ORIGINAL ARTICLE

Getting Clearer About Surgical Innovation A New Definition and a New Tool to Support Responsible Practice Katrina Hutchison, PhD,  Wendy Rogers, PhD, FRACGP,  y Anthony Eyers, FRACS,y and Mianna Lotz, PhD 

Objectives: This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the responsible introduction of surgical innovations. Background: Frameworks developed for the safer introduction of surgical innovations rely upon identifying cases of innovation; oversight cannot occur unless innovations are identified. However, there is no consensus among surgeons about which interventions they consider innovative; existing definitions are vague and impractical. Methods: Using conceptual analysis, this article synthesizes findings from relevant literature, and from qualitative research with surgeons, to develop an original definition of surgical innovation and a tool for prospectively identifying planned surgical innovations. The tool has been developed in light of feedback from health care professionals, surgeons, and policy makers. Results: This definition of innovation distinguishes between variations, introduction of established interventions, and innovations in surgical techniques or use of devices. It can be applied easily and consistently, is sensitive to the key features of innovation (newness and degree of change), is prospective, and focuses on features relevant to safety and evaluation. The accompanying tool is deliberately broad so that appropriate supports may, if necessary, be provided each time that a surgeon does something ‘‘new.’’ Conclusions: The definition presented in this article overcomes a number of practical challenges. The definition and tool will be of value in supporting responsible surgical innovation, in particular, through the prospective identification of planned innovations. Keywords: ethics, governance, surgery, patient safety, surgical innovation

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INTRODUCTION: THE NEED FOR A PRACTICAL DEFINITION

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urgical innovation is central to progress in surgery. However, it is also risky, because surgery is invasive and largely irreversible, and it is not always possible to know in advance which innovations will be successful. Recent initiatives attempt to address this problem by developing frameworks for assessing surgical innovations.1 –4 Although these are important contributions, frameworks such as From the Department of Philosophy, Macquarie University, Sydney, Australia; and yAustralian School of Advanced Medicine, Macquarie University, Sydney, Australia. Disclosure: Supported by an Australian Research Council Linkage grant LP110200217 ‘‘On the Cutting Edge: Promoting Best Practice in Surgical Innovation.’’ Also supported by grants from Bellberry Ltd, nonfinancial support from Western Sydney Local Health District, nonfinancial support from Houston Thomson Pty Ltd, nonfinancial support from the Royal Australian College of Surgeons, and nonfinancial support from the University of Otago, during the conduct of the study. However, the funders had no influence or control over the research findings. The authors declare no conflicts of interest. Reprints: Katrina Hutchison, PhD, Department of Philosophy, Macquarie University, Sydney, NSW 2109, Australia. E-mail: [email protected]. Copyright ß 2015 Wolters Kluwer Health, Inc. All rights reserved. ISSN: 0003-4932/14/26105-0821 DOI: 10.1097/SLA.0000000000001174

Annals of Surgery  Volume 262, Number 6, December 2015

those proposed by the IDEAL collaboration,1 –3 or the Schwartz4 ETHICAL model, lack a reliable method for identifying all instances of planned surgical innovation. Although these frameworks will support and evaluate recognized innovations, interventions that are not identified as innovative will fail to be captured. Existing definitions in the literature are not well suited to solve this identification problem. They appeal to criterion such as ‘‘significant difference’’ or ‘‘major variation,’’ without specifying what counts as significant or major.5,6 Some definitions also appeal to features of innovation that, although important, can be difficult to assess prospectively and may not always accompany innovation, thus limiting their value as defining characteristics. These include the level of risk of the innovation, the likely impact on future practice, and the prospects for publication of the outcomes.7 Surgeons themselves disagree about which procedures are innovative.8 Recent qualitative research exploring surgeons’ views of innovation found that some surgeons are reluctant to identify new interventions as ‘‘innovations’’ because doing so might increase the burdens of regulatory oversight and monitoring. For example, one surgeon suggested that it was a ‘‘huge inconvenience’’ if a procedure was considered an innovation rather than a mere variation, as ‘‘you’ve got to go to the new innovations committee.’’8(p276) Other research has found that some surgeons classify activities as ‘‘innovative clinical practice’’ to avoid research-related regulation but as ‘‘research’’ for publication purposes.9 There are significant implications for patient safety if it is left up to individual surgeons to decide whether or not their activity amounts to surgical innovation. Patients are exposed to risks, with sometimes tragic consequences (Fig. 1). This article presents an original definition that can prospectively identify many different types of planned surgical innovations. It can also be applied retrospectively to unplanned innovations to inform decisions about follow-up and subsequent use of that innovation. On the basis of the definition we have developed the Macquarie Surgical Innovation Identification Tool, a tool for assessing the nature of the planned innovation and the potential supports that may be warranted. Together, the definition and the identification tool can be used to support existing frameworks for oversight and evaluation of surgical innovations.

