Lifecycle of surgical devices: Global, environmental, and regulatory considerations.

BACKGROUND: Technological advancements, improved surgical access, and heightened demand for surgery have fueled unprecedented device and supply turnover impelling wealthy hospitals to upgrade continually and sell, donate, recycle, or dispose of used, expired, antiquated, or surplus goods. This paper reviews the issues related to device and supply lifecycles and discusses the opportunities and challenges they present for sustainable surgical growth in low- and middle-income (LMICs) countries. OBSERVATIONS: This review found, in LMICs countries, regulatory disparities persist that limit effective harmonization secondary to highly variable national policies and a lack of prioritized enforcement. Heterogeneity in the regulatory landscape, specifically in the classification, nomenclature, and identification of medical devices, encumbers effective regulation and distribution. Once devices are sold, donated, or reused in LMICs countries, complexities arise in regulatory compliance, maintenance, and appropriate use of these technologies. At the end of the lifecycle, waste management poses significant obstacles with limited resources hindering the implementation of best practices. CONCLUSION: There are major disparities in access to quality surgical equipment and supplies around the world. Improved communication between relevant stakeholders and harmonization of manufacture and disposal regulations will be needed to ensure adequate and appropriate responses to these challenges. TRIAL REGISTRATION NUMBER: Not applicable.

A global view of pediatric urology.

Over the course of approximately 60 years, the field of pediatric urology has evolved as a convergence of pediatric surgery, urology, and plastic surgery to address congenital anomalies of the urinary tract and genitalia in children. Guidelines for training and certification are narrowing in high-income countries (HICs) at the same time as the fertility rate is declining and the prevalence of complex genitourinary (GU) conditions is decreasing. In low-and middle-income countries (LMICs), health systems for large populations are currently in a state of stress. Here we briefly review the history of pediatric urology as a surgical subspecialty, identify unmet needs especially in LMICs and place the field in the context of a global surgical ecosystem. METHODS: The English language literature on workforce trends in pediatric urology, pediatric surgery and urology was reviewed as well as development of the emerging field of global surgery. Global surgery looks at the social, economic and political context of health systems as well as unmet clinical need. World trends in fertility rates were reviewed to identify regions of workforce surplus and gaps, supply chain needs, infrastructure and systems strengths and weaknesses. RESULTS: The proliferation of training programs in pediatric surgery and specialties in high-income countries (HICs) coupled with declining birth rates has led to a saturation of specialists and declining surgical case load. In LMICs, while the birth rate has also been declining, surgical specialization has not progressed. In the lowest income countries, especially in sub-Saharan Africa, training in pediatric surgical specialties and urology is rare. The broad workforce that supports surgical care, such as anesthesia, intensivist pediatrics, radiology, laboratory, and nursing face similar challenges. Supply chains for specialized pediatric urological surgery are weak. CONCLUSION: There is an evolving maldistribution of pediatric surgical and pediatric urological workforce globally, with too few practitioners in LMICs and too many in HICs. The high cost of specialized equipment limits access to quality care, and the supply chain for consumables and medication is patchy. In LIC's, basic community-based infrastructure for health including reliable electricity is lacking. Recent experience with Covid and environmental disasters has highlighted that even in HICs surgical resilience can be challenged. This is an opportunity to consider the state of children's urological care globally and to build resilience by identifying and addressing strengths and gaps.

Development of a Unifying Target and Consensus Indicators for Global Surgical Systems Strengthening: Proposed by the Global Alliance for Surgery, Obstetric, Trauma, and Anaesthesia Care (The G4 Alliance).

After decades on the margins of primary health care, surgical and anaesthesia care is gaining increasing priority within the global development arena. The 2015 publications of the Disease Control Priorities third edition on Essential Surgery and the Lancet Commission on Global Surgery created a compelling evidenced-based argument for the fundamental role of surgery and anaesthesia within cost-effective health systems strengthening global strategy. The launch of the Global Alliance for Surgical, Obstetric, Trauma, and Anaesthesia Care in 2015 has further coordinated efforts to build priority for surgical care and anaesthesia. These combined efforts culminated in the approval of a World Health Assembly resolution recognizing the role of surgical care and anaesthesia as part of universal health coverage. Momentum gained from these milestones highlights the need to identify consensus goals, targets and indicators to guide policy implementation and track progress at the national level. Through an open consultative process that incorporated input from stakeholders from around the globe, a global target calling for safe surgical and anaesthesia care for 80% of the world by 2030 was proposed. In order to achieve this target, we also propose 15 consensus indicators that build on existing surgical systems metrics and expand the ability to prioritize surgical systems strengthening around the world.

