ASP Advises Caution with Sterilizer Odors
Advanced Sterilization Products, the manufacturer of the Sterrad® line of hydrogen peroxide sterilizers recently sent a letter to hospital Risk Managers advising them that there have been a limited number of customer complaints that Sterrad models 50, 100S and NX can emit odors in to work environment if the sterilizer is not functioning properly. While not a recall, ASP are advising users to avoid any malodorous sterilizers and leave the room until the sterilizer can be serviced.
At least in some cases, the vapors contain hydrogen peroxide according to another letter from ASP discussing a failure mode of the vacuum pump in model 200s. While there have been reports of respiratory, eye and skin irritation in the FDA’s MAUDE database of adverse events with medical devices including sterilizers (class 2 medical devices), it is unclear what concentrations of hydrogen peroxide were present and whether the irritation was due only to the hydrogen peroxide or due also to other irritants such as the breakdown products of oil.
- 100NX: One healthcare worker (hcw) experienced a reaction of choking due to the odor….
- 100s: One healthcare worker reported reactions of dizziness, headache, loss of memory and blurred vision in one eye. …
- 200: Four healthcare workers “experienced skin rash and irritation on arms, neck, and hands. …
- 100NX: A healthcare worker experienced breathing problems (inflamed nostrils and no sense of smell) when working in the room with the four sterrad units….
Hydrogen peroxide vapor has almost no smell and so the above reports of foul smelling sterilizers received attention because there were other compounds such as pungent oil break down products also being emitted. However, hydrogen peroxide vapor does not always come with an added scent like natural gas, to inform users that there is a leak.
Chemical sterilization is essential to modern healthcare to sterilize those items that cannot be steam sterilized and hydrogen peroxide sterilization is the most important low temperature sterilization method in use today in healthcare.
Modern sterilizers are designed to very high standards but leaks can sometimes occur and a continuous monitor for hydrogen peroxide helps employers ensure that their people who work with sterilant compounds are not exposed, and helps reduce any doubts that operators may have about exposure to hydrogen peroxide.
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