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.

Quantifying Efficacy of Video Interventions about Adverse Events in Medical Student Education.

OBJECTIVES: The coronavirus disease 2019 pandemic catalyzed a rapid shift toward remote learning in medicine. This study hypothesized that using videos on adverse events and patient safety event reporting systems could enhance education and motivation among healthcare professionals, leading to improved performance on quizzes compared with those exposed to standard, in-person lectures. METHODS: Participants were randomly assigned to a group both watching the video and attending an in-person lecture or a group that received only the in-person lecture in this study performed in 2022. Surveys gathered demographic information, tested knowledge, and identified barriers to reporting adverse events. RESULTS: A total of 83 unique participants responded to the survey out of the 130 students enrolled (64%; 83/130). Among the students completing all of the surveys, the group who watched the Osmosis video had a higher average quiz score (6.46/7) than the lecture group (6.31/7) following the first intervention. Only 25% of respondents agreed or strongly agreed that they knew what to include in a patient safety report and only 10% agreed or strongly agreed that they knew how to access the reporting system. CONCLUSIONS: This study suggests virtual preclass video learning can be a beneficial tool to complement traditional lecture-based learning in medical education. Further research is needed to determine the efficacy of long-term video interventions in adverse events.

Any Questions? Understanding the Functional Health Literacy in Patients Who Underwent Ureteroscopy.

OBJECTIVE: To correlate health literacy of patients undergoing ureteroscopy and identify gaps within current patient education practices in order to better tailor the preoperative experience. METHODS: Eighteen patients were retrospectively recruited to complete an in-depth semistructured interview and the Test of Functional Health Literacy for Adults (TOFHLA). All interviews were recorded, transcribed, and then coded and analyzed using the grounded theory of analysis. RESULTS: The average participant age was 56.2 ± 12.8years, and 10 (55.6%) identified as female. Education level ranged from some high school to a professional degree. The average TOFHLA score was 88.1 ± 11.7. Irrespective of score, all participants felt they understood the purpose and basic elements of a ureteroscopy. The use of nontechnical language, repetition, and previous healthcare experiences were identified as positive aspects of the education experience. However, 72.2% (n = 13) identified the primary gap in understanding revolved around the use, purpose, and pain associated with stents. CONCLUSION: Functional health literacy is an essential element, but not the only factor informing patient education and comprehension. Current practices are effective in explaining the basics of a ureteroscopy, but even when identified health literacy is higher than expected, a gap remains in stent education. Efforts should be made to better understand how stents can be effectively explained to patients in addition to continuing to refine education practices to elicit true comprehension.

Implementation of a Standardized Tool for Root Cause Analysis Selection.

OBJECTIVES: This study sought to determine if a standardized root cause analysis (RCA2) selection algorithm, developed by the Veterans Affairs, would select high-risk events for RCA. METHODS: Physician-entered incident reports for all surgical service admissions and perioperative visits were queried over 12 months in the DATIX Clinical Incident Management System. Independent reviewers assigned potential harm and event frequency scores using an institutional scoring system and then calculated and rounded average scores. These were classified using RCA2 terminology (catastrophic, major, moderate, minor for harm; frequent, occasional, uncommon, remote for frequency). The scores were then evaluated with the standardized Safety Assessment Code Matrix (SAC) algorithm from the National Patient Safety Foundation's RCA2 guidelines to determine Potential Harm Scores. The SAC combines severity and probability to determine the necessity of conducting an RCA. Catastrophic and major high-frequency events (matrix score = 3) were classified as "RCA recommended." The study then compared cases selected for RCAs using the updated RCA2 algorithm against cases selected using a current, institutional-specific RCA selection process. RESULTS: One hundred four cases were reviewed, comprising 20 catastrophic, 48 major harm, 26 moderate harm, and 10 minor harm events. After removing 9 high-variance cases, our institution's current selection process selected 18 cases for RCAs, including 6/20 catastrophic, 8/39 major harm, and 4/36 moderate/minor harm events. Only 17.3% of cases had an RCA completed, while the standardized RCA2 algorithm recommended investigation for 56.7% of patient safety events, based on SAC Matrix scoring. Current RCA selection processes rendered 4 RCAs on low potential harm or low-frequency events, while 45 potential high-frequency, high potential harm events did not complete RCAs. CONCLUSIONS: Standardizing the selection of patient safety incidents for RCA using the RCA2 algorithm improves case identification based on the event frequency and potential harm score. Thus, this algorithm has the potential to advance patient safety.

