Never events in plastic surgery: An analysis of surgical burns and medical malpractice litigation.

INTRODUCTION: Burns and fires in the operating room are a known risk and their prevention has contributed to many additional safety measures. Despite these safeguards, burn injuries contribute significantly to the medical malpractice landscape. The aim of the present study is to analyze malpractice litigation related to burn and fire injuries in plastic and reconstructive surgery, identify mechanisms of injury, and develop strategies for prevention. METHODS: The Westlaw and LexisNexis databases were queried for jury verdicts and settlements in malpractice lawsuits related to burn and fire injuries that occurred during plastic surgery procedures. The Boolean terms included "burn & injury & plastic", "fire & injury & "plastic surg!"" in Westlaw, and "burn & injury & "plastic surg!"", "fire & injury & "plastic surg!"" in LexisNexis. RESULTS: A total of 46 cases met the inclusion criteria for this study. Overheated surgical instruments and cautery devices were the most common mechanisms for litigation. Plastic surgeons were defendants in 40 (87%) cases. Of the included cases, 43% were ruled in favor of the defendant, while 33% were ruled in favor of the plaintiff. Mishandling of cautery devices 6 (13%), heated surgical instruments 6 (13%), and topical acids 2 (4%) were the most common types of errors encountered. CONCLUSION: Never events causing burn injury in plastic and reconstructive surgery are ultimately caused by human error or neglect. The misuse of overheated surgical instruments and cauterizing devices should be the focus for improving patient safety and reducing the risk of medical malpractice. Forcing functions and additional safeguards should be considered to minimize the risk of costly litigation and unnecessary severe harm to patients.

Sales Representatives in the Operating Room: Conflict of Interest or Clinical Support?

BACKGROUND: The Physician Payment Sunshine Act, which became federal law in January 2012, mandated that medical device manufacturers must disclose any financial support provided to individual physicians on a publicly available Web site. The law reflects increasing concern about physician-industry relationships. METHODS: The connection between surgeon and sales representative creates possibilities for both financial and non-financial conflicts of interest (COIs). Indeed, COIs may be inherent when a sales representative is motivated by profit while also serving a critical role in many surgeries. RESULTS: The potential benefits and risks for patients, who may not even be aware of the sales representative's presence in the operating room, must be considered. CONCLUSIONS: This paper adds to the national discussion about neurosurgical physician-industry conflicts of interests and the issues relative to sales representatives in the operating room.

An Interdisciplinary Review of Surgical Data Recording Technology Features and Legal Considerations.

Surgical data recording technology has great promise to generate patient safety and quality data that can be utilized to potentially reduce medical errors. Variations of these systems aim to improve surgical technique, develop better training simulation, and promote adverse event investigation similar to the aims of black box technology utilized in other industries. However, many unknowns remain for surgical data recording utilization in operating rooms and clinical settings in the United States. This includes the need to appropriately design systems so they collect meaningful and useful data that can be discussed by surgical team members in an open and safe environment to optimize clinical care processes. In order to better understand the clinical and regulatory environment for surgical data recording systems, we conducted an interdisciplinary review to identify key technology approaches, and assess legal and regulatory implications associated with this potentially disruptive technology. We found technology ranging from audio and visual data, to systems utilizing mobile applications, and kinematic data capture. The data collected present legal questions over ownership of information and privacy, along with regulatory issues at the federal and state levels. The benefits of these data should be balanced with the need to develop appropriate policies and regulations that protect the interests of both clinicians and patients in order to encourage further innovation and better realize the potential of surgical data recording technology to improve clinical decision making and patient safety outcomes.

Effects of opting-out from federal nurse anesthetists' supervision requirements on anesthesiologist work patterns.

