Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Request a Trial
Hoodin is specifically designed to perform monitoring for a life science product throughout their entire life cycle. With Hoodin, you have the flexibility to set up monitoring for a specific product (brand name) or a product type (such as a device, IVD product, or drug.) The trial project you will have access to will be customized to monitor the product or product type of your preference.
You will get access to a 14- day free trial of Hoodin
Master Adverse Event Management with Expert Insights and Powerful Tools
Discover key insights on adverse event management with Karolina Nożewska. Watch our full webinar, explore Hoodin's tools for real-time monitoring, and learn proactive strategies to enhance patient safety. Access the full recording, along with the downloadable presentation, Q&A, tools for adverse events, and more, further down this page.
Case Studies Overview
Case Study 1: Veronika Valdova - Using Smart Tools for Post-Market Surveillance
Learn how Veronika Valdova, a medical device and drug safety consultant, successfully implemented Hoodin’s platform to streamline post-market surveillance and enhance compliance.
Case Study 2: Martin King - Smart Tools for Regulatory Intelligence
Discover how regulatory affairs and quality assurance expert Martin King used Hoodin’s platform to stay ahead of regulatory updates and maintain comprehensive surveillance.
Case Study 3: Marcus Emne - Applying AI for Product Surveillance
See how Marcus Emne, CEO of Hoodin, applied AI through Hoodin’s platform to set up effective product surveillance within the life sciences industry.
Why Advanced Adverse Events Monitoring Is Crucial
Adverse events can have severe consequences, extending beyond immediate harm to patients. They can lead to significant financial costs, such as the staggering £2 billion annually incurred by the UK healthcare system.
These events also erode trust, result in legal liabilities, and impact overall patient safety. Vigilant monitoring and proactive management are essential to mitigate these risks, enhance patient outcomes, and ensure compliance with regulatory standards. By staying ahead of potential issues, healthcare providers can prevent costly incidents and safeguard their reputation.
How Hoodin Supports Your Adverse Event Management
Hoodin’s platform provides a comprehensive solution for managing adverse events with advanced real-time monitoring and analysis. Our tools enable you to swiftly track and respond to incidents, ensuring compliance with regulatory standards, improving patient safety, and mitigating risks before they escalate. Experience proactive management like never before.
Access the Hoodin Free Trial Here
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Watch the Full Webinar
🎙️ Speaker: Karolina Nożewska
📚 Theme: Adverse Events: Learning from Others' Mistakes
🗓️ When: Sep 4, 4pm CET / 11am EST
⏱️ Duration: 49 minutes
Webinar Key Takeaways
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Today's Agenda: In this RAQA Deep Dives session, we will cover the importance of vigilance and continuous learning, accessing information about adverse events, common causes and impact of adverse events on patient safety, tools for measuring adverse events, and a case study on insulin pump malfunction.
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Definitions and Impact: Adverse events are undesirable experiences associated with the use of medical devices, ranging from minor issues like skin irritation to serious complications such as device malfunctions. Approximately 10% of hospital admissions are related to adverse events, many of which are preventable, highlighting the need for robust planning and vigilance.
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Accessing Information: Information about adverse events can be obtained from regulatory databases, industrial publications, case studies, and collaborative networks. Key sources include the FDA’s database and the European Database for Medical Devices.
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Common Causes of Adverse Events: These include issues in the initial design phase, manufacturing defects, and human factors such as user errors due to complex interfaces or inadequate instructions.
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Impact on Patient Safety: Adverse events can lead to increased patient morbidity and mortality, legal liabilities for manufacturers, and loss of trust in healthcare systems. Regulatory bodies mandate strict reporting and mitigation to enhance device safety.
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Case Study: The insulin pump malfunctioned by delivering excessive insulin doses due to a software bug, leading to hypoglycemia and serious health issues. The manufacturer issued a recall, and the FDA initiated tighter regulations on software testing for medical devices.
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Tools for Measuring Adverse Events: Useful tools include incident reporting systems, patient safety surveys, root cause analysis, trigger tools, electronic health records, clinical audits, and patient safety indicators.
Complete Resources
Here are the free downloadable resources related to the session:
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