As many of you know, the FDA issued a recall of the Steris System 1 sterilizer late last year because changes to the system over the years were not evaluated and approved by the FDA. Thus the FDA was unable to validate the effectiveness and safety of using that particular system. Because of this recall, hospitals have been transitioning to new sterilizer systems such as Steris Corporation’s System 1E and Advanced Sterilization Products’ Sterrad line of peracetic acid and hydrogen peroxide based sterilizers, respectively.
When switching from one sterilization system to another, hospitals often focus on sterilization efficacy and materials compatibility, but it is important to remember that all sterilants are used to kill microbial life, making them harmful to humans if exposure should occur. Therefore, whatever sterilizer is used, both employers and employees should be aware of potential exposure issues to liquid or gaseous chemical sterilants. Where gas exposure is a risk factor, continuous monitoring may be needed – especially where the odor threshold of the sterilant used is near or greater than the OSHA PEL or other recognized exposure limit such as the EPA’s AEGLs.
This is not a knock against the safety claims of sterilizer producers, but only to say that accidents can and do happen, due to equipment malfunction or wear and tear, as well as human error. Monitoring systems are not intended for when sterilizers are working properly, but to protect health care workers when an accident occurs.
In summary, as a healthcare facility is reviewing its sterilization system or process, it is very important to include questions about employee safety, including whether continuous monitoring of the workplace for sterilant gases and vapors is necessary.