Technology
Vol. 23 No 3 | Spring 2021
Feature
Ethical considerations for surgical innovation
Dr Naomi Holbeach
BSc, LLB(Hons), MBBS (Hons), MRMed, FRANZCOG Advanced Trainee

Surgical specialties, including gynaecology, have a long history of innovation. The introduction of novel technology into clinical practice is an important issue for the speciality as it continues to move forward and provide better surgical care to patients.1 Doctors have legal and ethical obligations in the delivery of patient care, whether the care is innovative or not. In Childs v Walton, for example, Samuels JA said that ‘[novelty] itself is neutral…But a new departure in professional practice or technique must conform to the accepted ethical standard of the profession’.2

Surgical innovation is also precious, and in the interests of improving surgical treatment we should introduce innovative technologies with care at every step. Failure to do so may undermine public trust in the profession as well as the innovation ultimately leading to a lost opportunity.

This is a brief summary of some of the issues that arise in relation to departures from standard care in the form of surgical innovation. For brevity, the issues considered here will include consent, surgical experience and training, preoperative planning, the role of clinical trials, documentation and postoperative follow up. The definition of surgical innovation has been debated elsewhere at length,3 4 5 6 7 but for the purposes of this piece it is the introduction of a novel surgical practice, which may include technology or devices.

Informing the patient that the procedure is novel

There is a duty to warn of material risks during preoperative discussions that was established by Rogers v Whitaker.8 The case famously involved a woman with unilateral blindness who underwent a procedure on the affected eye. She was informed of the risks of the procedure but not of the rare risk of sympathetic ophthalmoplegia. She was affected and left blind in both eyes. The High Court found that the risk of sympathetic ophthalmoplegia was significant to her and for this reason ought to have been discussed. Material risks that should be discussed in preoperative counselling include risks that a person in the position of the patient would attach significance to, and risks that the doctor knew or ought to have known this particular patient would attach significance to.

The innovative or novel nature of a new procedure is likely to be considered material and should be disclosed to a patient for a procedure that involves surgical innovation. The following three cases demonstrate this point and a number of others relevant to the discussion. In Health Care Complaints Commission v Reid (‘Reid’), the NSW Civil and Administrative Tribunal noted at the outset that the procedure, which was the implantation of the Tissue Fixation System, a type of vaginal mesh, was not mainstream and so the patient should be told that it was novel.9 In New Zealand, a robotic-assisted laparoscopic radical prostatectomy resulted in harm to a patient caused by the extended operating time due to the surgeon’s learning curve with the new procedure.10 As in Reid, the Commissioner concluded that the surgeon ought to have informed the patient that the procedure was new.11 In Mills v Oxford University Hospitals NHS Trust (‘Mills’) the patient suffered a major stroke following a neurosurgical debulking of a glioma using a minimally invasive endoscopically-assisted open craniotomy, which was not the standard approach at the time.12 The Court found that neither the approach nor surgical conduct was negligent, but the surgeon breached the duty to warn by not making it clear that the procedure was novel.13

There is evidence that, more than merely stating that the innovative surgery is new, it should be made clear to the patient that it is not first-line treatment and exists as an alternative to standard treatment options. In Mills, the Court found that novel surgical approach should have been offered as an alternative to the standard technique alongside a discussion about the comparative risks and benefits.14 The Court clarified that however the surgeon chose to describe the novelty of the procedure, it should have included an explanation that it was ‘not well established’ and that other surgeons employed an alternative approach.15 Likewise in Reid, there should have been a discussion about alternative treatments, and a particular discussion about the complications relating to the novel treatment.16

