TY - JOUR
AU1 - Calder, Lisa, A
AU2 - Héroux, Diane, L
AU3 - Bernard, Catherine, A
AU4 - Liu,, Richard
AU5 - Neilson, Heather, K
AU6 - Gilchrist, Andrew, D
AU7 - Fish, Joel, S
AB - Abstract Surgical fires and unintended intraoperative burns cause serious patient harm, yet surveillance data are lacking in Canada. Medico-legal data provide unique descriptions of these events which can inform burn prevention strategies. We extracted 5 years of data on closed (2012–2016) medico-legal cases involving surgical fires and burns from the database of our organization which, in 2016, provided medico-legal support to >93,000 Canadian physicians. We performed a retrospective descriptive analysis of contributing factors using an in-house coding system and case reviews. We identified 53 eligible burn cases: 26 from thermal sources (49.1%), 16 from fires (30.2%), 5 from chemical sources (9.4%), and 6 from undetermined sources (11.3%). Common burn sources were electrosurgical equipment, lasers, lighting, and improper temperatures (causing thermal burns), cautery or lasers combined with supplemental oxygen and/or a flammable fuel source (causing fire), and improperly applied solutions including antiseptics (causing chemical burns). Nontechnical factors also contributed to patient outcomes, such as nonadherence to protocols (15 cases, 28.3%), failures in surgical team communication (3 cases, 5.7%), and lost situational awareness leading to delays in recognizing and treating burns (7 cases, 13.2%). This retrospective study highlights a need for improved surgical safety interventions to address surgical fires and burns. These interventions could include: effectively implemented surgical safety protocols, surgical team communication strategies, and raising awareness about preventing, diagnosing, and managing surgical burns. Surgical fires that cause injury and other unintended intraoperative burns are considered “never events” by the Canadian Patient Safety Institute1 and in the United States, the Joint Commission recognizes surgical fires as “sentinel events.” 2 The Emergency Care Research Institute estimates that around 90 to 100 surgical fires happen nationally each year in the United States3 with some medical specialties possibly at higher risk of involvement. In American cross-sectional studies, for example, 25 to 45% of surveyed otolaryngologists and oculoplastic surgeons reported witnessing at least one surgical fire during their careers.3–5 These events can have devastating and lasting impacts not only on patients, but also on surgical teams. While institutions are intervening to prevent surgical burns,6–8 there is incomplete monitoring of these events at a national level in Canada.9 There are no national reporting mechanisms for tracking these events nor are there published reports of their frequency. The Canadian Institute for Health Information and the Canadian Patient Safety Institute jointly measure in-hospital, patient trauma outside the province of Quebec, but they do not measure surgical fires and burns explicitly.9 Evidence-based interventions are also scarce: a recent systematic review of surgical fire interventions showed the overall strength of evidence to be insufficient and suggested a need for further research.10 To design effective, targeted operating room interventions, an in-depth understanding of the factors contributing to surgical burns is needed. The fire triangle—comprising ignition or heat, fuel, and oxidizers as elements sufficient for fire11—is a well-known framework for surgical fire safety education and for identifying the causes of fire. Retrospective analyses of surgical burns have already informed prevention initiatives,9,12,13 but to our knowledge, relatively few involved systematically analyzing the roles of human factors14 such as team communication and situational awareness. Medico-legal data offers a unique, rich source of contextual information about the technical and nontechnical factors contributing to patient harm across a wide range of specialties and institutions. In the current study, we aimed to measure the occurrence of surgical burns due to chemicals, fire, and other thermal sources among closed Canadian medico-legal cases in recent years, and to further develop understanding about why they are happening. METHODS We performed a retrospective descriptive analysis of medico-legal data from Canadian Medical Protective Association (CMPA) to systematically identify factors contributing to surgical fires and burns, including burn sources and nontechnical factors, in medico-legal cases. The Advarra (formerly Chesapeake) Institutional Review Board approved the study. The Database Our organization is a not-for-profit mutual defence organization for physicians, and a leading provider of medico-legal and patient safety education. At the time of initiating this study, the CMPA had more than 93,000 physician members and a national database containing medico-legal data. The database included civil legal actions or threats of civil legal action and complaints to hospitals and regulatory authorities (i.e., provincial Colleges of Physicians and Surgeons or territorial medical regulatory authorities) about physician members of our organization, reported voluntarily by members. At the time of this study, analyses were made possible by systematically coding medico-legal information. For each closed medico-legal case, a medical analyst—an experienced, registered nurse—examined the events and coded information, including a series of contributing factors based primarily on peer expert opinions. Each factor was attributed to an appropriate healthcare provider or coded entity (eg, hospital, clinic). Peer experts were physicians retained by parties in the legal actions who provided their opinions on clinical, scientific, or technical issues surrounding the healthcare provided; they were typically of similar training and experience as the physicians whose care they were reviewing. Variable Definitions At the time of the study, medical analysts used the Canadian enhancement to the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10-CA) to code patient health conditions,15 and the Canadian Classification of Health Interventions (CCI) to code medical interventions.16 To code patient