Background Leksell frames are high precision CE-approved medical devices used in the stereotactic department, gamma unit and neurosurgery. They can be considered as “critical” because of their use and price. The French legislation recommends a prionicidal detergent to clean sterilisable devices, whereas the company only recommends enzymatic detergents.
Our position is uncomfortable. We have both to respect the recommendations provided by the company in order to protect the device’s surface and the legislation concerning the risk of prion colonisation, but those 2 elements are contradictory.
Purpose To highlight the impact of the cleaning process on the frames in order to optimise their management and guarantee they are used correctly. The cleaning process is selected by and under the pharmacist’s responsibility.
Material and methods We analysed the treatment of the frames from their use during surgery to their sterilisation. To build up a picture library we inspected the frames and their containers.
Results We noted 2 major concerns:
The plastic containers were damaged, linked to the high rate of use of the frames (14 sterilisation cycles/month). The use of metal containers would be more suitable.
4 out of the 11 frames were showing signs of several anomalies concerning the graduations and their visual appearance. Those anomalies could be linked to the anodized aluminium surface damaged by the alkaline detergent.
Conclusion The absence of a comprehensive approach of the data sheet provided by the company (neither including our detergent on the agreed list, nor prohibiting it) is a true concern, and involves the company in case of deficiency. After sharing feedback with other hospitals, it appeared they were being confronted with the same issues. The alkaline detergent seems to damage the graduations and to accelerate the wear of our frames. Although we haven’t experienced any aftermath yet, we must be aware of this concern. The consequences of misuse could be highly damaging for the patient.
Elekta’s data sheet for use of the Leksell stereotactic system
ReferenceNo conflict of interest.
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