This article is from in the February 2008 issue of DOTmed Business News. A list of registered users that provide sales & service can be found at the end.

Louis Pasteur popularized the sterilization of medical equipment the 1860s.

As a result of sterilizing infections and using antiseptic techniques in operating rooms, patient survival rates soared. Pasteur was an ardent advocate, preaching adherence to the sterile surgical practices also followed by Lister in England.
But if he were alive today, Pasteur would most likely revel in the magnitude of how far his methods have evolved into the advanced capabilities of modern-day sterilization and the state-of-the art equipment that goes along with it.

On a global basis, the medical sterilization systems and equipment market is pushing north of $2 billion. The US is the largest market for medical sterilization systems at about half of that, with Europe and Japan trailing. One form, steam sterilization is a $250 million business while another, Ethylene Oxide, is nearer to $300 million.

So why is there increased government and private pressure on the healthcare community to do something about the widespread problem of acquired infections (HAIs), which has affected 2.3 million hospital and ambulatory patients, causing as many as 99,000 deaths yearly.

If everything's so sterile, why is the FDA, citing strict standards for product quality control and assurance, legislating medical device producers to upgrade and expand sterilization and disinfection systems? The Joint Commission of Medical Standards (JCAHO) requires hospitals to document performance testing of all sterilizers found in surgery, central service, and other departments. Usually, the departments that have sterilizers are responsible for verifying proper sterilization performance and for keeping a record of the testing. Each department's data must be aggregated and reported.

Common Methods of Sterilazation

Common methods of sterilization include physical and chemical methods. Physical ugtilizes dry heat, steam, radiation and plasmas. Radiation relies on gamma radiation, electron beam, X-ray, ultraviolet, microwave and white (broad spectrum) light. Chemical methods include ethylene oxide, propylene oxide, chlorine dioxide, ozone gases and a variety of chemicals in liquid and vapor form, such as glutaraldehyde, hydrogen peroxide and peracetic acid.




According to Raef Warzynski, President of Eagle Technical Services, Eagle, WI, sterilizing equipment must pass a Bowie Dick test to verify that it is able to maintain a vacuum without any air leaks. "This test is mandatory in the health care market and performed daily," says Warzynski. He says that even though a sterilizer passes a Bowie Dick test, it could still have an internal steam leak causing poor vacuum levels, one of man reasons why qualified technicians must inspect sterilizers.

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