COOL OPTION Following manufacturers' instructions for use is key when performing low-temp sterilization.

Although manufacturers are re-engineering more of their instruments and devices to withstand the high heat and humidity of the autoclave, many items still require low-temperature sterilization before reuse. Flexible GI scopes, cameras and cautery cords, to name just a few, could be damaged by even a minimal amount of moisture or heat, and that won't change in the near future. Are you equipped to reprocess those items safely and effectively? Check out these 5 keys to low-temp sterilization success to find out.

1. Proper cleaning
Sterility assurance, regardless of what method is used, is based on proper cleaning and decontamination. The gold standard for sterility assurance level is 10^-6, meaning there is a 1 in 1,000,000 chance of a device not being sterilized after it's run through a cycle. That optimal level assumes you're dealing with normal bioburden levels in the device being reprocessed. If pre-cleaning and cleaning are inadequate, and the bioburden level is higher, you can no longer obtain a 10^-6 sterility assurance level. The instrument might achieve sterilization today, but inadequate cleaning allows biofilm to build up, which jeopardizes sterilization during future reprocessing cycles.

Pre-clean instruments and devices at the point of use to ensure they're ready for low-temp sterilization. Wipe the outside of the devices and flush lumens. Maintain the device in a moist environment — lay a damp towel over the top or place it in a specially designed bag to keep it from drying — until it can be cleaned manually and mechanically. Residue that's allowed to dry on the surfaces of an instrument or device is incredibly difficult to remove.

Transport items to the decontamination room in a closed container or bag. Remove heavy soil during gross manual cleaning, flush lumened channels and run items through an automated cleaning process, ideally one with features designed for the particular device you're cleaning.

BEFORE ALL ELSE Proper cleaning is still the essential first step to low-temperature sterilization.

Visually inspect items before packaging them for sterilization. Look to see if devices are clean, but also perform cleaning verification testing to see if your decontamination processes are effective. Most sterilization processes require that instruments are put back together after cleaning, but that's not always the case, so check the specific recommendations of individual instrument manufacturers.

2. The optimal sterilant
There is no sterilant that's considered better than another; the available options each have their pluses and minuses, and the right choice for your facility depends on the type of instruments you need to sterilize, how quickly you need to do it and the financial constraints in which you operate.

Ethylene oxide (EtO), for example, has a light molecular weight that makes it extremely effective at penetrating instruments, especially those with long lumens, to kill spores and bacteria. However, it requires a long chemical exposure time and is a human carcinogen. In addition, there are a lot of restrictions associated with its use, from OSHA guidelines about employee exposure, to the EPA's concerns about how much can be released into the environment, to local laws that might require members of your reprocessing team to obtain user permits before activating the units.

Hydrogen peroxide is another more practical option, and arguably the most commonly used in surgical facilities. Although it doesn't have the penetrating abilities of EtO, it's a powerful oxidizer. The vast majority of devices that require low-temp sterilization are compatible with hydrogen peroxide. It's also a chemical that our bodies produce naturally. At high concentration levels hydrogen peroxide can hurt microorganisms and people, but at the end of a sterilization cycle you end up with inert chemicals — water and hydrogen — that are no longer dangerous. Unlike other low-temperature sterilants, particularly EtO, the byproducts of hydrogen peroxide cycles won't harm your staff.

Hydrogen peroxide, however, is very sensitive to humidity, a drawback that can lead to aborted cycles. Facilities with hydrogen peroxide sterilizers should attempt to maintain an abort rate of less than 10%, which would be extremely high and unacceptable for steam sterilization. Even facilities that manage cycles closely will have abort rates in the 2% to 4% range. Investing in a unit that automatically checks humidity levels in the sterilization chamber before starting a cycle, and one that won't start one if levels are too high, will limit waste of the sterilant and help you avoid countless headaches.

3. Compatibility
Place instruments or devices in wraps or containers that are appropriate for the sterilization process you work with, because not every container can be used with low-temp sterilization. Check with a closed container's manufacturer to confirm that it can be used for low-temp sterilization, and consider purchasing containers directly from sterilizer manufacturers, so you can be sure you're using ones that are approved for use in their devices.

Can your unit sterilize devices in use at your facility? Make sure that it can. Sounds like commonsense advice, but I've seen several centers assume the low-temperature sterilizer they purchase will effectively reprocess any device that requires low-temp sterilization. That's not always the case. For example, a popular sterilizer on the market is available in several different models. Items validated for one model might not be validated for another, even though they sit under the umbrella of a single manufacturer.

Always check with instructions for use from instrument and device manufacturers to see exactly how their products must be sterilized; manufacturers must provide FDA validation of at least 1 sterilization process. Placing items through a low-temp sterilization cycle even though the instructions for use don't list it as a viable option risks damaging the devices or, worse, risks not sterilizing them completely. For quick reference, always keep manufacturers' instructions for use on file where they're easily accessible.

4. Sufficient size
Consider the size of the unit's chamber to ensure it accommodates the packaged devices you want to sterilize; no part of the wrap or container should touch the interior walls, to prevent aborted cycles and to ensure there's enough space for the sterilant to circulate and penetrate to the items inside. Never stack instrument packs or containers unless the devices' instructions for use clearly state that doing so is permissible.

5. Cost
Determine how the cycle times of the low-temp option you choose mesh with your instrument inventory and case volume. How quickly do you need to turn over instruments? A 3-hour cycle time for instruments needed every 2 hours won't cut it. Will you purchase more instruments because a lengthier sterilization method meets your specific reprocessing needs, or are you going to buy a different sterilizer so you can reprocess instruments more rapidly? How much the overall cost of sterilization, including the cost of the sterilant, impacts your per-cycle expense will help guide your decision.