered to make decisions that fit their beliefs, values, and choices. Words are important, and the words that we use with our patients are important.
Training and Credentialing Physicians in New Technologies and Techniques
The paradigms of training and credentialing are changing, both for established and newer procedures, and for surgeons in training and in practice. For residents in training, studies measuring the impact of the ACGME duty hour restrictions on surgical training are revealing disappointing results – minimal to no improvement in fatigue or sleep, yet worsening direct clinical experience, operative experience, and sense of clinical preparedness for practice. (15,16). In one noteworthy study, of 121 surgical procedures that were rated by surgical program training directors as core procedures (“graduating general surgery residents should be competent to perform the procedure independently”), 83 procedures (69%) were performed a mean of five times or less, and 63 procedures (52%) were performed a mode of zero times during residency training. (17) For this and other reasons, more than 80% of graduating general surgery residents now pursue additional training. (18) Teaching residents procedures that are uncommon and complex (and new?) presents additional challenges. (19)
In order to help bridge this gap, simulation is taking on a greater role in training, certification, and credentialing. The benchmarks for determining competence are also moving away from duration of training and number of procedures performed, toward “training to competence” as demonstrated objectively. Toward this new paradigm, SAGES and the ACS have co-developed, validated, and endorsed the Fundamentals of Laparoscopic Surgery (FLS), a program to assess and certify competence in the fundamentals of laparoscopic technique. FLS is now required by the American Board of Surgery as a necessary component of resident training and certification in the US, and these efforts are expanding to other nations as well. (20) For surgeons already in practice, some institutions now include the successful completion of FLS as a requirement for obtaining privileges in laparoscopic surgery. (21) Additionally, some professional liability insurance companies and third party payers now offer incentives to practicing surgeons who have achieved FLS certification. (22)
SAGES and its partner societies are also taking the lead in training and credentialing physicians in other knowledge and skill sets, developing programs for endoscopic surgery (Fundamentals of Endoscopic Surgery, FES), safe use of energy in surgery (Fundamentals for Use of Energy, FUSE), and robotic surgery (Fundamentals of Robotic Surgery, FRS). (23-29)
Tracking Outcomes of New Technologies and Techniques
When devices or techniques are new, and collective experience and data are limited, there is an obligation for early adopters to track outcomes. This can be accomplished through a variety of approaches, including IRB-approved studies, participation in prospective registries and consortia, institutional databases, NTC- or institution-related prospective review, and personal databases. Measuring outcomes, and establishing the systems to facilitate this, take considerable effort, coordination, time, and money, all challenges in an environment of decreasing resources. Nevertheless, doing so facilitates accumulation and sharing of information regarding the technology or procedure during its early phase of clinical application, an obligation for those surgeons choosing to be on the leading edge.
Balancing Responsibilities to Patients and Society
Finally, the cost and value of new technologies, to each of the many constituents in healthcare, must be addressed. Forces impacting health care and its delivery are increasingly important, particularly now as the US transitions to a national health care system. (30,31) At times however, a physician’s responsibility to advocate for individual patients on the one hand, and honor the responsibility to society for stewardship of finite resources on the other hand, may be competing considerations. Physicians do have responsibilities to both, as pointed out by the ACS in its “Code of Professional Conduct” and by the American Board of Internal Medicine (ABIM) in its Physician Charter on “Medical Professionalism in the New Millennium”. (32,33) To guide physicians struggling with conflicting responsibilities, the ABIM establishes the following principle: “Principle of primacy of patient welfare…Market forces, societal pressures, and administrative exigencies must not compromise this principle”.
In summary, the field of gastrointestinal and endoscopic surgery has made remarkable progress in recent years. This could not have occurred without the equally unprecendented advances in imaging, instrumentation, and other technologies and techniques. Surgeons have an obligation to continue bringing advances in care to patients – safely, timely, and cost effectively – and in doing so, manage a host of ethical considerations. The words of Andrew Boorde (1490-1549), a physician to King Henry VIII, bear repeating in this regard: “The surgeon must have a good eye and a steadfast hand (for surgery takes its name of this). He must have a good wit and memory and good judgment. Surgeons ought to be wise and gentle, sober and circumspect.”
Drs Strong, Forde, Mellinger, Crookes, and Sillin: no disclosures. Dr MadFadyen: Soft Tissue Sciences (Consultant, Advisory Committee). Dr Shadduck: Allergan Medical (Consultant), Bard Davol (Consultant), LifeCell (Consultant), Teleflex Medical (Consultant), and TransEnterix (Consultant).
- New York Times, Obituaries, July 27, 2003.
- Bhattacharya K. Kurt Semm: a laparoscopic crusader. J Minim Access Surg 2007; 3:35-36.
- Barkun JS, Randomised controlled trial of laparoscopic versus mini cholecystectomy. The McGill Gallstone Treatment Group. Lancet. 1992; 340:1116-1119.
- Williams LF Jr, Chapman WC, Bonau RA, et al. Comparison of laparoscopic cholecystectomy with open cholecystectomy in a single center, Am J Surg, 1993;165(4):459-65.
- Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. N Engl J Med 1991, 324:1073-1078.
- Joseph M, Phillips M, Farrell T, et al. Single incision laparoscopic cholecystectomy is associated with a higher bile duct injury rate: a review and a word of caution. Ann Surg 2012, 256:1-6.