harm, analysts applied our organization’s in-house harm classification framework adapted from the American Society for healthcare Risk Management’s Healthcare Associated Preventable Harm Level Classification Tool.17 Our harm classification indicated harmful incidents due to healthcare, harm due to inherent risk of healthcare, unknown cause of harm, near miss, and no health care-associated harm. When patient harm did occur, analysts assigned additional codes indicating harm severity (Table 1). Table 1. The CMPA’s in-house definitions relating to harm* Harmful incident: Based on peer expert opinion, the harm resulting from the care or services provided to the patient due to failures in the processes of care or in the performance of procedures, including provider error. Inherent risk: Based on peer expert opinion, a harmful incident that is a known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using current research, equipment, and techniques. Mild harm: Patient harm is symptomatic, symptoms are mild, loss of function or harm is minimal (permanent or temporary), and minimal or no intervention is required (eg, extra observation, investigation, review, or minor treatment). Moderate harm: Patient harm is symptomatic, requiring intervention (eg, additional operative procedure, additional therapeutic treatment), and increased length of stay, or causing permanent or temporary harm, or loss of function. Severe harm: Patient harm is symptomatic, requiring life-saving intervention or major medical/surgical intervention, shortening life expectancy, or causing major permanent or temporary harm or loss of function. Includes previous catastrophic disability. Harmful incident: Based on peer expert opinion, the harm resulting from the care or services provided to the patient due to failures in the processes of care or in the performance of procedures, including provider error. Inherent risk: Based on peer expert opinion, a harmful incident that is a known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using current research, equipment, and techniques. Mild harm: Patient harm is symptomatic, symptoms are mild, loss of function or harm is minimal (permanent or temporary), and minimal or no intervention is required (eg, extra observation, investigation, review, or minor treatment). Moderate harm: Patient harm is symptomatic, requiring intervention (eg, additional operative procedure, additional therapeutic treatment), and increased length of stay, or causing permanent or temporary harm, or loss of function. Severe harm: Patient harm is symptomatic, requiring life-saving intervention or major medical/surgical intervention, shortening life expectancy, or causing major permanent or temporary harm or loss of function. Includes previous catastrophic disability. *Adapted from the American Society for Healthcare Risk Management’s Healthcare Associated Harm Level Classification Tool.17 Open in new tab Table 1. The CMPA’s in-house definitions relating to harm* Harmful incident: Based on peer expert opinion, the harm resulting from the care or services provided to the patient due to failures in the processes of care or in the performance of procedures, including provider error. Inherent risk: Based on peer expert opinion, a harmful incident that is a known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using current research, equipment, and techniques. Mild harm: Patient harm is symptomatic, symptoms are mild, loss of function or harm is minimal (permanent or temporary), and minimal or no intervention is required (eg, extra observation, investigation, review, or minor treatment). Moderate harm: Patient harm is symptomatic, requiring intervention (eg, additional operative procedure, additional therapeutic treatment), and increased length of stay, or causing permanent or temporary harm, or loss of function. Severe harm: Patient harm is symptomatic, requiring life-saving intervention or major medical/surgical intervention, shortening life expectancy, or causing major permanent or temporary harm or loss of function. Includes previous catastrophic disability. Harmful incident: Based on peer expert opinion, the harm resulting from the care or services provided to the patient due to failures in the processes of care or in the performance of procedures, including provider error. Inherent risk: Based on peer expert opinion, a harmful incident that is a known risk associated with a particular investigation, medication, or treatment. It is the risk from undergoing a procedure in ideal conditions, performed by qualified staff using current research, equipment, and techniques. Mild harm: Patient harm is symptomatic, symptoms are mild, loss of function or harm is minimal (permanent or temporary), and minimal or no intervention is required (eg, extra observation, investigation, review, or minor treatment). Moderate harm: Patient harm is symptomatic, requiring intervention (eg, additional operative procedure, additional therapeutic treatment), and increased length of stay, or causing permanent or temporary harm, or loss of function. Severe harm: Patient harm is symptomatic, requiring life-saving intervention or major medical/surgical intervention, shortening life expectancy, or causing major permanent or temporary harm or loss of function. Includes previous catastrophic disability. *Adapted from the American Society for Healthcare Risk Management’s Healthcare Associated Harm Level Classification Tool.17 Open in new tab Analysts applied an in-house coding system to code contributing factors. The coding system included six broad categories capturing health care provider, team, and system issues. Within each broad category, analysts applied detailed codes for contributing factors, applying as many as necessary out of 167 possible codes. Medical analysts conducted quality assurance reviews of their coding, both electronically and in a group format on a weekly basis, in an effort to reduce misclassification. Case Extraction In the present study, we extracted medico-legal cases from our database using a priori eligibility criteria. For eligibility, a case must have involved a civil legal action (legal case), threat of legal action, or complaint to a regulatory authority (College) or hospital. Additionally for eligibility, our organization