Adverse Events in Robotic Surgery: A Retrospective Study of 14 Years of FDA Data

Understanding the causes and patient impacts of surgical adverse events will help improve systems and operational practices to avoid incidents in the future. We analyzed the adverse events data related to robotic systems and instruments used in minimally invasive surgery, reported to the U.S. FDA MAUDE database from January 2000 to December 2013. We determined the number of events reported per procedure and per surgical specialty, the most common types of device malfunctions and their impact on patients, and the causes for catastrophic events such as major complications, patient injuries, and deaths. During the study period, 144 deaths (1.4% of the 10,624 reports), 1,391 patient injuries (13.1%), and 8,061 device malfunctions (75.9%) were reported. The numbers of injury and death events per procedure have stayed relatively constant since 2007 (mean = 83.4, 95% CI, 74.2-92.7). Surgical specialties, for which robots are extensively used, such as gynecology and urology, had lower number of injuries, deaths, and conversions per procedure than more complex surgeries, such as cardiothoracic and head and neck (106.3 vs. 232.9, Risk Ratio = 2.2, 95% CI, 1.9-2.6). Device and instrument malfunctions, such as falling of burnt/broken pieces of instruments into the patient (14.7%), electrical arcing of instruments (10.5%), unintended operation of instruments (8.6%), system errors (5%), and video/imaging problems (2.6%), constituted a major part of the reports. Device malfunctions impacted patients in terms of injuries or procedure interruptions. In 1,104 (10.4%) of the events, the procedure was interrupted to restart the system (3.1%), to convert the procedure to non-robotic techniques (7.3%), or to reschedule it to a later time (2.5%). Adoption of advanced techniques in design and operation of robotic surgical systems may reduce these preventable incidents in the future.Comment: Presented as the J. Maxwell Chamberlain Memorial Paper for adult cardiac surgery at the 50th Annual Meeting of the Society of Thoracic Surgeons in January. See Appendix for more detailed results, discussions, and related work. Updated the header

Analysis of Safety-Critical Computer Failures in Medical Devices

Incidents due to malfunctioning medical devices are a major cause of serious injury and death in the United States. During 2006–2011, 5,294 recalls and around 1.2 million adverse events were reported to the U.S. Food and Drug Administration (FDA). Almost 23% of these recalls were due to computer-related failures, of which around 94% presented medium-to-high risk of severe health consequences (such as serious injury or death) to patients. This paper investigates the causes of failures in computer-based medical devices and their impact on patients, by analyzing human-written descriptions of recalls and adverse event reports, obtained from public FDA databases. We characterize computer-related failures by deriving fault classes, failure modes, recovery actions, and number of devices affected by the recalls. This analysis is used as a basis for identifying safety issues in life-critical medical devices and providing insights on the future challenges in the design of safety-critical medical devices.Princeton/MARCO / 2009-DT-2049Stanford/DTRA / 27451040-49741-AOpe

Safety Implications of Robotic Surgery: A Study of 13 Years of FDA Data on da Vinci Surgical Systems

Robotic surgical systems are intended to enable surgeons to perform minimally invasive operations with increased vision, precision, dexterity, and control, and to reduce the rate of injuries, blood loss, length of hospital stay, and post-operative complications. Recently, concerns regarding the safety and effectiveness of robot-assisted surgeries have heightened as an increased number of adverse events associated with the surgical robots have been reported to the U.S. Food and Drug Administration (FDA). Our study focuses on the analysis of the adverse events and recalls of da Vinci surgical systems, collected by the FDA over a period of 13 years from 2000 to 2012. We use the data on deaths, injuries, and robot malfunctions, combined with the technical problems and corresponding recovery actions taken by the company (provided by the recalls), together with systematic accident analysis using a tool called CAST. Using an automated natural language parsing tool trained with domain-specific dictionaries and part-of-speech and negation taggers, we extracted valuable information on the potential causes of robotic accidents in order to understand the effectiveness of using robotic devices for different minimally invasive procedures. We found that despite the increasing number of procedures being done with the da Vinci surgical system, a significant number of malfunctions and system downtimes with potentially adverse impacts on patients are being experienced. We provide insights on the use of existing state-of-the-art technologies for enhancing safety in future robotic surgical systems.National Science Foundation (NSF CNS10-18503 CISE); IBM Corporation; Infosys LtdOpe

Erythropoietic protoporphyria without skin symptoms-you do not always see what they feel

