Consolidated #Ebola Virus Disease Preparedness Checklist

The Consolidated Checklist for Ebola Virus Disease Preparedness is based on efforts by various national and international institutions, including WHO, CDC and UN OCHA.
It identifies 10 key components and tasks for both countries and the international community that should be completed within 30, 60 and 90 days respectively from the date of issuing this list. Minimal required resources in terms of equipment and material as well as human resources are defined. Key reference documents such as guidelines, training manuals and guidance notes will help the technical experts to implement required action in the key components.

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Monitoring #SelectAgent Theft, Loss and Release Reports in USA

cdc.gov

The APHIS/CDC Form 3, Report of Theft, Loss or Release of Select Agents and Toxins (TLR incident report) is the mechanism by which the theft, loss or release of a biological select agent and toxin (BSAT) is reported to the United States Department of Agriculture (USDA)/Animal and Plant Health Inspection Service (APHIS) or Health and Human Services (HHS)/ Center for Disease Control and Prevention (CDC). A total of seven hundred and twenty seven (727) TLR Incident Reports were received by CDC between 2004 and 2010.

REFERENCES:
Henkel RD, et al. Monitoring Select Agent Theft, Loss and Release Reports in the United States—2004-2010. Applied Biosafety Vol. 17, No. 4, 2012:171-180.
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Advancing infection control in dental care settings

ABSTRACT
Background and Overview. The authors set out to identify factors associated with implementation by U.S. dentists of four practices first recommended in the Centers for Disease Control and Prevention’s Guidelines for Infection Control in Dental Health-Care Settings—2003.
Methods. In 2008, the authors surveyed a stratified random sample of 6,825 U.S. dentists. The response rate was 49 percent. The authors gathered data regarding dentists’ demographic and practice characteristics, attitudes toward infection control, sources of instruction regarding the guidelines and knowledge about the need to use sterile water for surgical procedures. Then they assessed the impact of those factors on the implementation of four recommendations: having an infection control coordinator, maintaining dental unit water quality, documenting percutaneous injuries and using safer medical devices, such as safer syringes and scalpels. The authors conducted bivariate analyses and proportional odds modeling.
Results. Responding dentists in 34 percent of practices had implemented none or one of the four recommendations, 40 percent had implemented two of the recommendations and 26 percent had implemented three or four of the recommendations. The likelihood of implementation was higher among dentists who acknowledged the importance of infection control, had practiced dentistry for less than 30 years, had received more continuing dental education credits in infection control, correctly identified more surgical procedures that require the use of sterile water, worked in larger practices and had at least three sources of instruction regarding the guidelines. Dentists with practices in the South Atlantic, Middle Atlantic or East South Central U.S. Census divisions were less likely to have complied.
Conclusions. Implementation of the four recommendations varied among U.S. dentists. Strategies targeted at raising awareness of the importance of infection control, increasing continuing education requirements and developing multiple modes of instruction may increase implementation of current and future Centers for Disease Control and Prevention guidelines.
REFERENCE:
Jennifer L. Cleveland, et al.  Advancing infection control in dental care settings. JADA 2012;143(10):1127-1138.

Guidelines for Infection Control in Dental Health-Care Settings

This report consolidates previous recommendations and adds new ones for infection control in dental settings. Recommendations are provided regarding 1) educating and protecting dental health-care personnel; 2) preventing transmission of bloodborne pathogens; 3) hand hygiene; 4) personal protective equipment; 5) contact dermatitis and latex hypersensitivity; 6) sterilization and disinfection of patient-care items; 7) environmental infection control; 8) dental unit waterlines, biofilm, and water quality; and 9) special considerations (e.g., dental handpieces and other devices, radiology, parenteral medications, oral surgical procedures, and dental laboratories). These recommendations were developed in collaboration with and after review by authorities on infection control from CDC and other public agencies, academia, and private and professional organizations.
REFERENCE:
Guidelines for Infection Control in Dental Health-Care Settings, 2003. MMWR, December 19, 2003:52(RR-17).
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Recommendations on the Transport of Dangerous Goods, Model Regulation. Book UNECE 2013

Published:July 2013
ST/SG/AC.10/1/Rev.18
Complete set of two volumes
Sales No. 13.VIII.1
ISBN 978-92-1-139146-6
Price: US$ 155
Languages: E, F
(A, C, R forthcoming)
UNECE.ORG

These recommendations have been developed in the light of technical progress, the advent of new substances and materials, the exigencies of modern transport systems and, above all, the requirement to ensure the safety of people, property and the environment. They are addressed to governments and international organisations concerned with the regulation of the transport of dangerous goods. The Model Regulations cover the classification of dangerous goods, their listing, the use, construction, testing and approval of packagings and portable tanks, as well as consignment procedures such as marking, labelling, placarding and documentation.
This eighteenth revised edition contains various new and revised provisions concerning, inter alia, classification of solid oxidizing substances; transport of adsorbed gases; lithium batteries (including damaged or defective lithium batteries, lithium batteries for disposal or recycling); asymmetric capacitors; discarded packagings; ammonium nitrate and radioactive material; testing of gas cartridges and fuel cell cartridges; marking of bundles of cylinders; and the applicability of ISO standards to the manufacture of new pressure receptacles or service equipment.
UNECE: United Nations Economic Commision for Europe
Versión 2009 en Español

CLP Regulation and the transport of dangerous goods.