CURRENT PRACTICES FOR INTRODUCING SURGICAL INNOVATIONS Regulation of surgery is challenging. Surgical treatment is not just a procedure in the operating suite. Rather, it is a pathway incorporating preoperative, perioperative, and postoperative phases, all of which contribute to the safety and effectiveness of surgical interventions. Innovations likewise take a range of forms, including new devices, such as joint prostheses; the deployment of existing devices or equipment in different ways, such as the expanded use of the laparoscope or surgical robot; and new surgical techniques for a standard procedure, such as a novel anatomical approach. Reflecting this complexity, there are at present no standard pathways for assessing and regulating surgical innovations. Some regulations occur at national levels, for example, through the approval of new www.annalsofsurgery.com | 949

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FIGURE 1. A tragic innovation. A case study illustrating how innovation involving a change in instrument use and patient characteristics may not be prospectively identified and supported as innovation.

devices by bodies such as the US Food and Drug Administration or the Australian Therapeutic Goods Administration. Surgical innovations that do not involve a device, or that involve a device that has already been approved, are not subject to statutory requirements. Instead, surgeons are bound by professional and legal standards concerning scope of practice and standards of care.13 At local levels, institutions may be subject to health policy concerning the introduction of innovations14 and may have committees or other forms of oversight for reviewing surgical innovations. However, these forms of governance do not come into force until an intervention has been identified as innovative. But it is not always clear whose responsibility it is to make this identification or on what grounds it is made. As noted earlier, surgeons disagree about what counts as innovation and may not always be reliable in identifying their own innovations as such. It is particularly difficult for institutions to identify innovations that do not involve new devices requiring regulatory approval or purchase. The use of the morcellator on Bethany Bowen (Fig. 1) is an example of this kind of innovation because it used an existing device in a new context. At the inquest, the Oxford Radcliffe Hospitals Trust acknowledged that this should have been treated as an innovation, given that a morcellator was not usually used to treat pediatric patients.12 A reliable method for identifying surgical innovations is a necessary first step toward implementing innovation policies, ensuring that innovators have appropriate training and supports, informing patient consent processes, and triggering relevant evaluation frameworks.

FEATURES OF A RELIABLE DEFINITION To meet the challenges described earlier, a definition of surgical innovation must be: (1) Able to be applied easily and consistently to actual cases. Some currently proposed definitions of surgical innovation are vague, 950 | www.annalsofsurgery.com

using terms such as ‘‘major’’ or ‘‘significant’’ without clear guidance as to how these descriptors should be interpreted.5 –7 Terms such as these should be avoided in identifying or regulating surgical innovation unless they are accompanied by specific definitions and examples that resonate with surgeons, theater managers, hospital managers, and regulators. (2) Appropriately sensitive to actual current use of the term. It is important that the definition is sensitive to actual current use of the term in health care settings, otherwise there is a risk that it will not be accepted by surgeons and other health care professionals and thus not serve its intended purpose. However, previous research has found considerable variation in surgeons’ understanding of ‘‘innovation,’’ showing that further conceptual work is necessary to refine surgeons’ working definition of innovation.8 The definition should be as consistent as possible with actual use, subject to other requirements of the definition, such as practical value and coherence. (3) Comprehensive enough to identify the full range of surgical innovations. Innovative surgery cannot be identified by a single, essential feature common to all instances; however, newness and degree of change are key features.8 As these are multidimensional features, the definition should include multiple types of newness, such as altogether new, new to an anatomical location, and new to a patient group.8 Innovation can also involve changes in technique and changes in devices, which should be captured by the definition. (4) Able to distinguish surgical innovation from routine variation and from the introduction of procedures that have been established elsewhere. Determining the degree of change that delineates innovation from variation is challenging as there is no ‘‘bright line.’’ Therefore, to be useful, a definition of innovation must provide guidance as to which features of the innovation suggest that it is more than variation. A further distinction can be drawn between surgical innovation and the introduction of ß