The surgeon’s experience with novel technology

There is a learning curve for any new procedure and there is some evidence to suggest that this is relevant to include in preoperative discussions with the patient. The Commissioner in the New Zealand case above found that the urologist should have informed the patient of his limited experience performing the robotically-assisted laparoscopic prostatectomy.17 The conclusion of the Commissioner highlighted the surgeon’s awareness of how long he took to perform the surgery (six hours) compared to more experienced surgeons (two to three hours). It was accepted that the risk of complications increased with increased operating time, and this should have been discussed with the patient. Disclosing surgical competence was also addressed in Reid, where the Tribunal found that the failure to disclose that it was the surgeon’s first time as lead surgeon and that he required supervision was unprofessional conduct.18 The distinctions between surgeon, researcher, financier and innovator may lead to a conflict of interest as was the case in Health Complaints Commission v Petros.19 These cases do not directly comment on the steps that surgeons should take to train in a new procedure, but it would be advisable to comply with College, hospital or health department policies on supervision, ethics oversight, and credentialling with respect to novel surgical techniques.

Preoperative planning for new surgical techniques

Preoperative preparation and the experience of the surgical team as a whole is also relevant to the performance and success of a new procedure. The surgical team includes the surgical assistant, anaesthetist, and nursing and theatre staff. The Macquarie Surgical Innovation Identification Tool (MSIIT) can be a useful way to prospectively identify surgical innovation to trigger preoperative safety mechanisms and allow the surgical team to plan ahead. This short point of care questionnaire acknowledges the role that the entire surgical team play in optimising the surgical outcome.20 Preoperative planning could include training, discussions about anaesthesia and predicted anaesthetic time, equipment availability, contingency planning should there be intraoperative problems, whether a medical device representative should be present, and whether a surgeon experienced with the technique should be present. It may be important to inform some patients of these preparatory steps and precautions as well as the presence or participation of additional personnel in the procedure including surgical colleagues and medical device representatives.

The role of research and clinical trials

Considering the potential risks that surgical innovation poses, some would argue that all surgical innovation should occur in the context of research. Less is known about the safety and efficacy of surgical innovation, so how can it be confidently recommended and performed? Innovation in surgery is sometimes introduced through research and clinical trials, but in some cases it is introduced through innovative practice. The distinction between innovation and research is not always clear and there is overlap. Research is a systematic investigation that aims to create generalisable results.3 This differs from innovative practice where the innovation is primarily to benefit the individual patient.21

The NHMRC National Statement acknowledges that the distinction may not be clear and when advice on the appropriate course can be sought from a Human Research Ethics Committee or institutional review board.22 Some of the ethical considerations that will be relevant to deciding whether an innovation should be introduced through a clinical trial will include:

  • The nature and severity of the risks (eg. permanent, functional impact)
  • The nature of the technology (eg. permanent, implantable, energy-bearing or tissue-destructive)
  • The vulnerability of the population (eg. children, incompetent patients)
  • The nature of the condition (eg. if the condition is non-life-threatening or if the impact on quality of life is relatively minor)
  • The chance of success is low, or the predicted benefit is limited or not patient-centred

Follow up, documentation and communication

Postoperative care of the patient who has been treated with a novel surgical device or technology is another important element to consider. The Senate Committee report on vaginal mesh formed the view that women affected by complications of transvaginal mesh experienced great difficulty accessing medical assistance.23 Their recommendation was that women should be provided with a patient card and information booklet with advice on where to seek assistance in the event of an adverse event.24 The report also recognised the importance of establishing a national register of medical devices for which work is underway.25 The availability of information to patients, primary care providers and others is one way that we can ensure patients have access to care should adverse events occur, especially if they occur in the long term. The information provided could include a clear pathway for seeking assistance, especially if the primary surgeon is unable to provide care. In the absence of a national register for medical devices, clear and detailed documentation where a novel procedure has occurred will be valuable. Given that adverse events with respect to new medical technology may be unpredictable, delayed in onset and diagnosis, keeping medical records for an extended period of time could aid patients and colleagues to provide care for complications.

