DRUGCAM®, a video analysis system: Its impact on risk management in cytotoxic drug production units
4 October 2023A. Andrieu, A. Lassalle-Diguet, E. Raingeard, M. Palamini
Pharmacotechnie, CHD Vendée, La Roche-sur-Yon, France
The Drugcam® (DC®) "in process" monitoring system was implemented in the unit in 2018 as a corrective action in response to unacceptable failures identified during a risk analysis.
Identify and assess the impact of DC® on the production process for injectable chemotherapies away from its facility.
Two methods were used to assess the impact of DC® on risk management:
* A working group and an evaluation grid were set up to carry out a risk analysis FMECA CARTORISK® at a distance from the installation of the DC® tool. A comparison was made of 3 risk analyses carried out at different times (before, during and after the installation of DC®).
* An analysis of the anomalies identified by DC® by viewing 896 preparation videos in order to establish a lexicon of anomalies and to study their incidence and root causes.
The two risk analyses carried out before and after the installation of DC® identified 5 unacceptable risks, whereas the risk analysis carried out at the time of installation revealed only one unacceptable risk. Away from the installation: the FMECA® shows a different distribution of criticality compared with previous analyses. DC® reduces the criticality of the risks of non-compliant preparations, labelling errors and failure to detect preparation errors during release. However, its use has brought to light two new risks, namely the lack of knowledge about occupational exposure to cytotoxics and the emergence of misuse. An analysis of the videos shows that misuse is the second most common anomaly (29%), after a failure to detect by the tool (52%) and before preparation errors (14%). The misuses most frequently encountered were failure to comply with the DC Assist® scenario, defects in the presentation of objects to the camera, and a deterioration in good practice for checking trays and production sheets, with a risk of losing production prioritisation.
DC®, by reducing the criticality of the risks identified prior to its implementation, makes the injectable chemotherapy preparation stage safer and meets the initial objectives. At the same time, changes in practices linked to the tool are bringing to light new risks that had not been identified at the time of installation. Because of the way it works, DC® makes it possible to objectivise the frequency of risks that were unknown before it was introduced. Corrective action needs to be taken within the unit, such as assessing exposure to cytotoxics and working on good practice in using the tool in the form of practical exercises.