• Constance Châteauvieux, Line Farah, Emmanuel Guérot, Delphine Wermert, Judith Pineau, Patrice Prognon, Isabelle Borget, and Nicolas Martelli.
• Pharmacy Department, Georges Pompidou European Hospital, Paris, France.
• J Eval Clin Pract. 2018 Jun 1; 24 (3): 528-535.

Rationale, Aims, And ObjectivesThere is at present no standard methodology to analyse the organizational impacts (OIs) of medical devices (MDs), and the field is still in its infancy. The aim of the present study was to assess, at a hospital level, the organizational and economic impacts of the introduction of a new MD, specifically the single-use flexible bronchoscope (FB).MethodsBoth the organizational and economic impacts of the single-use FB were evaluated in comparison with the reusable FB currently used as standard practice in our institution. First, process maps were created for both devices (reusable and single use). Based on the 12 types of OI defined by Roussel et al, interviews were conducted with all stakeholders, and the positive and negative aspects of the reusable and single-use processes were analysed. In a second step, microcosting analysis was conducted to determine the most economical balance in use of the 2 technologies.ResultsProcess maps highlighted the complexity of the reusable device process when compared with the single-use device process. Among the 12 types of OI, the single-use FB process scored better than the reusable FB process in 75% of cases. With the "fleet" of 15 reusable FBs available in our institution, using single-use FBs would represent an extra cost of €154 per procedure. Single-use and reusable devices would have the same cost (€232 per procedure) with a theoretical annual activity of 328 bronchoscopies, which is much lower than our current activity (1644 procedures per year).ConclusionsOrganizational impact should be considered when assessing MDs. We show in this study that from an organizational viewpoint, there are many advantages to using single-use bronchoscopes. However, in economic impact, it is more cost-effective for our institution, with more than 1500 bronchoscopies performed annually, to use reusable devices.© 2018 John Wiley & Sons, Ltd.

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