OBJECTIVE: To estimate the impact of opting-out from Medicare supervision requirements for certified registered nurse anesthetists (CRNAs) on anesthesiologists' work patterns. DATA SOURCES/STUDY SETTING: Secondary data from two national surveys of anesthesiologists and the Area Health Resource File. STUDY DESIGN: We use a matching difference-in-difference regression which contrasts the change in work patterns for anesthesiologists in California, which dropped supervision requirements, to the change for similar anesthesiologists. Key outcome variables include the number of weekly hours worked, the type of work done, and type of care delivery teams. DATA COLLECTION/EXTRACTION METHODS: Self-reported national survey data drawn from members of the American Society of Anesthesiologists. PRINCIPAL FINDINGS: Anesthesiologists in California saw no change in time spent working or time spent supervising CRNAs. There was a decrease in direct care clinical work hours along with a shift in working more in intraoperative care, a decrease in postoperative care, and an increase in the percentage of cases supervising residents. CONCLUSIONS: Anesthesiologists had small but real responses to California's decisions to opt-out of the physician supervision requirement for CRNAs, doing more work in intraoperative care and less outside of the operating room. Total hours worked saw no change.

Legal perspectives on black box recording devices in the operating environment.

BACKGROUND: A video and medical data recorder in the operating theatre is possible, but concerns over privacy, data use and litigation have limited widespread implementation. The literature on legal considerations and challenges to overcome, and guidelines related to use of data recording in the surgical environment, are presented in this narrative review. METHODS: A review of PubMed and Embase databases and Cochrane Library was undertaken. International jurisprudence on the topic was searched. Practice recommendations and legal perspectives were acquired based on experience with implementation and use of a video and medical data recorder in the operating theatre. RESULTS: After removing duplicates, 116 citations were retrieved and abstracts screened; 31 articles were assessed for eligibility and 20 papers were finally included. According to the European General Data Protection Regulation and US Health Insurance Portability and Accountability Act, researchers are required to make sure that personal data collected from patients and healthcare professionals are used fairly and lawfully, for limited and specifically stated purposes, in an adequate and relevant manner, kept safe and secure, and stored for no longer than is absolutely necessary. Data collected for the sole purpose of healthcare quality improvement are not required to be added to the patient's medical record. CONCLUSION: Transparency on the use and purpose of recorded data should be ensured to both staff and patients. The recorded video data do not need to be used as evidence in court if patient medical records are well maintained. Clear legislation on data responsibility is needed to use the medical recorder optimally for quality improvement initiatives.

ANTECEDENTES: Es posible instalar un sistema de video y grabación de datos médicos en el quirófano, pero su implementación se ha visto limitada por las dudas relativas a la privacidad, uso de datos y aspectos de litigio. Estas dudas deberían superarse, motivo por el que en este trabajo se proponen unas guías sobre el uso de sistemas de registro en el ambiente quirúrgico. MÉTODOS: Se realizó una revisión en las bases de datos Pubmed y Embase y de la Biblioteca Cochrane. Se buscó la jurisprudencia internacional sobre el tema. Se establecieron unas recomendaciones prácticas y de las perspectivas legales adquiridas a través de la experiencia de la implementación y el uso de sistemas de video y registro de datos médicos en el quirófano. RESULTADOS: Se obtuvieron 116 referencias, de las que una vez eliminadas las duplicadas (n = 5) y revisados los resumenes, 31 artículos cumplían los criterios de eligibilidad. En el estudio final se incluyeron 20 artículos. De acuerdo con la Ley Orgánica de Protección de Datos (General Data Protection Regulation, GDRP) y la Ley de Transferencia y Responsabilidad de Seguro Médico (Health Insurance Portability and Accountability Act, HIPAA), los investigadores deben asegurar que los datos personales recopilados pertenecientes a los pacientes y profesionales de la salud se utilicen de manera justa y legal, con fines definidos y bien establecidos, de manera adecuada y relevante, y mantenidos a resguardo y almacenados no más tiempo del estrictamente necesario. No es necesario que los datos recopilados con el único propósito de mejorar la calidad de la atención médica se agreguen a la historia clínica del paciente. CONCLUSIÓN: Se debe asegurar por parte del personal sanitario como del paciente, la transparencia tanto en la utilización como en el objetivo de los datos almacenados. Los datos registrados en video no es necesario que sean usados como evidencia en procesos judiciales si la historia clínica de los pacientes cumple los estandares establecidos. Se precisa una legislación clara sobre la responsabilidad de los datos para la utilización óptima de los registros médicos en las iniciativas de mejora de la calidad.