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Annals of Surgery  Volume 262, Number 6, December 2015

A New Definition of Surgical Innovation

surgical procedures that are new to a particular surgeon or hospital but have been performed elsewhere. Although some surgeons may consider introduction to be a form of surgical innovation, we disagree because hospitals and surgeons can add long-established procedures to their repertoire. Introduction is, however, related to innovation in a number of important ways. First, in the case of recently established procedures, the difference between innovation and introduction can be difficult to discern. Second, all cases of innovation will also involve the procedure being taken up for the first time by a hospital or surgeon, so ‘‘introduction’’ can be a useful flag for identifying the occurrence of innovation. Introduction also raises a number of the same ethical and safety issues as are raised by innovation, including those related to learning curves and surgical volumes. (5) Prospective and focused on features relevant to safety and evaluation. Risk and likely impact are frequently cited features of surgical innovation.5,6,15,16 Risk, in particular, drives the concern for oversight. Conceptually, however, risk is not a defining and necessary feature of surgical innovation. Some innovations actually reduce risk relative to the standard practice, and innovation can, in principle and practice, be risk free (even if this is the exception rather than the norm). For that reason, we regard risk as a potential consequence of innovation rather than a necessary and defining feature of it. For example, recent Australian success with transplantation of hearts donated after circulatory death made use of the innovative Organ Care System (TransMedics).17 This system permits ex vivo reanimation and perfusion of the heart to perform functional assessments before transplant.18 The innovation in fact reduces the risk of transplanting a poorly functioning heart. With other innovations, risks may be unpredictable and unforeseeable or may occur well after the innovation procedure itself, and the risks may change over time. For example, laparoscopic cholecystectomy was initially associated with an increased incidence of injuries to the bile ducts, whereas some of the harms that eventuated from innovative metal-on-metal hip implants took some years to emerge.19 Also being unpredictable, the risk and likely impact of an innovation cannot be fully known until after the innovation has occurred. For all of these reasons, it is our view that risk and

likely impact should not be included in a definition that aims to identify surgical innovation prospectively.

A PRACTICAL DEFINITION OF SURGICAL INNOVATION A proposed definition of surgical innovation is set out in Table 1. It emphasizes features of innovation that are identifiable before the procedure taking place; it is articulated in a clear and simple table format with illustrative examples; and it has a taxonomic structure that recognizes both the different aspects of surgery that can be innovative (eg, techniques, devices) and the ways in which these can be innovative. It is sensitive to the way that surgeons and health care professionals themselves understand the concept of innovation,8 although not being unduly deferent—for that reason, some of the categories that surgeons associated with innovative surgery are omitted from our definition. For example, we omit ‘‘new to hospital’’ and ‘‘new in the hands of a fully qualified specialist surgeon’’ from our definition of surgical innovation because both can apply to longestablished procedures and new procedures: these are features of introduction rather than innovation. Furthermore, the surgeons’ views of newness are supplemented with additional categories identified through discussion with relevant stakeholders and analysis of existing literature. We include the category of ‘‘new to patient group,’’ which did not emerge from research with surgeons. Recognition of this category was prompted by cases such as that of Bethany Bowen (Fig. 1), in which a device was used in a pediatric context for the first time. To avoid trivializing the concept of ‘‘surgical innovation,’’ it is important that routine variations are not picked up by the definition. We thus recommend the use of a set of preliminary questions designed to probe the degree of change associated with the new procedure. These questions are presented in Table 2 and can help delineate the boundary between variation in clinical practice and surgical innovation. The questions function as an alternative to relying on vague descriptors such as ‘‘major’’ or ‘‘significant.’’ They also help identify what sorts of support might be needed to ensure safe practice. The questions in Table 2 are intended to be used alongside the definition but do not form part of the definition, given

TABLE 1. A Definition of Innovative Surgery With Illustrative Examples An Innovative Surgical Procedure Is Any Procedure That Meets 1 or More of the Following Criteria: Criteria 1

Examples

1a

Innovative technique: The technique used is new or differs from the standard technique in 1 or more of the following ways: Altogether new

1b

New to anatomical location

1c

New to patient group

2a

Innovative device: The tools or devices used are new, or the use differs from standard use in one of the following ways described: Altogether new