Perspectives on International Urological Volunteerism: A Survey of IVUmed Resident Scholar Alumni.

INTRODUCTION: The primary intentions of international surgical programs are to directly benefit those receiving medical care, educate local physicians and staff, and improve care delivery models. IVUmed, a nonprofit organization dedicated to providing urological care to resource poor areas of the world, provides scholarship opportunities for urology trainees. We assessed the motivations and barriers of IVUmed traveling resident scholars regarding continuing international surgical work after completion of the program. METHODS: An Internet based survey was sent to all previous IVUmed resident scholars assessing potential factors associated with repeat international service. Logistic regression was used to examine the association between survey responses and the likelihood of repeating an international service trip after completion of training. RESULTS: Of 196 IVUmed resident scholar participants 100 (51%) responded to the survey. Of the 69 attending surgeons 17 (25%) had repeated an international service trip. Altruism (100%), personal fulfillment (99%) and practicing in a resource limited setting (94%) were the most frequently cited motivating factors for repeat participation, while lack of time (96%) was the most commonly reported barrier. Respondents in private practice were less likely to participate in a subsequent trip compared to those in an academic setting (OR 0.16, CI 0.03-0.80, p = 0.03). No other factors were associated with the likelihood of repeating an international service trip. CONCLUSIONS: Among urologists who participated in a funded international scholarship program during residency repeat participation during the subsequent 7 years was modest. Private practitioners were less likely to repeat international service compared to academic urologists.

Global Surgical Ecosystems: A Need for Systems Strengthening.

BACKGROUND: As surgery is gaining recognition as a critical component of universal health care worldwide, surgical communities have come together with unprecedented unity to advocate for systems to support surgical care. This community has long believed that much care could be performed in a cost-effective manner even in low resource settings, despite skepticism voiced by many in public health. To do so will require the development of new systems and re-vamping of old systems that are not effective. In the last five years, coalitions, expert panels, commissions, consortia and alliances have emerged to address these issues and there has been landmark success in advocacy with a new resolution at the 2015 World Health Assembly to include surgical care as a component of universal health coverage. It is critical to understand the ecosystem that constitutes the surgical environment. A surgical ecosystem could be described as a network of people, processes, and materials necessary for surgical services in the context of the facilities and environment in which it functions. METHODS: We describe components of a functioning surgical ecosystem in terms of administration, support staff and clinicians, and the necessary sub-systems for providing consumable materials such as anesthetic medication and suture and sterile instruments. Related systems that must be integrated are facilities and utilities such as electricity, lighting, plumbing and waste management and even laundry. But especially in low and middle income countries (LMICs) lack of any one of these may be rate-limiting. The World Health Organization (WHO) has developed situational analyses and checklists for first level district hospitals to identify missing elements. CONCLUSIONS: A siloed approach cannot solve a systems problem. However, to scale up rapidly and to develop and sustain quality standards, a holistic "ecosystem" approach, including local and global professional societies and advocacy organizations will need to become engaged.

Building operative care capacity in a resource limited setting: The Mongolian model of the expansion of sustainable laparoscopic cholecystectomy.

