[Health technology assessment of innovative medical devices: Timing and decision at national and local level]. / Accès au marché des dispositifs médicaux innovants : articulation entre évaluations nationales et hospitalières.

INTRODUCTION: The Medical Device Committee (CODIMS) evaluates all innovative medical devices (MD) before their introduction in the hospitals of the Assistance publique-hôpitaux de Paris (AP-HP). At the national level, the Medical Device and Health Technology Evaluation Committee (CNEDiMTS) provides recommendation for MD with respects to reimbursement by the National Health Insurance Fund. The aim of this study is to compare the recommendations of both committees and to analyze their timing on a six-year period. MATERIAL AND METHOD: We selected all innovative MD assessed by the CODIMS between 2013 and 2018. We retrieved all the recommendations for these MD from the CNEDiMTS. We performed quantitative and qualitative analysis of data collected. RESULTS: On 30 innovative MD assessed by both the CODIMS and the CNEDiMTS, 11 (37%) evaluations were performed by the CODIMS before the CNEDiMTS evaluation. They occurred approximately a year before the CNEDiMTS recommendation (an average of 378 days). Among the 25 MD with a recommendation of both committees, the two opinions were consistent in 88 per cent of all cases. DISCUSSION/CONCLUSION: This study highlights that there is a good consistency between the recommendations of both committees. This suggests that the MD evaluations conducted at the hospital level are relevant and timely. Finally, a better coordination between the national and local levels should be promoted for the MD assessment.

[Review of patient-specific instrumentation for total knee prosthesis]. / Revue des guides personnalisés à usage unique dans les prothèses totales de genou.

OBJECTIVES: Single use patient-specific instruments (PSI) for total knee prosthesis are introduced as a new alternative to conventional ancillaries and computer assisted surgery by improving implants positioning. An exhaustive review was carried out to identify their specific characteristics, with their advantages and disadvantages. METHODS: Medical devices suppliers were consulted in 2015 for reviewing their PSI. Their technical, clinical and economic data were compared. The results had been submitted to an orthopaedics expert commission of our university hospital for clinical and financial opinion. RESULTS: Ten companies have provided the documentation for the analysis. PSI are manufactured by suppliers using a three dimensional printing method based on CT scans or MRI images. PSI are produced according to the surgeon's preferences after a preliminary data check, which can be performed by the suppliers' engineers, the surgeon and automatic calculation. Five suppliers can produce sterile PSI with optional delivery of 3D bone models. According to the experts, the studies failed to demonstrate the superiority of a PSI or hospital economic gain. The prices listed remain high and operating room time is not always significantly reduced. CONCLUSIONS: With the development of personalized medicine, the role of PSI grows in importance. They facilitate the surgeon's work by fully respecting the anatomy. These systems offer an interesting perspective in their technical and pedagogical aspects. But it seems premature to take them into routine use given the low number of high-level studies that were currently done.

[Perspective of the transition from reusable instruments to single use ancillary in orthopedic surgery]. / Ancillaires orthopédiques : évolution du matériel restérilisable vers l'usage unique, quels impacts ?

OBJECTIVES: Since 2009, single-use (SU) ancillaries for total knee arthroplasty (TKA) and total hip arthroplasty (THA) have been marketed to replace reusable ancillaries. The concept is not innovative but their use in orthopedics is still uncommon. An assessment has been done for the use of SU ancillary in Assistance publique-hôpitaux de Paris with the consequences for the patient, the surgeon and the hospital. METHODS: A technical and a clinical review has been done with those devices in 2015. The economic and organizational impacts were identified and submitted for opinion to committee experts in orthopedics. RESULTS: Three SU ancillaries are commercialized. No clinical studies are currently available. There is no reimbursement for SU ancillaries whereas reusable ancillaries are included in prosthesis reimbursement price. Although SU ancillaries (TKA and THA) saving costs for sterilization, the annual additional budget estimated for their purchase would approximately be 2.5 times higher. Nevertheless, indirect savings could be also considered in the long-term period (global costs for sterilization, volume effect…). For the same quality, according to the experts, organizational impacts are low for the patient and the surgeon but potentially important for the hospital, the nursing and pharmaceutical staff, and logistical activities. CONCLUSIONS: On logistic, clinical and financial aspects, SU ancillaries need more evaluation. The switch to SU ancillaries allows saving sterilization costs and time, and provided an immediate mobilization of the equipment but their interest must be demonstrated by clinical and economic data.

[Introduction of Health technology assessment at hospital]. / Mise en place de l'évaluation des technologies de santé en milieu hospitalier.

INTRODUCTION: The Medical Devices Committee (CODIMS) of the Assistance publique-Hôpitaux de Paris (AP-HP) is responsible for deciding whether innovative and costly sterile medical devices (SMD) should be adopted for the AP-HP network and for issuing recommendations on their proper use. The aim of this study was to qualify retrospectively the level of evidence of clinical studies used for the device evaluations by the CODIMS in 2012 and 2013 and to analyze the relationship between levels of evidence and decisions. MATERIAL AND METHOD: Executive summaries written in 2012 and 2013 about studied SMD was analyzed and the level of evidence of clinical studies used was qualified in high/low levels of evidence according to the scale of Sackett et al. Then, levels of evidence were correlated to decisions published by the CODIMS. RESULTS: Sixty-one files of SMD (72.1% of implantable MD) have been evaluated (225 clinical studies). Among them, only 28% of clinical studies had a high level of evidence (and 28.6% of MD at-risk) and 18% did not have any clinical studies. The CODIMS delivered an unfavourable opinion for 16 SMD: only 28 clinicals studies were available for evaluation. Among these, only 6 studies had a high level of evidence. DISCUSSION ET CONCLUSION: The amount and level of evidence of clinical studies is naturally correlated to admittance of SMD. These findings suggest that the clinical evidence used to demonstrate safety and efficacy for high-risk medical devices is based on clinical studies with poor quality data, making more difficult the evaluation of SMD in hospital. The development of a multi-criteria tool to help decision-making would improve the process of SMD evaluation by the CODIMS.