must have closed the case between January 1, 2012 and December 31, 2016. By definition, a civil legal case was “closed” once reaching a legal resolution either through dismissal, settlement, or a trial decision. Cases involving hospital or regulatory authority complaints closed when our organization received a closing letter from counsel. Furthermore for eligibility, cases must have involved a surgical intervention (CCI code INT 1*) with a location of the operating room, day surgery operating room, or clinic operating room. Additionally, eligible cases must have had a burn complication (ICD-10 codes T20-T32) (see Supplementary Digital Content 1 for inclusion/exclusion codes) and at least one coded, contributing factor based on peer expert opinion. We excluded obstetrical cases unless the patient underwent cesarean section (CCI code INT 5MD60*). We also excluded one medico-legal case that corresponded with two statements of claim on the same patient safety incident, to ensure we counted the patient only once in our analysis. Data Analysis The first stage of our analysis involved a quantitative, descriptive analysis of medico-legal cases. We used our organization’s in-house data analysis tool and the statistical software utility, version 9.4,18 to query frequencies and proportions of categorical variables of interest; namely, medico-legal details (case type, medico-legal outcome), patient characteristics (gender, age), intervention characteristics (physician specialty, operating room setting), harm classifications, and contributing factors. The second stage of our analysis was a detailed review of medico-legal data by three reviewers: two experienced, registered nurses and an anesthesiologist. One reviewer analyzed cases according to a variety of case characteristics and contributing factor themes. Two other reviewers independently reviewed each case to identify the direct sources of burn and, if related to fire, categorize them as fuel, oxygen, or ignition. Furthermore, two reviewers extracted characteristics of the burns (cause, severity, location, body surface area) and burn treatments, if possible, based on the documentation in the medico-legal case. RESULTS Our closed case analysis identified 53 surgical burn cases involving 53 patients. Table 2 shows an overview of patients and settings for the surgical burns. Most patients were adults between the ages of 19 and 64 years and the majority were female. Nearly one-fifth of the burns (18.9%) occurred in clinics. Tables 3 and 4 summarize the physician specialties and surgical interventions involved in the cases. The most commonly involved physicians specialized in gynecology or otolaryngology (Table 3). Surgical interventions ongoing at the time of the burns most often involved procedures on the head/neck or pelvic regions of the body, followed by procedures on the trunk (Table 4). Table 2. Patient characteristics and settings for medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 53 cases) Characteristics Frequency, n (%) Patient gender  Female 39 (73.6)  Male 14 (26.4) Patient age  Pediatric (0–18 yr) 7 (13.2)  Adult (19–64 yr) 38 (71.7)  Geriatric (65+ yr) 8 (15.1) Setting  Hospital operating room 43 (81.1)  Clinic operating room 10 (18.9) Characteristics Frequency, n (%) Patient gender  Female 39 (73.6)  Male 14 (26.4) Patient age  Pediatric (0–18 yr) 7 (13.2)  Adult (19–64 yr) 38 (71.7)  Geriatric (65+ yr) 8 (15.1) Setting  Hospital operating room 43 (81.1)  Clinic operating room 10 (18.9) Open in new tab Table 2. Patient characteristics and settings for medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 53 cases) Characteristics Frequency, n (%) Patient gender  Female 39 (73.6)  Male 14 (26.4) Patient age  Pediatric (0–18 yr) 7 (13.2)  Adult (19–64 yr) 38 (71.7)  Geriatric (65+ yr) 8 (15.1) Setting  Hospital operating room 43 (81.1)  Clinic operating room 10 (18.9) Characteristics Frequency, n (%) Patient gender  Female 39 (73.6)  Male 14 (26.4) Patient age  Pediatric (0–18 yr) 7 (13.2)  Adult (19–64 yr) 38 (71.7)  Geriatric (65+ yr) 8 (15.1) Setting  Hospital operating room 43 (81.1)  Clinic operating room 10 (18.9) Open in new tab Table 3. Specialties of the physicians involved in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 55 physicians)* Physician Specialty† Frequency Gynecology 10 Otolaryngology 9 Plastic surgery 8 Orthopedic surgery 8 General surgery 7 Anesthesiology 4 Urology 4 Ophthalmology 2 Trainees 2 Emergency medicine 1 Physician Specialty† Frequency Gynecology 10 Otolaryngology 9 Plastic surgery 8 Orthopedic surgery 8 General surgery 7 Anesthesiology 4 Urology 4 Ophthalmology 2 Trainees 2 Emergency medicine 1 *The total number of physicians exceeds the number of patients (n = 53) because some medico-legal cases involved more than one physician; therefore, percent is not shown. †Indicates a physician named in the medical-legal matter who was in the operating room with the patient at the time of the burn, and actively participated in the events leading to the burn. Open in new tab Table 3. Specialties of the physicians involved in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 55 physicians)* Physician Specialty† Frequency Gynecology 10 Otolaryngology 9 Plastic surgery 8 Orthopedic surgery 8 General surgery 7 Anesthesiology 4 Urology 4 Ophthalmology 2 Trainees 2 Emergency medicine 1 Physician Specialty† Frequency Gynecology 10 Otolaryngology 9 Plastic surgery 8 Orthopedic surgery 8 General surgery 7 Anesthesiology 4 Urology 4 Ophthalmology 2 Trainees 2 Emergency medicine 1 *The total number of physicians exceeds the number of patients (n = 53) because some medico-legal cases involved more than one physician; therefore, percent is not shown. †Indicates a physician named in the medical-legal matter who was in the operating room with the patient at the time of the burn, and actively participated in the events leading to the burn. Open in new tab Table 4. Distribution of surgical interventions by body region in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 73 interventions among 53 patients)* Region of Surgical Intervention Frequency Common Procedures† Head/neck 21 Cosmetic procedures involving the face, eg, rhytidectomy, laser treatment Ear, nose, and throat procedures, eg, tonsillectomy, adenoidectomy, resection