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.

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.

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.

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.

Variables in successful repair of urethrocutaneous fistula after hypospadias surgery.

PURPOSE: We evaluate variables affecting the success of repairs of urethrocutaneous fistula after hypospadias surgery. MATERIALS AND METHODS: The records of 123 boys who underwent fistula repair at Primary Children's Medical Center were reviewed. Of these patients 100 underwent initial fistula repair at our center (surgery was performed at our center in 82 and elsewhere in 18) and 23 were referred from elsewhere after unsuccessful fistula repairs. Patient age was 6 months to 34 years (median 3.21 years) and interval between surgeries was 3.7 months to 12 years (median 12.6 months). Several variables potentially affecting the success of fistula closure were retrospectively assessed. RESULTS: Including those patients referred from outside hospitals, fistulas were successfully closed in 71%, 72%, 77%, 100% and 100% of these patients after fistula repairs 1 to 5, respectively. Variables studied yielded stent 67.7% (36 of 54 cases) versus no stent 76.1% (35 of 46) and operating microscope 70.4% (59 of 71) versus loupes 72.4% (21 of 29) in terms of success. Success based on patient age yielded 65.5% for younger than 2 years (n = 29 patients), 71.7% for 2 to 5 (46), 64.7% for 6 to 12 (17) and 87.5% for older than 12 (8). When considering the type of original hypospadias repair and its affect on fistula closure success, a significantly lower success was noted with Yoke and King procedures (p = 0.007 and 0.037, respectively). In patients who underwent hypospadias surgery and all subsequent fistula closure attempts at our center, fistulas were successfully repaired in 72%, 67% and 100% of patients after attempts 1 to 3, respectively. Initial fistula repair was successful in 72% (59 of 82) of patients who underwent original hypospadias surgery at our center and in 67% (12 of 18) of those referred after hypospadias surgery at an outside hospital. CONCLUSIONS: Regarding urethrocutaneous fistula closure, the data from this study suggest that there is no clear difference in stent versus no stent and microscope versus loupes, age at fistula closure does not affect success, type of original hypospadias procedure may influence success (King and Yoke procedures were least successful), success rate is not negatively impacted in recurrent fistula cases, given a diverse group of fistulas, success of fistula repair for attempts 1 to 5 was 71%, 72%, 77%, 100% and 100%, respectively, and success rate in a tertiary pediatric urology setting is not influenced by whether the original hypospadias procedure or initial fistula closure was performed in the pediatric urology setting versus outside hospital.