Top

Published in:

01-08-2014 | Consensus Statement

Ethical considerations regarding the implementation of new technologies and techniques in surgery

Authors: Vivian E. Strong, Kenneth A. Forde, Bruce V. MacFadyen, John D. Mellinger, Peter F. Crookes, Lelan F. Sillin, Phillip P. Shadduck

Published in: Surgical Endoscopy | Issue 8/2014

Abstract

Ethical considerations relevant to the implementation of new surgical technologies and techniques are explored and discussed in practical terms in this statement, including (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 to encourage thought and dialogue about ethical considerations relevant to the implementation of new technologies and new techniques in surgery.

http://www.merriam-webster.com/dictionary/technology

New York Times, Obituaries, July 27, 2003

Bhattacharya K (2007) Kurt Semm: a laparoscopic crusader. J Minim Access Surg 3:35–36PubMedCentralPubMedCrossRef

Barkun JS (1992) Randomised controlled trial of laparoscopic versus mini cholecystectomy. The McGill Gallstone Treatment Group. Lancet 340:1116–1119PubMedCrossRef

Williams LF Jr, Chapman WC, Bonau RA et al (1993) Comparison of laparoscopic cholecystectomy with open cholecystectomy in a single center. Am J Surg 165:459–465PubMedCrossRef

Southern Surgeons Club (1991) A prospective analysis of 1518 laparoscopic cholecystectomies—The Southern Surgeons Club. N Engl J Med 324:1073–1078CrossRef

Joseph M, Phillips MR, Farrell TM et al (2012) Single incision laparoscopic cholecystectomy is associated with a higher bile duct injury rate: a review and a word of caution. Ann Surg 256:1–6PubMedCrossRef

Starnes BW (2013) A surgeon’s perspective regarding the regulatory, compliance, and legal issues involved with physician-modified devices. J Vasc Surg 57:829–831PubMedCrossRef

Strasberg S (2012) Single incision laparoscopic cholecystectomy and the introduction of innovative surgical procedures. Ann Surg 256:7–9PubMedCrossRef

10.

NIH The Belmont report 1979: ethical principles and guidelines for the protection of human subjects of research. http://ohsr.od.nih.gov/guidelines/belmont.html)

11.

Sachdeva AK, Russell TR (2007) Safe introduction of new procedures and emerging technologies in surgery: education, credentialing, and privileging. Surg Clin N Am 87:853–866PubMedCrossRef

12.

http://www.sages.org/about/resources/

13.

Weaver JP (1984) The problem with the operative permit. Surg Gynecol Obstet 159:579–580PubMed

14.

Weaver JP (1987) Beyond the operative permit. NC Med J 48:74

15.

Fitzgibbons SC, Chen J, Jaqsi R, Weinstein D (2012) Long-term follow-up on the educational impact of ACGME duty hour limits: a pre-post survey study. Ann Surg 256:1108–1112PubMedCrossRef

16.

Antiel RM, Reed DA, Van Arendonk KJ et al (2013) Effects of duty hour restrictions on core competencies, education, quality of life, and burnout among general surgery interns. JAMA Surg 148:448–455PubMedCrossRef

17.

Bell RH Jr, Biester TW, Tabuenca A et al (2009) Operative experience of residents in US general surgery programs: a gap between expectation and experience. Ann Surg 249:719–724PubMedCrossRef

18.

Valentine RJ, Jones A, Biester TW et al (2011) 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 254:520–525PubMedCrossRef

19.

Bell RH Jr (2011) How to teach uncommon and highly complex operations. J Gastrointest Surg 15:1726–1727PubMedCrossRef

20.

http://www.absurgery.org/default.jsp?news_newreqs

21.

Hafford MD, Van Sickle KR, Willis RE et al (2013) Ensuring competency: are fundamentals of laparoscopic surgery training and certification necessary for practicing surgeons and operating room personnel? Surg Endosc 27:118–126PubMedCrossRef

22.

Derevianko AY, Schwaitzberg SD, Tsuda S et al (2010) Malpractice carrier underwrites fundamentals of laparoscopic surgery training and testing: a benchmark for patient safety. Surg Endosc 24:616–623PubMedCrossRef

23.

Herron DM, Marohn M (2008) A consensus document on robotic surgery. Surg Endosc 22:313–325PubMedCrossRef

24.

Morgenthal CB, Richards WO, Dunkin BJ, Forde KA, Vitale G, Lin E, SAGES Flexible Endoscopy Committee (2007) The role of the surgeon in the evolution of flexible endoscopy. Surg Endosc 21:838–853 (Epub 16 Dec 2006) (review)

25.

Hanly EJ, Zand J, Bachman SL et al (2005) Value of the SAGES Learning Center in introducing new technology. Surg Endosc 19:477–483PubMedCrossRef

26.

Ho VP, Trencheva K, Stein SL, Milsom JW (2012) Mentorship for participants in a laparoscopic colectomy course. Surg Endosc 26:722–726PubMedCrossRef

27.

Feldman LS, Mayrand S, Stanbridge D et al (2001) Laparoscopic fundoplication: a model for assessing new technology in surgical procedures. Surgery 130:686–693PubMedCrossRef

28.

Sachdeva AK, Buyske J, Dunnington GL et al (2011) A new paradigm for surgical procedural training. Curr Probl Surg 48:854–968PubMedCrossRef

29.

Rattner DW, Park A (2003) Advanced devices for the operating room of the future. Semin Laparosc Surg 10:85–89PubMed

30.

Holland S, Hope T (2012) The ethics of attaching research conditions to access to new health technologies. J Med Ethics 38(6):366–371PubMedCrossRef

31.

Williams I, Bryan S, McIver S (2007) 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 12:73–79PubMedCrossRef

32.

American Board of Internal Medicine, Charter on Medical Professionalism (2002) http://www.abimfoundation.org/Professionalism/Physician-Charter.aspx

33.

American College of Surgeons, Code of Professional Conduct (2003) http://www.facs.org/memberservices/codeofconduct.html

Title: Ethical considerations regarding the implementation of new technologies and techniques in surgery
Authors: Vivian E. Strong
Kenneth A. Forde
Bruce V. MacFadyen
John D. Mellinger
Peter F. Crookes
Lelan F. Sillin
Phillip P. Shadduck
Publication date: 01-08-2014
Publisher: Springer US
Published in: Surgical Endoscopy / Issue 8/2014
Print ISSN: 0930-2794
Electronic ISSN: 1432-2218
DOI: https://doi.org/10.1007/s00464-014-3644-1

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Ethical considerations regarding the implementation of new technologies and techniques in surgery

Abstract

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Please log in to get access to this content

Other articles of this Issue 8/2014

Transvaginal specimen extraction versus conventional minilaparotomy after laparoscopic anterior resection for colorectal cancer: mid-term results of a case-matched study

SAGES guidelines for the introduction of new technology and techniques

Gut inflammation and expression of ICC in a fetal lamb model of fetoscopic intervention for gastroschisis

Robotic duodenopancreatectomy assisted with augmented reality and real-time fluorescence guidance

Laparoscopic versus open surgical management of small bowel obstruction: an analysis of short-term outcomes

Laparoscopic longitudinal pancreaticojejunostomy using cystoscope and endoscopic basket for clearance of head and tail stones