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Low level sterilization and ozone

Q We are looking into various options for low level sterilization and one of the newer processes we are considering is ozone. I know very little about this and was wondering if there are any known concerns relative to occupational safety and exposure when using this methodology.

A Every method of sterilization poses some degree of risk to occupational safety but following proper procedures and protocols in the workplace can minimize those risks and ensure a safe work environment. As is the case with any medical device it is essential that you receive and follow the sterilizer manufacturer’s instructions for use. Your sterilizer manufacturer can also provide you with detailed technical documentation and information on their equipment and the use of ozone. You will also want to obtain and review the manufacturers FDA 510k documents and obtain any relative MSDA data.

OSHA has established a permissible personal exposure limit for Ozone (PEL) at 0.1 ppm. Ozone can readily penetrate the upper respiratory system and exposure above the PEL can result in chest pain, cough, and shortness of breath. Studies have shown that as the exposure level increases so do the associated risks and adverse affects. In as little as four hours concentrations up to 1.2 ppm can result in drowsiness, pulmonary edema, fatigue, loss of concentration and cilia. Exposures above 1.2 ppm may cause severe lung damage with epithelial sloughing of the lower bronchi and airways, the formation of dense plasma cells and lymphocytes around the perivascular vessel and hemorrhagic pulmonary edema. NIOSH has established that an Ozone level of 5 ppm may present an immediate danger to life and can be fatal causing extreme pulmonary edema and hemorrhage. Ozone is certainly a meritorious and viable low temperature sterilization alternative. As with any process staff need to be educated on the proper use and application and the process needs to be monitored and managed. As you move forward in your quest carefully evaluate each option. Consider such things as total cycle times, chamber volume capacity, packaging requirements, QA processes, compatibility with medical devices you wish to sterilize, process limitations and the economics of procurement, installation, use and maintenance. You will find that all processes have some degree of occupational and or exposure risk so ensure you can implement the appropriate work practices to provide a safe and healthy work environment and that you can comply with any relative OSHA standards.

Ray Taurasi is Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His healthcare career spans over three decades as an Administrator, Educator, Technologist and Consultant. He is a member of AORN, AHA, SGNA, AAMI and a past president of IAHCSMM and has served on and contributed to many national committees with a myriad of professional organizations, manufacturers, corporations and prestigious healthcare networks. Taurasi has been a faculty member of numerous colleges teaching in the divisions of business administration and health sciences. In addition to this column he has authored several articles and has been a featured speaker on the international scene.