Total breakdown in a production unit: how to face the emergency?

Our Chemotherapy Reconstitution Unit includes 2 overpressure isolators, while our average daily production is estimated at 40 preparations. In August 2022, a first isolator broke down, forcing us to concentrate our production on a single isolator for 3 months. On October 20, the hospital was faced with an unprecedented situation: the failure of the only isolator still in operation, as the first one was still under corrective maintenance. The challenge was twofold: to maintain the availability of chemotherapy while controlling the risks associated with an unexpectedly degraded mode.

On October 20, a multi-disciplinary meeting brought together the pharmacist, oncologists, the nurse coordinator and hospital management, with the aim of establishing a fallback strategy. The decision was taken to maintain the original program as far as possible. Preparations of cytotoxic and immunotherapy were carried out under a laminar flow hood with closed systems, as the MSC II had a design flaw and was sending polluted air back into the production room.

This unprecedented situation required production to be maintained under conditions compatible with good preparation practices (unexposed personnel, and sterility of preparations intended for immunocompromised patients). Risk factors for undesirable events were identified: absence of a degraded procedure for a total breakdown, unknown duration of the breakdown, number of preparations planned. On October 20, the production delay was estimated at 3 hours, with a postponement of treatment for 3 patients within a maximum of 4 days. Downgraded production was necessary for 12 days. Additional costs were estimated at:

• Approximately €4,000 for closed systems (not usually used)
• Approximately €3,000 for leftover unused products that could not be stored in an extractor hood.
• The extra cost attributable to consumables could not be reliably assessed.
  The isolators were fixed on November 4, and conventional operations resumed on November 7.

This exceptional situation enabled us to measure the ability of our medical and pharmaceutical teams to adapt and collaborate and to prepare as well for a potential recurrence of this incident.
A declaration of serious adverse events was notified to the French regional health agency.

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