of lesions Shoulder/arms 3 Repairs, eg, Bankart lesion repair, rotator cuff repair Trunk 17 Cosmetic procedures, eg, breast augmentation, abdominoplasty Hernia repair Pelvic region 21 Gynecological procedures eg, endometrial ablation, vaginoplasty, hysterectomy Urological procedures, eg, resection of urethral diverticula, removal of malfunctioning artificial urethral sphincter Hip/lower limbs 11 Joint surgery, eg, hip, knee arthroplasty Repair of fractures Removal of hardware Region of Surgical Intervention Frequency Common Procedures† Head/neck 21 Cosmetic procedures involving the face, eg, rhytidectomy, laser treatment Ear, nose, and throat procedures, eg, tonsillectomy, adenoidectomy, resection of lesions Shoulder/arms 3 Repairs, eg, Bankart lesion repair, rotator cuff repair Trunk 17 Cosmetic procedures, eg, breast augmentation, abdominoplasty Hernia repair Pelvic region 21 Gynecological procedures eg, endometrial ablation, vaginoplasty, hysterectomy Urological procedures, eg, resection of urethral diverticula, removal of malfunctioning artificial urethral sphincter Hip/lower limbs 11 Joint surgery, eg, hip, knee arthroplasty Repair of fractures Removal of hardware *The total number exceeds the number of patients (n = 53) because some medico-legal cases involved surgical interventions on more than one region of the body; therefore, percent is not shown. †Examples of common interventions described in the medico-legal cases; not all surgical interventions are shown. Open in new tab Table 4. Distribution of surgical interventions by body region in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 73 interventions among 53 patients)* Region of Surgical Intervention Frequency Common Procedures† Head/neck 21 Cosmetic procedures involving the face, eg, rhytidectomy, laser treatment Ear, nose, and throat procedures, eg, tonsillectomy, adenoidectomy, resection of lesions Shoulder/arms 3 Repairs, eg, Bankart lesion repair, rotator cuff repair Trunk 17 Cosmetic procedures, eg, breast augmentation, abdominoplasty Hernia repair Pelvic region 21 Gynecological procedures eg, endometrial ablation, vaginoplasty, hysterectomy Urological procedures, eg, resection of urethral diverticula, removal of malfunctioning artificial urethral sphincter Hip/lower limbs 11 Joint surgery, eg, hip, knee arthroplasty Repair of fractures Removal of hardware Region of Surgical Intervention Frequency Common Procedures† Head/neck 21 Cosmetic procedures involving the face, eg, rhytidectomy, laser treatment Ear, nose, and throat procedures, eg, tonsillectomy, adenoidectomy, resection of lesions Shoulder/arms 3 Repairs, eg, Bankart lesion repair, rotator cuff repair Trunk 17 Cosmetic procedures, eg, breast augmentation, abdominoplasty Hernia repair Pelvic region 21 Gynecological procedures eg, endometrial ablation, vaginoplasty, hysterectomy Urological procedures, eg, resection of urethral diverticula, removal of malfunctioning artificial urethral sphincter Hip/lower limbs 11 Joint surgery, eg, hip, knee arthroplasty Repair of fractures Removal of hardware *The total number exceeds the number of patients (n = 53) because some medico-legal cases involved surgical interventions on more than one region of the body; therefore, percent is not shown. †Examples of common interventions described in the medico-legal cases; not all surgical interventions are shown. Open in new tab All patients in the study experienced healthcare-associated harm which had a negative impact on their health and quality of life; no patient died. Supplementary Digital Content 2 illustrates our harm classification. Forty-eight patients (90.6%) experienced “harmful incidents” usually classified as moderate severity. Some patients experienced ongoing functional vision impairment, trouble with swallowing and speech, and infection as a result of their burns. Medico-legal data indicated that 35 patients (66.0% of cases) required burn wound management such as debridement and skin grafting; although, additional patients may have received treatments that were not evident from the data. Long-term harm included permanent scarring, skin pigmentation changes, disfigurement, and psychological trauma including self-reported stress, anxiety, depression, sleep disturbances, and persistent apprehension about contacting the healthcare system following the incident. Five patients experienced harm that peer experts retained in the cases deemed an inherent risk of the procedure (Table 1). Inherent risk cases included burns from cautery that affected nontarget tissues despite surgical precautions and delayed presentation of cautery burns that surgeons could not have been expected to recognize intraoperatively. Medico-legal data often lacked full clinical descriptions of the burns. Among cases that did have these descriptions, the most frequent location of burns was the head/neck or trunk, and partial thickness burns were the most common severity (Table 5). Table 5. Burn characteristics in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 61 burns among 53 patients)* Burn Characteristics Frequency Body location  Head and neck 18  Upper body and/or shoulder 8  Trunk 19  Pelvic region 3  Hips and/or lower limbs 13 Burn severity†  Superficial 7  Partial thickness 17  Full thickness 5 Burn coverage and severity†  Burn <10% body surface area  Unspecified severity or no full thickness 26  <10% full thickness 7 Burn 10–19% body surface area  <10% full thickness 1  10–19% full thickness 1 Burn Characteristics Frequency Body location  Head and neck 18  Upper body and/or shoulder 8  Trunk 19  Pelvic region 3  Hips and/or lower limbs 13 Burn severity†  Superficial 7  Partial thickness 17  Full thickness 5 Burn coverage and severity†  Burn <10% body surface area  Unspecified severity or no full thickness 26  <10% full thickness 7 Burn 10–19% body surface area  <10% full thickness 1  10–19% full thickness 1 *The total number does not equal the number of patients (n = 53) because some patients experienced more than one burn. Furthermore, information about burn severity or burn coverage was not documented in the medico-legal data for 32 cases and 18 cases, respectively. Therefore, percent is not shown. †Burn severity assessment could occur at any point within the period