Medical Device Risk Management

[Virtual Presenter] Good morning everyone, today we will be presenting on medical device risk management. Our discussion will focus on the significance of identifying high-risk medical devices and the methods for effectively minimizing risks throughout a device's lifecycle. We will be introducing the ISO 14971 framework as a useful tool for managing risks, and will also share a specific example of Seeba Baby, a medical device that has undergone thorough testing to ensure its safety and effectiveness. It is our aim that this presentation provides you with insightful knowledge about medical device risk management, enabling you to make informed decisions regarding the devices you use and the risks associated with them..

[Audio] This presentation focuses on high-risk medical devices, specifically in relation to slide 2. The main topic of this slide is the importance of conducting tests on these devices to ensure their safety and effectiveness. The first thing discussed is the four key factors that determine whether a medical device is considered high-risk. These factors include: devices that are necessary for sustaining life or performing critical functions are high-risk due to the severity of consequences if they fail; devices that are invasive or used for extended periods of time are high-risk due to the potential for internal harm or complications; technologically complex devices that require precise operation are high-risk, as any malfunction or user error can result in serious harm; and devices that are susceptible to misuse or abuse are high-risk due to the potential for harm to the user or others. To illustrate these factors, we provide an example of Seeba Baby, a device used to support premature infants. This device is considered high-risk due to its life-sustaining function, invasive nature, complexity, and potential for misuse. In conclusion, it is crucial to conduct thorough testing on high-risk medical devices to ensure the safety and effectiveness for patients. These tests are essential in identifying potential issues and preventing harm to patients..

[Audio] This presentation focuses on high-risk medical devices and the importance of conducting tests on them. One example we will be discussing is the Seeba Baby, a high-risk device that requires extensive testing to ensure its safety and effectiveness. ISO 14971 provides a framework for risk management of medical devices, with a focus on identifying and mitigating risks throughout the device's lifespan. According to ISO 14971, a medical device is classified as high-risk if it meets specific criteria that evaluate the potential for harm. These criteria include a high severity of potential harm, a high probability of failure, complexity that adds risk, and challenging risk mitigation requirements. Throughout this presentation, we will delve into each of these criteria and also explore the specific testing necessary for the Seeba Baby. By the end, you will have a thorough understanding of the significance of testing high-risk medical devices and the unique challenges and considerations involved in this process..

[Audio] We are currently discussing medical equipments that have a high potential to cause harm to patients. The main focus is on Seeba Baby and the purpose of conducting tests. These devices have been assigned a specific level of risk, which is determined by a fuzzy logic model developed by Douglas Clarkson. This risk level is used to determine the appropriate service interval, unless there is an exception. However, some models have been found to have different risk levels depending on their location, and the devices are not being maintained according to the manufacturer's instructions. The current risk model is difficult to comprehend, and the results have to be adjusted to make sense. Moreover, there is a lengthy list of exceptions, and no other department is following this approach. Additionally, S-M-Ls (Specific Maintenance Levels) have been given a lower priority. It is crucial to address these issues in order to ensure the safety of patients and to effectively manage these medical devices..

[Audio] Discussions are currently taking place regarding high-risk medical devices and the significance of testing. According to a Swedish risk model from 2009, the likelihood of a medical device malfunction is dependent on three factors: Device Failure Factor, Device Maintenance Factor, and Device Function Factor. The Device Failure Factor is determined by multiplying the Mean Time to Failure with the Consequence to the patient/user. The Device Maintenance Factor is calculated by multiplying the Frequency of required maintenance by the Nature of the maintenance itself. The Device Function Factor is established based on the Redundancy of the device, following the manufacturer's instructions. An example of the application of this risk model will be given, using the Seeba Baby, a specific high-risk medical device. More information on this subject will be shared, so stay tuned..

