Gastroenterology-Urology Devices; Manual Gastroenterology-Urology Surgical Instruments and Accessories. Final rule; technical amendment.

The Food and Drug Administration (FDA) is amending the identification of manual gastroenterology-urology surgical instruments and accessories to reflect that the device does not include specialized surgical instrumentation for use with urogyencologic surgical mesh specifically intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures ("specialized surgical instrumentation for use with urogynecologic surgical mesh"). These amendments are being made to reflect changes made in the recently issued final reclassification order for specialized surgical instrumentation for use with urogynecologic surgical mesh.

Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System. Final order.

The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; gastroenterology-urology devices; classification of the vibrator for climax control of premature ejaculation. Final order.

The Food and Drug Administration (FDA) is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Medical devices; gastroenterology-urology devices; classification of the urethral insert with pump for bladder drainage. Final order.

The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

Gender Representation in Urologic Subspecialties.

OBJECTIVE: To examine associations between urologic subspecialization, surgeon gender and practice patterns among certifying urologists over the last 13 years. MATERIALS AND METHODS: Demographic data of certifying and recertifying urologists (2004 to 2015) were obtained from the American Board of Urology. We investigated gender-specific trends in self-reported practice type (academic practice, private practice), subspecialization, and employment as a full-time vs part-time physician, relative to certification year and cycle. RESULTS: Of 9140 urologists applying for certification or recertification over the study period, 815 (8.9%) were women. The largest proportion of female surgeon candidates (65.0%) was first-time certifiers. Women represented 16.7% of first-time certifying urologists (P < .001) and reported practicing in academia more frequently (23.6%) compared with 13.7% of men (P < .001). Female surgeons identified as subspecialists in greater numbers (46.4%) than their male counterparts (23.4%) across all certification years and cycle cohorts (P < .001). Women reported subspecializing in female urology (24.2%) and pediatrics (10.2%) at higher frequencies than their male colleagues (4.6% and 3.1% respectively, both P < .001). Female and male surgeon candidates requested certification in equal proportion in andrology and infertility (P = .83) and endourology (3.6% female vs 5.8% male, P = .13), however differed in oncology (4.2% female vs 7.2% male, P = .001). CONCLUSION: A growing proportion of certifying urologists are women, with the greatest enrichment among those seeking first-time certification. Since 2004, female surgeons account for a disproportionate volume of urologists who practice in the academic setting and identify as subspecialists.

Gastroenterology and urology devices; reclassification of the extracorporeal shock wave lithotripter. Food and Drug Administration, HHS. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule to reclassify from class III to class II the extracorporeal shock wave lithotripter, when intended for use to fragment kidney and ureteral calculi. FDA is taking this action on its own initiative in order to assure that these devices are regulated according to the appropriate degree of regulatory control needed to provide reasonable assurance of their safety and effectiveness.

Gastroenterology-urology devices; classification of tissue culture media for human ex vivo tissue and cell culture processing applications. Final rule.

The Food and Drug Administration (FDA) is classifying tissue culture media for human ex vivo tissue and cell culture processing applications into class II (special controls). The special control that will apply to this device is a guidance document entitled "Class II Special Controls Guidance Document: issue Culture Media for Human Ex Vivo Tissue and Cell Culture Processing Applications; Final Guidance for Industry and FDA Reviewers." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. The agency is classifying these devices into class II (special controls) in order to provide a reasonable assurance of the safety and effectiveness of the devices.

Galen-In-Use: using artificial intelligence terminology tools to improve the linguistic coherence of a national coding system for surgical procedures.

GALEN has developed a language independent common reference model based on a medically oriented ontology and practical tools and techniques for managing healthcare terminology including natural language processing. GALEN-IN-USE is the current phase which applied the modelling and the tools to the development or the updating of coding systems for surgical procedures in different national coding centers co-operating within the European Federation of Coding Centre (EFCC) to create a language independent knowledge repository for multicultural Europe. We used an integrated set of artificial intelligence terminology tools named CLAssification Manager workbench to process French professional medical language rubrics into intermediate dissections and to the Grail reference ontology model representation. From this language independent concept model representation we generate controlled French natural language. The French national coding centre is then able to retrieve the initial professional rubrics with different categories of concepts, to compare the professional language proposed by expert clinicians to the French generated controlled vocabulary and to finalize the linguistic labels of the coding system in relation with the meanings of the conceptual system structure.

