Situation of Crisis Management in a Cytotoxic Reconstitution Unit (URC)
Our Controlled Atmosphere Areas (ZAC) is equipped with 3 JCE® isulators which are around ten years old. They are very busy daily, about 20 sterilizations are carried out nominat using an agent sterilizing the MDI (peracetic acid, hydrogen peroxide, acetic acid). Following the increase in activity (50,000 chemotherapies achieved in 2017), the pharmacy technicians reported a strong MDI odor in the ZAC, especially after sterilization and the opening of the airlock. Some had to stop their activity for major irritations of the ORL sphere, migraines, or eye pain.
In response to this situation our goal was:
- to check the contamination rate of the ZAC
- to limit staff exposure to MDI
- working with the isolator supplier for thorough curative maintenance
These actions were carried out in collaboration with the technical service of the university hospital and work medicine.
Material and methods
Air samples were taken to ensure the presence or absence of MDI in the ZAC and, where appropriate, an exceeding of the authorized exposure threshold. In addition, complete maintenance of isolators by the supplier has been requested. Work medicine was also contacted to determine measures to limit exposure.
A complete maintenance of the isolators was carried out on several days, it showed numerous leaks as well in the circuit as in the airlock. Following this maintenance, the smells of MDI quickly decreased. Moreover, it was decided to realize 3 air sampling campaigns at one month intervals in order to evaluate the possible contamination rate of MDI in the ZAC. Finally, after discussion with the work medicine cartridge masks and the corresponding cartridges were ordered, to protect personnel waiting to check at the last campaign, the potential presence of MDI in the air. The first results of determination of per acetic acid are negative.
These events enabled us to review the maintenance conditions of our equipment with the supplier and the technical service. On the other hand, we became aware that we did not put in place degraded solutions for acute situations.