Erythropoietic protoporphyria (EPP) is an inherited disorder of the porphyrin metabolism that often remains undiagnosed in children. We report on a 4-year-old girl who had been suffering for 1 year from recurrent painful crises affecting her hands, feet, and nose following sun exposure. Objective skin lesions were absent until the age of 6. Porphyrin analysis revealed elevated free erythrocyte protoporphyrin (FEP) levels confirming the diagnosis of EPP. This illustrates that skin lesions might be completely absent in children affected with EPP, a fact that has only been reported once previously. Because EPP can manifest with few and unspecific cutaneous symptoms or no skin lesions at all, like in this patient, the diagnosis of EPP might be delayed or missed. EPP should be excluded in all photosensitive children, especially when discomfort is disproportionate to the extent of the cutaneous lesions. The clinic, pathophysiology, diagnosis, complications, and therapy of EPP are discussed

Rotating biological contactors : a review on main factors affecting performance

Rotating biological contactors (RBCs) constitute a very unique and superior alternative for biodegradable matter and nitrogen removal on account of their feasibility, simplicity of design and operation, short start-up, low land area requirement, low energy consumption, low operating and maintenance cost and treatment efficiency. The present review of RBCs focus on parameters that affect performance like rotational speed, organic and hydraulic loading rates, retention time, biofilm support media, staging, temperature, influent wastewater characteristics, biofilm characteristics, dissolved oxygen levels, effluent and solids recirculation, stepfeeding and medium submergence. Some RBCs scale-up and design considerations, operational problems and comparison with other wastewater treatment systems are also reported.Fundação para a Ciência e a Tecnologia (FCT

Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020 : the right to sight : an analysis for the Global Burden of Disease Study

Background: Many causes of vision impairment can be prevented or treated. With an ageing global population, the demands for eye health services are increasing. We estimated the prevalence and relative contribution of avoidable causes of blindness and vision impairment globally from 1990 to 2020. We aimed to compare the results with the World Health Assembly Global Action Plan (WHA GAP) target of a 25% global reduction from 2010 to 2019 in avoidable vision impairment, defined as cataract and undercorrected refractive error.Methods: We did a systematic review and meta-analysis of population-based surveys of eye disease from January, 1980, to October, 2018. We fitted hierarchical models to estimate prevalence (with 95% uncertainty intervals [UIs]) of moderate and severe vision impairment (MSVI; presenting visual acuity from <6/18 to 3/60) and blindness (<3/60 or less than 10° visual field around central fixation) by cause, age, region, and year. Because of data sparsity at younger ages, our analysis focused on adults aged 50 years and older.Findings: Global crude prevalence of avoidable vision impairment and blindness in adults aged 50 years and older did not change between 2010 and 2019 (percentage change −0·2% [95% UI −1·5 to 1·0]; 2019 prevalence 9·58 cases per 1000 people [95% IU 8·51 to 10·8], 2010 prevalence 96·0 cases per 1000 people [86·0 to 107·0]). Age-standardised prevalence of avoidable blindness decreased by −15·4% [–16·8 to −14·3], while avoidable MSVI showed no change (0·5% [–0·8 to 1·6]). However, the number of cases increased for both avoidable blindness (10·8% [8·9 to 12·4]) and MSVI (31·5% [30·0 to 33·1]). The leading global causes of blindness in those aged 50 years and older in 2020 were cataract (15·2 million cases [9% IU 12·7–18·0]), followed by glaucoma (3·6 million cases [2·8–4·4]), undercorrected refractive error (2·3 million cases [1·8–2·8]), age-related macular degeneration (1·8 million cases [1·3–2·4]), and diabetic retinopathy (0·86 million cases [0·59–1·23]). Leading causes of MSVI were undercorrected refractive error (86·1 million cases [74·2–101·0]) and cataract (78·8 million cases [67·2–91·4]).Interpretation: Results suggest eye care services contributed to the observed reduction of age-standardised rates of avoidable blindness but not of MSVI, and that the target in an ageing global population was not reached

Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study

Background Many causes of vision impairment can be prevented or treated. With an ageing global population, the demands for eye health services are increasing. We estimated the prevalence and relative contribution of avoidable causes of blindness and vision impairment globally from 1990 to 2020. We aimed to compare the results with the World Health Assembly Global Action Plan (WHA GAP) target of a 25% global reduction from 2010 to 2019 in avoidable vision impairment, defined as cataract and undercorrected refractive error. Methods We did a systematic review and meta-analysis of population-based surveys of eye disease from January, 1980, to October, 2018. We fitted hierarchical models to estimate prevalence (with 95% uncertainty intervals [UIs]) of moderate and severe vision impairment (MSVI; presenting visual acuity from <6/18 to 3/60) and blindness (<3/60 or less than 10° visual field around central fixation) by cause, age, region, and year. Because of data sparsity at younger ages, our analysis focused on adults aged 50 years and older. Findings Global crude prevalence of avoidable vision impairment and blindness in adults aged 50 years and older did not change between 2010 and 2019 (percentage change −0·2% [95% UI −1·5 to 1·0]; 2019 prevalence 9·58 cases per 1000 people [95% IU 8·51 to 10·8], 2010 prevalence 96·0 cases per 1000 people [86·0 to 107·0]). Age-standardised prevalence of avoidable blindness decreased by −15·4% [–16·8 to −14·3], while avoidable MSVI showed no change (0·5% [–0·8 to 1·6]). However, the number of cases increased for both avoidable blindness (10·8% [8·9 to 12·4]) and MSVI (31·5% [30·0 to 33·1]). The leading global causes of blindness in those aged 50 years and older in 2020 were cataract (15·2 million cases [9% IU 12·7–18·0]), followed by glaucoma (3·6 million cases [2·8–4·4]), undercorrected refractive error (2·3 million cases [1·8–2·8]), age-related macular degeneration (1·8 million cases [1·3–2·4]), and diabetic retinopathy (0·86 million cases [0·59–1·23]). Leading causes of MSVI were undercorrected refractive error (86·1 million cases [74·2–101·0]) and cataract (78·8 million cases [67·2–91·4]). Interpretation Results suggest eye care services contributed to the observed reduction of age-standardised rates of avoidable blindness but not of MSVI, and that the target in an ageing global population was not reached

Causes of blindness and vision impairment in 2020 and trends over 30 years, and prevalence of avoidable blindness in relation to VISION 2020: the Right to Sight: an analysis for the Global Burden of Disease Study

Background: Many causes of vision impairment can be prevented or treated. With an ageing global population, the demands for eye health services are increasing. We estimated the prevalence and relative contribution of avoidable causes of blindness and vision impairment globally from 1990 to 2020. We aimed to compare the results with the World Health Assembly Global Action Plan (WHA GAP) target of a 25% global reduction from 2010 to 2019 in avoidable vision impairment, defined as cataract and undercorrected refractive error. Methods: We did a systematic review and meta-analysis of population-based surveys of eye disease from January, 1980, to October, 2018. We fitted hierarchical models to estimate prevalence (with 95% uncertainty intervals [UIs]) of moderate and severe vision impairment (MSVI; presenting visual acuity from <6/18 to 3/60) and blindness (<3/60 or less than 10° visual field around central fixation) by cause, age, region, and year. Because of data sparsity at younger ages, our analysis focused on adults aged 50 years and older. Findings: Global crude prevalence of avoidable vision impairment and blindness in adults aged 50 years and older did not change between 2010 and 2019 (percentage change −0·2% [95% UI −1·5 to 1·0]; 2019 prevalence 9·58 cases per 1000 people [95% IU 8·51 to 10·8], 2010 prevalence 96·0 cases per 1000 people [86·0 to 107·0]). Age-standardised prevalence of avoidable blindness decreased by −15·4% [–16·8 to −14·3], while avoidable MSVI showed no change (0·5% [–0·8 to 1·6]). However, the number of cases increased for both avoidable blindness (10·8% [8·9 to 12·4]) and MSVI (31·5% [30·0 to 33·1]). The leading global causes of blindness in those aged 50 years and older in 2020 were cataract (15·2 million cases [9% IU 12·7–18·0]), followed by glaucoma (3·6 million cases [2·8–4·4]), undercorrected refractive error (2·3 million cases [1·8–2·8]), age-related macular degeneration (1·8 million cases [1·3–2·4]), and diabetic retinopathy (0·86 million cases [0·59–1·23]). Leading causes of MSVI were undercorrected refractive error (86·1 million cases [74·2–101·0]) and cataract (78·8 million cases [67·2–91·4]). Interpretation: Results suggest eye care services contributed to the observed reduction of age-standardised rates of avoidable blindness but not of MSVI, and that the target in an ageing global population was not reached. Funding: Brien Holden Vision Institute, Fondation Théa, The Fred Hollows Foundation, Bill & Melinda Gates Foundation, Lions Clubs International Foundation, Sightsavers International, and University of Heidelberg