Which regulatory agency approval is required for the manufacturing and labeling of an autoclave before its use in dental office?

OSHA requirements are set by statute, standards and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at https://www.osha.gov.

September 3, 2004

Ms. Elizabeth Rios
Certified Dental Assistant
Dental Hygiene Onsite, Inc.
224 Datura Street, 7th Floor
West Palm Beach, FL 33401

Dear Ms. Rios:

Thank you for your January 16, 2004 letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP) regarding the applicability of OSHA standards in processes involving autoclaving on dental instruments on private property. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any questions or situations not delineated within your original correspondence. The scenario and specific question you raised in your letter and through phone conversation with a member of the [DEP] staff have been rephrased below, followed by OSHA's response. We apologize for the delay in providing you a response.

Scenario: Dental Hygiene Onsite, Inc. employs dentists and dental hygienists who do not work in fixed dental office settings. Our services are entirely mobile, and our employees provide dental services to residents in long-term care facilities. Currently, the used instruments are being transported to our central office after being scrubbed, placed in an ultrasonic cleaner, bagged and sealed, and placed in a sealed plastic container. Autoclaving [steam sterilization] is currently being performed at our central office. As our business expands, our employees will be expected to be located in different counties and soon in different states. We would like to continue our mobile dental services by providing our practitioners with sterilization equipment that they may maintain in their homes for the sterilization of reusable instruments.

Question: What are the [OSHA] guidelines concerning autoclaving of used [dental] instruments on private property?

Response: There is no specific OSHA standard on the autoclaving of instruments. We would note that the Centers for Disease Control and Prevention (CDC) have developed guidelines and recommendations on the use and monitoring of sterilization equipment in dental healthcare settings, and the Food and Drug Administration (FDA) may also have relevant information in connection with that agency's approval of autoclaves.

Thank you for your interest in occupational safety and health. We hope you find this information helpful. OSHA requirements are set by statute, standards, and regulations. Our interpretation letters explain these requirements and how they apply to particular circumstances, but they cannot create additional employer obligations. This letter constitutes OSHA's interpretation of the requirements discussed. Note that our enforcement guidance may be affected by changes to OSHA rules. Also, from time to time we update our guidance in response to new information. To keep apprised of such developments, you can consult OSHA's website at