2b 2c

New to anatomical location New to patient group

or 2

Different incision position or size; combination of 2 procedures such as mastectomy and reconstruction; extension of microsurgical techniques; established procedure undertaken on a different category of patient Pioneering transplant surgery, eg, first heart transplant, first face transplant, first uterus transplant; use of hypothermia for neurosurgery Novel anatomical approach for existing procedure; use of established anastomotic techniques in new locations Expansion of indications to groups whose surgical outcomes may be different, such as children; people with comorbidities likely to influence surgical outcomes; patients of a different sex Surgical robot; new hip prosthesis; implant made from new material; use of laparoscope to perform procedure usually done without one; use of adult device or tool on a child Invention of the da Vinci robot; first use of laparoscope; first use of the endotracheal tube for anesthesia Application of laparoscopic instruments or robotic surgery to new organ or body cavity Use of device or tools in groups whose surgical outcomes may be different, such as children; people with comorbidities likely to influence surgical outcomes; patients of a different sex



Here we exclude procedures, such as fixation of fractures, which are not standardized to a particular anatomical location.

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TABLE 2. Questions to Clarify the Distinction Between Innovation and Routine Variation

procedures, accepting that not all of these will be innovative in ways that require special support, oversight, or evaluation, but with a view to triggering local processes for managing innovation. Such processes may begin with discussing the planned procedure with an independent peer, followed by referral to more formal processes if the peer thinks this is warranted. Such processes could include review by a senior third party (such as the head of the department) who can authorize the procedure; referral to an institutional innovations committee; changes to informed consent to emphasize the innovative nature of the proposed surgery; referral to an institutional research ethics review board; or some other course of action determined by institutional policy. A set of clarifying questions, developed in light of local regulatory structures, can be used to support review and decision making triggered by the identification tool. Use of questions such as those in Table 2, which are indicative, rather than exhaustive, will help define the nature and scope of the proposed innovation and hence what kinds of support or oversight may be necessary. The definition and the identification tool are appropriate for use alongside existing frameworks for the safe introduction and evaluation of innovative procedures, such as IDEAL and ETHICAL.1– 4 The definition and the tool address a narrow but important problem—the difficulty of identifying which procedures potentially require a greater degree of oversight and evaluation than routine procedures.

Proposed interventions may be innovative rather than routine variations if any of the following apply: 1. The likely outcomes of the change are unknown and/or have not been described before: a Is there an evidence base for this intervention with which you are familiar? b Do you know the likely outcomes of this intervention? c How do the risks differ from other comparable interventions? d What is your degree of certainty? e Have you sought a second opinion? 2. If successful, the outcomes are likely to be publishable or suitable for uptake more generally: a Would publication of your outcomes make a significant contribution to the evidence base for this intervention? b Do you think a surgical journal would be interested in publishing a case study? c Would you share the technique with your peers and expect wide uptake? 3. Special preparations should be undertaken by the surgeon and/or surgical team: a Have you undertaken, or should you undertake specific training for this technique, or for this use of this tool, in this patient? b Will the anesthesia time differ from that expected in the standard intervention? c Are changes to perioperative care required? d Have you, or ought you to have, briefed the team about the change to the procedure? e How will you inform the patient about the innovation? f Will the innovative nature of the intervention be recorded on the consent form?

that they relate to the consequences of surgical innovation rather than its defining characteristics. These questions address risk, in line with our earlier observation that concern about risk is the main driver of oversight of surgical innovation. These questions also prompt consideration of responses that will support responsible innovation, such as the need for training, and communication with the surgical team.

MACQUARIE INNOVATION IDENTIFICATION TOOL The definition set out in Table 1 is thorough; however, in this format, it is cumbersome to apply to individual cases. To overcome this, the identification tool (Fig. 2) has been developed. The tool captures the categories included in the definition and is designed to be used in conjunction with the preliminary questions for clarifying the degree of change and identifying potential risks (Table 2). The Macquarie Surgical Innovation Identification Tool (Fig. 2) aims to capture all instances of surgical innovation, casting a wide net in the interests of safety. For this reason, it captures cases of introduction and innovation—that is, procedures that are new to the surgeon or the hospital—even though some of these will not be innovative. To illustrate: item 2d asks whether the technique, instrument, or device is routinely used for the given indication in patients with a particular comorbidity. The item is intended to identify cases where the indications for a procedure are expanded to groups where the risks might be different, such as the expansion of endovascular techniques to patients with complicated type B aortic dissections or the use of endovascular techniques to treat aortic aneurysms in kidney transplant recipients.20,21 A ‘‘No’’ response would identify the procedure as potentially innovative, but the procedure in question may not be innovative in any sense worth capturing (eg, the patient may have a rare but irrelevant comorbidity). The primary use of the innovation identification tool is for flagging a wide range of 952 | www.annalsofsurgery.com

