The Department of Health in the state of Ohio has released an updated Infection Prevention and Control manual for 2009. This comprehensive document covers topics as far ranging as the management of pandemic influenza and how to deal with the threat of bioterrorism. One segment in this booklet deals specifically with issues of interest to sterile processing departments.
Section 4 focuses on disinfection and sterilization of surfaces, instruments, and equipment. The DOH divides items into 3 categories – Critical, Semi-Critical, and Non-Critical. Critical instruments are those that penetrate the tissue or vascular system of a patient. Needles, catheters and surgical instruments fall under this heading. All critical items must either be designed for single use or go through pressurized steam sterilization in an autoclave after each use.
Semi-critical instruments include speculums, many dental tools, and respiratory equipment. These come into contact with mucous membranes or skin that is not necessarily intact. They are subjected to high-level disinfection. The Ohio DOH has opted not to use glutaraldehydes. Instead, they prefer autoclaving for this level of disinfection also. The use of disposable products is another acceptable solution.
Thermometers fall into the category of semi-critical but are only required to be cleaned using intermediate disinfectants such as isopropyl alcohol. Thermometer sheaths are recommended as an additional protective measure. Non-critical items such as stethoscopes and blood pressure cuffs can also be wiped down with alcohol if they become contaminated. Low-level disinfectant such as diluted household bleach (which kills most viruses, fungi, and bacteria) is the standard for most non-critical items and surfaces. However, this is replaced with a stronger biocide if there is any risk of tuberculosis transmission.
Autoclave Maintenance Instructions
All DOH personnel using autoclaves must follow the manufacturer recommendations for validation. The use of chemical indicators is stipulated for individual loads. This is supplemented weekly with biological monitoring using spore strips. A control ampule that has not been subjected to autoclaving is compared to the sterilized spore sample to ensure an accurate result. 24 hour and/or 7 day incubation periods are used depending on the location. These QA documents are filed with the county health department.
Copies of all records are required to be kept on-site also. This way, if there is a problem any inadequately sterilized instruments can be more easily identified. If they have already been distributed and used, patient notification and monitoring must be carried out as well.
In addition to test results, the data for each sterilization load is also documented. This information includes the date, length of cycle, pressure, and temperature. A signature is required to add a level of accountability. Any failure to achieve a temperature of 121 degrees Celsius and a pressure of 15 psi for 30 minutes results in the autoclave being pulled from service. The instruments in the load must be reprocessed in a properly functioning sterilizer prior to use.
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