BACKGROUND: The benefits of laparoscopic cholecystectomy, including rapid recovery and fewer infections, have been largely unavailable to the majority of people in developing countries. Compared to other countries, Mongolia has an extremely high incidence of gallbladder disease. In 2005, only 2% of cholecystectomies were performed laparoscopically. This is a retrospective review of the transition from open to laparoscopic cholecystectomy throughout Mongolia. METHODS: A cross-sectional, retrospective review was conducted of demographic patient data, diagnosis type, and operation performed (laparoscopic versus open cholecystectomy) from 2005-2013. Trends were analyzed from 6 of the 21 provinces (aimags) throughout Mongolia, and data were culled from 7 regional diagnostic referral and treatment centers and 2 tertiary academic medical centers. The data were analyzed by individual training center and by year before being compared between rural and urban centers. RESULTS: We analyzed and compared 14,522 cholecystectomies (n = 4,086 [28%] men, n = 10,436 [72%] women). Men and women were similar in age (men 52.2, standard deviation 14.8; women 49.4, standard deviation 15.7) and in the percentage undergoing laparoscopic cholecystectomy (men 39%, women 42%). By 2013, 58% of gallbladders were removed laparoscopically countrywide compared with only 2% in 2005. In 2011, laparoscopic cholecystectomy surpassed open cholecystectomy as the primary method for gallbladder removal countrywide. More than 315 Mongolian health care practitioners received laparoscopic training in 19 of the country's 21 aimags (states). CONCLUSION: By 2013, 58% of cholecystectomies countrywide were performed laparoscopically, a dramatic increase over 9 years. The expansion of laparoscopic cholecystectomy has transformed the care of biliary tract disease in Mongolia despite the country's limited resources.

Expansion of laparoscopic cholecystectomy in a resource limited setting, Mongolia: a 9-year cross-sectional retrospective review.

BACKGROUND: The benefits of laparoscopic cholecystectomy have been largely unavailable to most people in developing countries. Mongolia has an extremely high incidence of gallbladder disease. In 2005, only 2% of cholecystectomies were being done laparoscopically. Open cholecystectomies were associated with high rates of wound infections, complications, and increased recovery time. Because of the unacceptable complications associated with open cholecystectomies, and nearly 50% of the nomadic population needing faster post-operative recovery times, a national project for the development of laparoscopic surgery was organised. Multi-institutional collaboration between the Mongolia Health Sciences University, the Dr W C Swanson Family Foundation (SFF), the University of Utah, Intermountain Healthcare, and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) led to the promulgation of a formalised countrywide laparoscopic training programme during the past 9 years. This is a retrospective review of the transition from open to laparoscopic cholecystectomy throughout Mongolia. METHODS: Demographic patient data, diagnosis, and operation preformed-laparoscopic versus open cholecystectomy, between January, 2005, and September, 2013, were collected and trends were analysed from seven regional diagnostic referral and treatment centres, and two tertiary academic medical centres from six of the 21 provinces (Aimags) throughout Mongolia. Data were analysed by individual training centre, by year, and then compared between rural and urban centres. FINDINGS: Nearly 16 000 cholecystectomies were analysed and compared (4417 [28·2%] men; 11 244 [71·8%] women). Men and women underwent laparoscopic cholecystectomy with the same frequency (41·2% men, 43·2% women) and had similar age (men, mean 52·2 years [SD 14·8]; women, mean 49·4 years [SD 15·7]). By 2013, 62% of gallbladders were removed laparoscopically countrywide as opposed to only 2% in 2005. More than 315 Mongolian practitioners have received laparoscopic training in 19 of 21 Aimags. On average 60% of cholecystectomies are done laparoscopically in urban surgical centres, up from 2%, versus 55% in rural surgical centres, up from 0%, in 2005. Laparoscopic cholecystectomy surpassed open cholecystectomy as the primary method for gallbladder removal countrywide in 2011. INTERPRETATION: By 2013, 62% of cholecystectomies countrywide were done laparoscopically, a great increase from 9 years ago. Despite being a resource limited country, the expansion of laparoscopic cholecystectomy has transformed the care of biliary tract disease in Mongolia. FUNDING: The University of Utah Center for Global Surgery.

IVUmed: a nonprofit model for surgical training in low-resource countries.

