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Steam sterilization and internal count sheets: assessing the potential for cytotoxicity.
Anne D Lucas1, Nancy Chobin, Ramona Conner
1US Food and Drug Administration Center for Device and Radiological Health, Silver Spring, MD, USA.
AORN Journal
|March 10, 2009
Summary
Ink transfer from count sheets to surgical instruments during steam sterilization is not cytotoxic. However, ink residue removal is difficult, necessitating a barrier for instrument reuse.
Area of Science:
- Medical Devices
- Sterilization Processes
- Biocompatibility Testing
Background:
- Surgical instruments are sterilized using steam.
- Count sheets are used during sterilization procedures.
- Ink transfer from count sheets to instruments is a potential concern.
Purpose of the Study:
- To evaluate the safety of ink transfer from count sheets to surgical instruments during steam sterilization.
- To assess the cytotoxicity of ink, toner, and labels after steam sterilization.
- To determine methods for mitigating ink residue issues.
Main Methods:
- Stainless steel instruments were exposed to inked paper and subjected to steam sterilization.
- Instruments were extracted and tested for cytotoxicity.
- Preprinted labels were also examined.
Main Results:
- No significant cytotoxic response was observed in extracts from instruments exposed to ink, toner, or labels.
- Ink residue on instruments after steam sterilization proved difficult to remove.
- Ink residue was detrimental to the surgical instruments.
Conclusions:
- Ink transfer from count sheets to surgical instruments during steam sterilization does not pose a significant cytotoxic risk.
- Ink residue is problematic for instrument maintenance and longevity.
- Utilizing a barrier between count sheets and instruments is recommended to facilitate instrument reuse.
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