Case study on the orientation of phaco hand pieces during steam sterilization processes

Abstract

Steam sterilization is an essential part of infection prevention. The literature shows that sterilization of medical instruments containing channels is not trivial. Phaco hand pieces have a simple configuration: a device contains a channel with a constant radius. No literature was found indicating whether the sterilization conditions on the inner surface of a phaco hand piece are influenced by the orientation of the hand piece. To determine whether the orientation of a phaco hand piece influences the results of a sterilization process of this device. A qualitative case study, including experiments, is performed with a protocolled combination of steam sterilizer, process, phaco hand piece, orientation of the phaco hand piece, and wrapping. In this specific case, the orientation of the hand piece influenced the result of the steam sterilization process; in vertically (upright) oriented phaco hand pieces with free water drainage, sterilization conditions are reproducibly established. In the same process, in horizontally oriented or vertically oriented hand pieces without free drainage, these conditions are not established in a reproducible way. In the investigated combination of sterilizer, process, load, loading pattern and wrapping, phaco hand pieces have to be oriented vertically (upright) with free water drainage to obtain steam sterilization conditions on the inner surface. It is likely that instruments with comparable configuration and dimensions will yield comparable results. It is therefore recommended that this issue is considered during the development of medical instruments and during performance qualifications of such instruments.