Patient injuries from anesthesia gas delivery equipment: a closed claims update.

BACKGROUND: Improvements in anesthesia gas delivery equipment and provider training may increase patient safety. The authors analyzed patient injuries related to gas delivery equipment claims from the American Society of Anesthesiologists Closed Claims Project database over the decades from 1970s to the 2000s. METHODS: After the Institutional Review Board approval, the authors reviewed the Closed Claims Project database of 9,806 total claims. Inclusion criteria were general anesthesia for surgical or obstetric anesthesia care (n = 6,022). Anesthesia gas delivery equipment was defined as any device used to convey gas to or from (but not involving) the airway management device. Claims related to anesthesia gas delivery equipment were compared between time periods by chi-square test, Fisher exact test, and Mann-Whitney U test. RESULTS: Anesthesia gas delivery claims decreased over the decades (P < 0.001) to 1% of claims in the 2000s. Outcomes in claims from 1990 to 2011 (n = 40) were less severe, with a greater proportion of awareness (n = 9, 23%; P = 0.003) and pneumothorax (n = 7, 18%; P = 0.047). Severe injuries (death/permanent brain damage) occurred in supplemental oxygen supply events outside the operating room, breathing circuit events, or ventilator mishaps. The majority (85%) of claims involved provider error with (n = 7) or without (n = 27) equipment failure. Thirty-five percent of claims were judged as preventable by preanesthesia machine check. CONCLUSIONS: Gas delivery equipment claims in the Closed Claims Project database decreased in 1990-2011 compared with earlier decades. Provider error contributed to severe injury, especially with inadequate alarms, improvised oxygen delivery systems, and misdiagnosis or treatment of breathing circuit events.

[Can we do a cesarean section in less than 30min in unsuitable premises in order to follow the recommendations of the ACOG?]. / Peut-on faire une césarienne en moins de 30min dans des locaux inadaptés afin de suivre les recommandations de l'ACOG ?

OBJECTIVES: This study aims to assess in clinical practice the "decision-to-delivery" interval for an emergency cesarean section depending on the type of care. MATERIALS AND METHODS: This is a retrospective study conducted at the maternity of the CHU of Caen Level III between 2004 and 2009. The comprehensive collection of data totals 294 emergency cesarean sections. The main indications were found to be: bradycardia, cord prolapse, uterine rupture, eclampsia, failure of vacuum extraction on fetal heart rate abnormality during expulsion, the suspicion of placental abruption and hemorrhage in placenta previa. Recorded activities day and night were individualized and the maternal and fetal complications related to the emergency. RESULTS: The mean "decision-to-delivery" interval is of 21.3±10.3minutes with 80.2% of cesarean sections within 30minutes (CE30) and 25.8% in less than 15minutes. Concerning the activity period, the average time at night is 22.5±10.3minutes with 20.7% <15minutes and 77.2% <30minutes and in the daytime, the average time is 20.1±10.1minutes with 31.2% <15minutes and 83.3% <30minutes. The laying of spinal anesthesia in the operating room significantly delays the time of extraction (54.9% vs. 91, 8% CE30, P<0.001), but the epidural before the cesarean section and general anesthesia is faster with 91.9% vs. 78.9% (P=0.002) and 91.8% vs. 81.6% (P=0.022) respectively CE30. We deplored 9 deaths of newborns. These nine deaths represent 3.2% of emergency caesarean sections with an average time of 20.7±14.7minutes. CONCLUSION: The time is influenced by the transition to the operating room, the type of anesthesia and lack of information clearly stated to the team. The fetal prognosis is not limited to the "decision-to-delivery" interval but it remains essential in situations of emergency. The 15 or 30minutes interval is discussed in the literature. Obviously, the delay must be appreciated based on certain parameters (medical personnel, architecture) and each Alpha must adapt their practice to the physical working environment to meet the recommended objectives. However, the introduction of a protocol for extreme emergencies would allow for optimal responsiveness of all the teams involved and should result in a compliance period of 30minutes. Teamwork and adherence to procedures can improve these results.

Operating room fires: a closed claims analysis.

