In various medical specialties, ultrasound probes are used for diagnostic purposes, gamma probes are used intraoperatively. With regard to the type of use and the resulting risk, ultrasound probes are usually classified by the operator as semi-critical, gamma probes as critical medical devices (according to the KRINKO recommendation from 2012).
The Committee for Hygiene, Construction and Technology has compiled a new recommendation on environmental conditions and their control in Reprocessing Units for Medical Devices. The aim of this publication is to present information on the state of the art and experience with respect to hospital hygiene, microbiology and audits. This information lays the groundwork for the formulation of requirements for the environmental conditions and their control and for bringing the current publication into line with the state of the art.
In an efficient quality management system processes must be monitored. The process monitoring measures must be planned and the outcomes documented. In that way discrepancies can be recognized at an early stage and remedial action taken.