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Copyright © 2015
INSIDE THE CURRENT ISSUE
by Jonathan A. Wilder, Ph.D & Charles O. Hancock, RAC, Stericert Co., division of H & W Technology, LLC
Steam quality may be the last uncontrolled variable in hospital steam sterilization. Steam sterilizers generally produce sterile product reliably, but there are times when things go awry for no obvious reasonâ€¦
The definition of steam quality is the measureable aspects of steam used for sterilization. These include the usual measures such as temperature and pressure, and the relationship between the two. Steam quality also includes other aspects of steam that are almost never measured in North America. Deviations from established ranges of these aspects of the steam can result in wet, damaged, or unsterile loads.
When good steam goes badâ€¦
Some of the effects of poor steam quality are:
Each of these has a specific cause. The degree of the problem can be measured, and the situation can be remedied. The good news is that all sterilizers cleared by the FDA for use in a healthcare facility can deliver good quality steam to the load and provide sterile, dry, and intact sterilization loads. The bad news is that any of them can experience any of these problems, and the cause is not always something that the end user can predict or determine.
It goes without saying that a sterilizer must be maintained properly to ensure proper, reliable operation. This includes preventative maintenance, calibration, and performance verification as described in AAMI ST79, â€śComprehensive guide to steam sterilization and sterility assurance in health care facilities.â€ť If a sterilizer is out of calibration, has leaks, or is otherwise not working in its normal manner, poor steam quality may be a result of those problems rather than the cause of difficulties. For this discussion, we assume that the sterilizer is in good repair. If it is not, needed maintenance should be done before steam quality is tested or blamed for difficulties.
Symptoms of steam quality problems
The four primary failures of steam quality are listed above. All of them can cause unsterile loads and/or damage instruments. The cost of repair of a laparoscope or similar device is upwards of $1,000 per incident. The financial and potential human cost of a recall of an unsterile load is greater.
The causes of each of these failures are discussed in detail below.
A wet load can be caused by a number of things, one of which is wet steam. Steam is composed of vaporized water, and steam delivered to a sterilizer should have essentially no liquid water in it. Sterilizers are designed for use with saturated steam and this is typically specified on the sterilizer manufacturerâ€™s installation drawings. Steam suitable for sterilization is defined in the European standards (EN 285, HTM2010) as having a dryness value of greater than 0.9 for non-metallic loads, and greater than 0.95 for metallic loads as delivered to the sterilizer chamber. The steam dryness value is simply the fraction of dry steam in the sample measured, with 0.9 dryness corresponding to 10% liquid water and 0.95 dryness corresponding to 5% liquid water. If the steam dryness value is too low, wet loads can occur.
Steam dryness is calculated by measuring the temperature change in a known amount of water and the mass of steam that was required to cause that temperature change. Ideally, the temperature rise would be exactly what would result if the energy in perfectly saturated steam was delivered to the water to heat it. This would result in a dryness value of 1.0. Normally, the dryness value is less than 1.0, as there are thermal losses in any piping system, and a sterilizer is no exception. Because the dryness value at the entry point to the sterilizer chamber can be quite a bit lower than the dryness value of the steam delivered to the sterilizer, measurements of steam dryness should be made at the entry point or by sampling the steam in the chamber.
Wet steam can be the result of engineering issues. These can be:
Other causes of wet steam
Other causes of wet loads can be that they are too dense; that is, too much weight in too small a volume. The AAMI standard for sterilization containers has a limit of 25 pounds in a container, with no specification of density. The European standard for containers, EN 868-8, has a limit of 10 kg (22.4 lbs.) in a â€śstandard sterilization volumeâ€ť of 30 cm x 30 cm x 60 cm, about 1.9 cu. ft. This is a density of 11.75 lb./cu. ft. Our experience is that if a containerâ€™s density is less than this, there should be no problem with load wetness, assuming that the steam is suitably dry to begin with.
Damage to loads can take place in two ways. There can be thermal damage, and there can be staining and/or corrosion of the instruments and packaging materials.
You might ask how thermal damage can occur if the instruments are sterilized at temperatures prescribed in the itemâ€™s DFU. The answer is that the steam could be superheated.
Superheat is the situation of having more energy in the steam than the steam temperature would lead you to expect. Conversely, superheat is also a situation in which the temperature of the steam is higher than the saturation temperature for its actual water content. It can result from the following sources:
Any of these can cause there to be too much energy in the steam for its pressure, temperature and water content. If this energy is released in the load, damage can occur to instruments as their temperature rises above the recommended processing temperature. The temperature shown on the sterilizer controls is generally not sensitive to superheat, as it is measured in the drain of the sterilizer chamber, and superheat will have been dissipated into the load, chamber wall, or door and backhead before it reaches the drain.
Sterilization indicators and sterility failures
A load run with any of the three steam quality problem listed above may have failed sterilization indicators and also may be unsterile. For superheat, non-condensable gases, and wet steam, too little energy is delivered to the load, since steam that is too dry (superheat), too wet (wet steam), or contains non-condensable gases, has less energy available than saturated steam to inactivate microorganisms. Non-condensable gases can also cause air pockets in the load where steam does not penetrate, meaning that local islands of unsterility may exist in the load. Because these are localized, if an indicator is not in the â€śislandâ€ť, you could never know that an area is unsterile.
Staining and corrosion
Both of these have similar causes; something other than water in the steam. These may be impurities like steam piping treatments, rust in the facility steam pipes or in the sterilizer jacket or plumbing. If the problem is caused by piping anticorrosion treatments, the solution is to cut the treatments back or eliminate them. Anticorrosion treatments are especially problematic with stainless steel sterilizer jackets and chamber, which tend to pass the treatments on to the load. Older, tool steel sterilizers are more likely to chemically bind the treatments before they reach the chamber, since these sterilizers, like steel piping, have corrosion in the jacket that eats up the treatments before they can get to the load.
Chemical analysis of condensed steam can tell you what is doing the staining, and analysis of supplied steam and steam collected from the sterilizer chamber can tell you if it is problem with the source or with the sterilizer plumbing or jacket.
Each of these quantities can be measured and solutions found. The first step is to measure, even if there are no problems. This should be done at initial installation, or at or around preventative maintenance to establish a baseline for the system. Measurements made when there are no problems can also tell you if your sterilizer is close to having a problem.
If there is a problem, all relevant quantities should be measured. Persons experienced in steam quality analysis can usually make cost-effective suggestions to fix the problems, and of course measure to see if the problem is, in fact, fixed.
Almost all steam sterilization failures may be attributed to poor steam quality, as long as packaging and loading are carried out properly and the equipment is well maintained. Analysis of these failures is not straightforward for the hospital, and can only be done using specialized equipment. The practices presented in this article will help avoid steam-quality related problems, but do not substitute for actual analysis of the steam quality parameters. Although the US does not have any requirements for steam quality analysis, if you donâ€™t know why it isnâ€™t working, and steam quality was never checked, now may be the time.
Definitions of steam quality parameters and effects of their deviations from accepted values