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Background: During an orthopedic or trauma surgery procedure, when an implantable medical device is unpackaged, not implanted and cannot be resterilized, it is considered "waste". The cost burden falls on the hospital. The French Social Security Code provides for add-on reimbursement for certain expensive or very specialized devices (supplementary list of costly implants). To allow its restocking without linking it to a patient or reimbursement request, the wasted implant is tracked in a computerized database. The economic impact of these wasted implants is not known in France. This led us to conduct a retrospective study: 1) to determine the percentage and number of wasted implants, 2) to identify elements related to the surgery that impact implant waste., Hypothesis: Various elements of the surgical environment (type of procedure, specialty, surgeon experience, time of year) can independently contribute to the non-implantation of a medical device., Methods: We carried out a retrospective observational study of data collected prospectively in the database of our teaching hospital in 2016. The primary outcome was the percentage of wasted implants. The secondary outcome was the mean cost of these wasted implants. These parameters were determined for all the implants used in orthopedics and trauma surgery and tracked in this department, then for each variable hypothesized to led to non-implantation. Our analysis was descriptive, then comparative., Results: In our database, 29,073 devices were tracked (€3,761,180), of which 1995 devices were wasted (6.9%). The total cost of the wasted implants was €179,193 (4.8% of the overall cost). The breakdown of the wasted implants was 430 (4.4%) from the add-on list (average cost of €293.10) versus 1565 implants associated with the hospital's diagnosis-related group payment system (average cost of €33.90). Trauma surgery procedures had significantly more wasted implants than orthopedic surgery (1135 vs. 860 (p<0.01)), although the individual cost was less (€59.20 vs. €130.10 (p<0.01)). Fracture fixation implants were more likely to be wasted than ligament reconstruction or arthroplasty implants, with a lower mean cost. More implants were wasted during hip arthroplasty than during other arthroplasty procedures. Less experienced surgeons wasted more implants than more experienced surgeons (1087 vs. 905 (p<0.01)) but these implants cost less (€69.20 vs. €114.80 (p<0.05)). The percentage of implants wasted was higher during the resident changeover period relative to the other months of the year (772 vs. 1223 (p<0.01))., Discussion: This study is the first attempt at quantifying the number and cost of wasted implants in the context of orthopedics and trauma surgery at a teaching hospital in France. While trauma surgery is associated with more wasted implants, the cost burden is higher in orthopedics. Surgeons, by virtue of their experience and teaching mandate, have a decisive role managing this cost burden., Type of Study: IV, Retrospective study., (Copyright © 2019. Published by Elsevier Masson SAS.)

Background and Purpose: Decompressive craniectomy is the most common justification for cranioplasty. A medico-economial study based on the effective cost of the hydroxyapatite prosthesis, the percentage of autologous bone graft's loss due to bacterial contamination and the healthcare reimbursment, will allow us to define the best strategy in term of Healthcare economy management for the cranioplasties. A comparison was made between the two groups of patients, autologous bone flap versus custom-made prosthesis in first intention, based on the clinical experience of our department of neurosurgery., Results: No differences was shown between the two groups of patients, in terms of lenght of in-hospital stay and population's characteristics or medical codification. The mean cost of a cranioplasty using the autologous bone graft in first intention was €4045, while the use of hydroxyapatite prosthesis led to a cost of €8000 per cranioplasty., Conclusion: In term of Healthcare expenses, autologous bone flap should be used in first intention for cranioplasties, unless the flap is contaminated or in specific indications, when the 3D custom-made hydroxyapatite prosthesis should be privilegied., (Copyright © 2012 Elsevier Masson SAS. All rights reserved.)

Background: Scientific evidence supports decision-making on the use of implantable medical devices (IMDs) in clinical practice, but IMDs are thought to be far less investigated than drugs. In the USA, studies have shown that approval process of high-risk medical devices was often based on insufficiently robust studies, suggesting that evidence prior to marketing may not be adequate. This study aimed to ascertain level of evidence available for IMDs access to reimbursement in France., Methods: The objective was to examine the scientific evidence used for IMDs assessment by the French National Authority for Health. We collected all public documents summarising supportive clinical data and opinions concerning IMDs issued in 2008. An opinion qualifies the expected benefit (EB) of the IMD assessed as sufficient or insufficient, and if sufficient, the level of improvement of the expected benefit (IEB) on a scale from major (level I) to no improvement (level V). For each opinion, the study with the highest level of evidence of efficacy data, and its design were collected, or, where no studies were available, any other data sources used to establish the opinion., Results: One hundred and two opinions were analysed, with 72 reporting at least one study used for assessment (70.6%). When considering the study with the highest level of evidence: 34 were clinical non-comparative studies (47.2%); 29 were clinical comparative studies of which 25 randomised controlled trials (40.3%); 5 were meta-analyses of randomised controlled trials (6.9%); and 4 were systematic literature reviews (5.6%). The opinions were significantly different according to the study design (p < 0.001). The most frequent design for insufficient EB, IEB level V and IEB level IV was a non-comparative study (10/19, 52.6%; 15/24, 62.5%; and 8/15, 53.3%; respectively). For the 30 opinions with no supporting clinical study, 16 (53.3%) were based on an expert-based process, 9 (30.0%) were based on the conclusions of a previous opinion (all concluding IEB level V), and 5 (16.7%) reported no data (concluding insufficient EB for 4 and IEB level V for 1)., Conclusions: This study confirmed that level of evidence of clinical evaluation of IMDs is low and needs to be improved.

The aim of this study was the medico-economic evaluation of the closure of ostium secundum type interatrial communications in 32 patients, treated by cardiac catheterisation (group A: n = 17) or by surgery (group B: n = 15). The success rate was 100% with the 2 techniques. With national cost scale data we evaluated the overall cost of the 2 treatments using the information system medical program, starting from homogenous groups of patients: 150 catheterisation, 169 and 170 surgery. As the value for the homogenous group of 150 patients was much lower than the price of the material used for catheterisation, an adjusted group of 150 patients including the price of this material was created. An evaluation in terms of an artificial index of activity was also performed. The average duration of hospital stay for group A was reduced by 6.1 days compared to group B (p < 0.001). The overall cost was lower in group A than in group B (p < 0.001), using the real and "adjusted" homogenous group of 150 patients, with a respective reduction of 7,582 Euros and 3,731 Euros. Surgery and catheterisation scored 8,167 points (17,756 Euros) and 2,726 points (5,926 Euros) per patient respectively on the artificial activity index. In conclusion, catheterisation reduced the duration of hospital stay and brought an economic benefit for the Assurance Maladie compared to surgery. However, surgery is more profitable for the hospital than catheterisation because of the high cost of the prosthesis, which is not taken into account with a homogenous group of non-specific patients. This could hamper the development of this innovative technique in a hospital subjected to overall budgetary constraints.