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Our study investigated how the standard of surgical care is assessed within the English and Welsh litigation process. The 'shadowline' represents the dividing line between acceptable and unacceptable standards of care. Our hypothesis was that different assessors risk adopting materially different interpretations regarding the acceptable standard of care. Any variation in the interpretation of where the shadowline falls will create uncertainty and unfairness to surgeons and patients alike. We summarised the legal literature and suggested the factors affecting the assessment of surgical standards. We illustrated our findings on distribution curves. There was a risk that the shape of the curve and the location of the shadowline may vary according to the assessor. Importantly, a gap may have developed between the legal and clinical shadowlines in respect of the consenting process. We suggested how a gap between the surgical and legal shadow lines could be narrowed. Clinical governance, balanced literature and realistic expert assessments were all part of the solution.

Informed consent for surgery has become a critical component of surgical practice. There are specific legal requirements for what has to be disclosed to patients and for the accompanying documentation. The hospital consent for surgery form with the patient’s signature is a small part of the process. A quality assurance review of the documentation of informed consent by our surgical group indicated major deficiencies and prompted this article (and its Appendix containing further information). Our intent was to inform surgeons about modern standards and to discuss particular challenges. Informed consent for surgery entails what surgeons communicate to their patients about the proposed surgery and is a key element in the trust patients have in surgeons. It is of increasing importance, and we must keep up to date with patient and legal expectations.

Background Access to quality and timely emergency and essential surgical care and anesthesia (EESCA) is an integral component of the right to health as reinforced by the ratification of the World Health Assembly Resolution 68.15. However, this resolution is merely a guideline and has not been able to bolster the necessary political will to promote EESCA. Our objective was to evaluate international treaties, which carry legal obligations, for EESCA-related text, and develop a human rights-based framework to support EESCA advancement and advocacy. Methods We conducted a comprehensive review of all the UN Treaty Collection—Certified True Copies (CTCs) of multilateral treaties database from December 2015 to April 2016. The relevant text was manually searched to abstract and analyze to identify major themes supporting a human rights-based approach to EESCA. Results Multiple treaties in the UN database addressed EESCA in the areas of human rights, refugees and stateless persons, health, penal matters, and disarmament. A total of 13 treaties containing 23 articles had language that endorsed aspects of EESCA. The three major themes, supported by the phraseology in the treaties, included: (1) equal access to EESCA (eight articles); (2) timely care of injured and those with emergency surgical conditions (eight articles); and (3) protection, rehabilitation, psychosocial support, and social security (seven articles). Conclusions A number of United Nations multilateral treaties support available and equitable EESCA. These findings can be used to galvanize support and encourage signatory Member States to promote and implement EESCA development initiatives.

Little is known about the social and political factors that influence priority setting for different health services in low- and middle-income countries (LMICs), yet these factors are integral to understanding how national health agendas are established. We investigated factors that facilitate or prevent surgical care from being prioritized in LMICs. We undertook country case studies in Papua New Guinea, Uganda, and Sierra Leone, using a qualitative process-tracing method. We conducted 74 semi-structured interviews with stakeholders involved in health agenda setting and surgical care in these countries. Interviews were triangulated with published academic literature, country reports, national health plans, and policies. Data were analyzed using a conceptual framework based on four components (actor power, ideas, political contexts, issue characteristics) to assess national factors influencing priority for surgery. Political priority for surgical care in the three countries varies. Priority was highest in Papua New Guinea, where surgical care is firmly embedded within national health plans and receives significant domestic and international resources, and much lower in Uganda and Sierra Leone. Factors influencing whether surgical care was prioritized were the degree of sustained and effective domestic advocacy by the local surgical community, the national political and economic environment in which health policy setting occurs, and the influence of international actors, particularly donors, on national agenda setting. The results from Papua New Guinea show that a strong surgical community can generate priority from the ground up, even where other factors are unfavorable. National health agenda setting is a complex social and political process. To embed surgical care within national health policy, sustained advocacy efforts, effective framing of the problem and solutions, and country-specific data are required. Political, technical, and financial support from regional and international partners is also important.

Innovative surgery raises four kinds of ethical challenges: potential harms to patients; compromised informed consent; unfair allocation of healthcare resources; and conflicts of interest. Lack of adequate data on innovations and lack of regulatory oversight contribute to these ethical challenges. In this paper these issues and the extent to which problems may be resolved by better evidence-gathering and more comprehensive regulation are explored. It is suggested that some ethical issues will be more resistant to resolution than others, owing to special features of both surgery and innovation.

During the European Molecular Imaging Meeting (EMIM) 2013, the fluorescence-guided surgery study group held its inaugural session to discuss the clinical implementation of fluorescence-guided surgery. The general aim of this study group is to discuss and identify the steps required to successfully and safely bring intraoperative fluorescence imaging to the clinics. The focus group intends to use synergies between interested groups as a tool to address regulatory and implementation hurdles in Europe and operates within the intraoperative focus group of the World Molecular Imaging Society (WMIS) that promotes the same interests at the WMIS level. The major topics on the critical path of implementation identified within the study group were quality controls and standards for ensuring accurate imaging and the ability to compare results from different studies, regulatory affairs, and strategies to increase awareness among physicians, regulators, insurance companies, and a broader audience. These hurdles, and the possible actions discussed to overcome them, are summarized in this report. Furthermore, a number of recommendations for the future shape of the fluorescence-guided study group are discussed. A main driving conclusion remains that intraoperative imaging has great clinical potential and that many of the solutions required are best addressed with the community working together to optimally promote and accelerate the clinical implementation of fluorescence imaging towards improving surgical procedures.

Ten years ago, Megan Shinal sought the care of neurosurgeon Steven Toms for the surgical treatment of a recurrent nonmalignant tumor in the pituitary region of her brain. In their twenty‐minute meeting, Shinal did not make a final decision about which surgical approach she wished to pursue. Subsequently, she spoke with Tom's physician assistant once by phone and once in person, when she signed the consent form, which did not appear to designate which surgical approach she had chosen. During the operation—a total resection—Toms perforated Shinal's carotid artery, resulting in hemorrhage, stroke, brain injury, and partial blindness. The jury found that Toms had fulfilled his informed‐consent obligations prior to performing the resection; however, in June 2017, the Supreme Court of Pennsylvania overturned the decision, relying on the Pennsylvania Medical Care Availability and Reduction of Error Act. The court found that the language of the act is unambiguous in its requirement that “a physician's duty to provide information to a patient sufficient to obtain her informed consent is non‐delegable.” Presumably, this rule of nondelegation applies beyond the surgical theater to other major treatment decisions. And it is unclear whether it applies to other professionals in a subordinate position to the treating physician, such as residents and fellows.

Informed consent has different implications and requirements in law and bioethics, and some irreconcilable disputes with the reality of surgical practice in the National Health Service. This article explores and discusses various aspects of informed consent that are of critical importance for practising surgeons in all specialties.

Doctors are exhorted to be candid with their patients when clinical errors occur. This paper discusses the history of candour in surgical law as well as recommendations resulting from the Mid Staffordshire public inquiry. It also looks at why candour is necessary and where the threshold should lie. Provided surgeons understand that a duty of candour is engaged at a certain threshold of harm, then disclosure of misadventure to patients or their relatives becomes simply a matter for clinical judgement, just in the same way as a surgeon judges which potential operative complications need to be disclosed during the consenting process.