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 (
