New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter II - Administrative Rules and Regulations
Subchapter I - Environmental Health
Part 70 - Regulated Medical Waste
Subpart 70-3 - Requirements For Autoclaves Used To Treat Regulated Medical Waste
Section 70-3.2 - Operational requirements
Current through Register Vol. 46, No. 12, March 20, 2024
(a) Each facility seeking to operate an autoclave shall develop an operation plan, and shall submit such plan to the department for review and approval prior to using the autoclave to treat regulated medical waste. Any change in procedures related to the operation of the autoclave shall be reflected in a modified plan, which shall be dated with each revision.
(b) No autoclave shall be used to treat regulated medical waste without department approval of the facility's operation plan and any modifications made to such plan on or after the effective date of this regulation.
(c) The operation plan shall be designed to promote safe and effective operation of the autoclave. The operation plan shall include, minimally, procedures to ensure:
(d) Any modification of an approved operation plan with potential to substantially alter treatment efficacy shall be submitted to the department for approval. Prior to approving a modified plan, the department may require that validation testing be conducted again by the facility, and the results submitted for department review.
(e) Whenever an autoclave fails to operate in accordance with pre-established operating parameters, the facility shall:
(f) Monitoring autoclave operator.
No autoclave that fails to attain 4 log 10 reduction in viable spores concentration upon challenge testing shall be used to treat regulated medical waste. Whenever time/temperature-sensitive materials fail to show expected results (i.e., a color change), the load shall be handled as untreated waste, and the facility shall demonstrate, through a repeat of validation testing, that the autoclave effectively treats regulated medical waste before resuming its use for treatment purposes.
(g) Containment of regulated medical waste for treatment by autoclaving shall be by a container or containment system designed to withstand the temperature and pressure of autoclaving, and may, except for sharps, consist soley of a red bag.
(h) If the container or containment system does not, by design, allow steam to come into direct contact with waste material, the operator shall take action to ensure such contact.
(i) Sharps treated by autoclaving shall be destroyed prior to disposal.