Section 590. Performance standards

All sterilizers for regulated medical waste shall maintain the following level of operational performance at all times:

1. Operational temperature and detention. Whenever regulated medical wastes are treated in a steam sterilizer, all the regulated medical waste shall be subjected to the following operational standards (at 100% steam conditions and all air evacuated):

a. Temperature of not less than 250°F for 90 minutes at 15 pounds per square inch of gauge pressure;

b. Temperatures of not less than 272°F for 45 minutes at 27 pounds per square inch of gauge pressure; or

c. Temperatures of not less than 320°F for 16 minutes at 80 pounds per square inch of gauge pressure.

Equivalent combinations of operational temperatures, pressure and time may be approved by the director if the installed equipment has been proved to achieve a reliable and complete kill of all microorganisms in regulated medical waste at design capacity. Written requests for approval of an equivalent standard shall be submitted to the director. Complete and thorough testing shall be fully documented, including tests of the capacity to kill B. stearothermophilus. Longer steam sterilization times are required when a load contains a large quantity of liquid.

2. Operational controls and records.

a. Steam sterilization units shall be evaluated under full loading for effectiveness with spores of B. stearothermophilus no less than once per month.

b. A log shall be kept at each steam sterilization unit that is complete for the preceding three-year period. The log shall record the date, time and operator of each usage; the type and approximate amount of regulated medical waste treated; the dates and results of calibration; and the results of effective testing described in subdivision 2 a of this section. Where multiple steam sterilization units are used, a working log can be maintained at each unit and such logs periodically consolidated at a central location. The consolidated logs shall be retained for three years and be available for review.

c. Except as described in subdivision 2 d of this section, regulated medical waste shall not be compacted or subjected to violent mechanical stress before steam sterilization; however, after it is fully sterilized it may be compacted in a closed container.

d. Except as provided in 9VAC20-120-550, 9VAC20-120-600 E or 9VAC20-120-650 D, regulated medical waste shall be ground or shredded into particles that are no larger than an approximate size of 0.75 inches in any dimension. If size reduction takes place prior to treatment, it shall occur in a closed unit immediately preceding the treatment unit. Size reduction following treatment must occur within 24 hours of leaving the treatment unit. Transfer from a grinder or shredder to or from a treatment unit shall be under forced draft ventilation that removes fumes from the operations area to a safe discharge.

e. All process units for the preparation or treatment of regulated medical waste shall be in closed vessels under a negative pressure atmospheric control that filters all vents, discharges, and fugitive emissions of air from the process units through a high efficiency particulate air (HEPA) filter with an efficiency of 99.97% of 0.3 microns. Air and gases which have themselves been sterilized by the process are not required to pass through a filter.

Historical Notes

Derived from VR672-40-01:1 § 8.2, eff. June 29, 1994; amended, Volume 18, Issue 18, eff. June 19, 2002.

Statutory Authority

§ 10.1-1402 of the Code of Virginia.