Reprocessing ultrasonic transducers

Authors: B. Amann, T. Appel, F. Aravopoulou, P. Bröcheler, M. Bertram, A. Carter, D. Diedrich, C. Diekmann, R. Frey, B. Früh, J. Graf, M. Härtel, A. Jones, M. Kamer, G. Kirmse, M. Kostrzewa, I. Mock, S. Krüger, R. Otzmann, K. Roth, M. Schick-Leisten, M. Schreiner, T. Schwibbe, U. Zimmermann

1. Introduction
Ultrasonic transducers are indispensable components of the modern medical armamentarium
since ultrasound is used to visualize on a screen, and sometimes make audible, several organs and body regions. Often, ultrasonic examination is confined to body surface areas but can also be used to penetrate natural body openings for diagnostic purposes. Ultrasound penetrates deeper into the tissues the lower its frequency. But there are limits since the declining frequency is also accompanied by a reduction in the spatial resolution.
Ultrasonic transducers must be reprocessed after use on a patient so that they can then be reused for another patient. Often, the manufacturer specifies different reprocessing processes for the various components, e.g. connectors, control panel and the parts used for the actual examination, thus rendering reprocessing even more complex. Whereas cleaning of ultrasonic transducers can generally be easily verified through visual inspection, a product whose efficacy has been demonstrated by appropriate tests and approved by an expert must be used for disinfection. The transducer manufacturers must give precise details of what constitutes an ➜ EFFECTIVE DISINFECTION PROCESS for these medical devices (KRINKO/BfArM Recommendation
[2], Annex 8/Appendix 7 and 8).
It is imperative to always use protective sheaths, in particular for ultrasound examinations through natural body orifices, since the barrier against pathogens is normally weaker than on healthy skin. However, the use of such protective sheaths should never be misinterpreted as a reason for less rigorous transducer reprocessing [3].
All staff members entrusted with reprocessing must have the required expertise in medical device reprocessing. To ensure problem-free reprocessing, the premises operator must formulate a ➜ STANDARD OPERATING PROCEDURE (SOP).
All staff members entrusted with reprocessing have to receive a documented training (training certificate) to guarantee correct reproccessing according to the manufacturer’s instructions. According to the KRINKO-BfArM Recommendation [2] (Section 1, General requirements) the reprocessing process must be validated to reproducibly ensure successful reprocessing at all times.

Download this recommendation here: AKQ_en_ZT_3_17


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