The US Food and Drug Administration (FDA) regulates medical devices for
safety. To protect the health and safety of patients and dental health care
personnel, as well as to ensure the longevity of professional dental devices and
equipment, CDC recommends using FDA-cleared devices for instrument
reprocessing and following the manufacturer’s Instructions for Use.
Commercially available dishwashers are not FDA-cleared for reprocessing
instruments in medical or dental health care settings. Additionally, commercially
available detergents contain chemicals that have not been evaluated for
compatibility with medical-grade instruments and are not designed to
reprocess medical instruments.
FDA has approved several types of devices for presoaking, cleaning, and
disinfecting, including ultrasonic cleaners, washer-decontaminators, and
washer-disinfectors. FDA’s website also has guidance on medical washers and
medical washer-disinfectors.
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