Objectives: To better understand the process of hospital acquisition of innovative medical devices (MDs) and the hospital-based health technology assessment (HB-HTA) pathways in France, an in-depth study based on a quantitative approach is needed. The aim of the present study was to assess through a national survey how HB-HTA is currently implemented in French hospitals and to identify its level of formalization. Methods: A quantitative online survey was conducted among hospitals performing HB-HTA in France, with a focus on the acquisition of innovative MDs for individual use. The survey, conducted between March and June 2022, was developed by a scientific board composed of members of the French-speaking Society for HB-HTA. Results: Sixty-seven out of 131 surveyed hospitals with HB-HTA activities responded, including 29 university hospitals, 24 nonprofit private hospitals, and 14 local hospitals. Sixty-one respondents (91 percent) reported the existence of a process dedicated to evaluating innovative MDs; of these, 16 declared that their hospitals had a formalized unit with HB-HTA activity. These units were more frequently found in larger hospitals with more than 500 inpatient beds (n = 16, p = 0.0160) and in university hospitals (n = 12, p = 0.0158). No hospital reported any collaboration with HAS, the French national HTA agency. Conclusion: A diverse range of HB-HTA organizations with different structural levels exist in France for MD procurement linked to the category of hospitals. The study highlights the need for recognition of HB-HTA activity at the regulatory level in France and for direct collaboration between HTA activities performed at local and national levels.

The purpose of this article is to investigate the common facilitators and barriers associated with the implementation of hospital-based health technology assessment (HB-HTA) across diverse hospital settings in seven countries. Through a two-round Delphi study, insights were gathered from a panel of 15 HTA specialists from France, Hungary, Italy, Kazakhstan, Poland, Switzerland, and Ukraine. Experts initially conducted a comprehensive review of the HB-HTA implementation in their respective countries, identifying the barriers and facilitators through descriptive analysis. Subsequently, panel experts ranked these identified barriers and facilitators on a seven-point Likert scale. A median agreement score ≥ 6 and interquartile range (IQR) ≤ 1 was accepted as reaching a consensus. Out of the 12 statements categorized as external and internal barriers and facilitators, the expert panel reached consensus on six statements (two barriers and four facilitators). The external barrier, which achieved consensus, was the lack of the formal recognition of the role of HB-HTA in national or regional legislations. The internal barrier reaching consensus was the limited availability of human resources dedicated to HB-HTA. This qualitative study indicates that HB-HTA still has progress to make before being formally accepted and integrated across most countries, although by building on the facilitating factors we identified there may be an opportunity for the implementation of internationally developed strategies to strengthen HB-HTA practices.

The medical technology sector is characterised by a constant influx of innovations with the potential to revolutionise patient care. In France, there are several pathways for medical devices to enter the market, from diagnosis-related group tariffs to reimbursement lists. However, traditional regulatory pathways can delay market access for innovative technologies. In response, France has established Early Access Programs to expedite patient access to medical devices. This paper looks at three of these Early Access Programs for medical devices. Innovation Funding, introduced in its final version in 2015, provides temporary coverage for innovative devices and facilitates data collection for informed funding decisions. Transitional Coverage (PECT), established in 2021, targets CE-marked devices for rare or serious conditions. Transitional coverage for digital health applications (PECAN), introduced in 2022, covers digital medical devices, either therapeutic or for patient monitoring. Innovation funding has been granted to 16 technologies out of 35 applications (46%) since 2015. 6 technologies out of 11 (64%) applications benefit from PECT. PECAN, in its first year, has granted a telemonitoring solution with a favourable opinion. The French experience could provide valuable lessons for the development of a harmonised European framework to ensure that innovative medical technologies benefit those who need them, while maintaining high safety standards.

Objectives: This study aimed to assess the budget and organizational impact of progressively replacing the intraoperative cell salvage centrifugation-based systems currently installed in French hospitals with the same™ system, a new autotransfusion medical device.Methods: An Organizational and Budget Impact Model (OBIM) was developed based on two methodological guidelines issued by the French Health Authority (Haute Autorité de Santé, HAS). The OBIM was also developed based on a pragmatic literature review, hospital data and hospital pharmacists' expertise.Results: Considering an average hospital cohort of 600 cardio-thoracic surgery patients, with 57% experiencing mild hemorrhages, 23% moderate hemorrhages, and 20% massive hemorrhages, and a same™ market share of 33% in Year 1, the implementation of same™ resulted in significant savings. With an average allogeneic transfusion of 4.19 packed red blood cells (RBC) and 0.62 platelet concentrate per patient based on National Hemovigilance Report of the ANSM (French National Agency for the Safety of Medicines and Health Products) and when using same™ system a reduction of 45% of RBC transfusion associated with a reduction of 60% and 90% of platelet use for moderate and massive hemorrhages respectively, the first year annual saving amounted to €44,601 and the cumulated saving over 5 years to €535,206.Discussion: This model structure was developed based on overall hospitals' needs and acknowledged guidelines, with inputs based on French literatures and hospital data, so findings were specifics to a context. Among the inputs, the number of annual same™ procedure is not based on device capability but rather on hospital capability with the number of operating rooms used for cardio-thoracic surgery equipped with the device.Conclusions: The results of this OBIM demonstrated the economic and organizational benefits of same™ for hospitals. This benefit results mainly of a reduction in the use of allogeneic blood products (RBCs, platelets).

Aims: The rising burden of cardiovascular diseases, especially atrial fibrillation, has increased demand for electrophysiology (EP) procedures in Europe, driving greater reliance on disposable devices like diagnostic and ablation catheters. Reprocessing single-use medical devices offers potential economic and environmental benefits, yet concerns persist regarding device integrity and safety. Under the European Union Medical Device Regulation, reprocessing is permitted if national laws allow it; however, implementation varies across Member States. This systematic literature review evaluates the safety and performance of reprocessed cardiac EP catheters originally intended for single use. Methods and results: Following PRISMA guidelines, literature searches of PubMed and Embase identified in vitro and in vivo studies that examined the safety and functionality of reprocessed EP catheters. Key outcomes included infection risk, device sterility, mechanical and electrical integrity, and adverse events. Twelve studies (four in vivo and eight in vitro) involving >1200 patients and multiple catheter brands were included. Under stringent reprocessing protocols, reprocessed EP catheters showed comparable safety and mechanical performance to new devices. However, gaps remain in evidence regarding prion and fungal contamination, the maximum number of safe reprocessing cycles, and the detection of rare complications. Conclusion: The absence of adverse events and reliable performance associated with reprocessed EP catheters reported in this study may encourage European countries that have not yet authorized single-use medical device reprocessing to consider its adoption. However, the broader implementation of this practice remains contingent on its applicability and logistical feasibility within each national context.