[Audio] It is necessary to have a discussion about the significance of testing medical devices, particularly those with a higher probability of failure, such as Seeba Baby. This specific device has a failure frequency of more than three times per year and can lead to life-changing or fatal consequences. To determine the required maintenance frequency and level for Seeba Baby, a 5x5 matrix was utilized. This involved multiplying the frequency of maintenance with the level of maintenance needed. According to this analysis, Seeba Baby requires maintenance more than once per year, with the replacement of parts and calibration being the most crucial maintenance levels. Furthermore, we calculated the device function factor for Seeba Baby, which takes into consideration the impact of the failure on the device's service, the level of redundancy, and whether the failure results in a disruption to treatment. Seeba Baby has a significant impact on service, no redundancy, and failure to function, meaning that any malfunction of this device can greatly affect patient care. Lastly, we established the risk level band for Seeba Baby, which is classified as high risk and has a score of 35-60. This indicates that Seeba Baby is a device that requires close monitoring and testing to ensure its safety and effectiveness. In conclusion, testing medical devices is crucial to guaranteeing patient safety and preventing catastrophic failures. Seeba Baby is a high-risk device that requires thorough testing and maintenance to ensure its safe and effective utilization. Thank you for your attention..

[Audio] We will be discussing the importance of conducting tests on high-risk medical devices, specifically the Seeba Baby ventilator and how its risk score is determined. The risk score takes into account various factors such as design, functionality, and potential for harm. These factors are assessed through a series of tests to determine the overall risk level of the device. It's essential to note that high-risk medical devices require extra attention and care to ensure their safety and effectiveness. By conducting tests and evaluations, we can identify any potential issues or risks associated with these devices and take precautionary measures before they cause harm. In conclusion, properly testing high-risk medical devices is crucial in ensuring the safety and effectiveness of these devices. This helps prevent harm and improves the quality of healthcare for patients. Thank you for your attention..

[Audio] Defibrillators are devices that are used to treat cardiac arrhythmias such as ventricular fibrillation and ventricular tachycardia. They deliver an electric shock to the heart to restore its normal rhythm. However, if used improperly or if there are defects in the device, serious consequences can result. To ensure the safety and effectiveness of defibrillators, regular testing is necessary. These tests can be divided into three categories: basic checks, system and software checks, and monitoring checks. Basic checks involve visual and battery inspections, system and software checks involve software updates and self-tests, and monitoring checks involve E-C-G and alarm checks. Therapeutic checks involve shock, pacing, and safety tests. Regular testing is critical to ensure the safety and effectiveness of defibrillators, and we hope this presentation has provided you with a better understanding of the importance of defibrillator testing and how it can save lives..

[Audio] We are currently on slide 9 out of 10 in our presentation on high-risk medical devices. Today we will be discussing the significance of conducting tests on these devices and a specific case study of Seeba Baby. Seeba Baby is a medical device used for neonatal ventilation that is equipped with various features to monitor and ensure the safety and well-being of the patient. In this presentation, we will be focusing on two main areas of testing: E-C-G and Monitoring Checks and Therapeutic and Safety Functionality Checks. In the E-C-G and Monitoring Checks, we will be conducting several tests to ensure the accuracy of the device. The E-C-G check will test the signal processing of the device, while the Heart Rate Alarm Check and S-P-O-2 and E-T-C-O-2 Check will ensure the functionality of the heart rate and oxygen saturation monitoring features. Additionally, the Notch Filter Check will test the noise reduction features for E-C-G readings. In the Therapeutic and Safety Functionality Checks, we will be testing the Seeba Baby's synchronized cardioversion mode and shock delivery at various energy levels. We will also be verifying the device's response to advisory and C-P-R prompts, testing pacing functionality, and ensuring compliance with safety standards to prevent electrical hazards. Finally, we will be performing a final 30 joule shock test to confirm consistent energy delivery. It is crucial to test high-risk medical devices to ensure their safety and effectiveness. Seeba Baby is just one example of a device that requires thorough testing to ensure the best possible outcomes for patients. In conclusion, our presentation on high-risk medical devices has covered the importance of testing these devices and the specific case study of Seeba Baby. We hope that this information will help healthcare professionals better understand the importance of testing medical devices and ensure the safety and well-being of their patients. Thank you for your attention..

[Audio] In this presentation, we will be discussing high-risk medical devices and the importance of medical device risk management. Our focus will be on the significance of conducting tests to ensure the safety, reliability, and patient-centered care of these devices. Our belief is that medical device risk management should uphold the highest standards of compassion, respect, and excellence, with a prioritization of patient-centered care above all else. We thank you for listening and hope you have found this presentation informative and useful..