Posted September 19, 2016
By Jack Tetrault
“Challenges & Solutions for Reusable Medical Devices Requiring Reprocessing”
There’s been an important development in the 2016 FDA science priorities that involves taking a stronger look at the reprocessing cycle and the impact on reusable medical devices. The regulations aim to enhance technologies associated with reprocessing as well as the related design of the medical devices. And as reprocessing gets more focus and attention, this development will naturally lead to a closer examination of the device design characteristics and relation to life-cycle and fit-for-use properties.
Why the Shift in Priorities?
Demand for high performing aluminum anodized products in the medical industry has never been higher. Driven by poor performing anodic coatings, the medical industry has attempted to replace aluminum anodized products with several substitutes. A few that come to mind are nylon-coated trays and cases, and plastic, stainless steel, and titanium materials have also been investigated to replace aluminum equipment. The underlying need is real. However, the substitutes chosen to replace anodized aluminum, so far, have all had their share of problems as well.
Anodized Aluminum Remains Viable for Medical Devices
Up to now, there has been a certain amount of tolerance for these poorer performing anodized products because it was accepted that this was just how anodize reacted to the conditions that the medical industry exposed them to. In particular, fading of color during sterilization, and the dissolution of the coating during cleaning with more aggressive cleaning agents—the latter being managed through more restrictive cleaning protocols, but not always effectively. However, certain high-profile incidents of cross contamination and patient infection have raised the awareness of how reprocessing of the device is a key consideration when commercialization a new device; and this has given more data on the actual cleaning performance as well as performance of the coating. Thusly, there has been an increased call for improved anodize performance.
The MICRALOX® Solution
New technology has been born of this demand, which is increasing the chances that anodized aluminum will remain the top choice of manufacturers. MICRALOX® is a patented aluminum oxide coating with a micro-crystalline barrier that revolutionizes aluminum anodizing. MICRALOX® produces a long lasting, virtually indestructible surface that delivers dramatically superior chemical corrosion resistance and eliminates color fading due to super-heated steam, and is an excellent alternative to stainless steel, plastic, and other materials.
2016 FDA Science Priorities
While MICRALOX® offers a viable solution for aluminum anodizing for medical devices, the need to continue to educate the anodizing and medical industries about challenges and solutions remains. It’s understandable that the FDA is taking a closer look at the priorities that surround reusable medical devices requiring reprocessing. Are you familiar with these changes, their priorities, and what that means for your devices made from aluminum? Do you need to get up to speed on them? DCHN understands the importance of this FDA priority and has proactively created solutions to help you design your devices with these properties in mind.
Our one-hour, pre-recorded webinar, Challenges & Solutions for Reusable Medical Devices Requiring Reprocessing will 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
This pre-recorded webinar explores this new technology, as well as the possible choices in the medical world for reusable medical equipment that undergoes sterilization, cleaning, and/or disinfecting. Get instant access to this recording to learn about these regulatory issues that impact the aluminum anodizing industry today, and into the future. Watch the webinar now!