Authors: B. Hornei, M.-Th. Linner, A. Jones
FA HBT A. Carter, K. Wiese, M. Schick-Leisten, A. Wentzler, U. Haffke, M. Scherrer
The Committee for Hygiene, Construction and Technology (FA HBT) of the German Society of Sterile Supply (DGSV) together with the DGSV board invited experts to meetings in 2016 and 2017 to discuss in detail the topic of control of environmental conditions in a Reprocessing Unit for Medical Devices (RUMED).
These participants were microbiologists from infection control laboratories, hospital infection control medical and nursing staff, RUMED management personnel, experts from certification bodies and as guest a representative from the Robert Koch Institute (RKI). Our thanks to the participants of this “Expert Panel”.
This present article is now being published following a series of questions submitted to the Committee for Hygiene, Construction and Technology (FA HBT) regarding the need for, and feasibility of, control of environmental conditions. There is uncertainty about the control methods, test sites, control intervals and evaluation of the findings. Likewise, who is responsible for conduct and assessment of control measures is often unclear. At the time of certification of a Quality Management System in RUMEDs it is revealed time and again that control of environmental conditions is not being, or not adequately, observed.
The aim of this publication is to provide information on the current state of knowledge and applicable requirements and present the experiences made by hospital infection control teams, microbiologists and auditors. The requirements for air quality (microbiological, physical) and occupational health and safety aspects shall not be addressed.
The article is intended for RUMED operators, RUMED managements as well as for hospital infection control medical and nursing staff and the supervisory authorities.
Read more in Steri-World Issue 02/18.