Abstract
Regulations concerning different modes of transport of dangerous goods are well harmonized at global level: they were then looked at as a model for developing Globally Harmonized System of Classification and Labelling of Chemicals (GHS), (on which CLP Regulations is based). Transport regulations do not cover some hazard classes, such as germ cell mutagenicity, carcinogenicity, reproductive toxicity, having been evaluated that such hazards are not relevant in transport because in general, in case of accident, no repeated and prolonged exposure takes place. Other differences with CLP Regulation are related to the use of "building block approach". Transport labels, which were used as a basis for GHS, can be used, instead of CLP pictograms, on packages during transport.

REFERENCE:

Benassai S. CLP Regulation and the transport of dangerous goods. Ann Ist Super
Sanita. 2011;47(2):153-6. doi: 10.4415/ANN_11_02_06. PubMed PMID: 21709384.

Transporte de sustancias infecciosas

Transportation fo Dangerous
Goods  Bulletin

El gobierno de Canadá acaba de publicar una guía (en inglés) para el empaque y envío de sustancias peligrosas que pueden descargar aqui. 

This Bulletin explains the requirements of the Transportation Dangerous Goods (TDG) Regulations when shipping infectious substances. It does not change, create, amend or allow deviations from the Transportation Dangerous Goods (TDG) Regulations. For specific details, consult the TDG Regulations.

 Las regulaciones para 2013-2014 de la Organización Mundial de la salud, fueron publicadas desde enero de este año, y pueden verlas aquí.

This publication provides information for identifying, classifying, marking, labelling, packaging, documenting and refrigerating infectious substances for transportation and ensuring their safe delivery. The document provides practical guidance to facilitate compliance with applicable international regulations for the transport of infectious substances by all modes of transport, both nationally and internationally.

ABSA High Containment Laboratory Accreditation Program

La Asociación Americana de Seguridad Biológica (ABSA) tiene implementado un Programa de Acreditación de Laboratorios que fué desarrollado para Laboratorios Bioseguridad Nivel 3 (BSL3) y Laboratorios de Animales Bioseguridad Nivel 3 (ABSL3). El propósito del programa de acreditación es asegurar que las instalaciones de biocontención tienen implementadas las prácticas necesarias, procedimientos, personal, equipo de protección, animales, plantas y un ambiente para minimizar las potenciales infecciones asociadas al laboratorio. Para mayor información sobre este programa visiten:

http://absa.org/aiahclap.html

WHO Regulations for the Transport of Infectious Substances 2013-2014 #li

Publication details

Number of pages: 34 pages
Publication date: 2012
Languages: English
WHO reference number: WHO/HSE/GCR/2012.12

Downloads => Document here in PDF (971kb) and presentation in Power Point

Overview

This publication provides information for identifying, classifying, marking, labelling, packaging, documenting and refrigerating infectious substances for transportation and ensuring their safe delivery. The document provides practical guidance to facilitate compliance with applicable international regulations for the transport of infectious substances by all modes of transport, both nationally and internationally, and include the changes that apply from 1 January 2013. The current revision replaces the document issued by the World Health Organization (WHO) in 2010 (document WHO/CDS/EPR/2010.8). This publication, however, does not replace national and international transport regulations.

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#ARTÍCULO: Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment

>>  COMPLETE TABLE  <<

Abstract:
We describe herein, limitations on research at biosafety level 4 (BSL-4) containment laboratories, with regard to biosecurity regulations, safety considerations, research space limitations, and physical constraints in executing experimental procedures. These limitations can severely impact the number of collaborations and size of research projects investigating microbial pathogens of biodefense concern. Acquisition, use, storage, and transfer of biological select agents and toxins (BSAT) are highly regulated due to their potential to pose a severe threat to public health and safety. All federal, state, city, and local regulations must be followed to obtain and maintain registration for the institution to conduct research involving BSAT. These include initial screening and continuous monitoring of personnel, controlled access to containment laboratories, accurate and current BSAT inventory records. Safety considerations are paramount in BSL-4 containment laboratories while considering the types of research tools, workflow and time required for conducting both in vivo and in vitro experiments in limited space. Required use of a positive-pressure encapsulating suit imposes tremendous physical limitations on the researcher. Successful mitigation of these constraints requires additional time, effort, good communication, and creative solutions. Test and evaluation of novel vaccines and therapeutics conducted under good laboratory practice (GLP) conditions for FDA approval are prioritized and frequently share the same physical space with important ongoing basic research studies. The possibilities and limitations of biomedical research involving microbial pathogens of biodefense concern in BSL-4 containment laboratories are explored in this review.
Referencia:
Shurtleff AC, et. al. Impact of Regulations, Safety Considerations and Physical Limitations on Research Progress at Maximum Biocontainment. Viruses. 2012 December; 4(12): 3932–3951.

NOM Criterios para proyectos de investigación para la salud en seres humanos.

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El día 4 de Enero de 2013 se publicó en el Diario Oficial de la Federación, la NOM que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos.

1. Objetivo
Esta norma establece los criterios normativos de carácter administrativo, ético y metodológico, que en correspondencia con la Ley General de Salud y el Reglamento en materia de investigación para la salud, son de observancia obligatoria para solicitar la autorización de proyectos o protocolos con fines de investigación, para el empleo en seres humanos de medicamentos o materiales, respecto de los cuales aún no se tenga evidencia científica suficiente de su eficacia terapéutica o rehabilitatoria o se pretenda la modificación de las indicaciones terapéuticas de productos ya conocidos, así como para la ejecución y seguimiento de dichos proyectos.

2. Campo de aplicación
Esta norma es de observancia obligatoria, para todo profesional de la salud, institución o establecimiento para la atención médica de los sectores público, social y privado, que pretendan llevar a cabo o realicen actividades de investigación para la salud en seres humanos, con las características señaladas en el objetivo de la presente norma.

REFERENCIA:
DOF: 04/01/2013
NORMA Oficial Mexicana NOM-012-SSA3-2012, Que establece los criterios para la ejecución de proyectos de investigación para la salud en seres humanos.
http://dof.gob.mx/nota_detalle.php?codigo=5284148&fecha=04/01/2013

NOTA (15/01/2013):  El apartado 9, habla de la constitución, inscripción y funcionamiento de los Comités de Investigación, Etica en la Investigación y Bioseguridad.

Animal Disease Traceability

On Thursday, December 20th, the U.S. Department of Agriculture (USDA) announced a final rule establishing general regulations for improving the traceability of U.S. livestock moving interstate.

For more Info visit: TRACEABILITY

VIDEO: BSL3 inspection for select agents #biosecurity #CDC

Este video, en inglés, sirve con fines educativos para instituciones o individuos quienes poseen, almacenan o transfieren microorganismos controlados (Select Agents) y toxinas en Estados Unidos. Este video puede ser utilizado en programas de entrenamiento para personal o como herramienta para programas de entrenamiento. Puedes ver y descargar este y otros videos en: SelectAgents.Gov

BSL3 Inspection

Toxins Inspection

#WHO Laboratory Assesment Tool

El "Laboratory Assessment Tool.zip" ofrece una guía para evaluar laboratorios y sistemas nacionales. La audiencia blanco es cualquier persona que evalúa laboratorios: autoridades nacionales de salud, agencias multilaterales, organizaciones no gubernamentales (NGO´s), resposables de laboratorio, etc. Este documento describe los procesos generales para evaluar laboratorios y proporciona dos cuestionarios que ayudan a evaluar los sistemas de laboratorios nacionales (anexo 1) y laboratorios individuales (anexo 2). Los evaluadores pueden utilizar los cuestionarios tal y como se presentan o acondicionar los materiales disponibles para que cumplan con requerimientos locales o específicos y adecuarlos mejor al contexto de evaluación. Los cuestionarios se encuentran en formato PDF y pueden ser fácilmente impresos, y en archivos Excel que permiten calculos matemáticos automáticos de indicadores cuando se responde a las preguntas y el análisis de datos. Pueden descargar el Archivo ZIP o descargar los archivos individuales.
Publication details:
Number of pages: 35
Publication date: 2012
Languages: English
WHO reference number: WHO/HSE/GCR/LYO/2012.2

NOM-007-SSA3-2011

El 27/03/2012 se publicó en el Diario Oficial de la Federación la nueva NOM-007-SSA3-2011, Para la organización y funcionamiento de los laboratorios clínicos
Para quienes no la han revisado, pueden verla en:
http://dof.gob.mx/nota_detalle.php?codigo=5240925&fecha=27/03/2012

Guideline for Microbial Risk Assessment

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Scientists from the Environmental Protection Agency (EPA), U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) and joined by scientists from other federal agencies developed the Guideline for Microbial Risk Assessment: Pathogenic Microorganisms with Focus on Food and Water (231 pp, 1.24Mb). This document provides a common framework to perform microbial risk assessment (MRA). It lays out a flexible set of approaches, methods, and tools for use to conduct their microbial risk assessment and provide more transparency to the process and results. This guideline addresses issues specific to microbial risk, e.g., secondary transmission, immune status, and growth and die-off of organisms, as well as addressing concepts generic to classical chemical risk assessment.