of patient care. If multiple levels of burn severity were documented for the same burn location then, for the purpose of our analysis, we reported the highest-severity burn that was documented in the medico-legal data. Open in new tab Table 5. Burn characteristics in medico-legal, surgical burn cases closed by the CMPA, 2012–2016 (n = 61 burns among 53 patients)* Burn Characteristics Frequency Body location  Head and neck 18  Upper body and/or shoulder 8  Trunk 19  Pelvic region 3  Hips and/or lower limbs 13 Burn severity†  Superficial 7  Partial thickness 17  Full thickness 5 Burn coverage and severity†  Burn <10% body surface area  Unspecified severity or no full thickness 26  <10% full thickness 7 Burn 10–19% body surface area  <10% full thickness 1  10–19% full thickness 1 Burn Characteristics Frequency Body location  Head and neck 18  Upper body and/or shoulder 8  Trunk 19  Pelvic region 3  Hips and/or lower limbs 13 Burn severity†  Superficial 7  Partial thickness 17  Full thickness 5 Burn coverage and severity†  Burn <10% body surface area  Unspecified severity or no full thickness 26  <10% full thickness 7 Burn 10–19% body surface area  <10% full thickness 1  10–19% full thickness 1 *The total number does not equal the number of patients (n = 53) because some patients experienced more than one burn. Furthermore, information about burn severity or burn coverage was not documented in the medico-legal data for 32 cases and 18 cases, respectively. Therefore, percent is not shown. †Burn severity assessment could occur at any point within the period of patient care. If multiple levels of burn severity were documented for the same burn location then, for the purpose of our analysis, we reported the highest-severity burn that was documented in the medico-legal data. Open in new tab Contributing Factors Medico-legal data indicated a variety of sources contributing to burns (Table 6). Thermal burns not caused by fire were the most common type of surgical burn overall (26 cases, 49.1%). In nine of these cases peer experts attributed the burns to surgeons inadvertently burning anatomical structures lying close to the intended tissue despite taking standard precautions. Six thermal burn cases related to improper temperatures of water, saline, or surgical equipment that teams failed to cool sufficiently before using. The remainder generally related to improper handling, positioning, or malfunctioning of surgical equipment (eg, cautery, lasers, lighting). Table 6. Sources of burns for patients involved in medico-legal cases closed by the CMPA, 2012–2016 (n = 53 cases) Source of Burn* Description Frequency, n (%)† Thermal (heat), not fire Unintentional contact with nearby structures Burns to unintended anatomical structures while using a heat source, despite standard precautions to avoid them, eg, thermablation, lipolysis, cautery, laser 9 (17.0) Improper temperatures Hot water bottles or saline bags for patient positioning/warming; flash sterilized instruments or devices not sufficiently cooled; hot water for applying cast 6 (11.3) User error, improper use or improper handling of equipment, wrong device supplied Improper connections; make-shift OR padding (using flammable material); failure to adhere to manufacturer’s specifications; improper handling of cautery cables or pads; equipment ordering errors 6 (11.3) Equipment malfunction Laser, cautery, thermablation device 3 (5.7) Light source External light source; failure to turn off laparoscope when not in use 2 (3.8) Total, thermal 26 (49.1) Fire Ignition and fuel Cautery in contact with drapes or pooled/wet preparation solution 8 (15.1) Ignition and supplemental oxygen Cautery or laser in presence of supplemental oxygen via ETT or nasal prongs (causing airway fire) or involving patient’s skin/hair 5 (9.4) Ignition, fuel, and supplemental oxygen Cautery or laser in contact with preparation solution, drapes, or dry gauze/sponges in the presence of open-flow supplemental oxygen; unprotected ETT cuff lacking wet pledgets 3 (5.7) Total, fire 16 (30.2) Chemical Preparation solution, wrong solution, or disinfectant Pooling or improper concentration; wrong or “bad batch” of solution; chemical reaction to disinfectant 5 (9.4) Total, chemical 5 (9.4) Unknown Peer experts unable to establish the source or cause Suspected causes were malfunction or improper handling of equipment (eg, cautery, light source, grounding pads, reamer) or preparation solution 6 (11.3) Total, unknown 6 (11.3) Source of Burn* Description Frequency, n (%)† Thermal (heat), not fire Unintentional contact with nearby structures Burns to unintended anatomical structures while using a heat source, despite standard precautions to avoid them, eg, thermablation, lipolysis, cautery, laser 9 (17.0) Improper temperatures Hot water bottles or saline bags for patient positioning/warming; flash sterilized instruments or devices not sufficiently cooled; hot water for applying cast 6 (11.3) User error, improper use or improper handling of equipment, wrong device supplied Improper connections; make-shift OR padding (using flammable material); failure to adhere to manufacturer’s specifications; improper handling of cautery cables or pads; equipment ordering errors 6 (11.3) Equipment malfunction Laser, cautery, thermablation device 3 (5.7) Light source External light source; failure to turn off laparoscope when not in use 2 (3.8) Total, thermal 26 (49.1) Fire Ignition and fuel Cautery in contact with drapes or pooled/wet preparation solution 8 (15.1) Ignition and supplemental oxygen Cautery or laser in presence of supplemental oxygen via ETT or nasal prongs (causing airway fire) or involving patient’s skin/hair 5 (9.4) Ignition, fuel, and supplemental oxygen Cautery or laser in contact with preparation solution, drapes, or dry gauze/sponges in the presence of open-flow supplemental oxygen; unprotected ETT cuff lacking wet pledgets 3 (5.7) Total, fire 16 (30.2) Chemical Preparation solution, wrong solution, or disinfectant Pooling or improper concentration; wrong or “bad batch” of solution; chemical reaction to disinfectant 5 (9.4) Total, chemical 5 (9.4) Unknown Peer experts unable to establish the source or cause Suspected causes were malfunction or improper handling of equipment (eg, cautery, light