Feedback (“RETEX”) about a prolonged breakdown of air treatment in the cytotoxic production area

23 November 2020

Julie Fillon1, Samy Houari1, Fatima Tendjaoui1, Adrien Vello1, Corine Duvernet1, Marine Lecuyer1, Tracy Marie1, Sandrine Derebergue2, Patrick Cornelie3, Guy Benoit1. 1 : Service de Pharmacie, Département Pharmacotechnie, Hôpital Tenon 4 rue de la Chine 75020 Paris
2 : Equipe Opérationnelle d’Hygiène, Hôpital Tenon 4 rue de la Chine 75020 Paris
3 : Direction des Ressources Humaine –Gestion des risques Professionnels, Hôpital Tenon 4 rue de la Chine 75020 Paris

After a global failure of the air treatment of our cytotoxic production unit, an alternative had to be urgently developed for an initially planned period of 5 weeks. As production is carried out under 2 positive air pressure isolators, in a controlled atmosphere area classified D, and with between 80 and 100 preparations daily, it was necessary to maintain the availability of chemotherapy to clinical departments while controlling the risks associated with the application of an unexpected degraded mode. A RETEX was implemented with the objective of analyzing our response capacity and developing recommendations.

Material and Method
A crisis meeting including pharmacists, pharmacy department manager, technical services manager, operational hygiene team and risk manager allowed the assessment of the production abilities with
different degraded mode, in terms of productivity, quality and safety for patients and staff. The chosen option was re-evaluated twice a week until the problem was resolved. A hot debriefing meeting was organized on day 25 in order to propose recommendations.

Results Discussion
The analysis showed that the usual degraded procedure (transfer to a laminar flow hood) could not be implemented, due to a heating failure awaiting repair, and a single workstation, insufficient over a long period. The alternatives to this degraded mode were :
* transfer to another production unit of the hospital group, but there was no sufficient capacity for the entire production on 1 external unit, and the logistical flow was not set up.
* implementation of external rental structures: no time or budget for implementation
* continuance of activity in usual area without ventilation, with reinforced monitoring of the environment.
This last option was adopted for the immediate period, with the installation of 2 air purifiers, bi-weekly air quality monitoring, extemporaneously preparation of chemotherapy treatments. Particulate values in class D could be maintained, except for 2 samples on day 14. Isolator controls remained class A compliant. The air treatment was finally repaired on day 15 and environmental controls all returned to class D compliance on day 17. The risk of staff exposure to cytotoxics could not be controlled in the absence of pressure differential between rooms.
The debriefing highlighted the vulnerability of our unit, and the recommendations made during the RETEX focused on the need to anticipate new degraded solutions.

This experience allowed us to better prepare for new production interruptions (unit dating from 2009) and to increase the number of degraded solutions.

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