Centro de estética y control de peso corporal: norma técnica No. 010-2019­DRACES / Center for aesthetics and body weight control: technical standard No. 010-2019 ­ DRACES

DRACES [Departamento de Regulación, Acreditación y Control de Establecimientos de Salud] Este documento tiene como objeto "la Regulación, Autorización y Control de los Centros de Estética y Control de Peso Corporal, en concordancia con el Reglamento para la Regulación, Autorización, Acreditación y Control de Establecimientos de Atención para la Salud, Acuerdo Gubernativo No. 376-2007." Es de carácter obligatorio, por lo que se aplica tanto a centros privados, sociales y/o públicos. Contiene además, las definiciones de los conceptos relacionados al tema principal, además de la infraestructura que deberá tener cada centro, incluidos el equipo y recurso humano y técnico. Especialmente relevante es la descripción de conceptos del equipo técnico que es utilizado en este tipo de centros, así como las terapias que suelen brindarse. Contiene además, sección de desechos bioinfecciosos no punzo-cortantes y otros más, propios del trabajo de estos centros. Así como "Condiciones de Bioseguridad".

Evaluación del riesgo biológico en laboratorios de Control de la Calidad del Instituto Finlay / Evaluation of biological risk in quality control laboratories of the Finlay Institute

El Instituto Finlay dedicado a producir vacunas empleando agentes biológicos, durante años, viene capacitando al personal de las áreas que presentan mayor potencial de riesgos, dada la importancia de proteger a sus trabajadores, instalaciones, equipos y producciones. Por ello se comenzaron a realizar evaluaciones de riesgos según métodos empleados por otros países, como España. Este trabajo tuvo como objetivo principal evaluar el riesgo biológico en laboratorios de Control de la Calidad, tales como el laboratorio de Bacteriología y el laboratorio de Pruebas Biológicas. Otros objetivos fueron, analizar la aplicación de la legislación nacional vigente de Bioseguridad y proponer un programa de acciones. El estudio se realizó en el último trimestre del año 2011 y primer semestre del año 2012. Se utilizaron como instrumentos de calidad, el método de la observación, listas de chequeo, entrevistas, tormentas de ideas y análisis documental. Los resultados mostraron que: ambos laboratorios cumplieron la legislación vigente de Bioseguridad, se identificaron los factores de riesgos más frecuentes, de ellos los de mayor nivel de riesgo y se obtuvo un programa de acciones correctivas encaminado a la solución de problemas detectados. Se demostró la posibilidad de la aplicación de un método cuantitativo, escogido para evaluar el riesgo y la implementación del programa de acciones correctivas con resultados satisfactorios(AU)

The Finlay Institute, dedicated to producing vaccines using biological agents, has for years been training personnel in the areas with the greatest risk potential, given the importance of protecting its workers, facilities, equipment and production. Therefore, risk assessments were started according to methods used by other countries, such as Spain. The main objective of this work was to evaluate the biological risk in Quality Control laboratories, such as the Bacteriology laboratory and the Biological Testing laboratory. Other objectives were to analyze the application of the current national Biosecurity legislation and propose a program of actions. The study was conducted in the last quarter of 2011 and the first semester of 2012. The observation method, checklists, interviews, storms of ideas and documentary analysis were used as quality instruments. The results showed that: both laboratories complied with the current Biosafety legislation, the most frequent risk factors were identified, including those with the highest level of risk and a program of corrective actions aimed at solving problems detected was obtained. The possibility of the application of a quantitative method, chosen to evaluate the risk and the implementation of the program of corrective actions with satisfactory results was demonstrated(AU)

Wheat Blast: Past, Present, and Future.

The devastating wheat blast disease first emerged in Brazil in 1985. The disease was restricted to South America until 2016, when a series of grain imports from Brazil led to a wheat blast outbreak in Bangladesh. Wheat blast is caused by Pyricularia graminis-tritici ( Pygt), a species genetically distinct from the Pyricularia oryzae species that causes rice blast. Pygt has high genetic and phenotypic diversity and a broad host range that enables it to move back and forth between wheat and other grass hosts. Recombination is thought to occur mainly on the other grass hosts, giving rise to the highly diverse Pygt population observed in wheat fields. This review brings together past and current knowledge about the history, etiology, epidemiology, physiology, and genetics of wheat blast and discusses the future need for integrated management strategies. The most urgent current need is to strengthen quarantine and biosafety regulations to avoid additional spread of the pathogen to disease-free countries. International breeding efforts will be needed to develop wheat varieties with more durable resistance.

A Plea for the Renewal of the ISBR.

The recent meeting of the International Society for Biosafety Research (ISBR) focused on so-called genetically modified organisms. For decades, in most regulatory frameworks, recombinant DNA-modified organisms have been the wrong focus of unbalanced agri-food regulations. The ISBR should instead adopt a scientifically defensible and truly risk-based perspective, abandoning a misleading pseudo-category.

Characterization of Departures from Regulatory Requirements Identified During Inspections Conducted by the US Federal Select Agent Program, 2014-15.

We studied departures from regulatory requirements identified on US Federal Select Agent Program (FSAP) inspections to increase transparency regarding biosafety and security risk at FSAP-regulated entities and identify areas for programmatic improvement. Regulatory departures from inspections led by Centers for Disease Control and Prevention inspectors during 2014-15 were grouped into "biosafety," "security," and "other" observation categories and assigned a risk level and score reflecting perceived severity. The resulting 2,267 biosafety (n = 1,153) and security (n = 1,114) observations from 296 inspections were analyzed by frequency and risk across entity and inspection characteristics. The greatest proportion of biosafety observations involved equipment and facilities (28%), and the greatest proportion of security observations involved access restrictions (33%). The greatest proportion of higher-risk observations for biosafety were containment issues and for security were inventory discrepancies. Commercial entities had the highest median cumulative risk score per inspection (17), followed by private (13), academic (10), federal government (10), and nonfederal government (8). Maximum containment (BSL-4) inspections had higher median biosafety risk per inspection (13) than other inspections (5) and lower security risk (0 vs 4). Unannounced inspections had proportionally more upper risk level observations than announced (biosafety, 21% vs 12%; security, 18% vs 7%). Possessors of select agents had higher median biosafety risk per inspection (6) than nonpossessors (4) and more upper risk level security observations (10% vs 0%). Programmatic changes to balance resources according to entity risk may strengthen FSAP oversight. Varying inspection methods by select agent possession and entity type, and conducting more unannounced inspections, may be beneficial.

Certification & validation of biosafety level-2 & biosafety level-3 laboratories in Indian settings & common issues.

With increasing awareness regarding biorisk management worldwide, many biosafety laboratories are being setup in India. It is important for the facility users, project managers and the executing agencies to understand the process of validation and certification of such biosafety laboratories. There are some international guidelines available, but there are no national guidelines or reference standards available in India on certification and validation of biosafety laboratories. There is no accredited government/private agency available in India to undertake validation and certification of biosafety laboratories. Therefore, the reliance is mostly on indigenous experience, talent and expertise available, which is in short supply. This article elucidates the process of certification and validation of biosafety laboratories in a concise manner for the understanding of the concerned users and suggests the important parameters and criteria that should be considered and addressed during the laboratory certification and validation process.