BACKGROUND: To assess patterns of injury and liability associated with operating room (OR) fires, closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1985 were reviewed. METHODS: All claims related to fires in the OR were compared with nonfire-related surgical anesthesia claims. An analysis of fire-related claims was performed to identify causative factors. RESULTS: There were 103 OR fire claims (1.9% of 5,297 surgical claims). Electrocautery was the ignition source in 90% of fire claims. OR fire claims more frequently involved older outpatients compared with other surgical anesthesia claims (P < 0.01). Payments to patients were more often made in fire claims (P < 0.01), but payment amounts were lower (median $120,166) compared to nonfire surgical claims (median $250,000, P < 0.01). Electrocautery-induced fires (n = 93) increased over time (P < 0.01) to 4.4% claims between 2000 and 2009. Most (85%) electrocautery fires occurred during head, neck, or upper chest procedures (high-fire-risk procedures). Oxygen served as the oxidizer in 95% of electrocautery-induced OR fires (84% with open delivery system). Most electrocautery-induced fires (n = 75, 81%) occurred during monitored anesthesia care. Oxygen was administered via an open delivery system in all high-risk procedures during monitored anesthesia care. In contrast, alcohol-containing prep solutions and volatile compounds were present in only 15% of OR fires during monitored anesthesia care. CONCLUSIONS: Electrocautery-induced fires during monitored anesthesia care were the most common cause of OR fires claims. Recognition of the fire triad (oxidizer, fuel, and ignition source), particularly the critical role of supplemental oxygen by an open delivery system during use of the electrocautery, is crucial to prevent OR fires. Continuing education and communication among OR personnel along with fire prevention protocols in high-fire-risk procedures may reduce the occurrence of OR fires.

From the operating room to the courtroom: a comprehensive characterization of litigation related to facial plastic surgery procedures.

OBJECTIVES/HYPOTHESIS: Malpractice litigation has increased in recent decades, contributing to higher health-care costs. Characterization of complications leading to litigation is of special interest to practitioners of facial plastic surgery procedures because of the higher proportion of elective cases relative to other subspecialties. In this analysis, we comprehensively examine malpractice litigation in facial plastic surgery procedures and characterize factors important in determining legal responsibility, as this information may be of great interest and use to practitioners in several specialties. STUDY DESIGN: Retrospective analysis. METHODS: The Westlaw legal database was examined for court records pertaining to facial plastic surgery procedures. The term "medical malpractice" was searched in combination with numerous procedures obtained from the American Academy of Facial Plastic and Reconstructive Surgery website. RESULTS: Of the 88 cases included, 62.5% were decided in the physician's favor, 9.1% were resolved with an out-of-court settlement, and 28.4% ended in a jury awarding damages for malpractice. The mean settlement was $577,437 and mean jury award was $352,341. The most litigated procedures were blepharoplasties and rhinoplasties. Alleged lack of informed consent was noted in 38.6% of cases; other common complaints were excessive scarring/disfigurement, functional considerations, and postoperative pain. CONCLUSIONS: This analysis characterized factors in determining legal responsibility in facial plastic surgery cases. Several factors were identified as potential targets for minimizing liability. Informed consent was the most reported entity in these malpractice suits. This finding emphasizes the importance of open communication between physicians and their patients regarding expectations as well as documentation of specific risks, benefits, and alternatives.

[Chemical risk in operating rooms and technical progress: the obligations and responsibilities of law]. / Rischio chimico nelle sale operatorie e progresso tecnico: obblighi e responsabilità di legge.

We are going to consider the specific applications of the new legal system and of the most recent body of laws to those work environments of particular risk, such as healthcare facilities and in particular operating rooms. In such environments, volatile chemicals classified as "dangerous" are used with consequent exposure to "chemical risk", both of those persons professionally involved, depending on the type of activity, and of the patients to whom such activities are addressed in the same environment. Once the chemical risk is framed in the existing regulatory system, it must be specifically evaluated the application of the same principle to the particular chemical risk arising from the use of anesthetic agents in the operating room, for example sevoflurane and desflurane, being careful to test wether and how much this risk can be eliminated or reduced to minimum in relation to the new achievements of the technical progress. So, as soon as the quality of "dangerous chemical agent" of the "volatile chemicals" and of the "volatile liquid anesthetic" (sevoflurane and desflurane) as well--which are characterized by a lower degree of toxicity and for this reason are mostly used in current chemical practice, preferable to some anesthetic gases such as nitrous oxide--is legally verified, it is necessary to relate the scientific and technical data which result from the current "state of art" also to the other binding regulations that are imposed for the "prevention and protection from chemical agents", according to the relative Title IX of the TUSL (Unique text for Safety and Health at Work).

