The Food and Drug Administration (FDA) has determined that a risk of infection
exists with these devices because of their potential failure to sterilize dental
instruments and has required their commercial distribution to cease unless the
manufacturer les a premarket approval application. If a bead sterilizer is used,
dental health care personnel assume the risk of using a dental device FDA has
deemed neither safe nor effective.
What is air removal testing (e.g., Bowie-Dick Test)?
An air removal test is designed to detect inadequate air removal in pre-vacuum
sterilizers. Air not removed from the sterilizer chamber prevents steam from
contacting the items in a load and therefore interferes with sterilization. Follow
manufacturer instructions for how to perform the test and frequency of testing.
If a sterilizer fails the air removal test, the sterilizer should not be used until it
passes inspection by sterilizer repair personnel.
bead sterilizers
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