DISCUSSION The categories and distinctions in the definition are informed by earlier qualitative research into surgeons’ views of surgical innovation, published in this journal.8 Basing the categories on qualitative research ensures that the definition is sensitive to the concept of ‘‘surgical innovation’’ deployed by surgeons and their coworkers. The definition thus reflects the issues as surgeons perceive them and are more likely to be accepted in practice. However, the definition draws selectively from actual usage to be consistent to the extent possible while being narrow enough to be of practical value. Insights from the qualitative research have been supplemented with categories drawn from existing literature on surgical innovation. For example, concerns about indication and patient group were raised by cases from the literature. The different ways in which a procedure or device can be new are specified into categories 1a–1c and 2a–2c of Table 1. They include altogether new, new to anatomical location, and new to the category of patient. These categories, along with the qualifying questions in Table 2, provide reference points with greater precision than is offered by terms such as ‘‘significant’’ or ‘‘major.’’ The identification tool is structured somewhat differently from the definition (Table 1) to maintain a simple ‘‘Yes/No’’ question format. However, it captures the same kinds of procedures, with altogether new and new to anatomical location, for example, being identified by question 2, which asks whether the techniques, instruments, and/or devices to be used are routinely used to treat the indication in question. As noted in the previous section, the tool also incorporates categories associated with the introduction of a procedure: new in the hands of a fully qualified specialist surgeon and new to a geographical location (hospital). These categories are useful flags because, unlike other categories, this is clearly binary: either the surgeon has performed the procedure before or the surgeon has not performed the procedure before. Given that instances of innovation are always also instances of introduction, the question will identify all innovations. One of the reasons surgical innovation is difficult to define, and particular instances sometimes difficult to identify, is because the concept of innovation groups together phenomena that do not share a ß

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Annals of Surgery  Volume 262, Number 6, December 2015

A New Definition of Surgical Innovation

FIGURE 2. Macquarie Surgical Innovation Identification Tool. A practical tool to identify potentially innovative procedures to prompt appropriate support.

single essential feature. To overcome this problem, the definition draws upon the concept of ‘‘family resemblance’’ developed by the philosopher Ludwig Wittgenstein. Wittgenstein illustrates this point by reference to the example of games. He points out that, although games have similarities, they don’t all share any particular feature. Candidate features turn out not to be common to all games—for example, they are not all entertaining, they do not always have the objective of winning, and they do not always involve multiple players.22 The important insight we take from Wittgenstein is that we cannot expect the definition of a concept such as surgical innovation to be simple—it is not the sort of thing that can be expressed in a single, neat sentence. An overly simple definition will be no match for the complexity of surgical practice and the many ways in which it can be innovative. The definition presented here is intended to enable prior identification of the various features of a given procedure that indicate its innovative nature. It focuses on ways in which an intervention or device might be ‘‘new’’ so that planned surgical innovation can be identified in advance. For this reason, the features of procedures that can be difficult to identify until after the event, including risk, impact, and prospects for publication, are not included in the definition. These features are conceptually unsuitable as defining features, as they are not fully knowable in advance; rather, they are possible consequences of innovation. Nevertheless, it is often possible to estimate something about risk and likely impact before the introduction of a new procedure, and we support risk assessments as part of the responsible introduction of surgical

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innovations. Questions on these features thus appear in the clarifying questions (Table 2).

CONCLUSIONS Frameworks for evaluating and regulating surgical innovations (such as the IDEAL framework and the ETHICAL framework1 –4) are predicated on the assumption that the innovation in question has been identified. However, identifying surgical innovation is complex and contentious while failures to do so can have devastating consequences. The definition of surgical innovation and the associated identification tool presented in this article provide a simple and effective way for identifying surgical innovations in advance of their occurrence. The definition overcomes a number of problems. It can be applied consistently by different institutions, practitioners, and health care professionals in varying roles, in diverse locations, and at different times. The descriptions of features that identify a procedure as innovative rather than a mere variation in routine practice are categorized (eg, 1a–1c in Table 1), described specifically, and illustrated by examples. The definition encompasses the notion that the procedures grouped together under the concept of ‘‘surgical innovation’’ need not share any one essential characteristic but rather possess ‘‘family resemblance.’’ Thus, it is broad enough to identify multiple forms of innovation, including innovative techniques and innovative devices. The definition and the identification tool are likely to be of practical use in supporting surgical innovation because they can identify planned innovations before they are undertaken. Finally, the identification tool is readily utilizable in training, practice, and policy contexts.

