Surgical smoke: articulating the problem.

This six-part series focuses on surgical smoke evacuation legislation and policy. It provides answers to important frequently asked questions (FAQs) about surgical smoke from policymakers and people not working in perioperative services and suggests resources and tools to help you become a strong advocate for surgical smoke evacuation. The FAQs and legislative checklists that will be shared will cover the basics of surgical smoke and its harmful effects, strategies and solutions for eradicating surgical smoke in the OR, the role of regulatory agencies, and how to lay the groundwork for successful state legislation on your own and in tandem with AORN's Government Affairs Department.

Analysis of malpractice claims: The Franco-Belgian "Cœlio Club" experience.

Malpractice claims are a regularly increasing concern in gastrointestinal surgery. The goal of this study was to compare the current status of claims in two different French-speaking communities by a retrospective descriptive study of surgeons' experiences, from the beginning of their practice up until December 31 2014. Data included the number, the reasons, and the results of medicolegal claims and their jurisdictions. Forty-three surgeons participated in this study. Two hundred medicolegal claims were analyzed. The mean number was 5.8 per surgeon. Bariatric surgery, colorectal surgery and parietal surgery were the most exposed. Forty-six (23%) faults were noted, while no fault was pronounced in 139 (69.5%) cases. The main reasons for lodging complaints were nosocomial infections, anastomotic leaks, poor postoperative care, hollow organ perforation, peripheral neurologic complication, and insufficient preoperative information. Forty-four percent of the complaints were analyzed by the conciliation and compensation commissions and 43.5% by the High Court. In the French-speaking group, there were 13 complaints, two of which gave rise to compensation. French surgeons are highly exposed to complaints: in French law, clumsiness or technical maladdress is considered as a fault. The patient should be informed preoperatively of all possible severe risks of a medical procedure. In Belgium, complications are exceptional and are considered random therapeutic events. Adhering to the recommendations emanating from the French High Authority of Health and Learned Societies as well as accreditation issued by the same High Authority should allow to decrease the number of undesirable events related to care and malpractice.

Impact of the Affordable Care Act on trauma and emergency general surgery: An Eastern Association for the Surgery of Trauma systematic review and meta-analysis.

BACKGROUND: Trauma and emergency general surgery (EGS) patients who are uninsured have worse outcomes as compared with insured patients. Partially modeled after the 2006 Massachusetts Healthcare Reform (MHR), the Patient Protection and Affordable Care Act was passed in 2010 with the goal of expanding health insurance coverage, primarily through state-based Medicaid expansion (ME). We evaluated the impact of ME and MHR on outcomes for trauma patients, EGS patients, and trauma systems. METHODS: This study was approved by the Eastern Association for the Surgery of Trauma Guidelines Committee. Using Grading of Recommendations Assessment, Development and Evaluation methodology, we defined three populations of interest (trauma patients, EGS patients, and trauma systems) and identified the critical outcomes (mortality, access to care, change in insurance status, reimbursement, funding). We performed a systematic review of the literature. Random effect meta-analyses and meta-regression analyses were calculated for outcomes with sufficient data. RESULTS: From 4,593 citations, we found 18 studies addressing all seven predefined outcomes of interest for trauma patients, three studies addressing six of seven outcomes for EGS patients, and three studies addressing three of eight outcomes for trauma systems. On meta-analysis, trauma patients were less likely to be uninsured after ME or MHR (odds ratio, 0.49; 95% confidence interval, 0.37-0.66). These coverage expansion policies were not associated with a change in the odds of inpatient mortality for trauma (odds ratio, 0.96; 95% confidence interval, 0.88-1.05). Emergency general surgery patients also experienced a significant insurance coverage gains and no change in inpatient mortality. Insurance expansion was often associated with increased access to postacute care at discharge. The evidence for trauma systems was heterogeneous. CONCLUSION: Given the evidence quality, we conditionally recommend ME/MHR to improve insurance coverage and access to postacute care for trauma and EGS patients. We have no specific recommendation with respect to the impact of ME/MHR on trauma systems. Additional research into these questions is needed. LEVEL OF EVIDENCE: Review, Economic/Decision, level III.

Regulation of Surgical Procedures and Health Care Facilities Rankings in Nepal.

Globally, millions of surgeries are performed each year to compliment and manage a diverse set of medical conditions. Adverse surgical outcomes constitute a major proportion of avoidable death and disabilities in the hospital, especially in low-income countries like Nepal. A comprehensive study on the standards of surgical procedures and its institutional regulations is missing. We discuss here the importance of surgical regulation based on it's financial as well as healthcare implications in the Nepalese healthcare system. Keywords: health care facilities; safety; surgery; surgical procedures; WHO.

Regulation on introducing process of the highly difficult new medical technologies: A survey on the current status of practice guidelines in Japan and overseas.

Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Proceedings From the Society for Advancement of Blood Management Annual Meeting 2017: Management Dilemmas of the Surgical Patient-When Blood Is Not an Option.

Vigilance is essential in the perioperative period. When blood is not an option for the patient, especially in a procedure/surgery that normally holds a risk for blood transfusion, complexity is added to the management. Current technology and knowledge has made avoidance of blood transfusion a realistic option but it does require a concerted patient-centered effort from the perioperative team. In this article, we provide suggestions for a successful, safe, and bloodless journey for patients. The approaches include preoperative optimization as well as intraoperative and postoperative techniques to reduce blood loss, and also introduces current innovative substitutes for transfusions. This article also assists in considering and maneuvering through the legal and ethical systems to respect patients' beliefs and ensuring their safety.

The Price of Medical Tourism: The Legal Implications of Surgery Abroad.

Medical tourism, or traveling abroad to obtain medical services, has evolved into a global health care phenomenon, with over 15 million U.S. patients each year seeking medical care internationally, representing a $50 billion dollar industry in 2017. Speculation and media fascination about the growing industry, diverse destinations, and rationale behind the medical tourists is rampant; however, the legal implications of tourism medicine, particularly when it goes wrong, are often unclear. On the international stage, accreditation agencies are limited in scope and practice, legal jurisdiction is difficult to establish, and the enforcement of rulings is nearly impossible. Patients seeking tourism medicine have little legal recourse and shoulder all the legal burden.

Medical Malpractice Lawsuits Involving Surgical Residents.

Importance: Medical malpractice litigation against surgical residents is rarely discussed owing to assumed legal doctrine of respondeat superior, or "let the master answer." Objective: To better understand lawsuits targeting surgical trainees to prevent future litigation. Design, Setting, and Participants: Westlaw, an online legal research database containing legal records from across the United States, was retrospectively reviewed for malpractice cases involving surgical interns, residents, or fellows from January 1, 2005, to January 1, 2015. Infant-related obstetric and ophthalmologic procedures were excluded. Exposures: Involvement in a medical malpractice case. Main Outcomes and Measures: Data were collected on patient demographics, case characteristics, and outcomes and were analyzed using descriptive statistics. Results: During a 10-year period, 87 malpractice cases involving surgical trainees were identified. A total of 50 patients were female (57%), and 79 were 18 years of age or older (91%), with a median patient age of 44.5 years (interquartile range, 45-56 years). A total of 67 cases (77%) resulted in death or permanent disability. Most cases involved elective surgery (61 [70%]) and named a junior resident as a defendant (24 of 35 [69%]). Cases more often questioned the perioperative medical knowledge, decision making errors, and injuries (53 [61%]: preoperative, 19 of 53 [36%]) and postoperative, 34 of 53 [64%]) than intraoperative errors and injuries (43 [49%]). Junior residents were involved primarily with lawsuits related to medical decision making (21 of 24 [87%]). Residents' failure to evaluate the patient was cited in 10 cases (12%) and lack of direct supervision by attending physicians was cited in 48 cases (55%). A total of 42 cases (48%) resulted in a jury verdict or settlement in favor of the plaintiff, with a median payout of $900 000 (range, $1852 to $32 million). Conclusions and Relevance: This review of malpractice cases involving surgical residents highlights the importance of perioperative management, particularly among junior residents, and the importance of appropriate supervision by attending physicians as targets for education on litigation prevention.

Beyond a Moral Obligation: A Legal Framework for Emergency and Essential Surgical Care and Anesthesia.

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.

Prioritizing Surgical Care on National Health Agendas: A Qualitative Case Study of Papua New Guinea, Uganda, and Sierra Leone.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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.

Perioperative Complications in Obstructive Sleep Apnea Patients Undergoing Surgery: A Review of the Legal Literature.

