Latest news with #AdverseEvent
The Herald Scotland
29-05-2025
- Health
- The Herald Scotland
Why do so many Scots die from a stroke?
His son, James has told the Herald he had to wait 17 hours for the surgery that might have saved his life and are demanding changes to treatment in Scotland. It has emerged that an NHS Greater Glasgow and Clyde's Significant Adverse Event Review (SAER) into Mr Bundy's death from August of last year, seen by the Herald states that there is no night-time provision - between 8pm and 8am - for thrombectomy across any health board area in Scotland. What is a stroke? A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells dying within minutes. Strokes are medical emergencies that require prompt treatment to minimize brain damage and potential complications. What is the stroke rate in Scotland? The European Standardised Rate for strokes in Scotland in 2022-23 year was 479.2 per 100,000 of population, the highest since the start of Public Health Scotland's records in 2013-14, when it was 398.0. ------------------------------------------------------------------------------------------------------------------------ READ MORE: Revealed: Scotland's failure to give 24/7 treatment for strokes 'costing lives' 'Devastating consequences': Anger as Scot Govt slashes stroke thrombectomy funding --------------------------------------------------------------------------------------------------------------------------Nearly 20,000 Scots have died from strokes over five years to the end of 2022. There were 3,806 deaths in Scotland in 2023 where cerebrovascular disease, including stroke, was the underlying cause. There are approximately 12,000 hospital admissions for stroke each year in Scotland, averaging 33 admissions per day. In 2023/24, the number of new cases of cerebrovascular disease, including stroke, in Scotland was 239 per 100,000 population. This represented a nine per cent decrease compared to 262 per 100,000 in 2014/15. Why do people die from a stroke? Primarily because it disrupts the blood supply to the brain, depriving brain cells of oxygen and nutrients. Brain tissue is highly sensitive to oxygen deprivation. Within minutes, affected brain cells begin to die. If blood flow is not quickly restored, critical areas of the brain that control breathing, heart function, and consciousness can be permanently damaged. Eight five percent of case are ischemic strokes and they are caused by a blocked artery (blood clot or atherosclerosis). James Bundy (left) with late father Tony (Image: Contributed) Brain tissue beyond the blockage begins to die and swelling (cerebral edema) can increase pressure inside the skull, compressing vital brain areas or cutting off additional blood flow. Why have so many Scots died from a stroke? Stroke is one of the biggest causes of Scotland after heart disease and cancer. It has in the past been seen as being due to a combination of health inequalities, lifestyle factors, and systemic issues in prevention and treatment. While stroke mortality in Scotland has declined over recent years, it has historically been higher than in many other parts of the UK and Europe. According to the Scottish Public Health Observatory, over the 20-year period from 1990 to 2010, Scotland had higher mortality rates for cerebrovascular disease, including stroke, than those in the rest of the UK and other Western European countries. Public Health Scotland in a briefing last year said Scotland has a "high prevalence" of the risk factors associated with cerebrovascular disease such as smoking and high blood pressure. Despite a substantial decrease in rates of death over previous decade, treating and preventing stroke was seen as a national clinical priority for Scotland According to University of Edinburgh guidance about strokes from last year there is concern that given increasing population exposure to some of the key risk factors for stroke in Scotland - obesity, smoking, alcohol misuse, high blood pressure, diabetes - that the incidence of stroke may increase in future years. What treatments are available for stroke victims in Scotland? Treatment for stroke in Scotland involves immediate medical intervention followed by rehabilitation: Thrombolysis involves the administration of clot-dissolving medication and is for ischemic strokes. Thrombectomy involves the surgical removal of a blood clot from a brain artery. Medications are often needed to control blood pressure, cholesterol, and prevent further clotting. Multidisciplinary teams provide physiotherapy, occupational therapy, and speech-language therapy. Community-based programs also support patients in regaining independence. The Scottish Government's Stroke Improvement Plan launched three years ago emphasised equitable and timely access to diagnosis, treatment, and rehabilitation services across all regions. What is the outlook for stroke survivors? According to Public Health Scotland as of 2023, survival rates have improved, with 84% to 86% of patients surviving 30 days or more following their first emergency admission to hospital with a stroke over the past ten years. (Image: Getty) However, recovery can vary. Some individuals recover fully, while others may experience long-term disabilities. Rehabilitation can take months or years and may involve adapting to new ways of living. But support services are available to assist stroke survivors in their recovery journey. How can strokes be prevented? According to the NHS, preventative measures include maintaining a healthy diet and regular exercise, controlling blood pressure and cholesterol levels and avoiding smoking and excessive alcohol consumption. Additionally, managing underlying conditions like atrial fibrillation with appropriate medications can reduce stroke.
Associated Press
17-04-2025
- Health
- Associated Press
Medical Device Studies, Regulatory Requirements and Adverse Event Reporting Training Course (ONLINE EVENT: May 7-8, 2025)
DUBLIN--(BUSINESS WIRE)--Apr 17, 2025-- The 'Medical Device Studies: Regulatory Requirements and Adverse Event Reporting Training Course' has been added to offering. This seminar provides an essential overview of medical device clinical evaluations, clinical investigations and PMCF studies with particular emphasis on the adverse event reporting requirements during these studies. The course will concentrate mostly on the new Medical Device Regulations (MDR) with some references to the existing Medical Device Directives. It will provide a good introduction to medical device clinical studies and serve as an update for those with experience who need to keep abreast of the regulatory changes and the methods of handling adverse events during the study period. It also covers the new requirements regarding periodic safety update reports (PSURs) and the summary of safety and clinical performance. Certification: Who Should Attend: Agenda: Clinical evaluation - An Overview Clinical investigations - An Overview PMS and PMCF Quiz on clinical evaluation, clinical investigation and PMCF New requirements of the MDR The competent authority and the Notified Body Workshop on the new requirements of the MDR Vigilance reporting How to define and classify adverse events Vigilance workshop The regulatory requirements for monitoring and reporting adverse events during regulatory and PMCF studies The MDR - clinical elements Speakers: Janette Benaddi Director of Clinical & Consulting Europe NAMSA Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years' experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Janette has worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products as well as regulatory expertise for CE marking of devices. Specifically she has been involved in writing and reviewing hundreds of Clinical evaluation reports for the medical device industry, she has also provided training to Notified bodies in this subject. Janette qualified as a registered nurse in 1984, she has a BSc in Management studies, a Diploma in Company Direction, and a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist and Chartered Director. Janette sits on several committees in the device community and industry and has been an instrumental advocate of improving and advancing medical device research in the UK. Janette has published several articles relating to medical device regulation and clinical studies. For more information about this conference visit About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. View source version on CONTACT: Laura Wood, Senior Press Manager [email protected] For E.S.T Office Hours Call 1-917-300-0470 For U.S./ CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 KEYWORD: INDUSTRY KEYWORD: HEALTH PRACTICE MANAGEMENT MEDICAL DEVICES SOURCE: Research and Markets Copyright Business Wire 2025. PUB: 04/17/2025 08:20 AM/DISC: 04/17/2025 08:20 AM
