Health Technology Assessment: Managing the introduction and use of medical devices in clinical practice in Italy

Expert Review of Medical Devices

Volumn 6, Issue 3, 2009, Pages 251-257

  Migliore, Antonio ^a   Ratti, Marco ^a   Cerbo, Marina ^a   Jefferson, Tom ^a  

^a National Agency for Regional Health Services   (Italy)

Author keywords

Health Technology Assessment; Hip prosthesis; Joint implants; Point of care test; Rapid bedside test; Register; Regulation; Risk; Wireless capsule for endoscopy

Indexed keywords

ARTICLE; BIOMEDICAL TECHNOLOGY ASSESSMENT; CAPSULE ENDOSCOPY; CLINICAL PRACTICE; COLON DISEASE; COST EFFECTIVENESS ANALYSIS; DIAGNOSTIC ACCURACY; IMMUNOASSAY; INFLUENZA; ITALY; MEDICAL INSTRUMENTATION; PATIENT SAFETY; REIMBURSEMENT; TOTAL HIP PROSTHESIS; APPARATUS, EQUIPMENT AND SUPPLIES; ECONOMICS; MEDICAL TECHNOLOGY; METHODOLOGY; REVIEW; STANDARD;

BIOMEDICAL TECHNOLOGY; EQUIPMENT AND SUPPLIES; ITALY; PHYSICIAN'S PRACTICE PATTERNS; TECHNOLOGY ASSESSMENT, BIOMEDICAL;

EID: 67651040730     PISSN: 17434440     EISSN: 17452422     Source Type: Journal    
DOI: 10.1586/erd.09.2     Document Type: Article

References (23)

1. Schuh JCL. Medical device regulations and testing for toxicologic pathologists. Toxicol. Pathol. 36, 63-69 (2008).
2. Spencer SA, Nicklin SE, Wickramasinghe YA, Nevill A, Ellis SJ. An essential 'health check' for all medical devices. Clin. Med. 3(6), 543-545 (2003).
3. Garattini L, Casadei G. Health technology assessment: for whom the bell tolls? Eur. J. Health Econ. 9(4), 311-312 (2008).
4. Cavallo A, Cerbo M, Fella D, Jefferson T, Migliore A, Perrini MR. AGE.NA.S. HTA Report - Prostheses for primary total hip replacement in Italy, Rome, September (2008).
5. Bernardini F, Cerbo M, Jefferson T, Lo Scalzo A, Ratti M. AGE.NA.S. HTA Report - Wireless Capsule Endoscopy in the diagnosis of small bowel disease, Rome, September (2008).
6. Amicosante AMV, Cerbo M, Jefferson T, Paone S, Velardi L. AGE.NA.S. HTA Report - Rapid (bed-side) tests for in?uenza, Rome, Italy, September (2008).
7. Italian National Institute of Health. PNLG-8: revisione sistematica sulle protesi d'anca: affidabilità dell'impianto. Italian National Institute of Health, Rome, Italy (2004).
8. Italian National Institute of Health. KCE: endoscopie par capsule, Centre Federal d'Expertise des Soins de Santè, 25B. Italian National Institute of Health, Rome, Italy (2006).
9. Aamodt A, Nordsletten L, Havelin L et al. Documentation of hip prostheses used in Norway: a critical review of the literature from 1996-2000. Acta Orthop. Scand. 75(6), 663-676 (2004).
10. Ni GX, Lu WW, Chiu KY et al. Cemented or uncemented femoral component in primary total hip replacement? A review from a clinical and radiological perspective. J. Orthop. Surg. 13(1), 96-105 (2005).
11. Morshed S, Bozic KJ, Ries MD et al. Comparison of cemented and uncemented fixation in total hip replacement: a meta-analysis. Acta Orthop. 78(3), 315-326 (2007).
12. Varela-Lema L, Ruano-Ravina A. Development and use of a quality scale for assessing studies that analyze the diagnostic capacity of capsule endoscopy. Endoscopy 38(12), 1261-1267 (2006).
13. Kolling C, Simmen BR, Labek G, Goldhahn J. Key factors for a successful National Arthroplasty Register. J. Bone Joint Surg. Br. 89, 1567-1573 (2007).
14. Labek G, Stoica CI, Bohler N. Comparison of the information in arthroplasty registers from different countries. J. Bone Joint Surg. Br. 90, 288-291 (2008).
15. Robertsson O. Knee arthroplasty registers. J. Bone Joint Surg. Br. 89, 1-4 (2007).
16. Whiting P, Rutjes AWS, Reitsma JB, Bossuyt PMM, Kleijnen J. The development of QUADAS: a tool for the quality assessment of studies of diagnostic accuracy included in systematic reviews. BMC Med. Res. Methodol. 3, 25 (2003).
17. Wallner PE, Konski A. A changing paradigm in the study and adoption of emerging health care technologies: coverage with evidence development. J. Am. Coll. Radiol. 5(11), 1125-1129 (2008).
18. Littell JH. Evidence-based or biased? The quality of published reviews of evidence-based practices. Child. Youth Serv. Rev. 30(11), 1299-1317 (2008).
19. Bliziotis IA, Paraschakis K, Vergidis PI, Karavasiou AI, Falagas ME. Worldwide trends in quantity and quality of published articles in the field of infectious diseases. BMC Infect. Dis. 5, 16 (2005).
20. Miller FG, Pearson SD. Coverage with evidence development: ethical issues and policy implications. Med. Care 46(7), 746-751 (2008).
21. Hutton J, Trueman P, Henshall C. Coverage with evidence development: an examination of conceptual and policy issues. Int. J. Technol. Assess. Health Care 23(4), 425-432 (2007).
22. Dobrow MJ, Goel V, Upshur RE. Evidence-based health policy: context and utilisation. Soc. Sci. Med. 58(1), 207-217 (2004).
23. Claxton K, Ginnelly L, Sculpher M, Philips Z, Palmer S. A pilot study on the use of decision theory and value of information analysis as part of the NHS Health Technology Assessment programme. Health Technol. Assess. 8(31), 1-103, iii (2004).