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    What you NEED to know about single-use instruments

    Why dental professionals shouldn't use these products more than once.

    After using a disposable instrument, it can be pretty tempting to put that instrument through the sterilization process and use it a second time — especially if it seems to be made well and looks like it’s strong enough to handle it. This is something many (if not most) dentists have done at least once to save a little money. Unfortunately, this can result in a variety of problems that do your practice — and your patients — more harm than good.

    Reusing disposable instruments puts your patients at risk. Not only is there the potential for cross-contamination, but if single-use products are put to work more than once, they’re simply not going to be as effective as they should be, no matter how strong or well-made they look. This hurts the quality of the care you provide and could negatively impact a patient’s experience in your practice.

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    “I have this discussion with dentists frequently and I ask them what if that was your daughter in your chair? Would you use a new set of instruments? They don’t like to answer that question,” says John Ferone, Henry Schein’s executive director, global endodontic category management. “Then I ask why should the standard of care be any different whether it’s your daughter or any other patient? That seems to resonate. It’s a reality check.”

    This isn’t an issue that’s unique to the dental industry, says Christine Santagate, director, northeast regional operations at Regulatory and Quality Solutions (R&Q). It happens in the medical field in general, with many healthcare professionals seeing reusing disposable items as a cost-saving measure. But it’s important to understand that these products are single-use for a reason. Devices have to be tested to prove they can be used in more than one procedure and provide the same results each time. If they can’t, then they’re only indicated for one-time use.

    If you want to provide your patients with the best care possible, one way is to become familiar with the FDA’s single-use guidance, understand why it’s in place and then actually follow the agency’s recommendations. Single-use products can offer your practice many benefits, but only if they’re used properly.  

    The policy

    Guidance from the FDA on single-use or disposable devices goes across the board for all medical devices that can be packaged sterile or non-sterile, depending on their end use, Santagate says. For single-use items, the guidance states products should only be used on one patient during a single procedure and then properly disposed.

    Single-use instruments“The FDA recommends that providers follow the labeling for individual products, including whether the device is single-use or multi-use. If device reprocessing instructions are not provided, it should be considered single-use,” according to the FDA. “The provision of reprocessing instructions would require a new premarket clearance (510(k), which is a type of premarket review) as reprocessing changes the intended use of the product.”

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    Even though the guidance is clear, many providers still opt to not follow it, mainly because they think reusing certain instruments saves them money. When a violation is reported, the manufacturer is notified and then required to contact the dentist to clarify the instructions for single-use, Santagate explains.

    “Dental staff can contact the FDA and alert them about misuse. Anybody can do that,” she says. “The FDA might not be coming in and checking on you, but they are auditing manufacturers and making sure they have appropriate labeling and instructions. It’s important to remember these products aren’t made to be reused. These devices haven’t been tested to go into the autoclave or disinfectant, and putting them through the sterilization process might compromise them.”

    Continue to page two to read more...

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