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Ophthalmology FAQ

Is Statim suitable for ophthalmology?
How does the ongoing industry debate concerning the presence of endotoxin in steam sterilizers affect Statim?
Is the potential presence of endotoxin in a water reservoir specific to Statim?
If endotoxin are detectable in the autoclave water reservoir is this a cause for concern?
If I use Statim in my practice, how can I best avoid DLK?

Q: Is Statim suitable for ophthalmology?
A:
Absolutely. Statim is widely used by ophthalmologists due to it's extremely fast cycle time and its reputation as the most gentle autoclave for expensive, delicate instruments such as microkeratomes.
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Q: How does the ongoing industry debate concerning the presence of endotoxin in steam sterilizers affect Statim?
A:
Together with Dr. James Whitby, University of Western Ontario, SciCan has conducted research pertaining to the potential presence of endotoxin in the water reservoirs of steam autoclaves such as Statim.
The study concluded that when endotoxin are present in the water reservoir as a result of 'standing' water, the reduction in endotoxin levels between the Statim water reservoir and the steam generator was such that there were NO detectable endotoxin present in the steam used in the sterilization process itself.
As a result of his testing, Dr. Whitby disproved the hypothesis that biologically active endotoxin would be present in steam to serve as a causative agent for Diffuse Lamellar Keratitis (DLK).
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Q: Is the potential presence of endotoxin in a water reservoir specific to Statim?
A:
ABSOLUTELY NOT. DLK is an issue that can potentially affect ANY steam autoclave equally, in that bacteria and therefore endotoxin could likely be present in any body of standing water such as a sterilizer reservoir.
However, we do not support the hypothesis that biologically active endotoxin would be present in the steam generated by Statim to serve as a causative agent for Diffuse Lamellar Keratitis (DLK).
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Q: If endotoxin are detectable in the autoclave water reservoir is this a cause for concern?
A:
No, this is not necessarily a cause for concern. Although in the past, endotoxin have been thought to be heat resistant or "heat stable", this has been based on "dry heat." There has been no data located in the literature on endotoxin stability when exposed to "moist heat".
The study conducted by Dr. James Whitby demonstrated a significant reduction in the biological activity of endotoxin in the steam generator, at a minimum of 95% reduction. This work also showed that if reservoir endotoxin levels remained below 5.0 EU/ml, no detectable level of biologically active endotoxin would be delivered to goods sterilized in the cycle.
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Q: If I use Statim in my practice, how can I best avoid DLK?
A:
For situations where the presence of endotoxin is a serious cause for concern, SciCan would recommend a more aggressive approach, involving daily replacement of reservoir water. This would require emptying the water reservoir at the end of each workday and leaving the reservoir empty during the period of non-use (overnight or longer). After the power switch is turned OFF, the reservoir can be emptied using the built-in drain, if fitted; otherwise, completely siphon or suction the water out using clean tools. The reservoir should then be refilled with steam-distilled water at the beginning of the next workday. Except when filling or emptying, the reservoir should be kept capped at all times.
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