Dental Handpiece Sterilization!

This guidance was written prior to the February 27, 1997 implementation of FDA'srn rnGood Guidance Practices, GGP's. It does not create or confer rights for or on any personrn rnand does not operate to bind FDA or the public. An alternative approach may be used ifrn rnsuch approach satisfies the requirements of the applicable statute, regulations, or both.  rnThis guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .  rnDear Doctor:  rnThis is to notify you that the Food and Drug Administration (FDA) recommends that reusablern rndental handpieces and related instruments (such as aidwater syringes and ultrasonic scalers)  rnbe heat sterilized between each patient use. Handpieces that cannot be heat sterilizedrn rnshould be retrofitted to attain heat tolerance. Handpieces that cannot be retrofitted andrn rnthus not heat sterilized should not be used. Chemical disinfection is not recommended.  rnThe Centers For Disease Control (CDC) fact sheet entitled "HIV Transmission in Dentalrn rnSettings," issued May 15, 1992, states "CDC and the American Dental Association have alwaysrn rnrecommended that dental handpieces be autoclaved between each patient, but in the 1980'srn rnnot all handpieces could physically withstand heat sterilization. Since 1989 CDC hasrn rnrecommended that those dental handpieces that cannot be autoclaved only be used until thern rnpractitioner can replace them with a handpiece that can be autoclaved. Components of allrn rndental handpieces currently made in the U.S. are either heat-stable or can be replaced withrn rncomponents that are heat-stable."  rnThe American Dental Association document entitled "Infection Control Recommendations forrn rnthe Dental Office and the Dental Laboratory" published in a supplement to the August 1992rn rnissue of The Journal of the American Dental Association states, "Although no documentedrn rncases of disease transmission have been associated with contaminated dental handpieces orrn rnprophy angles, sterilization between patients with acceptable methods which assure internalrn rnas well as external sterility is recommended for these instruments." For the complete text ofrn rnthis document, refer to the supplement to the August 1992 issue of The Journal of thern rnAmerican Dental Association