#WHO guidelines on hand hygiene in health care

Overview. The WHO guidelines on hand hygiene in health care provide health-care workers (HCWs), hospital administrators and health authorities with a thorough review of evidence on hand hygiene in health care and specific recommendations to improve practices and reduce transmission of pathogenic microorganisms to patients and HCWs. The present guidelines are intended to be implemented in any situation in which health care is delivered either to a patient or to a specific group in a population. Therefore, this concept applies to all settings where health care is permanently or occasionally performed, such as home care by birth attendants. Definitions of health-care settings are proposed in Appendix 1.

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Lista de antineoplásicos y otras substancias peligrosas en hospitales #NIOSH 2012

IR A NIOSH DOCUMENT

The National Institute for Occupational Safety and Health (NIOSH) Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings was published in September 2004. In Appendix A of the Alert, NIOSH identified a sample list of major hazardous drugs. The list was compiled from information provided by four institutions that have generated lists of hazardous drugs for their respective facilities and by the Pharmaceutical Research and Manufacturers of America (PhRMA) from the American Hospital Formulary Service Drug Information (AHFS DI) monographs [ASHP/AHFS DI 2003]. The 2004 list was updated in 2010; this update adds 26 drugs to the 2010 list. These additions are new drugs or existing drugs that had new warnings from 2007 to 2009. 
Referencias: 

• Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings 2004
• NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings 2012 

Publica Science artículo de Fouchier sobre la transmisión de influenza H5N1

Ir al artículo original

Finalmente la revista Science publica el controversial artículo original de Fouchier et al. sobre la transmisión de influenza H5N1 en mamíferos.

REFERENCIAS

• Comentario editorial por Bruce Alberts. >> H5N1 << 
• Herfst et al. Airborne Transmission of Influenza A/H5N1 Virus Between Ferrets. Science 22 June 2012: Vol. 336 no. 6088 pp. 1534-1541. Artículo original
• Anthony S. Fauci and Francis S. Collins. Benefits and Risks of Influenza Research: Lessons Learned. Science 22 June 2012: 1522-1523.
• Mark S. Frankel. Regulating the Boundaries of Dual-Use Research. Science 22 June 2012: 1523-1525.
• Carrie D. Wolinetz. Implementing the New U.S. Dual-Use Policy. Science 22 June 2012: 1525-1527.

ABSTRACT
Highly pathogenic avian influenza A/H5N1 virus can cause morbidity and mortality in humans but thus far has not acquired the ability to be transmitted by aerosol or respiratory droplet (“airborne transmission”) between humans. To address the concern that the virus could acquire this ability under natural conditions, we genetically modified A/H5N1 virus by site-directed mutagenesis and subsequent serial passage in ferrets. The genetically modified A/H5N1 virus acquired mutations during passage in ferrets, ultimately becoming airborne transmissible in ferrets. None of the recipient ferrets died after airborne infection with the mutant A/H5N1 viruses. Four amino acid substitutions in the host receptor-binding protein hemagglutinin, and one in the polymerase complex protein basic polymerase 2, were consistently present in airborne-transmitted viruses. The transmissible viruses were sensitive to the antiviral drug oseltamivir and reacted well with antisera raised against H5 influenza vaccine strains. Thus, avian A/H5N1 influenza viruses can acquire the capacity for airborne transmission between mammals without recombination in an intermediate host and therefore constitute a risk for human pandemic influenza.

International Laboratory Safety Culture Survey

La prestigiosa revista Nature realiza en colaboración con el Centro para la Seguridad de Laboratorios de la Universidad de California y BioRAFT una encuesta (International Laboratory Safety Culture Survey [english]) sobre cultura de seguridad en laboratorios de investigación, e invitan a todos los investigadores a que participen, de forma anonima. La encuesta toma responderla entre 15 y 20 minutos y realiza preguntas sobre el tipo de materiales que se utilizan en investigación y que representan un riesgo para el personal, prácticas de entrenamiento, políticas de seguridad, actitudes y creencias, así cono su impacto en investigación. No están realizando invitaciones directas así que todos los interesados pueden participar visitando la página de Nature (AQUI), o directamente en la encuesta (AQUI).