Overview of Robotic Surgery in the U.S. Military: From Conception to Utilization, and Future Applications.

This column explores the inception, challenges, and prospects of robotic surgery in the military. It highlights the military's role in developing early prototypes, current utilization, training struggles, partnerships with civilian organizations, and potential future applications. The military's influence on the evolving landscape of robotic surgery is emphasized.

Urologic Trauma Management for Military Providers.

INTRODUCTION: Genitourinary (GU) trauma resulting from combat and the treatment of these injuries is an inadequately explored subject. While historically accounting for 2 to 5% of combat-related injuries, GU-related injuries escalated considerably during U.S. involvements in Iraq and Afghanistan due to improvised explosive devices (IEDs). Advanced body armor increased survivability while altering injury patterns, with a shift toward bladder and external genitalia injuries. Forward-deployed surgeons and military medics manage treatment, with Role 2 facilities addressing damage control resuscitation and surgery, including GU-specific procedures. The review aims to provide an overview of GU trauma and enhance medical readiness for battlefield scenarios. MATERIALS AND METHODS: This review examined urologic trauma management in combat, searching PubMed, Cochrane Central, Scopus, and Web of Science databases with search terms "wounds" OR "injuries" OR "hemorrhage" AND "trauma" AND "penile" OR "genital" AND "combat." Records were then screened for inclusion of combat-related urologic trauma in conflicts after 2001 and which were English-based publications. No limits based on year of publication, study design, or additional patient-specific demographics were implemented in this review. RESULTS: Ultimately, 33 articles that met the inclusion criteria were included. Included texts were narrowed to focus on the management of renal injuries, ureteral trauma, bladder injuries, penile amputations, urethral injuries, testicular trauma, Central nervous system (CNS) injuries, and female GU injuries. CONCLUSIONS: In modern conflicts, treatment of GU trauma at the point of injury should be secondary to Advanced Trauma Life Support (ATLS) care in addition to competing non-medical priorities. This review highlights the increasing severity of GU trauma due to explosive use, especially dismounted IEDs. Concealed morbidity and fertility issues underscore the importance of protection measures. Military medics play a crucial role in evaluating and managing GU injuries. Adherence to tactical guidelines and trained personnel is vital for effective management, and GU trauma's integration into broader polytrauma care is essential. Adequate preparation should address challenges for deploying health care providers, prioritizing lifesaving and quality-of-life care for casualties affected by GU injuries.

Should Military Veterans Be Classified as High Risk for Prostate Cancer Screening? A Systematic Review and Meta-analysis.

OBJECTIVE: To assess the unique risks of prostate cancer among U.S. veterans, and to advocate for improved care by raising awareness of the gaps in current AUA guidelines that do not address the specific needs of military personnel and veterans. METHODS: Ovid interface, Google Scholar, PubMed, and Medline were searched for studies investigating prostate cancer in veterans published between 1975 and 2023. Search terms: "veteran", "military", "molecular markers", "prostate cancer", "prostate cancer risk", and "military exposure" were used. Articles meeting inclusion criteria underwent analysis, data synthesis, and meta-analysis where applicable. RESULTS: Results from 45 articles indicate a significant increase in prostate cancer risk associated with exposure to Agent Orange (OR 1.97 [95% CI: 1.64-2.37], P <.00001), aromatic hydrocarbons (OR 1.14 [95% CI: 1.01-1.28], P = .03), and a slight increase with cadmium exposure (OR 1.03 [95% CI: 0.96-1.09], P = .42). While some evidence suggests an association between Camp Lejeune and prostate cancer risk in retrospective cohort studies, logistical regression analysis study did not entirely substantiate this relationship. CONCLUSION: This review identifies several exposures that elevate prostate cancer risk. Military veterans should be further questioned about their exposures and potentially treated as a high-risk screening group. Further research is warranted to strengthen these associations, as the current evidence remains limited.