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It remains to evaluate this identification tool in practice. Evaluation will be challenging, as there is no current ‘‘gold standard’’ for identifying surgical innovation, against which it can be compared. The task of evaluating the tool in practice is outside the scope of this project. However, a trial would yield useful data about the number and nature of innovative procedures occurring in particular institutions and may help refine and improve the identification tool itself. It is hoped that uptake of this definition and the identification tool will improve safety and contribute to the responsible introduction of surgical innovations.

ACKNOWLEDGMENTS The authors thank the anonymous reviewers whose comments led to a number of improvements in the manuscript.

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9. Reitsma A, Moreno J. The ethics of innovative surgery: U.S. surgeons’ definitions, knowledge and attitudes. In: Reitsma A, Moreno J, eds. Ethical Guidelines for Innovative Surgery. Hagerstown, MD: University Publishing Group; 2006:173–198. 10. Memorandum by Mrs Clare Bowen (PS 79). Document tabled for the UK House of Commons Health Committee report into Patient Safety. 2009. Available at: http://www.publications.parliament.uk/pa/cm200809/cmselect/ cmhealth/151/151we22.htm. Accessed November 11, 2014. 11. Gazette Reporter. Regrets of surgeon in child death case. The Wiltshire Gazette and Herald, Friday 23rd November, 2007. Available at: http:// www.gazetteandherald.co.uk/news/1854314.regrets_of_surgeon_in_child_de ath_case/. Accessed November 11, 2014. 12. Memorandum by the Oxford Radcliff Hospitals NHS Trust (PS 102). Document tabled for the UK House of Commons Health Committee report into Patient Safety. 2009. Available at: http://www.publications.parliament.uk/pa/ cm200809/cmselect/cmhealth/151/151we49.htm. Accessed November 11, 2014. 13. New Zealand Health and Disability Commissioner. A report on decision 08HDC20258. Available at: http://www.hdc.org.nz/media/89819/08hdc20258 surgeon.pdf. Accessed February 2014. 14. New South Wales Ministry of Health Policy Directive (PD2005_333). Clinical practice—model policy for safe introduction of new interventional procedures. 2005. Available at: http://www.health.nsw.gov.au/policies/PD/ 2005/pdf/PD2005_333.pdf. Accessed February 2014. 15. Krummel T. What is surgery? Semin Pediatr Surg. 2006;15:237–241. 16. Riskin D, Longaker M, Gertner M, et al. Innovation in surgery: a historical perspective. Ann Surg. 2006;244:686–693. 17. TransMedics. Organ Care System. Andover, MA: TransMedics; 2014. Available at: http://www.transmedics.com/wt/page/organ_care. Accessed November 2014. 18. St Vincent’s Health Australia. Australian doctors transplant first circulatory death human heart. ScienceDaily. Available at: www.sciencedaily.com/ releases/2014/10/141024144822.htm. Accessed November 2014. 19. Cohen D. How safe are metal-on-metal hip implants? BMJ. 2012;344:1–5. 20. Parsa CJ, Schroder JN, Daneshmand MA, et al. Midterm results for endovascular repair of complicated acute and chronic type B aortic dissection. Ann Thorac Surg. 2010;89:97–104. 21. Machado R, Almeida P, Loureiro L, et al. Endovascular aortic aneurysm repair in kidney transplant recipients. Transplant Proc. 2011;43:145–149. 22. Wittgenstein L. Philosophical Investigations. 4th ed. Hacker PMS, Schulte J, eds. Anscombe GEM, Hacker PMS, Schulte J, trans. Chichester: WileyBlackwell; 2009.

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Getting Clearer About Surgical Innovation: A New Definition and a New Tool to Support Responsible Practice.

This article presents an original definition of surgical innovation and a practical tool for identifying planned innovations. These will support the r...
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