American Dental Tech Blog

Category Archives: Industry

  • Amalgam Separation Requirements Changing

    A ruling to reduce the mercury load into publicly owned treatment works (POTW) for waste water has been proposed by the EPA.

    This will require the implementation of the best management practices (BMP), including the use of amalgam separators on or before sewer discharge lines. Amalgam separators that are certified to satisfy ISO standard 11143 are a key component of BMP’s as published by the ADA.

    Studies measuring the mercury load in sewer lines (at the street level), both before and immediately after dental offices, have shown more than 100% increase in mercury levels immediately downstream from dental offices. This study shows that 50% of the total load handled by POTW may be attributed to dental offices.

    The rule would, also, allow grandfathering of existing separator systems. It would only require the normal routine maintenance (e.g. cartridge changes as indicated by the separator mfr.), rather than routine testing of waste lines.

    It was announced by the EPA, in part, to encourage early adoption of amalgam separators certified under ISO standard 11143. Any separator installed prior to implementation of the rule will not be required to be replaced for the life of the separator. The ruling will start being implemented by the EPA in September of this year.

    If the EPA implements this new rule on schedule, it will not replace local regulations that might be more restrictive. Click here to determine if you already have an amalgam separator requirement where you practice.

    The EPA’s complete announcement can be seen here.

    For those Canadians reading this post, this is old news to you. It is already something you have implemented. You can read more about your regulations here.

  • 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.