Preliminary hazard analysis applied to a chemotherapy compounding robot

E. Seguin, J. Lupaka, M-L. Brandely, M. Jobard, R. Batista Service de Pharmacie Clinique, Groupe des Hôpitaux Universitaires Paris Centre - site Cochin, Assistance Publique Hôpitaux de Paris, 27 rue du Faubourg Saint Jacques, 75014 Paris, France

Aims
The robot Kiro Oncology®(Grifols, Spain) was set up in our production unit because of an increasing number of chemotherapy preparations. Since 2016, 23% of the preparations for the hospital group have been performed using the robot. A Preliminary Hazard Analysis (PHA) was carried out in our unit to identify specific risks about robotized chemotherapy compounding process.

Method
The multidisciplinary working group (pharmacists, pharmacy technician and Grifols technician) met 6 times from February to May 2020, in order to identify, analyze, prioritize and assess the risks associated with this process. Two scales (severity degree of hazard and possibility of occurrence of hazard) were defined to evaluate initial and residual criticality after the implementation of the corrective actions.

Results
The studied process was divided into 6 phases. The analysis identified 3 main dangers: in decreasing order of frequency the human factor, the organizational factor and the technical factor. Twelve priority situations were identified with 15 scenarii developed: 8/15 (53%) have a tolerable initial risk under control (level 2). After proposing 11 corrective measures, the scenarii became either acceptable as it was (87%, 13/15) or tolerable under control (13%, 2/15). The phases with most of the dangerous situations were preparation of the cycle and pharmaceutical release of the preparations. Implementation of the majority of corrective actions allowed a rapid improvement in our practices, since they were easily achievable (optimization of the back label "to be validated" affixed to the preparation if a problem occurred during automated cycle, implementation of preparations quarantine, real-time validation of pending preparations by the quality pharmacist). Other actions require greater efforts in terms of human and financial resources (bidirectional interfacing between CHIMIO® software (Computer engineering, France) and that of the robot (Kirolink®, Grifols, Spain), improvement of drugs recognition in addition to the datamatrix system and improvement of the IT management of alarms).

Discussion/conclusion
This PHA shows that robotization does not exclude the difficulty of controlling risks linked to the human factor. Despite the corrective actions, 2 scenarii were still critical with a residual criticality of level 2 (tolerable risk under control), which means that the associated corrective actions couldn’t reduce the criticality in level 1 (acceptable risk as it is). For these scenarii, the risk reduction measures are part of an action plan to manage their implementation and keep risks to a minimum.

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