The FDA’s Final Guidance on medical device remanufacturing has underscored the critical need for quantitative testing. This type of testing is essential to ensuring compliance with their Guidance because it verifies that devices meet stringent safety and performance standards. Achieving accurate and reliable quantitative testing isn’t feasible without the right combination of advanced technology and … Continue reading
The U.S. Food and Drug Administration (FDA) recently issued Final Guidance on the definition and determination of what constitutes “remanufacturing” for reusable medical devices. This update aims to ensure consistency and adherence to federal regulations by original equipment manufacturers (OEMs) and third-party suppliers, distinguishing remanufacturing from servicing. This distinction clearly outlines the regulatory guidance entities … Continue reading
The recent release of the FDA’s Final Guidance on remanufacturing of medical devices sent ripples through the healthcare industry. This is especially true for healthcare organizations (HCOs) heavily reliant on reusable medical devices. This new guidance aims to clarify the distinction between servicing and remanufacturing activities, both of which are crucial for ensuring patient safety … Continue reading
The FDA’s Final Guidance on repair versus remanufacturing of medical devices has important implications for hospital suppliers. It goes beyond simple terminology — new definitions and requirements have real impacts on patient safety and hospital liability. Misinformation can lead to reputational damage and even legal repercussions. Understanding the key differences between repair and remanufacturing — … Continue reading
Recent FDA guidance on remanufacturing medical devices has shed light on the crucial distinction between repair and remanufacturing activities. Ensuring proper maintenance and repair of reusable medical devices is essential for both patient safety and continued functionality throughout equipment lifespan. Navigating the new guidelines and complying with the testing requirements can be a challenge for … Continue reading
In medicine, ensuring the safety and efficacy of equipment is paramount. From complex surgical tools to diagnostic instruments, medical devices play a crucial role in patient care — and the U.S. Food and Drug Administration (FDA) is at the forefront of mandating requirements to govern them. Specifically, the FDA releases guidance that sets the tone … Continue reading
In a perfect vision of society, healthcare would be universally accessible, with timely and effective treatment available to all. Yet the reality is often marred by challenges such as geographic isolation, financial constraints, and a scarcity of resources, all of which hinder access for many communities. Amid these challenges, advancements in medical technology are emerging … Continue reading
If the digital age has taught us anything, it’s that information is valuable — and powerful. This has always been a fundamental truth in the world of healthcare. Today, we’re seeing a marriage of digital capabilities and healthcare philosophies in pursuit of improving patient care. Nowhere is this more evident than within the scope of … Continue reading
Ultrasound is a tried-and-true technology, applicable across a spectrum of clinical applications. It’s becoming more critical with the shift toward value-based care (VBC). Today’s technology offers decisive point-of-care ultrasounds, delivery, and treatment monitoring as part of complex care plans. Yet, unlocking the full potential of ultrasound in VBC requires more than just a skilled hand … Continue reading
Healthcare is in a period of necessary evolution, with traditional fee-for-service models giving way to a focus on delivering value: providing improved outcomes at lower costs. This journey requires innovative tools, and one imaging technology stands out: ultrasound. Its accuracy, efficiency, accessibility across a myriad of clinical applications, and lower cost are proving remarkably suited … Continue reading