source, grounding pads, reamer) or preparation solution 6 (11.3) Total, unknown 6 (11.3) ETT, endotracheal tube; OR, operating room. *According to peer expert opinions in the medico-legal cases. †Percent totals do not equal 100% due to rounding. Open in new tab Table 6. Sources of burns for patients involved in medico-legal cases closed by the CMPA, 2012–2016 (n = 53 cases) Source of Burn* Description Frequency, n (%)† Thermal (heat), not fire Unintentional contact with nearby structures Burns to unintended anatomical structures while using a heat source, despite standard precautions to avoid them, eg, thermablation, lipolysis, cautery, laser 9 (17.0) Improper temperatures Hot water bottles or saline bags for patient positioning/warming; flash sterilized instruments or devices not sufficiently cooled; hot water for applying cast 6 (11.3) User error, improper use or improper handling of equipment, wrong device supplied Improper connections; make-shift OR padding (using flammable material); failure to adhere to manufacturer’s specifications; improper handling of cautery cables or pads; equipment ordering errors 6 (11.3) Equipment malfunction Laser, cautery, thermablation device 3 (5.7) Light source External light source; failure to turn off laparoscope when not in use 2 (3.8) Total, thermal 26 (49.1) Fire Ignition and fuel Cautery in contact with drapes or pooled/wet preparation solution 8 (15.1) Ignition and supplemental oxygen Cautery or laser in presence of supplemental oxygen via ETT or nasal prongs (causing airway fire) or involving patient’s skin/hair 5 (9.4) Ignition, fuel, and supplemental oxygen Cautery or laser in contact with preparation solution, drapes, or dry gauze/sponges in the presence of open-flow supplemental oxygen; unprotected ETT cuff lacking wet pledgets 3 (5.7) Total, fire 16 (30.2) Chemical Preparation solution, wrong solution, or disinfectant Pooling or improper concentration; wrong or “bad batch” of solution; chemical reaction to disinfectant 5 (9.4) Total, chemical 5 (9.4) Unknown Peer experts unable to establish the source or cause Suspected causes were malfunction or improper handling of equipment (eg, cautery, light source, grounding pads, reamer) or preparation solution 6 (11.3) Total, unknown 6 (11.3) Source of Burn* Description Frequency, n (%)† Thermal (heat), not fire Unintentional contact with nearby structures Burns to unintended anatomical structures while using a heat source, despite standard precautions to avoid them, eg, thermablation, lipolysis, cautery, laser 9 (17.0) Improper temperatures Hot water bottles or saline bags for patient positioning/warming; flash sterilized instruments or devices not sufficiently cooled; hot water for applying cast 6 (11.3) User error, improper use or improper handling of equipment, wrong device supplied Improper connections; make-shift OR padding (using flammable material); failure to adhere to manufacturer’s specifications; improper handling of cautery cables or pads; equipment ordering errors 6 (11.3) Equipment malfunction Laser, cautery, thermablation device 3 (5.7) Light source External light source; failure to turn off laparoscope when not in use 2 (3.8) Total, thermal 26 (49.1) Fire Ignition and fuel Cautery in contact with drapes or pooled/wet preparation solution 8 (15.1) Ignition and supplemental oxygen Cautery or laser in presence of supplemental oxygen via ETT or nasal prongs (causing airway fire) or involving patient’s skin/hair 5 (9.4) Ignition, fuel, and supplemental oxygen Cautery or laser in contact with preparation solution, drapes, or dry gauze/sponges in the presence of open-flow supplemental oxygen; unprotected ETT cuff lacking wet pledgets 3 (5.7) Total, fire 16 (30.2) Chemical Preparation solution, wrong solution, or disinfectant Pooling or improper concentration; wrong or “bad batch” of solution; chemical reaction to disinfectant 5 (9.4) Total, chemical 5 (9.4) Unknown Peer experts unable to establish the source or cause Suspected causes were malfunction or improper handling of equipment (eg, cautery, light source, grounding pads, reamer) or preparation solution 6 (11.3) Total, unknown 6 (11.3) ETT, endotracheal tube; OR, operating room. *According to peer expert opinions in the medico-legal cases. †Percent totals do not equal 100% due to rounding. Open in new tab In 16 cases (30.2%), the source of burn was a surgical fire (Table 6). Among these cases, unsafe use of cautery or lasers was a common theme. Skin preparation solutions also contributed to fires, with some surgical team members failing to let antiseptic agents dry sufficiently before placing drapes, or teams inadvertently allowing antiseptic agents to pool underneath patients. The most common agent, when described in such cases, was a 2% chlorhexidine-70% isopropyl alcohol mixture. Peer experts identified supplemental oxygen as a source in half of the fires (8 of 16 cases). These cases involved operating room teams not decreasing oxygen concentrations to the lowest possible level during cautery, or administering 100% oxygen during the procedure. Surgical fires also involved open-flow oxygen through nasal prongs resting outside of the nares, handheld tracheal masks, and an endotracheal tube cuff inflated with air instead of saline for a high-risk procedure involving the airway (associated with a gap in knowledge of standard practice). Five cases involved chemical burns (Table 6). The source of burn in multiple cases was a preparation solution. We also identified nontechnical factors contributing to burns. Poor communication within the surgical team was a criticism by peer experts in three cases (5.7%) in which surgical team members failed to alert others about hot surgical equipment or supplemental oxygen in the presence of cautery. Other criticisms related to situational awareness: in seven cases (13.2%), there was a delay in the diagnosis and treatment of a burn. Delays resulted from surgeons unknowingly causing burns and later attributing patient soreness to another cause, or surgeons failing to appreciate the severity of a burn and delaying plastic surgery referrals. Another common criticism, in 15 medico-legal cases (28.3%), related to surgical safety protocols. For instance, peer experts noted surgical teams not allowing solutions to