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Source text - English All XXX prefilled catheter flush syringes are steam terminally sterilized.
Why is terminal sterilization important?
XXX syringes are filled with saline or heparin in a FDA-registered, cGMP controlled clean room. The syringes are 100% steam terminally sterilized, labeled and packaged in ready-to-use, unit-dose packaging.
The FDA addressed the issue of terminal sterilization of drug products in their “Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practices. Sept 2004 ed. In section III. Scope, they stated “It is a well-accepted principle that sterile drugs should be manufactured using aseptic processing only when terminal sterilization is not feasible.” Additionally, this document further addresses issues the FDA have identified over the years with aseptic filling processes (footnote 3).
Steam terminal sterilization, also known as autoclaving, is used daily in nearly every hospital and healthcare facility in the world. The processes are well known and reliable. XXX prefilled syringes are 100% steam terminally sterilized.
Translation - Spanish Todas las jeringas XXXprecargadas de lavado son esterilizadas en forma terminal en autoclave.
¿Por qué es importante la esterilización terminal?
Las jeringas XXX son cargadas con solución salina o heparina en una habitación limpia y controlada con cGMP, registrada en la FDA. Las jeringas son etiquetadas y esterilizadas en forma terminal en autoclave en un 100%, y envasadas en dosis unitarias – listas para usar.
La FDA hace hincapié en el aspecto de la esterilización terminal de los productos con drogas en la publicación “Guidance for Industry – Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practices. Sept 2004 ed. sección III. En este ámbito, declararon "Las drogas estériles deben ser manufacturadas utilizando un proceso aséptico solamente cuando no es viable realizar una esterilización terminal; este es un principio totalmente aceptado." Asimismo, este documento lleva la atención hacia aspectos que la FDA ha identificado a lo largo de los años con los procesos de llenado aséptico (nota al pie3).
La esterilización terminal en autoclave es utilizada a diario en casi todos los hospitales e instalaciones sanitarias en el mundo. El proceso es bien conocido y confiable. Todas las jeringas XXX de lavado precargadas son esterilizadas en un 100% en forma terminal en autoclave.
Spanish to English: Mismatch paciente-prótesis aórtica. Comparación alejada por eco-Doppler transtorácico versus el estimado en el preoperatorio
Source text - Spanish Mismatch paciente-prótesis aórtica. Comparación alejada por eco-Doppler transtorácico versus el estimado en el preoperatorio
Introducción:
El mismatch paciente-prótesis (MPP) aórtica se asocia con peor evolución posoperatoria.
La utilización del área del orificio aórtico efectivo (AOE) para cada tipo de prótesis, indexado por la superficie corporal (SC) en el momento quirúrgico, puede permitir la elección de un tamaño de prótesis adecuado para cada paciente y así evitar el MPP.
Objetivo
Comparar la estimación de MPP por las AOE tabuladas con la diagnosticada en el posoperatorio alejado por eco-Doppler.
Material y métodos
Se analizaron retrospectivamente 57 pacientes, 43 hombres, con prótesis aórtica, operados más de 6 meses antes del estudio. Se calculó la SC del parte quirúrgico y el AOE indexada tabulada, el AOE posquirúrgica con eco-Doppler transtorácico por la ecuación de continuidad y se comparó el MPP prequirúrgico y posquirúrgico. Se consideró MPP aórtico un AOE indexada < 0,75 cm2/m2.
Resultados
Se observó una prevalencia de MPP preoperatorio del 29,8% y posoperatorio del 54,4% (p = 0,029), con el 31% de MMP grave. La prevalencia de sobrepeso en la muestra estudiada fue del 80%.
Conclusiones
En este grupo de pacientes con alta prevalencia de sobrepeso, la estimación del AOE preoperatoria indexada por SC de cada tipo de prótesis para predecir el MPP posoperatorio mostró diferencias significativas entre el diagnóstico del MPP estimado en el preoperatorio y el calculado por eco-Doppler en el posoperatorio. En futuros estudios es necesaria la inclusión de un grupo poblacional mayor, así como la revisión del método de cálculo del área valvular (p. ej., del tracto de salida del ventrículo izquierdo).
Translation - English Comparison between Patient-Aortic Valve Prosthesis Mismatch Determined by Transthoracic Echo-Doppler at Late Follow-up versus Preoperative Estimation
Background
Patient-aortic valve prosthesis mismatch (PPM) is associated with poor postoperative outcomes. Determination of aortic effective orifice area (EOA) indexed for body surface area (BSA) is useful to select suitable type and size of heart valve prosthesis in order to prevent patient-prosthesis mismatch.
Objective
The objective of this study was to compare the PPM estimated by indexed EOA with PPM determined by echo-Doppler at late follow-up.
Material and Methods
Fifty seven patients (43 men) who had undergone an aortic valve replacement in the previous 6 months were retrospectively assessed. After calculating BSA from the surgical report, indexed EOA, postoperative EOA (determined by the continuity equation with transthoracic echo-Doppler), preoperative and postoperative PPM were compared. An indexed EOA < 0.75 cm2/m2 was considered aortic PPM.
Results
The prevalence of preoperative and postoperative PPM was 29.8% and 54.4%, respectively (p=0.029); 31% of MMP was severe. The prevalence of overweight in this sample was 80%.
Conclusions
In this group of patients with a high prevalence of overweight, the estimation of preoperative EOA indexed for BSA in order to predict postoperative PPM according to the type of prosthesis, showed significantly differences between preoperative PPM and postoperative PPM calculated by echo-Doppler.
Further studies should not only include a larger sample, but should also check the method used for calculating valvular area (for example, in the left ventricular outflow tract).
As a medical doctor with years of experience dealing with patients and diseases, reading papers in English was a must to be up-to-date. The practice gained reading medical articles in English added technical vocabulary to my knowledge of the language.
I deeply enjoy doing medical translations.
I hope you'd like to trust in my expertise.
Background:
Lower Certificate in English, University of Cambridge, United Kingdom
Certificate of Proficiency in English, University of Cambridge, United Kingdom.
Diploma of Superior de Capacidad, Asociación Argentina de Cultura Inglesa
Medical Doctor, Faculty of Medicine, National University of Buenos Aires, Argentina.
Cardiologist, Ministry of Health, Argentina.
Technical Skills:
My areas of expertise are general medicine (all areas), cardiology, pharmaceutical, clinical trials, and evidence based medicine.
Medical information directed to patients and health professionals.
Medical papers.
Translating and evaluating medical documents and instructional materials for domestic or international use.
Expertise 
