The beneficial role of gastrointestinal endoscopy for the prevention, diagnosis, and treatment of many digestive diseases and cancer is well established. Like many sophisticated medical devices, the endoscope is a complex, reusable instrument that requires reprocessing before being used on subsequent patients. The most commonly used methods for reprocessing endoscopes result in high-level disinfection. To date, all published episodes of pathogen transmission related to gastrointestinal endoscopy have been associated with failure to follow established cleaning and disinfection/sterilization guidelines or use of defective equipment. Despite the strong published data regarding the safety of endoscope reprocessing, concern over the potential for pathogen transmission during endoscopy has raised questions about the best methods for disinfection or sterilization of these devices between patient uses.
Despite the high prevalence of psychiatric and substance use disorders in this population, many remain untreated. The consequences of terminating welfare assistance are worthy of further investigation, given the potential for adverse effects on both mothers and their young children.
Positioning or repositioning a patient on the OR bed in preparation for a surgical procedure presents a high risk for musculoskeletal disorders, such as low-back and shoulder injuries, for perioperative personnel. Safe patient handling requires knowledge of current ergonomic safety concepts, scientific evidence, and equipment and devices to ensure that neither the patient nor the caregiver is at risk for injury. AORN Ergonomic Tool 2: Positioning and Repositioning the Supine Patient on the OR Bed provides guidelines that enable perioperative personnel to determine safe methods for positioning and repositioning a patient in the semi-Fowler, lateral, or lithotomy position in preparation for surgery.
The Perioperative Nursing Data Set (PNDS) is a nursing language that provides standardized terminology to support perioperative nursing practice. The PNDS represents perioperative nursing knowledge and comprises data elements and definitions that demonstrate the nurse's influence on patient outcomes. Emerging issues and changes in practice associated with the PNDS standardized terminology require ongoing maintenance and periodic in-depth review of its content. Like each new edition of the Perioperative Nursing Data Set, the third edition, published in 2010, underwent content validation by numerous experts in clinical practice, vocabulary development, and informatics. The goal of this most recent edition is to enable the perioperative nurse to use the PNDS in a meaningful manner, as well as to promote standardization of PNDS implementation in practice, both in written documentation and the electronic health record.
Lifting the arms, legs, or head of a patient while prepping these areas for surgery can exert strong forces on the muscles and joints of the shoulders and backs of perioperative team members who perform this task, which may lead to work-related musculoskeletal disorders. AORN Ergonomic Tool 3: Lifting and Holding the Patient's Legs, Arms, and Head While Prepping provides scientifically based determinations of the amount of weight perioperative personnel can safely lift and hold manually for up to one, two, and three minutes using one hand or both. If these weight limits are exceeded, additional staff members or assistive devices are needed to help with the task.
• An application to Health Canada (HC) to market a new drug in Canada is done by the sponsoring pharmaceutical company; the application typically includes animal data, chemistry and manufacturing data, and the results from clinical trials of various phases. The amount of data submitted in support of a new chemical entity frequently reaches hundreds of volumes.• The role of drug evaluators is to critically assess both the data and the sponsor's interpretation of the data in order to determine, on a population basis, the potential benefits and the potential harms (i.e., risks) associated with taking the drug. Evaluators apply regulatory expertise to reach an evidence-and contextbased recommendation as to the risk-benefit profile of the drug within the context of the proposed conditions of use.
ABSTRACT:The role of regulatory drug submission evaluators in Canada is to critically assess both the data submitted and the sponsor's interpretation of the data in order to reach an evidence-, and context-based recommendation as to the potential benefits and potential harms (i.e., risks) associated with taking the drug under the proposed conditions of use. The purpose of this document is to outline the regulatory framework in which this assessment occurs, including: defining what "authorization to market a drug in Canada" means, in terms of the role of the sponsor, the responsibility of Health Canada in applying the Food and Drugs Act prior to and after marketing authorization, and the distinction between regulatory authorization versus physician authorization; highlighting organizational, process and legal factors within Health Canada related to authorization of clinical trials and authorization to market a drug; considerations during the review process, such as regulatory and scientific issues related to the drug, patient populations and trial designs; application of international guidelines, and decisions from other jurisdictions; regulatory realities regarding drug authorization, including the requirement for wording in the Product Monograph to accurately reflect the information currently available on the safe and effective use of a drug, and that hypothesis-confirming studies are essential to regulatory endorsement; current issues related to the review of therapies for dementia, such as assessing preventative treatments, and therapies that have symptomatic versus disease-modifying effects, statistical issues regarding missing data, and trial design issues. RÉSUMÉ: Cadre de réglementation canadien sur les médicaments. Au Canada, le rôle de ceux qui évaluent les soumissions à l'organisme de réglementation est critique, tant en ce qui concerne l'évaluation des données soumises que leur interprétation par le promoteur afin d'arriver à une recommandation basée sur les données et sur le contexte quant aux bénéfices et aux dangers (c.-à-d. aux risques) potentiels associés à la prise du médicament, tels que décrits dans la soumission. Le but de ce document est de faire une esquisse du cadre réglementaire régissant cette évalua...
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