- Starnes BW. A surgeon’s perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices. J of Vascular Surgery 2013 57; 3:829-31.
- Strasberg S, Single Incision Laparoscopic Cholecystectomy and the Introduction of Innovative Surgical Procedures, Ann Surg, 256:1, 7-8, 2012.
- NIH. The Belmont Report 1979: ethical principles and guidelines for the protection of human subjects of research. Available at: http://ohsr.od.nih.gov/guidelines/belmont.html)
- Sachdeva A, Russell T, Safe Introduction of New Procedures and Emerging Technologies in Surgery: Education, Credentialing, and Privileging. Surg Clin N Amer, 2007:853-866.)
- Weaver JP. The problem with the operative permit. Surg Gynecol Obstet 1984, 159(6):579-80.
- Weaver JP. Beyond the operative permit. NC Med J 1987, 48(2):74.
- Fitzgibbons SC, Chen J, Jaqsi R, Weinstein D. Long-term follow-up of the educational impact of ACGME duty hour limits: a pre-post survey study. Ann Surg 2012, 256(6):1108-12.
- Antiel RM, Reed DA, Van Arendonk KJ, et al. Effects of duty hour restrictions on core competencies, education, quality of life, and burnout among general surgery interns. JAMA Surg 2013, doi: 10.1001/jamasurg.2013.1368.
- Bell RH Jr, Biester TW, Tabuenca A, et al. Operative experience of residents in US general surgery programs: a gap between expectation and experience. Ann Surg 2009, 249(5):719-24.
- Valentine RJ, Jones A, Biester TW, et al. General surgery workloads and practice patterns in the United States, 2007 to 2009: a 10-year update from the American Board of Surgery. Ann Surg 2011, 254(3):520-5.
- Bell RH Jr. How to teach uncommon and highly complex operations. J Gastrointest Surg 2011, 15(10):1726-7
- Derevianko AY, Schwaitzberg SD, Tsuda S, et al., Malpractice carrier underwrites Fundamental of Laparoscopic Surgery training and testing: a benchmark for patient safety. Surg Endosc, 2010, 24(3):616-23.
- Herron DM, Marohn M, et al. The SAGES-MIRA Robotic Surgery Consensus Group. A Consensus Document on Robotic Surgery. https://www.sages.org/publications/guidelines/consensus-document-robotic-surgery/.
- Morgenthal CB, Richards WO, Dunkin BJ, Forde KA, Vitale G, Lin E; SAGES Flexible Endoscopy Committee. The role of the surgeon in the evolution of flexible endoscopy. Surg Endosc. 2007 Jun; 21(6):838-53. Epub 2006 Dec 16. Review.
- Hanly EJ, Zand J, Bachman SL, et al. Value of the SAGES Learning Center in introducing new technology. Surg Endosc 2005, 19:477-83.
- Ho VP, Trencheva K, Stein SL, et al. Mentorship for participants in a laparoscopic colectomy course. Surg Endosc 2012, 26:722-6.
- Feldman LS, Mayrand S, Stanbridge D, et al. Laparoscopic fundoplication: a model for assessing new technology in surgical procedures. Surgery 2001, 130:686-93.
- Sachdeva AK, Buyske J, Dunnington GL, et al. A new paradigm for surgical procedural training. Curr Prob Surg 2011, 48:854-968.
- Rattner DW, Park A. Advanced devices for the operating room of the future. Semin Laparosc Surg 2003, 10:85-9.
- Holland S, Hope T, The ethics of attaching research conditions to access to new health technologies. J Med Ethics, 2012:38(6):366-71.
- Williams L, Bryan S, McIver S. How should cost-effectiveness analysis be used in health technology coverage decisions? Evidence from the National Institute for Health and Clinical Excellence approach. J Health Serv Res Policy, 2007; 12:73-79.
- American Board of Internal Medicine, Charter on Medical Professionalism, 2002; http://www.abimfoundation.org/Professionalism/Physician-Charter.aspx
- American College of Surgeons, Code of Professional Conduct, 2003.
This document was prepared and revised by SAGES Ethics Liaison Group
This document was reviewed and approved by the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in Apr 2014.
For more information please contact:
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Guidelines for clinical practice are intended to indicate preferable approaches to medical problems as established by experts in the field. These recommendations will be based on existing data or a consensus of expert opinion when little or no data are available. Guidelines are applicable to all physicians who address the clinical problem(s) without regard to specialty training or interests, and are intended to indicate the preferable, but not necessarily the only acceptable approaches due to the complexity of the healthcare environment. Guidelines are intended to be flexible. Given the wide range of specifics in any health care problem, the surgeon must always choose the course best suited to the individual patient and the variables in existence at the moment of decision.
Guidelines are developed under the auspices of the Society of American Gastrointestinal and Endoscopic Surgeons and its various committees, and approved by the Board of Governors. Each clinical practice guideline has been systematically researched, reviewed and revised by the guidelines committee, and reviewed by an appropriate multidisciplinary team. The recommendations are therefore considered valid at the time of its production based on the data available. Each guideline is scheduled for periodic review to allow incorporation of pertinent new developments in medical research knowledge, and practice.