BACKGROUND: Obstructive sleep apnea (OSA) is common in patients undergoing surgery. OSA, known or suspected, has been associated with significant perioperative adverse events, including severe neurologic injury and death. This study was undertaken to assess the legal consequences associated with poor outcomes related to OSA in the perioperative setting. METHODS: A retrospective review of the legal literature was performed by searching 3 primary legal databases between the years 1991 and 2010 for cases involving adults with known or suspected OSA who underwent a surgical procedure associated with an adverse perioperative outcome. OSA had to be directly implicated in the outcome, and surgical mishaps (i.e., uncontrolled bleeding) were excluded. The adverse perioperative outcome had to result in a lawsuit that was then adjudicated in a court of law with a final decision rendered. Data were abstracted from each case regarding patient demographics, type of surgery, type and location of adverse event, associated anesthetic and opioid use, and legal outcome. RESULTS: Twenty-four cases met the inclusion criteria. The majority (83%) occurred in or after 2007. Patients were young (average age, 41.7 years), male (63%), and had a known diagnosis of OSA (96%). Ninety-two percent of cases were elective with 33.3% considered general procedures, 37.5% were ears, nose and throat procedures for the treatment of OSA, and 29.1% were considered miscellaneous interventions. Complications occurred intraoperatively (21%), in the postanesthesia care unit (33%), and on the surgical floors (46%). The most common complications were respiratory arrest in an unmonitored setting and difficulty in airway management. Immediate adverse outcomes included death (45.6%), anoxic brain injury (45.6%), and upper airway complications (8%). Overall, 71% of the patients died, with 6 of the 11 who suffered anoxic brain injury dying at an average of 113 days later. The use of opioids and general anesthetics was believed to play a role in 38% and 58% of cases, respectively. Verdicts favored the plaintiffs in 58% of cases and the defendants in 42%. In cases favoring the plaintiff, the average financial penalty was $2.5 million (±$2.3 million; range, $650,000--$7.7 million). CONCLUSIONS: Perioperative complications related to OSA are increasingly being reported as the central contention of malpractice suits. These cases can be associated with severe financial penalties. These data likely underestimate the actual medicolegal burden, given that most such cases are settled out of court and are not accounted for in the legal literature.

Federal policy supporting improvements in transitioning from pediatric to adult surgery services.

For children with complex medical conditions that require ongoing surgical intervention, planning for the transition from pediatric to adult surgical care is essential. Services that support healthcare transition from specialty pediatric practices into adult practices are often inadequate, and the healthcare policy process has been slow to respond to the call to action by both professional and patient organizations. However, The Patient Protection and Affordable Care Act of 2010 (PPACA), arguably the most significant healthcare reform legislation since the enactment of Medicaid and Medicare in the mid-1960s, includes several provisions with direct influence on access to care and quality for adolescents transitioning to adult surgical care. We present a brief background on the rationale for improving surgical transition plans, the challenges of enacting the plans, and the relevance of PPACA in shaping health policy change around transition to adult services.

[Surgical procedures involved in claims for alleged defects in praxis]. / Procedimientos quirúrgicos objeto de reclamación por presunto defecto de praxis.

Medical professional liability and adverse events in health care are major concerns worldwide and the analysis of claims for alleged defects in praxis is a potential source of knowledge. High rates of adverse events and complaints have been reported in surgical procedures. This article analyzes the claims registered by the Council of Medical Colleges in Catalonia between 1986 and 2012, and explores surgical procedures claimed (ICD- 9-CM coding), as well as the final outcome of the claim. Among the 5,419 records identified on surgical procedures, the interventions of the musculoskeletal system and skin and integument showed the highest frequencies. Interventions related to "non-curative" medicine should be emphasized because of their higher rates of economical agreement or condemnation outcomes, which were significantly higher for mastopexia. The results underscore the importance of the surgical area in medical professional liability and the high risk of payouts among those procedures belonging to the so-called "non-curative" medicine.

Scientific evaluation and pricing of medical devices and associated procedures in France.

Medical devices are many and various, ranging from tongue spatulas to implantable or invasive devices and imaging machines; their lifetimes are short, between 18 months and 5 years, due to incessant incremental innovation; and they are operator-dependent: in general, the clinical user performs a fitting procedure (hip implant or pacemaker), a therapeutic procedure using a non-implantable invasive device (arrhythmic site ablation probe, angioplasty balloon, extension spondyloplasty system, etc.) or follow-up of an active implanted device (long-term follow-up of an implanted cardiac defibrillator or of a deep brain stimulator in Parkinson's patients). A round-table held during the XXVIII(th) Giens Workshops meeting focused on the methodology of scientific evaluation of medical devices and the associated procedures with a view to their pricing and financing by the French National Health Insurance system. The working hypothesis was that the available data-set was sufficient for and compatible with scientific evaluation with clinical benefit. Post-registration studies, although contributing to the continuity of assessment, were not dealt with. Moreover, the focus was restricted to devices used in health establishments, where the association between devices and technical medical procedures is optimally representative. An update of the multiple regulatory protocols governing medical devices and procedures is provided. Issues more specifically related to procedures as such, to non-implantable devices and to innovative devices are then dealt with, and the proposals and discussion points raised at the round-table for each of these three areas are presented.

[The new patient rights act : the significance for surgeons]. / Zum neuen Patientenrechtegesetz : Bedeutung für den Chirurgen.

The committee draft for the new patient rights act was approved by the Federal Cabinet on 23 May 2012. Both the demands of the patient representative of the Federal government and some of the demands from the cornerstone paper of the State commission were taken into consideration.The draft of the new act contains comprehensive amendments to the Civil Code with the subtitle"Treatment contract in accordance with §630" and encompasses §§630a-h. The valid legal situation is therefore to all intents and purposes now codified.