BACKGROUND: Low- and middle-income countries (LMICs) face both training and infrastructural challenges for surgical care, particularly for specialty care, such as for urology. Practitioners charged with caring for these patients have few options for basic or advanced training. OBJECTIVES: IVUmed, a nonprofit organization, has for 20 years supported urological educational programs in 30 LMICs by coordinating a network of US and international academic and private providers, institutions, industry partners, and professional societies. METHODS: IVUmed's motto, "Teach One, Reach Many" has emphasized a teach-the-teacher approach. Program partners, such as Hopital General de Grand Yoff in Dakar, Senegal, have advanced from little urological subspecialty availability to having the capacity to treat a wide range of conditions while also teaching surgeons from Senegal and neighboring countries. CONCLUSIONS: Long-term program commitments; effective communication; and a shared vision among the program site, the coordinating nongovernmental organization, and supporting organizations facilitate the development of thriving surgical teaching programs capable of serving local communities and conducting outreach training.

Epididymitis: a 21-year retrospective review of presentations to an outpatient urology clinic.

PURPOSE: We describe patient characteristics and age distribution of epididymitis in an outpatient pediatric urology referral practice during a 21-year period. MATERIALS AND METHODS: We retrospectively reviewed all pediatric patients diagnosed with epididymitis or epididymo-orchitis (ICD9 604.9) either clinically or with the aid of scrotal ultrasound at Primary Children's Medical Center from 1992 through 2012. Charts were reviewed to record demographic and clinical features, as well as radiological and laboratory data. Multiple acute episodes occurring in individual patients were recorded. RESULTS: A total of 252 patients were identified. Mean ± SD age at first presentation was 10.92 ± 4.08 years. The majority of cases occurred during the pubertal period (11 to 14 years) and few patients younger than 2 years were diagnosed with epididymitis (4%). A total of 69 boys (27.4%) experienced a second episode of epididymitis. Scrotal ultrasound results were consistent with epididymitis in 87.3% of cases (144 of 165). Urine culture results were available in 38 patients and were positive in 7 (21%). Positive urine culture was associated with an anatomical abnormality on followup voiding cystourethrogram (RR 5.7, 95% CI 1.37-23.4). Physical activity was noted as a likely precipitating factor in 23 patients and a recent urinary tract infection was identified in 20. CONCLUSIONS: The majority of cases of epididymitis occur around the time of puberty in early adolescence, with relatively few cases occurring during infancy. Recurrent episodes of epididymitis are more common than previously reported and may affect as many as a fourth of all boys with acute epididymitis.

Surgical outcomes and cultural perceptions in international hypospadias care.

PURPOSE: This study was designed to assess perceptions of untreated hypospadias and quality of life in culturally disparate low or middle income countries, to highlight the demographic and care differences of patient groups treated for hypospadias in the surgical workshop context, and to evaluate the long-term outcomes achieved by these workshop groups. MATERIALS AND METHODS: Family member perceptions of hypospadias, perioperative process measures and urethrocutaneous fistula rates were compared between 60 patients from Vietnam and Senegal treated for hypospadias through training workshops by local surgeons and pediatric urologists from the U.S. between 2009 and 2012, of whom approximately 42% had previously undergone repair attempts. RESULTS: More than 90% of respondents surveyed believed that untreated hypospadias would affect the future of their child at least to some degree. Patient cohorts between the 2 sites differed from each other and published high income country cohorts regarding age, weight for age and frequency of reoperation. Telephone based outcomes assessment achieved an 80% response rate. Urethrocutaneous fistula was reported in 39% and 47% of patients in Vietnam and Senegal, respectively. CONCLUSIONS: Family members perceived that the social consequences of untreated hypospadias would be severe. Relative to patient cohorts reported in practices of high income countries, our patients were older, presented with more severe defects, required more reoperations and were often undernourished. Urethrocutaneous fistula rates were higher in cohorts from low or middle income countries relative to published rates for cohorts from high income countries. Our study suggests that outcomes measurement is a feasible and essential component of ethical international health care delivery and improvement.

Parameatal urethral cysts in prepubertal males.