Legal, ethical and professional concepts within the operating department.

There are a number of desirable healthcare practices, such as the requirement for consent and confidentiality, and a respect for the patient, that are ethically sound and legally required (Staunton & Chiarella 2008). The purpose of the law is to provide a deterrent to malpractice, and compensation when things go wrong. All health professionals should be actively aware of the law and its various key concepts. These are primarily negligence, consent, accountability, confidentiality and advocacy (Watson & Tilley 2004). This article is designed to identify the concepts that are important within the operating department. Legal, ethical and professional perspectives that underpin these concepts will be discussed along with relevant case law, ethical theory and the Health Professions Council's (HPC) code of conduct.

[Legal aspects of video registration during operations--the digital operating room assistant: opportunity or threat?]. / Juridische aspecten van videoregistratie bij operaties. De digitale operatieassistent: kans of bedreiging?

Video registration in hospitals is becoming increasingly frequent and an increasing number of surgical procedures are performed with the help of video imaging. The Technical University of Delft is developing a safety system that will use video images to directly inform medical staff of technical problems during surgery so that necessary adjustments can be made in time: the digital operating room assistant. However, the saving of video images is legally considered to be processing of personal data. Dutch privacy legislation requires that certain legal demands are taken into consideration. From legal point of view three situations can be distinguished where video images are being used: (a) as an essential part of treatment (endoscopic surgery, for example), (b) to enhance the quality of the procedure, and (c) for the purposes of peer assessment or education. To whom and in which way consent has to be asked, differs per situation. We recommend that video recordings of crucial points in the operation are included in the patient file. The same counts for incidental findings or complications if, according to the standard of a good caregiver, this is necessary for the further treatment of the patient. In addition to the doctor and the patient, in certain circumstances, access to the video recordings may also be granted to the Health Care Inspectorate and, to the Public Prosecutor. Covert video recording of an employee is a breach of privacy and essentially punishable by law. Video recordings may not themselves be used to assess the performance of the surgeon involved.

Effect of US State Certificate of Need regulation of operating rooms on surgical resident training.

PURPOSE: Government regulation of health care services helps prevent costs associated with expansion and duplication of services in the United States. Certificate of Need (CON) helps restrict construction of ambulatory surgery facilities and hence controls delivery of surgical intervention, but concern exists about whether this affects resident exposure to an appropriate caseload. This study investigated how CON laws impact on surgical caseload as an index of resident surgical training. METHODS: This retrospective study used State Inpatient Data compiled by the Health Care Utilization Project. Mean per capita rates of 26 diverse surgical procedures were evaluated in 21 states with CON laws and 5 states without between 2004 and 2006. The proportion of procedures performed in teaching facilities was also assessed. Student's t-tests were used to evaluate differences in these parameters between regulated and non-regulated states (a = 0.05). Multivariate analysis of variance permitted evaluation of the types of procedures that underwent shift in location performed. RESULTS: States with CON laws did not differ significantly in procedural rates for any of the investigated surgical procedures; however, such regulation was associated with different trends in teaching center caseload, depending on the type of procedure. Complex procedures, such as Whipple operations (p = 0.14) or resection of acoustic neuroma (p = 0.37), underwent no redistribution. Conversely, common procedures that might have previously been performed in private settings, such as total hip replacement (p = 0.003) or mastectomy (p = 0.01), did occur more commonly in teaching facilities under CON regulation. CON law did not result in relocation of surgical procedures away from teaching institutions. CONCLUSIONS: These results suggest that government regulations do not discriminate against teaching facilities. Surgical residents in states with such regulation gain similar or superior exposure to procedures as residents in states without such laws.