Single-use flexible bronchoscopes compared with reusable bronchoscopes: Positive organizational impact but a costly solution.

RATIONALE, AIMS, AND OBJECTIVES: There 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). METHODS: Both 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. RESULTS: Process 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). CONCLUSIONS: Organizational 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.

Existing reporting guidelines for clinical trials are not completely relevant for implantable medical devices: a systematic review.

OBJECTIVES: The aim of this study was to determine relevant items for reporting clinical trials on implantable medical devices (IMDs) and to identify reporting guidelines which include these items. STUDY DESIGN AND SETTING: A panel of experts identified the most relevant items for evaluating IMDs from an initial list based on reference papers. We then conducted a systematic review of articles indexed in MEDLINE. We retrieved reporting guidelines from the EQUATOR network's library for health research reporting. Finally, we screened these reporting guidelines to find those using our set of reporting items. RESULTS: Seven relevant reporting items were selected that related to four topics: randomization, learning curve, surgical setting, and device information. A total of 348 reporting guidelines were identified, among which 26 met our inclusion criteria. However, none of the 26 reporting guidelines presented all seven items together. The most frequently reported item was timing of randomization (65%). On the contrary, device information and learning curve effects were poorly specified. CONCLUSION: To our knowledge, this study is the first to identify specific items related to IMDs in reporting guidelines for clinical trials. We have shown that no existing reporting guideline is totally suitable for these devices.