Nuevo horizonte en la lucha contra la resistencia bacteriana / New horizont in the fight against bacterial resistance

No disponible

Semiología renal y genitourinaria en pediatría: primera parte / Nephrologoy and urology semiology in children: first part

A pesar de los avances tecnológicos, la historia clínica y el examen físico continúan y continuarán siendo la base de un buen enfoque y aproximación diagnóstica correcta, por ésto, la semiología sigue siendo un área muy importante en la medicina. En ésta revisión se plantea una guía sistemática e integral para la evaluación del sistema nefro-urológico en el niño desde las herramienta básicas y fundamentales como la historia clínica, el examen físico con sus componentessemiológicos en lo normal y lo patológico, integrando además los métodos diagnósticos de laboratorio e imagen disponibles en la actualidad, para lograr un buen enfoque y aproximación diagnóstica en niños con enfermedad renal.

Despite technological advances, medical history and physical examination remain the foundation of a good approach and correct diagnosis; semiology remains a very important area in medicine. In this review a systematic and comprehensive guide for the evaluation of nephron urological system in children is presented, with emphasis in medical history, physical examination and semiotic aspects, in normal and pathological conditions; additionally laboratory and imaging studies available to achieve a good diagnostic approach in children with renal disease are presented.

Hemangioma papilar como causa de macrohematuria. Presentación de un caso y revisión de la literatura / Papillary hemangioma as a cause of macrohematuria. A case report and review of the literature

La hematuria recidivante unilateral supone un reto diagnóstico y terapéutico para el urólogo. El hemangioma renal (HR) figura entre las posibles causas. La localización en la papila renal es típica. Se presenta un caso de hematuria secundaria a HR que fue diagnosticado en primera instancia como síndrome del cascanueces. Tras una revaloración se realizó ureterorrenoscopia que demostró un hemangioma papilar sangrante. La lesión fue tratada con fotovaporización láser con buen resultado. Se revisa la etiopatogenia, diagnóstico y las opciones terapéuticas frente al HR sangrante (AU)

Unilateral recurrent hematuria is a diagnostic and therapeutic challenge for the urologist. The renal hemangioma (RH) is a possible cause. The location is typically the renal papilla. A case of hematuria secondary to RH who was diagnosed at first instance and nutcracker syndrome is presented. After a diagnostic reassessment ureterorenoscopy was performed which showed a bleeding papillary hemangioma. The lesion was treated with laser PVP with good results. The pathogenesis, diagnosis and therapeutic options against the bloody RH is reviewed (AU)

A system that facilitates the orientation within procedure nomenclatures through a semantic approach.

The representation of medical concepts should provide the flexibility required to support several purposes. We have implemented a model in which medical terms are represented in a standard format based on a semantic description of the terms. We have focused on the description of procedures. Underlying this project is the assumption that information about medical procedures is crucial in the healthcare system. A prototype has been developed for urology. Because of the large number of terms in the Unified Medical Language System (UMLS) and the abundance of links between them, we have experimented in the use of the UMLS as the foundation for our concept base. We assess the usefulness of this approach and discuss its improvements.

The resource-based relative value scale: methods, results and impacts on urology.

Increased concern for rising health care costs in the United States has led to the passage of legislation to reform physician payment for Medicare services based on resource inputs. In January 1992 the Health Care Financing Administration began implementing the new law, which replaces the existing Medicare system of physician payment with a fee schedule based on the resource-based relative value scale (RBRVS). We summarize the methods and data used to derive the RBRVS for urology. A national random sample of 115 practicing urologists completed structured telephone surveys to provide ratings of physician time and work required before, during and after most frequently performed urological services. Subsequent survey cycles with urologists provided further refinement. Urologists then participated in a cross-specialty physician panel to link services from all specialties onto a common scale. This common scale was adjusted for geographic differences in practice overhead costs and malpractice insurance premiums. A monetary conversion factor, determined by the Health Care Financing Administration, was then applied to convert the RBRVS into a Medicare fee schedule. The merits and demerits of the scientific process used to develop and maintain the relative value scale are extensive. While statistically valid and reproducible, the study results have been altered in the political arena. The results and impacts of the new Medicare payment system on urology will be significant, although it is not yet clear how urological practice will be affected. Although faring better than most surgical specialties, urologists stand to lose approximately 8% of their Medicare income when the new fee schedule is fully implemented. There will be relative gains for evaluation and management services and losses for most invasive procedures.

