The FDA released the 2016 science priorities from the Center for Devices and Radiological Health (CDRH). The report reminds us of their mission: the CDRH is responsible for assuring the safety, effectiveness, performance and quality of medical devices and radiation-emitting products used to treat, prevent, and diagnose disease—with the goal of protecting and promoting the public health. This regulatory science mission includes and is aimed at “improving the assessment of the safety, effectiveness, performance and quality of medical devices and radiation-emitting products throughout the product life cycle thereby reducing the time to market, improving safety, and making the process least burdensome.”
One of the top 10 priorities is to “improve the quality and effectiveness of reprocessing reusable medical devices.” Looking at this priority more closely, the top concerns for reprocessing reusable medical devices made from aluminum are:
- Reuse of devices introduces the risk of infection transmission to patients between uses.
- Reusable devices are commonly used in patient care and many reusable devices have evolved into more complex designs, making them more challenging to reprocess.
- To minimize patient harm from inadequately reprocessed devices and to enhance the safety, effectiveness, performance, and/or quality of these devices, it is critical to develop a comprehensive approach to address the effectiveness of reprocessing techniques.
Are You Ready for These Changes?
Are you familiar with these changes, their priorities, and what it means for your devices made from aluminum? We’ve created a webinar that examines the issues and how to specify anodic coating properties to stay ahead of this development.
Join us for our hour-long webinar: Challenges & Solutions for Reusable Medical Devices Made from Aluminum Requiring Reprocessing on Tuesday June 7th, 2016, at 11 a.m. PST; 2 p.m. EST.
We’ll bring you up to speed on:
- FDA 2016 Science Priorities
- Metal Finishing: Aluminum Anodizing & Printing
- New Performance Requirements
- Micro-Crystaline Aluminum Oxide: the MICRALOX® Solution
DCHN understands the importance of this FDA priority and has proactively created solutions to help you design your aluminum medical devices with these properties in mind. Join us as we discuss these regulatory issues that impact the aluminum anodizing industry today and into the future. Register today!
If you know of colleagues who might be interested in attending this webinar, let them know about this informative webinar. We look forward to your participation.
Click below to register for the webinar now!