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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.

Rationaleaims and objectives Like health technology assessment (HTA) agencies, hospitals are faced with requests for innovative and costly medical devices. However, local decision makers are frequently confronted with a lack of high-quality clinical data when assessing the effectiveness of innovative medical devices. The aim of this study was to quantify the level of evidence available for innovative medical devices in the context of hospital-based HTA. Methods We searched the Medline, Embase and Cochrane Library databases for articles, letters and reports relating to 32 innovative medical devices requested at our hospital between January 2008 and March 2012. All clinical studies retrieved were screened and classified according to the Sackett 5-point level-of-evidence scale. Results We screened and classified 217 studies: 215 clinical trials and 2 cost-effectiveness studies. Only 47 of the 215 clinical studies (22%) provided high-level clinical evidence (levels 1–2); 33 (15%) were randomized controlled trials (RCTs). More than half of the 215 studies (52.1%) included fewer than 30 patients. Only 14 of the 47 high-quality studies reported the amount of missing data. For implantable medical devices, 84 (71.8%) studies specified the follow-up period and the mean follow-up period was 18.9 months. Finally, methodological quality did not increase with the risk level of the medical device. Conclusions Our findings confirm that only a few studies of innovative medical devices provide high-level clinical evidence. Nevertheless, RCT may be the ‘gold standard’ for drugs, but it is not always appropriate for medical devices. Changes to the European regulation of medical devices, with the requirement for a demonstration of clinical efficacy and safety before release onto the European market, have raised expectations.

Rationale Due to the increase of new cancer cases, our chemotherapy compounding unit must face with ever-growing production needs. To support this increasing workload, we decided to anticipate the preparation of several anti-cancer drugs. Aims and objectives To help us in the decision making, we needed a modern tool able to combine several criteria for selecting appropriate medications for an anticipated preparation. The aim of this study was to assess the decision-making software, FabAct® (Version 1.0). Methods FabAct® ranked all of the anti-cancer drugs used in our chemotherapy compounding unit according to price, chemical stability, compounding difficulties, dosage and production per year. Then, we started to anticipate currently the preparation of four medications and conducted a follow-up of destroyed preparations between January and May 2007. We tried to identify the destruction causes and calculated the time saved for the patients and for the pharmacy technicians. Results According to the decision-making software, the first four drugs for an anticipated preparation were: fluorouracil, cisplatin, carboplatin and paclitaxel. A total of 3913 (50.2%) anticipated preparations were performed and among those, 470 (12%) were destroyed. The main cause of destruction was due to the preparation expiration. Finally, the mean waiting time per patient was reduced from 118 minutes to 68 minutes after the application of the anticipated model. Conclusion According to this 5-month follow-up, FabAct® helped us to select appropriate anti-cancer drugs to anticipate the compounding. Most of the anticipated preparations were administrated to patients and the patient waiting time was significantly reduced.

Due to the increase of new cancer cases, our chemotherapy compounding unit must face with ever-growing production needs. To support this increasing workload, we decided to anticipate the preparation of several anti-cancer drugs.To help us in the decision making, we needed a modern tool able to combine several criteria for selecting appropriate medications for an anticipated preparation. The aim of this study was to assess the decision-making software, FabAct(®) (Version 1.0).FabAct(®) ranked all of the anti-cancer drugs used in our chemotherapy compounding unit according to price, chemical stability, compounding difficulties, dosage and production per year. Then, we started to anticipate currently the preparation of four medications and conducted a follow-up of destroyed preparations between January and May 2007. We tried to identify the destruction causes and calculated the time saved for the patients and for the pharmacy technicians.According to the decision-making software, the first four drugs for an anticipated preparation were: fluorouracil, cisplatin, carboplatin and paclitaxel. A total of 3913 (50.2%) anticipated preparations were performed and among those, 470 (12%) were destroyed. The main cause of destruction was due to the preparation expiration. Finally, the mean waiting time per patient was reduced from 118 minutes to 68 minutes after the application of the anticipated model.According to this 5-month follow-up, FabAct(®) helped us to select appropriate anti-cancer drugs to anticipate the compounding. Most of the anticipated preparations were administrated to patients and the patient waiting time was significantly reduced.