Conclusion

The introduction of novel technology in gynaecology offers potential benefits to patients, the healthcare system and gynaecologists. The nature of innovation and novel technology in healthcare is that there are risks and some risks cannot be known at the outset. As a result, particular care is needed to ensure that patients are informed, that the surgeon and surgical team are prepared and trained for the surgery, that preoperative planning is meticulously done, and that documentation and communication are clear. Future work in this area will hopefully bring clarity around doctors’ ethical and legal obligations when engaging in innovative surgical practice, offering greater confidence to innovate safely and responsibly.

 

References

  1. Riskin DJ, Longaker MT, Gertner M, Krummel TM. Innovation in Surgery. Ann Surg. 2006;244(5):686–93.
  2. Childs v Walton. Vol. [1990], NSWCA. p. 41.
  3. Biffl WL, Spain DA, Reitsma AM, et al. Responsible Development and Application of Surgical Innovations: A Position Statement of the Society of University Surgeons. Journal of the American College of Surgeons. 2008;206(6):1204–9.
  4. Birchley G, Ives J, Huxtable R, Blazeby J. Conceptualising Surgical Innovation: An Eliminativist Proposal. Health Care Anal. 2020;28(1):73–97.
  5. Earl J. Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine. The American Journal of Bioethics. 2019;19(6):7–18.
  6. Rogers WA, Lotz M, Hutchison K, et al. Identifying Surgical Innovation: A Qualitative Study of Surgeons’ Views. Annals of Surgery. 2014;259(2):273–8.
  7. The National Commission for the Protection of Human Subjects of Biomedical and Behavioural Research. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Department of Health, Education, and Welfare; 1979.
  8. Rogers v Whitaker. Vol. 175, CLR. 1992. p. 479.
  9. Health Care Complaints Commission v Reid. Vol. 2018, NSWCATOD. p. 162.
  10. Health and Disability Commissioner. Informed Consent to Innovative Treatment. New Zealand; 2009. Report No.: 08HDC20258. Available from: www.hdc.org.nz/decisions/search-decisions/2009/08hdc20258/
  11. Health and Disability Commissioner. Informed Consent to Innovative Treatment. New Zealand; 2009. Report No.: 08HDC20258. Available from: www.hdc.org.nz/decisions/search-decisions/2009/08hdc20258/
  12. Mills v Oxford NHS Trust. Vol. [2019], EWHC. p. 936.
  13. Mills v Oxford NHS Trust. Vol. [2019], EWHC. p. 936.
  14. Mills v Oxford NHS Trust. Vol. [2019], EWHC. p. 936.
  15. Mills v Oxford NHS Trust. Vol. [2019], EWHC. p. 936.
  16. Health Care Complaints Commission v Reid. Vol. 2018, NSWCATOD. p. 162.
  17. Health and Disability Commissioner. Informed Consent to Innovative Treatment. New Zealand; 2009. Report No.: 08HDC20258. Available from: www.hdc.org.nz/decisions/search-decisions/2009/08hdc20258/
  18. Health Care Complaints Commission v Reid. Vol. 2018, NSWCATOD. p. 162.
  19. Health Care Complaints Commission v Petros. Vol. [2019], NSWCATOD. p. 83.
  20. Hutchison K, Rogers W, Eyers A, Lotz M. Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice. Annals of Surgery. 2015;262(6):949–54.
  21. Margo CE. When Is Surgery Research? Towards an Operational Definition of Human Research. Journal of Medical Ethics. 2001;27(1):40–3.
  22. National Health and Medical Research Council. National Statement on Ethical Conduct in Human Research. 2007. Available from: www.nhmrc.gov.au/about-us/publications/national-statement-ethical-conduct-human-research-2007-updated-2018#
  23. Senate Community Affairs Committee. Number of Women in Australia who have Transvaginal Mesh Tapes and Related Matters. 2018. Available from: www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report
  24. Senate Community Affairs Committee. Number of Women in Australia who have Transvaginal Mesh Tapes and Related Matters. 2018. Available from: www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report
  25. Senate Community Affairs Committee. Number of Women in Australia who have Transvaginal Mesh Tapes and Related Matters. 2018. Available from: www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/MeshImplants/Report

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