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Medical devices: Council adopts new measures to help prevent shortages The Council has adopted new rules updating the law on medical devices in order to help prevent shortages and ease the transition to greater transparency and access to information. The regulation adopted today amends the legislation on medical devices, including in-vitro diagnostic medical devices (IVDs), by: further extending the transition period for certain IVDs enabling a gradual roll-out of EUDAMED, the new electronic database requiring manufacturers to flag up potential shortages of critical medical devices and IVDs Overview of the key changes In 2017, new rules were introduced to modernise and update the EU framework for IVDs, guaranteeing their safety and effectiveness. The amendment adopted today extends the deadline for transitioning to the new system under certain conditions, to avoid shortages of critical IVDs without compromising on safety. The new regulation also enables a gradual roll-out of the European database on medical devices (EUDAMED) by requiring manufacturers to provide information about their products to existing EUDAMED modules without needing to wait for the remaining modules to be completed. This mandatory registration is expected to take effect as of late 2025. Today’s revision also introduces an obligation for manufacturers to give prior notice about any interruption of supply of certain critical medical devices or IVDs to relevant authorities, health institutions, healthcare professionals and economic operators to whom they supply the device. https://lnkd.in/d6vuMSzC

Medical Devices classes categories shows usage against higher or lower risk #AuraCare #MedicalEquipment #MedicalDevice #MedicalEquipmentSupplier #Healthcare #Manufacturer

Medical Equipment Classes with Aura Care Enhancing Healthcare with Aura Care’s Medical Equipment Expertise In the dynamic realm of medical Equipment, ensuring safety and efficacy is paramount. At Aura Care, we pride ourselves on delivering high-quality medical equipment that aligns with regulatory standards. Let’s delve into the significance of medical Equipment classes and how manufacturers like Aura Care navigate this intricate landscape. Decoding Medical Equipment Classes: A Crucial Regulatory Framework When it comes to medical equipment, regulatory agencies play a pivotal role in safeguarding patients and users. The classification system, as defined by esteemed bodies like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), categorizes devices into different classes based on the associated risk. This classification is not just a regulatory formality but a key determinant of the pathway manufacturers must follow. Aura Care’s Commitment to Safety: Understanding Device Classes Class I: Crafting Confidence in Low-Risk Devices Aura Care acknowledges the importance of low-risk devices, exemplified by everyday essentials like bandages and tongue depressors. These products, subject to minimal regulatory control, play a crucial role in healthcare settings. Our commitment to quality ensures that even in Class I, we adhere to rigorous standards. Class II: Elevating Standards in Moderate-Risk Devices Moderate-risk devices, such as powered wheelchairs and diagnostic equipment, require a higher level of regulatory scrutiny. Aura Care’s dedication to excellence is evident in the meticulous processes involved in bringing these devices to market. We navigate the regulatory landscape with precision, ensuring compliance with premarket notification requirements. Class III: Pioneering Excellence in High-Risk Devices For high-risk devices like implantable pacemakers and life-supporting equipment, Aura Care goes above and beyond. With stringent regulatory requirements and the need for premarket approval, our commitment to safety and efficacy stands as a testament to our dedication to advancing healthcare technologies responsibly. Class IV (in some regulatory systems): Reserved for Exceptional High Risk Some regulatory systems, like the European Union, have a Class IV designation for certain high-risk devices that require additional scrutiny. These devices often involve new technologies or present unique challenges in terms of safety and efficacy. Redefining Medical Equipment Excellence In conclusion, the classification of medical devices is not merely a bureaucratic process; it’s a commitment to excellence and a testament to Aura Care’s dedication to advancing healthcare responsibly and safely. Explore the range of medical equipment at Aura Care and witness the difference in quality and commitment. #aura #auracare #healthcare #medicalequipment #medicaldevice #medicalequipmentsupplier #medicaldevicesales #MedicalDeviceRisks

Mindray Patient Monitors Available at Auxo Medical In the ever-evolving field of healthcare, patient monitoring plays a crucial role in ensuring the well-being and safety of patients. Auxo Medical, a trusted provider of medical supplies, offers a wide range of patient monitors, including those from the renowned brand Mindray. With their commitment to innovation and accuracy, Mindray patient monitors are a reliable choice for healthcare professionals in various medical care settings. The Importance of Patient Monitors Patient monitors are essential devices that provide healthcare professionals with real-time information about a patient’s vital signs and overall condition. These monitors enable medical practitioners to detect any changes or abnormalities […] Read the full article online: https://lnkd.in/eyuFEbTm #Accutor #AuxoMedical #biomed #biomedical #BiomedicalEquipment #DPM #ePM10 #ePM12 #Mindray #MindrayPatientMonitors #PatientMonitors

On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. The Rules encompass three parts: https://lnkd.in/gggZqxNs

