American Dental Tech Blog

Category Archives: News

News at American Dental Accessories

  • FDA Guidelines For Reusing Medical Devices

    In a recent announcement, the FDA has published the final guidelines for the reuse of medical devices. These new recommendations will help both dental professionals and manufactures to stop the possibility of infection from spreading across devices and practices.

    The reuse of medical devices is common, which makes this news release pretty important. With the advancement of technology, reusable medical device designs are more difficult to reprocess to remove the contaminants that might remain. Manufacturers will have to develop safer products and provide clear directions for device use, as well as instructions for reprocessing correctly. There are six listed criteria that should be addressed in the manufacturer instructions:

    1. Labeling should reflect the intended use of the device.
    2. Reprocessing instructions for reusable devices should advise users to thoroughly clean the device.
    3. Reprocessing instructions should indicate the appropriate microbicidal process for the device.
    4. Reprocessing instructions should be technically feasible and include only devices and accessories that are legally marketed.
    5. Reprocessing instructions should be comprehensive.
    6. Reprocessing instructions should be understandable.

    For more elaboration on their suggestions, please see the FDA reuse guidelines here.

    Ultimately, these safety measures will help aid patients being treated and those using the devices feel more at ease with the technology they are using, purchasing, and reselling.

  • FDA Approves First Biosimilar Product: Zarxio

    There is some good news for dental patients suffering from oral cancer. The U.S. Food and Drug Administration announced that Zarxio (filgrastim-sndz) has been approved as the first biosimilar product in the USA.

    In order to be considered "biosimilar," the product needs to be approved as being highly similar to an already-approved biological product (known as being the reference product). It also can't have any clinically meaningful differences in terms of the safety and effectiveness from the reference product. For Zarxio, the reference product is Neupogen.

    Neupogen (filgrastim) is man-made from a protein that stimulates the growth of white blood cells and helps fight off infection. Typically it is used to treat patients with a lack of white blood cells caused by cancer, bone marrow transplants, or chemotherapy.

    The difference between a biosimilar product and generic medicines is that the biosimilars are large, complex molecules produced by living organism. The generic man-made products have small molecules that are produced by chemical synthesis. Biosimilars aren't new to other countries. They have been using them for quite a few years already, but it is a big step for the United States drug industry.

    To learn more about this announcement, visit the maker's of Zarxio website (Sandoz) or read the full FDA press release here.

  • American Dental Sponsors CE at UMSOD

    The University of Minnesota School of Dentistry is presenting a course on infection control and equipment maintenance and repair in the dental office. The course will be presented on January 31st, 2015.

    The course will feature hands-on training with dental equipment. The focus will be on minor issues that staff can easily address in office.

    This course will empower doctors and staff to attend to minor issues in office to minimize downtime from equipment failures. Schedules for routine maintenance will be outlined helping to reduce equipment failures as well. This course will pay for itself if it saves you from even one service call!

    Up-to-date OSHA concerns and hazardous waste regulations will also be discussed including disinfection of equipment surfaces and materials.

    Attendees will receive 5.5 hours of CE credit.

    For more information, or to register, visit the University of Minnesota online:

    http://www.dentistry.umn.edu/dentalce/courses/dental-equipment-maintenance/index.htm

    American Dental is proud to lend support to this fantastic course offering from the University of Minnesota School of Dentistry.