Isolator Renewal: Don’t forget anything!

4 October 2023

C. Jutard, C. Carbasse, E. Coget, M. Rigoni, A. Roche, M.-L. Ducassou, C. Cousin, P. Brouard
Centre Hospitalier Universitaire de Nîmes, France

Our University Hospital’s chemotherapy compounding unit produces 33,000 preparations a year. The replacement of the isolators was carried out over several weeks while maintaining production. Establishing a schedule and coordinating various professions were imperative. Based on our experience, we propose a management tool for such a project, describing the actions taken in chronological order.

Materials and Methods
The creation of a Gantt chart provided a chronological representation of the project stages. The main topics were divided into subtasks.

Eight themes have been identified: production during the transition period, relocation, organisation of the future Controlled Atmosphere Area (CAA), works management, control methods, hygiene, medical device (MD), management and communication. In terms of production, we rented isolators placed in an unpacking room. A multidisciplinary working group defined the tasks for each position, the MD and drug circuit, the production of non-cytotoxic standardised doses in the preparation room, and possible overtime. Another group focused on organising the future CAA to define the work requirements (isolators placement, preparations and people paths). Quotes have been asked for electrical and air handling systems, as well as painting and ceiling repairs. The relocation required coordination of refrigeration technicians, furniture and Information Technology department, as well as finding a temporary temperature monitoring system. We anticipated the adaptation and development of our control system (DrugCam®) for the rented and the new isolators. Several hygiene aspects were considered: dust prevention, post-works cleaning, CAA requalification, microbiological sampling, choice of a new compatible detergent/disinfectant, waste circuit. Care units, doctors and patients were informed. Doctors were asked to anticipate their prescriptions. Six months elapsed between the selection of the new isolators and the completion of the work.

Having an anticipation tool for this type of project is essential to take all aspects into account. It allows you to manage the change process with calm and to have time to deal with unexpected events. The involvement of the teams is critical during this crucial time to maintain patient safety.

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