dry completely or leaving soaked pads on patients because they were rushing, leading to fire. In other cases peer experts identified deficient processes for ensuring correct equipment orders and deficient policies on the use of cautery in the presence of supplemental oxygen or for maintaining equipment. In five medico-legal cases (9.4%), peer experts criticized physicians for incomplete (or lacking) documentation in the medical record. These cases involved surgeons providing inadequate documentation of the informed consent process, of the burn incident, or of postoperative visits and subsequent burn care. There were also peer expert criticisms relating specifically to the informed consent process. In four cases (7.5%) before surgery, a surgeon failed to discuss with the patient the risk of burns that may result from using cautery or lasers. DISCUSSION Between 2012 and 2016, there were 53 analyzable medico-legal cases closed by our organization that involved surgical burns. The most common source of burn, in nearly half of the cases, was a nonfire thermal source. In addition to identifying burn sources (often cautery or lasers), peer experts noted poor team communication, lost situational awareness causing delays in diagnosing and treating postoperative complications, and nonadherence to surgical safety protocols. The frequency of events in our study is noteworthy since, to our knowledge, this is the first in-depth analysis of surgical burn cases in Canada ever published. This finding cannot be applied to incidence rates, though, because medico-legal data do not reflect all patient safety incidents and, at the time of this study, there was no mandatory reporting system. We can only comment that the number of surgical fires and burns leading to a medico-legal matter in Canada was low at the time our study. Of 53 analyzed burn cases, 24 occurred in Ontario, Canada’s most populated province. Comparatively, the Canadian Institute for Health Information reported nearly 7 million surgical procedures in Ontario hospitals during this time.19,20 At least three retrospective analyses of medico-legal data were published previously on this topic,3,21,22 describing surgical burns21 or fires3,22 in the United States since 1980s. Our study adds Canadian data to this limited body of work with several key distinctions. A primary distinction is our systematic analysis of the nontechnical factors and system issues contributing to the medico-legal cases. Moreover, we reported all sources of burns, not only due to fire. Another distinction was the size and breadth of our study. We believe that this is the first study of cases from a national medico-legal database covering a range of medico-legal matters (civil legal, regulatory authority, and hospital) across all medical specialties. Previous studies were more limited in size (n = 7)3 or scope, that is, to one specialty area3,22 or a subgroup of cases that proceeded to trial court systems in 35 states in the United States.21 The breadth of our study enabled us to rank medical specialty areas by involvement, to identify areas of higher medico-legal risk. Whereas the majority of surgical burns literature describes surgeries of the head, neck, and upper body3,4,22,23 leading to fires, we examined all surgical burns in a broader context and found slightly different results: we identified gynecology and otolaryngology as the most frequently involved specialties, and surgeries involving the pelvis and head/neck as the most frequently involved procedures. In a similar analysis, Choudhry et al21 reported general surgeons as the most frequent specialty and orthopedic surgery as the most frequent procedure. Caution is needed when interpreting these findings, however, given the relatively small sample size in both studies (n = 53 and n = 139, respectively). The level of patient harm in our study is consistent with a previous American medico-legal analysis,21 including missing data for clinical variables. Notably, information about burn coverage (body surface area) and burn severity was lacking in many cases. On the other hand, the nature of our data allowed us to report long-term patient outcomes such as psychological harm. There are previous reports of surgical burn patients experiencing posttraumatic stress disorder and anxiety3,24 and we also found evidence of this; although these cases may be underrepresented since we relied solely on documentation in the medico-legal files. We do not know the nature of psychological or physical harm experienced by surgical teams. Our analysis of burn sources showed that the majority of incidents in our study—and 100% of the surgical fire cases—involved the use of electrosurgical equipment or lasers. Energy-based surgical devices are a known cause of burns in the United States25 and electrocautery and lasers are common sources11,21,23; one previous study showed that electrocautery was involved in 90% of surgical fires.22 The Fundamental Use of Surgical Energy (FUSE) educational curriculum for surgeons, in part, aims to prevent adverse events from electrosurgery.26 Related resources are offered through the Council on Surgical and Perioperative Safety’s (previously the US FDA’s) Preventing Surgical Fires Initiative.13 Furthermore, the Emergency Care Research Institute11 and the Canadian Patient Safety Institute9 offer risk mitigation strategies for handling cautery and lasers. These strategies address the use of this equipment in proximity to vulnerable tissues, and timing of their activation. Surgical nursing societies27,28 offer guidance as well; namely, on the safe storage and visual inspection of equipment, and on institutional policies for surgical energy devices. Many of the same resources address the control of oxidizers. The American Society of Anesthesiologists Task Force on Operating Room Fires algorithm for fire prevention includes recognizing, communicating, and minimizing an oxidizer-enriched atmosphere (oxygen or nitrous oxide) in proximity to an ignition source.29 Specific guidelines address oxidizers during surgeries of the head, face, neck or upper chest. Within these guidelines, surgical teams are advised to minimize the use of open oxygen delivery and maintain supplemental oxygen at concentrations <30% when safe to do