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Low-temperature Sterilization Rises in Popularity

The global sterilization equipment market topped $3 billion in 2012 and will grow to reach an estimated $4.2 billion by 2017, according to a new report by MarketsandMarkets. Steam sterilization, despite being the oldest method, is still the most preferred in a health care setting, according to the market researcher. Steam sterilizers are the workhorse in many facilities due to their relative ease of use, low costs and short cycle times when compared to low temperature sterilization methods.

Many components of today’s advanced surgical tools cannot tolerate the high heat of steam sterilizers. Demand for low-temperature alternatives has driven manufacturers to create safer, faster low-temperature sterilizers. MarketsandMarkets predicts that the technology will become an essential element of ORs and central sterile processing departments in the next few years.

Low-temperature sterilization options include:

Peracetic acid: Used in small tabletop sterilizers in the OR, peracetic acid is most useful for immersible instruments and is a common method for endoscopes and endoscope accessories. Cycles can be as short as 23 minutes, making peracetic acid a good method for small loads or single instruments that need to be used immediately. Because instruments come out of the sterilizer wet, is not an appropriate method for sterile storage.

Ethylene oxide: Ethylene oxide is one of the oldest low-temperature sterilization methods. It can sterilize a wide range of equipment, including porous materials and lumens, without the risk of corrosion. But its cycle time can be as long as 16 hours, depending on the manufacturer, because proper sterilization requires long exposure and aeration times. The toxic gas is considered carcinogenic by the Occupational Health and Safety Administration, which in 2002 began requiring facilities to post a cautionary sign wherever EO is used. Some states now require exhaust systems as well. Though manufacturers have released new EO technology that uses a lower dose, or EO combined with another chemical to make the method safer, many facilities have switched to newer low-temperature sterilization methods that have shorter cycle times and pose fewer safety risks.

Ozone: Ozone sterilizers, which use only water, oxygen and electricity, are a low-cost alternative to other low-temperature sterilization methods. Cycle times can be as long as 4.5 hours.

Hydrogen peroxide gas plasma or vapor: A hydrogen peroxide gas plasma cycle can take as few as 28 minutes, while vapor cycles run about 55 minutes. Only dry, wrapped items can be sterilized in these small, self-contained units.

Nitrogen dioxide: A company called Noxilizer, Inc., founded in 2004 by Dr. James Bernstein, has developed a nitrogen dioxide sterilization process that is currently being used in industrial applications. A hospital model, Eniware, is currently in development. The sterilant is supplied as a liquid, which then turns to room-temperature vapor. The sterilizer does not require electricity to run. According to techbriefs.com, nitrogen dioxide provides a log-linear microorganism population reduction as exposure time is increased. With most devices, a high sterility assurance level can be achieved with 20 to 40 minutes of exposure time. Nitrogen dioxide shows promise as an effective method of low-temperature sterilization in the future.

MarketsandMarkets lists the following major players in the global sterilization market: Getinge, Steris, Sterigenics, Sakura, 3M, Cantel Medical and Advanced Sterilization Products.

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