PPT-1 GUIDANCE ON THE USE OF THE HSE FATIGUE & RISK INDEX FOR INVESTIGATIONS

2 Purpose The purpose of this document is to provide all investigators and designated competent persons a brief and awareness of how to use the Fatigue and Risk Index FRI as part of investigations We are providing this guidance document to ensure that fatigue including the FRI is adequately considered as part of the Level 1 investigation and Levels 2 amp 3 as a potential causal factor of an incident . Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER March 2014 ClinicalMedical 16617dftdoc 030614 brPage 2br Guidance for Industry Chronic Fatigue Sy 3 1 Research ethics committee approval3 2 Grounds for objection 4 3 Labelling of medical devices Assistant Professor in Neurology . Medical Director. Vanderbilt Sleep Disorders Center. Fatigue Science & Safety. Occupational Sleep Medicine. None. Disclosures. EXXON VALDEZ. DRIVING. WHEN. DROWSY. (Tel) 301-827-4573 (Internet) http://www.fda.gov/cder/guidance/index.htm (Tel) 800-835-4709 or 301-827-1800 (Internet) http://www.fda.gov/cber/guidelines.htm Contains Nonbinding Recommendations risk index for shiftworkers Prepar ed by QinetiQ Centre for Human Sciences & Simon Folkard Associates Limited for the Health and Safety Executive 2006 RESEARCH REPOR T 446 The development of a f Steven R. Hursh, Ph.D.. President, IBR and. Professor, Johns Hopkins University School of Medicine. September 1, 2011. Major Fatigue Factors. Time of Day. : . between midnight and 0600 hrs.. Recent Sleep. What is fatigue?. The main factors are:. Loss of sleep. “Acute . sleep loss” . – . not obtaining our required sleep for one night e.g. 5hrs instead of usual 8hrs.. “Cumulative sleep loss” – having 6hrs sleep instead of usual 8hrs over several days.. Review of Proposal. Presenter: Jacques R Conaway, MD, FCCP, FAASM. Medical Director, Sleep Center. Member, Emerging Physician Leadership Council. . September 2, 2013. 1. Fatigue Management Program. Prof Philippa Gander PhD, FRSNZ. Dr Karyn O’Keeffe PhD. Outline. Background to the project. Principles. Project Team. Fatigue risk management. Legal requirements. Causes and consequences of fatigue. Specific topic 2: Managing fatigue risks Suggested approach for sites The suggested approach for sites on this Introduction Fatigue, as it affects control of MAHs, is an issue which has been little Outline. Background to the project. Project aims, processes and outputs. Fatigue is inevitable when 24/7 cover is required. Project aims include evidence-based fatigue risk management . The aim is to work together to implement a new approach. Harriet . McCaffrey, Specialist Physiotherapist . Dr Marta . Prytys. , Clinical . Psychologist. Locomotor ME/CFS Service. . Aims . What is post COVID syndrome. Top tips and tools . F. atigue management interventions . Analysis from 2022 LV and Mobile Equipment SI reported that the top 3 contributing factors were. service and maintenance of LV and Mobile Equipment . At-risk driving behaviours and,. Fatigue . 39% of top 3 contributing factor related directly to Fatigue..