so.9,11,13 Peer expert opinions in our study support the relevance of these recommendations in Canada. It is noteworthy that surgical burns in our study were less often attributed to fire (30.2%) or chemicals (9.4%) than to nonfire thermal burns (49.1%). In a comparable analysis, Choudhry et al21 reported 18% of burn claims related to fire, 8% to chemicals, and 74% to other sources. Guidelines for preventing thermal burns, available in Canada through the Canadian Patient Safety Institute9 and nursing societies,28 address thermal sources of burns in our study; namely, casting injuries, electrosurgical equipment, grounding pads, and heat packs. They also address the safe use of skin preparation solutions and disinfectants.28 Our systematic approach to analyzing the nontechnical and system factors contributing to burns, to our knowledge, is unique for this topic. Our results supported three areas for possible intervention, the first being surgical team communication. While peer experts documented poor team communication in only three of the medico-legal cases in our study, we noted missed opportunities for effective team communication in other cases as well. The intraoperative nontechnical performance of a surgical team, which includes team communication, has been tied directly to a team’s technical performance30 which, in turn, may lead to patient safety events. Hence, team communication is a major emphasis in educational resources for surgical fire and burn prevention9,11,27,29 and communication strategies are proposed in the literature, including using a Fire Risk Assessment in the surgical time-out31,32 and fostering surgical cultures of safety.33 Structured intraoperative communication is encouraged between anesthesia professionals administering gases, surgeons controlling an ignition source, and nurses applying antiseptic agents and drapes.11 Other areas for improvement relate to lost situational awareness and inadequate institutional policies and procedures. Institution-based educational programs, such as the Royal College of Physicians and Surgeons of Canada’s situational awareness curriculum,34 may help to address these issues by heightening knowledge and awareness among surgical teams. In 2003, the Joint Commission advised health care organizations to inform staff members specifically about the risks of surgical fires35 and since that time, educational interventions—ranging from educational videos,36 reading materials, and testing26,37 to simulation-based training7,38,39—were developed. Knowledge gained from these initiatives could be complemented with institutional policies aimed at surgical burn risk reduction. For instance, the surgical safety checklist could be adapted locally to incorporate risk factors for burns. There were also some important limitations in our study. For one, we did not capture all surgical burns in Canada but rather, only those that resulted in medico-legal matters reported voluntarily to our organization by physicians. Our results, therefore, may overrepresent certain types of patients or surgical specialties. Second, given this was an aggregate analysis of medico-legal documentation, we often lacked clinical specificity. Missing information may have biased our results, particularly those relating to burn characteristics and patient harm and, furthermore, we could not confirm the involvement of burn specialists in diagnosing the burns. A further limitation may be an underrepresentation of system-related factors contributing to the events since our coding system, at the time, captured only a limited number of system factors. Additionally, given the retrospective nature of our study, we could not prove causation. Finally as in any medico-legal analyses, our contributing factors analysis was prone to recall bias,40 hindsight bias, and outcome bias.41 CONCLUSIONS These results provide evidence that surgical burns are continuing to occur in Canada and causing significant physical and psychological harm to patients. Our analysis supports the relevance of recommendations that already exist in Canada for surgical burn prevention. It also identifies the need for improved surgical safety interventions in hospitals and clinics across a variety of medical specialty areas. Our results support interventions that include effectively implemented safety protocols as well as strategies for effective communication between anesthesiologists, nurses, and surgeons. They also support interventions that raise awareness and knowledge about surgical burn prevention, recognition, and management. If frontline health care providers work together with hospital administrators and quality improvement professionals to implement these interventions, the safety of Canadian surgical patients could be enhanced. Furthermore, the impact of interventions will not be clear without systematic reporting of surgical burns to fully understand the magnitude and severity of the problem. ACKNOWLEDGEMENTS The authors wish to thank the Data Capture team in the Department of Medical Care Analytics at the CMPA for medico-legal coding related to this study. The authors also thank Angela Houle for statistical support, and Erica Wright for assisting with the literature review. The results of this study, in part, were published previously by the CMPA in the December, 2017 issue of Perspective magazine. Parts of this material are based on data and information provided by the Canadian Institute for Health Information. However, the analyses, conclusions, opinions, and statements expressed herein are those of the authors and not those of the Canadian Institute for Health Information. REFERENCES 1. Canadian Patient Safety Institute. Never events for hospital care in Canada: safer care for patients . Ottawa, ON : Canadian Patient Safety Institute ; 2015 . WorldCat COPAC 2. The Joint Commission . Comprehensive Accreditation Manual for Hospitals Web site. 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TI - Surgical Fires and Burns: A 5-Year Analysis of Medico-legal Cases
JF - Journal of Burn Care & Research
DO - 10.1093/jbcr/irz108
DA - 2019-10-16
UR - https://www.deepdyve.com/lp/oxford-university-press/surgical-fires-and-burns-a-5-year-analysis-of-medico-legal-cases-u3rpaK2cPp
SP - 886
VL - 40
IS - 6
DP - DeepDyve
ER -