On May 11, 2024, China’s National Medical Products Administration (NMPA) released the Announcement on Rules for the Classification of Medical Device Products (hereinafter referred to as the Rules). The enforcement of the Rules will start from September 1, 2024. Background The Rules will replace the current version of the working procedures and requirements for the classification of medical devices,   stipulated in Document No. 127 of 2017. In recent years, the medical device industry has developed rapidly, which presented new challenges for classifying and managing medical devices, such as for responding to the public emergency incidents. The need to further optimize the process, requirements, and efficiency of classification work has become urgent. Therefore, the NMPA organized the revision of the Rules, also aimed at supporting some of the tasks assigned in the Opinions of the National Medical Products Administration on Further Strengthening and Improving the Classification Management of Medical Devices, namely, enhancing the quality and efficiency of classification determination work, and promoting the innovative development of medical devices. The Rules encompass three parts: https://lnkd.in/gggZqxNs

The TMC is the world’s largest medical complex, TMC has played a pivotal role in shaping the future of healthcare. Today, TMC is on a mission to further accelerate the pace of healing by harnessing their collective expertise in innovation, research, development, production, and patient care within a single, centralized medical ecosystem. Looking ahead, it’s clear that treatment is becoming more curative, more personalized, and more-timely than ever before. TMC’s commitment to collaborative medicine and research continues to better millions of lives. In the early 1940s, a group of visionary Houstonians conceived a world-class medical district – Texas Medical Center (TMC). Over the past seven decades, the original 134 acres have grown to over 1,345 acres sitting at the heart of Houston. Today, TMC is home to 106,000 employees, 50,000 life science students, and thousands of volunteers. More than 160,000 people visit TMC daily with over 10 million patient encounters annually. As a center of innovation advancing life sciences through collaboration, education, and research, The TMC is well-positioned to continue its evolution in the coming years. Over the next five years, TMC will expand its 50 million square feet of medical, research, and office space with an additional 3 million square feet currently in the planning. The world’s top medical professionals' partner at the TMC to provide a level of care that can only come from the collaboration created within the TMC. With access to resources, clinical trials, and treatments from across the TMC ecosystem, the promise of a healthier future is fulfilled daily for hundreds of thousands of patients from around the world.

FDA: 2024 CDRH Safety Report April 17, 2024 The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health (CDRH) Today, CDRH is issuing two companion reports that detail the Center's commitment to further advance our core pillars of safety and innovation. The CDRH 2024 Safety Report is an update to our 2018 Medical Device Safety Action Plan and features steps we have taken in recent years to assure the safety of medical devices keeps pace with the evolving technology. The CDRH 2024 Innovation Report highlights our work to advance innovation and the progress we have made to make the U.S. market more attractive to top device developers. As we have long stated, safety and innovation are not polar opposites, but rather two sides of the same coin. Our focus on safety and innovation stems from our vision to protect and promote the public health by assuring that medical devices on the U.S. market are high-quality, safe and effective, and that patients and providers have timely and continued access to these devices. Since 2009, CDRH has focused our efforts on advancing the development of safer, more effective medical devices that provide a significant benefit to the public health. As such, we enhanced our clinical trial and premarket review programs, including the 510(k) and De Novo pathways, and created new programs like the Breakthrough Devices Program, the Safety and Performance Based Pathway and the Safer Technologies Program to help reduce barriers for innovators. As a result of these actions and other past and ongoing efforts, the number of innovative medical devices authorized annually in the U.S. has increased five-fold since 2009. https://lnkd.in/ezM-U2HM

Article Based on Medical Technology #snsinstitutions #snsdesignthinkers #snsdesignthinking Medical technology has a major strategic factor in positioning the hospital and its perception in the competitive environment of healthcare providers. Numerous dazzling new biomedical devices and systems are continuously being introduced. They are being introduced at a time when the pressure on hospitals to contain expenditures is mounting. Therefore, forecasting the deployment of medical technology and the capacity to continuously evaluate its impact on the hospital require that the hospital be willing to make the commitment and to provide the support such a program. An in-house “champion” is needed in order to provide the leadership that continuously and objectively plans. This figure might use additional in-house or independent expertise as needed. To focus the function of this program in large, academically affiliated, and government hospitals, the position of a chief technology officer (CTO) is becoming justifiable. While executives have traditionally relied on members of their staffs to produce objective analyses of the hospital’s technological needs, they nevertheless are too often subjected to the biases of various interest groups, including marketing and vendor appeals. More than one executive has made a purchasing decision for biomedical technology only to discover later that some needed or expected features were not included with the installation or that those features were not yet approved for delivery. These features have come to be known as “futureware” or “vaporware.” Or, alternatively, it may be discovered that the installation has not been adequately planned, ending therefore as a disturbing, unscheduled, expensive, and long undertaking. Most hospitals that will be providers of quality care will be conducting technology assessment activities in order to be able to project needs for new assets and to efficiently manage existing assets within the limits of the available resources. In order to be effective, an interdisciplinary approach and a cooperative attitude are required because the task is complex. The ability to integrate information from disciplines such as clinical, technical, financial, administrative, and facilities in a timely and objective manner is critical to the success of the assessment. Medical technology includes medical and surgical procedures, drugs, equipment and facilities, and the organizational and supportive systems within which care is provided. This definition focuses on equipment, systems, facilities, and procedures (but not drugs).