By Nancy Chobin, RN, AAS, ACSP, CSPM, CFER
Q: We reprocess vaginal specs for some local doctors' offices. I recently learned that once the office staff receives the instruments, they are then opening up the individual sterile peel pouches and then place the “unprotected” vaginal speculums into the exam table to be ready for use by the provider. Is there anything we can purchase to use for transportation purposes that will save us time and money and skip the sterilization process of these items?
A: This is an excellent question, especially with many sterile processing departments (SPDs) now processing devices for offsite clinics and doctors' offices. Vaginal speculums fall under the semi-critical devices category (Spaulding).
According to the Centers for Disease Control and Prevention (CDC)'s Guideline for Disinfection and Sterilization in Health Care Facilities, 2008, “Semi-critical items contact mucous membranes or non-intact skin. This category includes respiratory therapy and anesthesia equipment, some endoscopes, laryngoscope blades 24, esophageal manometry probes, cystoscopes 25, anorectal manometry catheters, and diaphragm fitting rings. These medical devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible. Intact mucous membranes, such as those of the lungs and the gastrointestinal tract, generally are resistant to infection by common bacterial spores but susceptible to other organisms, such as bacteria, mycobacteria, and viruses. Semi-critical items minimally require high-level disinfection using chemical disinfectants. Glutaraldehyde, hydrogen peroxide, ortho-phthalaldehyde, and peracetic acid with hydrogen peroxide are cleared by the Food and Drug Administration (FDA) and are dependable high-level disinfectants provided the factors influencing germicidal procedures are met. When a disinfectant is selected for use with certain patient-care items, the chemical compatibility after extended use with the items to be disinfected also must be considered.
High-level disinfection traditionally is defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores. The FDA definition of high-level disinfection is a sterilant used for a shorter contact time to achieve a 6-log10 kill of an appropriate Mycobacterium species. Cleaning followed by high-level disinfection should eliminate enough pathogens to prevent transmission of infection.” However, many facilities do sterilize their vaginal speculums. Steam sterilization is the usual method however you should always follow the instrument manufacturer’s instructions for use regarding the cycle type (gravity or pre-vacuum), temperature and exposure time.
The real question is how will the speculums be handled and stored after disinfection or sterilization? How are they being protected from re-contamination from hands and the environment? The Joint Commission is specifically looking at how any high-level disinfected item is protected from re-contamination.
If the speculums will be presented as sterile, they should be packaged in packaging material approved for the sterilization process. Some of the smaller speculums could probably be packaged in paper-plastic pouches. Heavier ones may need to be wrapped.
If the speculums are not needed in a sterile environment, it is acceptable to sterilize them, unwrapped, in the recommended cycle. At the end of the cycle, allow to cool then, using clean hands or donning clean, powder-free gloves, package in a zip-lock bag. Affix a tamper-evident seal (e.g., “Clean Not Sterile Label”) to the top of the bag. This will protect the speculums from contaminates if placed in a drawer or bin unprotected. This process (sterilization without packaging) is considered sterilization to prevent cross contamination. However, since there is no packaging to maintain the sterility of the speculum, the bag must be labeled accordingly.
If the speculum manufacturer has validated for a high-level disinfection process, the facility can use this process if desired. If this is the ONLY recommended method, then high-level disinfection MUST be used. However, after processing and drying, the speculums must still be protected from re-contamination. Since high-level disinfection is performed without packaging, it is essential that the speculums be placed in a tamper-evident bag (e.g. a zip-lock bag) and a label such as “High Level Disinfected” affixed over the seal on the bag. This label permits documenting the date and initials of the person who prepared the device.
Today, there are also single use speculums (plastic) that may be applicable in some patient treatment areas.
In summary, when processing devices, sterile processing personnel make the decision how items will be packaged taking into account the size and weight of the device, the manufacturer’s recommended processing instructions for high-level disinfection or sterilization, the potential number of times the package will be handled and where the package will be stored. It is important to provide maximum protection for devices to ensure they will be safe when used on the patient.
Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant/educator.