Oncologic outcomes of pelvic organ-preserving radical cystectomy vs. Standard radical cystectomy: A systematic review and meta-analysis.

BACKGROUND AND OBJECTIVE: Radical Cystectomy is indicated in muscle-invasive bladder cancer and select cases of nonmuscle invasive bladder cancer. Women often undergo additional reproductive organ removal, greatly impacting sexual function and quality of life. Pelvic organ-preserving radical cystectomy aims to mitigate these effects, but its oncologic outcomes are not well-defined. This presents a meta-analysis of available literature on oncological outcomes of pelvic organ-preserving radical cystectomy in women with muscle invasive disease. METHODS: A systematic search across PubMed, Web of Science, Scopus, and Google Scholar was performed to identify studies comparing oncological outcomes between pelvic organ-preserving radical cystectomy and standard radical cystectomy in women with muscle-invasive bladder cancer or high-risk or recurrent nonmuscle invasive cancer. The search included English or Spanish studies, statistically comparing overall survival, cancer-specific survival, and recurrence-free survival. Statistical analysis used Review Manager, employing fixed or random-effects models based on heterogeneity. KEY FINDINGS AND LIMITATIONS: Six retrospective studies met inclusion criteria, totaling 597 patients of which 303 received pelvic organ-preserving radical cystectomy and 294 received standard radical cystectomy. Overall Survival was not different between the 2 groups (HR 1.05 [0.77, 1.43]; P = 0.77). Cancer-Specific Survival also was found to be not different between the 2 groups (HR 1.27 [0.86, 1.87]; P = 0.22). Additionally, recurrence-free survival was not different between the 2 groups (HR 0.85 [0.41, 1.75]; P = 0.65. Four of the included studies exhibited a moderate risk of bias, with 1 study demonstrating low risk and the remaining study manifesting a serious risk of bias. CONCLUSION: The comparison showed no significant differences in overall survival, cancer-specific survival, or recurrence-free survival rates.

Comparison of peritoneal interposition flaps and sealants for prevention of lymphocele after robotic radical prostatectomy and pelvic lymph node dissection: a systematic review, meta-analysis, Bayesian network meta-analysis, and meta-regression.

Lymphocele is one of the most common complications after radical prostatectomy. Multiple authors have proposed the use of vessel sealants or peritoneal interposition techniques as preventive interventions. This study aimed to aggregate and analyze the available literature on different interventions which seek to prevent lymphocele through a Bayesian Network. A systematic review was performed to identify prospective studies evaluating strategies for lymphocele prevention after robot assisted laparoscopic prostatectomy + pelvic lymph node dissection. Data was inputted into Review Manager 5.4 for pairwise meta-analysis. Data was then used to build a network in R Studio. These networks were used to model 200,000 Markov Chains via MonteCarlo sampling. The results are expressed as odds ratios (OR) with 95% credible intervals (CrI). Meta-regression was used to determine coefficient of change and adjust for pelvic lymph node dissection extent. Ten studies providing data from 2211 patients were included. 1097 patients received an intervention and 1114 patients served as controls. Interposition with fenestration had the lowest risk of developing a lymphocele (OR 0.14 [0.04, 0.50], p = 0.003). All interventions, except sealants or patches, had significant decreased odds of lymphocele rates. Meta-analysis of all the included studies showed a decreased risk of developing a lymphocele (OR 0.42 [0.33, 0.53], p < 0.00001) for the intervention group. Perivesical fixation and interposition with fenestration appear to be effective interventions for reducing the overall incidence of lymphocele.

Adherence to AUA guidelines for the work-up, medical management, surgical evaluation and treatment of BPH: Work from a quality improvement collaborative.

