American Dental Tech Blog

Category Archives: Dental Industry News

  • Bupivacaine HCI Injection Recall

    Be aware of any injections of Bupivacaine HCI from Hospira. The lot in particular is Lot #38-515-DK. It was distributed from July 2014 to September 2014. The expiration of the affected products is February 2016.

    A customer noticed orange and black, visible particles within a single-dose, glass vial. The risks related to this issue include: localized inflammation of injection, a low-level allergic or immune response, or granuloma formation or mechanical irritation of the tissue, especially in patients with an allergy or sensitivity to iron oxide. These reactions can be in both humans and animals.

    If you have any existing inventory of this recalled lot, stop use and distribution. Notify all users and sources of the products. For more information on this press release, go to the FDA website or Hospira's website.

  • 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.