An entirely new generation of sterilizer – utilizing ozone as the sterilizing agent – is on the verge of being installed in hospitals across Canada. The Quebec-City-based company TSO3 received authorization from Health Canada last May to put the 125L, the company’s first ozone sterilizer, on the market. Five pilot sites are already in operation in hospitals in Montreal and Quebec City. And negotiations are under way with other Canadian hospitals to install this new technology for the sterilization of medical instruments. “After eight years of research and development, it’s exciting to see our work bearing fruit,” said Jocelyn Vézina, the CEO of TSO3.
With the 125L, TSO3 has pulled off a major coup – a genuine technological breakthrough. Prior to this device, Europeans and Americans unsuccessfully tried to develop an ozone sterilizer for hospitals. And when TSO3 presented their work to the experts, their response was, to say the least, eloquent. Without beating around the bush, Charles O. Hancock, from his office in New York, says: “Ozone sterilization technology is new and exciting, and the potential is practically limitless.” Mr. Hancock is a renowned specialist in the field of sterilization who acts as an advisor to the Canadian and the American governments, medical and surgical instrument manufacturers, hospitals, etc.
Flattering words, but they still don’t express the full scope of this new technology. To understand, compare the 125L process with the low temperature ethylene oxide process utilized in 70 per cent of hospitals on the planet. In fact, TSO3 researchers went to work eight years ago precisely with the goal of replacing the ethylene oxide process.
“The ozone sterilization technology from TSO3 is the most economical, leaves no toxic residues, is environmentally friendly, and is safe for both the user and the patient,” says Dr. Richard Marchand at the Université de Montréal, one of the six sterilization specialists in Canada. He adds, “The effectiveness of the 125L has been clearly demonstrated at all levels. The device has undergone every test. And its short sterilization cycle means hospitals can reduce their instrument inventory. I’m convinced this new sterilization method will quickly take over, and not only in Canada…”
Certification of the 125L from the American Food and Drug Administration (FDA) is expected by the end of the year. “We are currently in discussions with medical device manufacturers,” says Mr. Vézina. “The partner selected will be in charge of distributing the 125L in the United States and elsewhere in the world. The launch of the 125L on the North American market is planned for early 2003.”
The advantages of ozone over ethylene oxide are clear. With the 125L , this will be the first time in 50 years that a new sterilization technology will generate a surplus in hospital budgets. But there’s more: since 1998, researchers at TSO3, the Université de Montréal and the ƒcole Polytechnique have been working on deactivating prions, infectious proteins that transmit Cruetzfeldt-Jakob disease, the human form of mad cow disease. Last April, preliminary testing carried out in a Health Canada laboratory in Winnipeg showed the 125L’s potential for deactivating prions. The ozone sterilization process reached the limit of detection during this first series of tests on infectious prions. “In terms of chemistry, the effectiveness of ozone on the deactivation of prions is clear: ozone has the potential to completely destroy prions because it destroys the proteins and prions are proteins. Ozone, as is well known, breaks the chemical bonds of the proteins,” clarifies Professor Bernard Legube, a chemist at the Université de Poitiers, France, and a world specialist in ozone and oxidization processes.
New tests are under way to demonstrate the superiority of ozone over other sterilization methods for the deactivation of prions. “Later this fall, in collaboration with the Université de Montréal and at the same Health Canada lab, we will see whether medical instruments contaminated with prions, then sterilized in the 125L, will remain infectious after sterilization,” explains Dr. Marchand.
Once Professor Legube’s assertion has been verified, the TSO3 technology will be crowned as the one and only sterilization technology perfectly effective against prions, perhaps none too soon. Just last August, major Canadian media reported that authorities at St. Paul’s Hospital in Saskatoon contacted 71 patients with the news they may have been contaminated by surgical instruments used on a patient who died of Creutzfeldt-Jakob disease.