INTRODUCTION: Previous studies noted varied adherence to clinical practice guidelines (CPGs), but studies are yet to quantify adherence to American Urological Association BPH guidelines. We studied guideline adherence in the context of a new quality improvement collaborative (QIC). METHODS: Data were collected as part of a statewide QIC. Medical records for patients undergoing select CPT codes from January 2020 to May 2022 were retrospectively reviewed for adherence to selected BPH guidelines. RESULTS: Most men were treated with transurethral resection of the prostate. Notably, 53.3% of men completed an IPSS and 52.3% had a urinalysis. 4.7% were counseled on behavioral modifications, 15.0% on medical therapy, and 100% on procedural options. For management, 79.4% were taking alpha-blockers and 59.8% were taking a 5-ARI. For evaluation, 57% had a PVR, 63.6% had prostate size measurement, 37.4% had uroflowmetry, and 12.3% were counseled about treatment failure. Postoperatively, 51.6% completed an IPSS, 57% had a PVR, 6.50% had uroflowmetry, 50.6% stopped their alpha-blocker, and 75.0% stopped their 5-ARI. CONCLUSIONS: There was adherence to preoperative testing recommendations, but patient counseling was lacking in the initial work-up and preoperative evaluation. We will convey the data to key stakeholders, expand data collection to other institutions, and devise an improvement implementation plan.

Unplanned 120-Day ED Visits and Readmission Rates Following Common Stone Procedures.

OBJECTIVE: To quantify emergency department (ED) visits and hospital admissions (HA) after common urologic stone procedures including ureteroscopy (URS), shockwave lithotripsy (SWL), and percutaneous nephrolithotomy (PCL) which are a concern of payors, providers, and patients. MATERIALS AND METHODS: This is a retrospective cohort study using claims data from the IBM MarketScan Commercial and Medicare Supplement databases. Adults with a urologic stone diagnosis and no history of stone procedure in prior 12 months who underwent stone procedures between 2012 and 2017 were included. All-cause ED visits and HA were evaluated during 30, 60, 90, and 120-day periods following the index urologic stone procedure. RESULTS: A total of 166,287 patients were included in the analytic cohort. For inpatient-indexed procedures, cumulative ED visits rates following stone procedure at 120 days was 18.8% for URS, 19.2% for SWL, and 23.6% for PCL. A similar trend was observed with ED visit rates, following outpatient indexed procedures at 120 days with a cumulative rate of 14.2% of SWL patients, 14.9% of URS patients, and 17.3% of PCL. A similar trend was found when examining HA. ED and HA rates increased steadily through the 120-day time period. CONCLUSION: Rates of ED visits and HA following common stone procedures continue to rise at least up to 120 days following the index procedure whether in the outpatient or inpatient settings. While rates of unplanned care are similar for URS and SWL, patients undergoing PCL return to the hospital at higher rates.

Locally advanced solitary fibrous tumour of the prostate.

Solitary fibrous tumours (SFTs) are rare mesenchymal neoplasms composed of spindle cells, most often occurring in the pleura. SFTs arising from the prostate are exceptionally rare, with only around 40 cases reported in literature to date. We report a man in his 60s who was referred to our clinic for elevated prostate-specific antigen and presented with mild obstructive lower urinary tract and defecatory symptoms. Prostate needle-core biopsy revealed neoplastic spindle cells that strongly expressed CD34. Cross-sectional imaging demonstrated a 12 cm locally advanced heterogeneous prostate mass with intravesical extension and mass effect on the anterior rectum. Radical cystoprostatectomy with orthotopic neobladder reconstruction was performed, and the diagnosis of primary prostatic SFT was made based on histological characteristics and immunophenotyping. We present diagnostic, clinical management and prognostic considerations in patients with primary prostatic SFT.

Adult granulosa cell tumour of the testis: an uncommon tumour.

A male patient in his late 20s was admitted to the hospital after presenting with left abdominal, back and scrotal pain that had begun approximately 2 weeks earlier. He had a history of a stable left testicular mass for 3 years, and a physical exam revealed a non-tender, firm left testicular mass and a mild left varicocele. Testicular tumour markers were normal, but a scrotal ultrasound revealed a 2 cm hypoechoic left testicular lesion. Staging imaging showed no retroperitoneal adenopathy or pulmonary metastases.The patient underwent left radical inguinal orchiectomy with no evidence of extratesticular or spermatic cord involvement. His surgical pathology revealed a left pT1a 2.3 cm adult granulosa cell tumour of the testis with no lymphovascular invasion. The tumour was positive for inhibin and negative for OCT3/4, supporting the diagnosis.