PURPOSE: Parameatal urethral cyst in boys is an uncommon and often poorly understood condition. We describe the largest known series of 18 prepubertal boys with parameatal cysts. MATERIALS AND METHODS: We retrospectively reviewed the charts of all pediatric patients at our institution diagnosed with a penile cyst according to our office database between 1992 and 2010. Charts were reviewed to determine patient demographics, symptomatology, pathology, cyst characteristics and treatment. RESULTS: We identified 18 patients during the last 18 years who were diagnosed with a parameatal cyst. Most patients (66%) were asymptomatic. All cysts were less than 1 cm in diameter. Of the patients 50% were circumcised before presentation and 78% underwent surgical excision. There have been no recurrences in patients who underwent excision. One patient had spontaneous resolution of the cyst during the first few weeks of life. Pathology results were available for 6 patients. Three specimens contained a single type of epithelium and 3 contained a combination of transitional, cuboidal and/or columnar epithelia. The transitional and cuboidal epithelia were the most common components. There was no evidence of malignancy in any of the specimens and only 1 specimen contained an inflammatory infiltrate. CONCLUSIONS: Parameatal cysts are a benign, usually asymptomatic condition that may contain a variety of epithelial types. The cysts may resolve spontaneously in neonates but are also easily excised with minimal risk of recurrence.

250 consecutive unilateral extravesical ureteral reimplantations in an outpatient setting.

PURPOSE: Unilateral extravesical ureteral reimplantation is comparable to intravesical procedures and more effective than subureteral injection to resolve vesicoureteral reflux. Initial reports showed that the procedure could be feasibly done on an outpatient basis. We present further data on a large series of consecutive, planned, outpatient unilateral extravesical ureteral reimplantations. MATERIALS AND METHODS: A total of 250 consecutive patients underwent scheduled outpatient unilateral extravesical ureteral reimplantation. We retrospectively reviewed their records. Patient data were collected on reflux laterality and grade, operative time, hospital stay, complications, need for rehospitalization and resolution rate on radiography 1 month postoperatively. RESULTS: A total of 209 females (84%) and 41 males (16%) underwent planned outpatient extravesical ureteral reimplantation, including on the left side in 158 (63%) and on the right side in 92 (37%). Mean reflux grade was 3.2 with grades II to V in 64 (26%), 96 (38%), 74 (30%) and 16 cases (7%), respectively. Average operative time was 63 minutes and average length of stay, defined as time from initial admission in to discharge home, was 6.2 hours (range 3 to 10 hours). Short-term and late complications occurred in 9 (3.6%) and 8 patients (3.2%), respectively. CONCLUSIONS: Extravesical ureteral reimplantation for unilateral vesicoureteral reflux may be consistently done on an outpatient basis with a reasonable complication rate and a low postoperative hospital admission rate.

Is there a learning curve for subureteric injection of dextranomer/hyaluronic acid in the treatment of vesicoureteral reflux?

OBJECTIVE: To answer the question: 'Is there a learning curve associated with a subureteric injection of Deflux(®)?' MATERIALS AND METHODS: We retrospectively reviewed charts of patients who received subureteric injection of dextranomer/hyaluronic acid (Deflux(®){AQ2}) (225 procedures) for treatment of vesicoureteral reflux (VUR) by four surgeons. The study included 55 patients, 82 ureters, who had postoperative follow-up with a voiding cystogram or nuclear medicine cystogram. Exclusion criteria were prior anti-refluxing procedures, duplicated collecting systems, and non-achievement of a negative intraoperative cystogram. Patients were divided into two groups based on whether or not they received an intraoperative cystogram after the injection. The two groups were compared for VUR resolution rates on follow-up imaging. RESULTS: Twenty patients underwent an intraoperative cystogram (Group 1, 33 ureters) and 35 did not (Group 2, 49 ureters). The two groups were similar in age, preoperative reflux grade, amount of Deflux injected into each ureter, and time to postoperative studies. In Group 1, 11 ureters (33.3%) and also, in Group 2, 11 ureters (22.4%) had reflux on follow-up imaging. CONCLUSIONS: There was no improvement in VUR resolution rate following subureteric injection of Deflux(®) when an intraoperative cystogram demonstrated no reflux to be present immediately after injection. Of ureters that did not reflux on intraoperative cystograms, one-third displayed return of reflux on follow-up imaging, which suggests no learning curve and that failures are not likely to be caused by poor surgical technique.