Cateterismo intermitente limpio en una consulta de urología general. Utilidad de la pauta decreciente / Decreasing frequency pattern in patients with clean intermittent catheterization for bladder voiding dysfunction

OBJETIVO: Evaluar la utilidad terapéutica y morbilidad del cateterismo intermitente limpio (CIL) usando una pauta decreciente de pacientes con disfunción de vaciado vesical (DVV) de etiología múltiple. MÉTODOS: Se realizó un estudio retrospectivo de pacientes con DVV en los que se indicó CIL. Se valoró la presentación clínica, el residuo postmiccional (RPM) y los hallazgos del estudio urodinámico (EUD), y su respuesta al CIL en pauta decreciente, las complicaciones y la aceptación del tratamiento. El objetivo primario fue la respuesta favorable a las pautas decrecientes de CIL. RESULTADOS: Se evaluaron 27 pacientes con DVV. De ellos, 15 (56%) mujeres y 12 (44%) hombres. La edad media fue de 54,33 años (32-82) y el tiempo de seguimiento medio fue 23,5 meses (2-66). La media del volumen por sondaje y número de los mismos decreció en todos los grupos de pacientes. El 40,7% de todos los pacientes no precisó realizar CIL tras un tiempo medio de 7,38 meses. El tiempo medio hasta alcanzar un residuo estable o ausencia del mismo fue de 9,76 meses (0,75-63). La única complicación fueron las infecciones del tramo urinario (cistitis leve en 7 pacientes y orquiepididimitis en 2). El 70,4% de los pacientes respondió a la encuesta telefónica. El 79% manifestó no haber tenido mayores dificultades en el aprendizaje del CIL, el 52,7% manifestó continuar con CIL. La puntuación media de satisfacción personal con el CIL fue de 6/10 puntos. CONCLUSIÓN: El CIL con pauta decreciente permite que la mitad de los pacientes se liberen del cateterismo. La otra mitad disminuye significativamente el número de sondajes, con escasa interferencia en la vida diaria y muy altas tasas de adherencia la tratamiento. Resulta una técnica efectiva, bien aceptada y bien aprendida por la mayoría de pacientes con DVV en un amplio grupo de indicaciones, más allá de la disfunción neurógena (AU)

OBJECTIVES: To evaluate usefulness and morbidity of clean intermittent catheterization (CIC) using a decreasing pattern in patients with bladder voiding dysfunction (BVD) of varied etiology. METHODS: We performed a retrospective study of patients with BVD in whom CIC was indicated. We evaluated the clinical presentation, post-void residual urine (PVR), results of the urodynamic studies (UDS), and response to CIC in a decreasing pattern, complications and patient adherence. The primary endpoint was a favorable response to CIC in a decreasing frequency pattern. Secondary endpoints were complications and patient perception of it. RESULTS: We evaluated a total of 27 patients with BVD. Of these, 15 (56%) were women and 12 (44%) were men. Mean age was 54.33 years (32-82) and mean follow-up time was 23.5 months (2-66). The mean catheterized volume and the number of catheterizations decreased in all groups of patients. 40.7% of all patients did not need to perform catheterization after an average time of 7.38 months. The average time to reach a stable PVR or the lack of it was 9.76 months (0.75 to 63). The only complication recorded were urinary tract infection (UTI) presenting as mild cystitis in 7 patients and orchitis in 2 patients. 70.4% (19/27) responded to the telephone survey. 79% (15/19) said they have had no major difficulty in learning CIC, 52.7% (10/19) said to be continuing CIC, and the mean personal rating was 6/10. CONCLUSION: CIC in a decreasing pattern allows almost half of the patients to be totally free from catheterization. The other half reduces significantly the number of catheterizations, with little interference in their daily lives. It is an effective technique, well accepted and well learned by most patients with BVD in a wide range of indications, beyond neurogenic dysfunction (AU)