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Frequently Asked Questions - Bead Sterilizer

 

Are bead sterilizers an effective means of sterilization?

Bead sterilizers are not acceptable for sterilization of items between patients. Studies have shown inconsistent heating and significant temperature variation in these devices. Also, there is no system to monitor exposure of the instrument to sterilization conditions or to demonstrate that sterilization exposure parameters have been achieved in the device. Furthermore, there is no way to maintain sterility of items following removal from the bead sterilizer.

The Food and Drug Administration (FDA) is the governmental agency that regulates medical and dental devices. In January 1997, the FDA published a notice in the Federal Register requiring manufacturers marketing bead sterilizers in the United States to submit premarket approval (PMA) applications for the devices within 90 days. The PMA is a detailed and extensive submission used for higher risk devices; evidence must be submitted showing the safety and effectiveness of the device. The FDA reclassified bead sterilizers to Class III (premarket approval) because there is an unreasonable risk of illness and injury due to potential failure of the device to sterilize dental instruments adequately. According to the FDA, no one has submitted any PMA requests for these devices; therefore, there are no legally marketed bead sterilizers at this time. If a bead sterilizer is used, the user is assuming the risk of using a dental device that the FDA has deemed not to be safe and effective.

Common acceptable methods for heat sterilization include steam, dry heat, and unsaturated chemical vapor. The only sterilization devices that should be used in dental offices are those that have been approved by the FDA.

Selected References and Additional Resources

Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008

U.S. Department of Health and Human Services Food and Drug Administration. 21 CFR Part 872 Dental Devices; Endodontic Dry Heat Sterilizer; final rule. Federal Register 1997;62(13):2900.

 

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