“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”
The FDA is hosting it next town hall on medical device sterilization on April 29. The session will include discussion on topics and formats for future sessions in the series.
“We’ve arrived at a historically strong rule that will protect the most exposed communities from toxic air pollution while also ensuring that there will be a process that safeguards our nation’s critical supply of sterilized medical equipment.”
The Joint Commission and Kaiser Permanente are accepting applications now through April 30 for the 2024 Bernard J. Tyson National Award for Excellence in Pursuit of Healthcare Equity. The award recognizes major achievements in improving healthcare disparities.
“FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO),” the second in a series of medical device sterilization town hall discussions hosted by the FDA, will take place on January 26 from 12:00pm – 1:00pm ET.
Bob Tilling, VP of Global Sales at Kallik, delves into dupe culture and its link to counterfeit drugs, and explains how developments in label management can foil illicit traders.
Researchers found that mechanical stress caused by implants leads immune cells to activate RAC2 and other proteins, which then summon additional immune cells, including types that can combine to attack a large invader. These findings may help improve the design and safety of implants.
Instructional materials help users grasp how to use a device safely. Renée Bailey, Certified Instructional Technologist (CIT), explains how effective instructional materials are vital for the medtech design process, and shares necessary considerations to produce instructions that are coherent, easy to understand and aligned with the human factors engineering process.
The FDA has updated its guidance, Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process,” to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” in pre-market applications.
Magnetic resonance imaging (MRI) helps discover serious threats early and in a precise and painless way. However, patient safety may be in danger when medical implants interact with the electromagnetic environment. The developers of such implants are obliged to check the safety of their products under these conditions.
