Medical device assessment: scientific evidence examined by the French national agency for health – a descriptive study

BMC Public Health

Francois R Chapuis¹  Karen Maes-Beny²  Evelyne Decullier³  Laure Huot³ 

[1] Conférence Nationale des Comités de Protection des Personnes dans la recherche biomédicale, Comité de Protection des Personnes Sud-Est III, Lyon, 69003, France;Hospices Civils de Lyon, Pôle Information Médicale Evaluation Recherche, Unité de Recherche Clinique, Lyon, 69003, France;Université Lyon 1, Lyon, 69003, France

关键词: Clinical trials;    Level of evidence;    Health technology assessment;    Implantable medical devices;   

Others  :  1163390
DOI  :  10.1186/1471-2458-12-585

 received in 2011-10-26, accepted in 2012-06-15,  发布年份 2012

【 摘 要 】

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.

【 授权许可】

   
2012 Huot et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Maisel WH: Medical device regulation: an introduction for the practicing physician. Ann Intern Med 2004, 140(4):296-302.
• [2]Monsein LH: Primer on medical device regulation. Part I. History and background. Radiology 1997, 205(1):1-9.
• [3]EUCOMED: Eucomed data supplies. http://www.eucomed.org/medical-technology webcite
• [4]Haut Conseil pour l'Avenir de l'Assurance Maladie: Note sur les Dispositifs Médicaux. http://www.securite-sociale.fr/institutions/hcaam/avis/hcaam_note_290508.pdf webcite
• [5]Fuchs VR: New priorities for future biomedical innovations. N Engl J Med 2010, 363(8):704-706.
• [6]INAHTA: International Network of Agencies for Health Technology Assessment (INAHTA): Health Technology Assessment Glossary. 2006. http://www.inahta.org/HTA/Glossary/#_G webcite
• [7]Haute Autorité de Santéhttp://www.has-sante.fr/portail/jcms/c_5443/english?cid=c_5443 webcite]
• [8]Code de la Sécurité Sociale: Article L: 165-1.Current to July 23, 2009. http://www.legifrance.gouv.fr webcite
• [9]Dhruva SS, Bero LA, Redberg RF: Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. Jama 2009, 302(24):2679-2685.
• [10]Kramer DB, Mallis E, Zuckerman BD, Zimmerman BA, Maisel WH: Premarket clinical evaluation of novel cardiovascular devices: quality analysis of premarket clinical studies submitted to the Food and Drug Administration 2000-2007. Am J Ther 2010, 17(1):2-7.
• [11]Agence Nationale d'Accréditation et d'Evaluation en Santé: Guide d'analyse de la littérature et gradation des recommandations. 2000. http://www.has-sante.fr/portail/upload/docs/application/pdf/analiterat.pdf webcite
• [12]Reed SD, Shea AM, Schulman KA: Economic implications of potential changes to regulatory and reimbursement policies for medical devices. J Gen Intern Med 2008, 23(Suppl 1):50-56.
• [13]EUCOMED: Eucomed HTA Position Paper. 2008. http://www.eucomed.org/uploads/Modules/Publications/Eucomed%20position%20paper%20on%20Health%20Technology%20Assessment%20(HTA).pdf webcite
• [14]Huot L, Decullier E, Aulagner G, Chapuis FR: Medical device evaluation: what are the needs? Presse Med 2010, 39(10):1097-1098.
• [15]Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market. 2007. Official Journal of the European Union L 247 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF webcite
• [16]Sedrakyan A, Marinac-Dabic D, Normand SL, Mushlin A, Gross T: A framework for evidence evaluation and methodological issues in implantable device studies. Med Care 2010, 48(6 Suppl):S121-S128.
• [17]Ramsey SD, Luce BR, Deyo R, Franklin G: The limited state of technology assessment for medical devices: facing the issues. Am J Manag Care 1998, 4:SP188-SP199.
• [18]Hines JZ, Lurie P, Yu E, Wolfe S: Left to their own devices: breakdowns in United States medical device premarket review. PLoS Med 2010, 7(7):e1000280.
• [19]Garber AM: Modernizing device regulation. N Engl J Med 2010, 362(13):1161-1163.
• [20]Wilson CB: Adoption of new surgical technology. BMJ 2006, 332(7533):112-114.
• [21]Gabbay J, Walley T: Introducing new health interventions. BMJ 2006, 332(7533):64-65.
• [22]Konstam MA, Pina I, Lindenfeld J, Packer M: A device is not a drug. J Card Fail 2003, 9(3):155-157.
• [23]Tunis SR, Stryer DB, Clancy CM: Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Jama 2003, 290(12):1624-1632.
• [24]Black N: Why we need observational studies to evaluate the effectiveness of health care. BMJ 1996, 312(7040):1215-1218. Clinical research ed
• [25]Concato J, Shah N, Horwitz RI: Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000, 342(25):1887-1892.
• [26]Rao SV, Califf RM, Kramer JM, Peterson ED, Gross TP, Pepine CJ, Williams DO, Donohoe D, Waksman R, Mehran R, et al.: Postmarket evaluation of breakthrough technologies. Am Heart J 2008, 156(2):201-208.
• [27]Mehran R, Leon MB, Feigal DA, Jefferys D, Simons M, Chronos N, Fogarty TJ, Kuntz RE, Baim DS, Kaplan AV: Post-market approval surveillance: a call for a more integrated and comprehensive approach. Circulation 2004, 109(25):3073-3077.
• [28]Raab GG, Parr DH: From medical invention to clinical practice: the reimbursement challenge facing new device procedures and technology–part 1: issues in medical device assessment. J Am Coll Radiol 2006, 3(9):694-702.
• [29]Dhalla IA, Garner S, Chalkidou K, Littlejohns P: Perspectives on the National Institute for Health and Clinical Excellence's recommendations to use health technologies only in research. Int J Technol Assess Health Care 2009, 25(3):272-280.