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FDA issues safety advice on multiple-use dental dispensers

July 15, 2014

Silver Spring, Md.—The U.S. Food and Drug Administration July 13 published safety information on its website about multiple-use dental dispensers, also known as dental syringes.

Dentists use the devices to administer adhesives and endodontic materials and to make dental composites and apply impression materials. The advisory does not define disposable syringes or dental needles for injection of anesthetics as multiple-use dental dispensers.

According to the FDA, manufacturers typically supply multiple-use dental dispensers as pre-filled syringes with disposable tips intended to be discarded after each patient use, while the dispensers containing the remaining dental material are stored for reuse.

Risk of cross-contamination is possible when multiple-use dental dispensers are improperly used to treat patients, the FDA points out in the safety advisory:

“Contamination or infection control issues arise for future patients when the body or housing of multiple-use dental dispensers comes in contact with a previous patient’s cheek or lips, or when the dispenser is handled by a dental practitioner whose gloves have become contaminated with previous patient’s blood or saliva.”

Multiple-use dental dispensers cannot be reprocessed using sterilization, such as in a steam autoclave, or immersion due to potential damage to the material contained in the dispensers. Once contaminated, the FDA says that the devices cannot be adequately disinfected when wiped with a chemical disinfecting solution. To avoid cross-contamination to future patients, the FDA recommends disposal of contaminated multiple-use dental.

To review the safety advisory, including a list of do’s and don’ts for multiple-use dental dispensers, visit the FDA Web page Multiple-Use Dental Dispenser Devices.