435
Views
11
CrossRef citations to date
0
Altmetric
Review

Quality criteria for medical device registries: best practice approaches for improving patient safety – a systematic review of international experiences

, &
Pages 49-64 | Received 14 Aug 2016, Accepted 02 Dec 2016, Published online: 28 Dec 2016

References

  • European Commission. Communication from the Commission to the European Parliament, the Council, The European economic and social committee and the committee of the regions. [updated 2013 Sep11; cited 2016 Nov 27]. Available from: https://ec.europa.eu/digital-single-market/en/news/communication-commission-european-parliament-council-european-economic-and-social-committee-a-0
  • European Commission. Press Release: safer, more effective and innovative medical devices. Brussels, [updated 2012 Sep 26; cited 2016 Nov 27]. Available from: http://europa.eu/rapid/press-release_IP-12-1011_en.htm
  • Campbell B, Stainthorpe AC, Longson CM. How can we get high quality routine data to monitor the safety of devices and procedures? BMJ. 2013;346:f2782. Epub 2013/05/09.
  • Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA. 2001;286:793–799. Epub 2001/08/22
  • Hume KM, Crotty CA, Simmons CJ, et al. Medical specialty society-sponsored data registries: opportunities in plastic surgery. Plast Reconstr Surg. 2013;132:159e–167e. Epub 2013/06/29
  • Zhang S, Kriza C, Schaller S, et al. Recalls of cardiac implants in the last decade: what lessons can we learn? PLoS One. 2015;10: e0125987. Epub 2015/05/12.
  • FDA. A global fight against dangerous counterfeit and unapproved medical products: from operation pangea to FDA’s global strategic framework; [cited 2015 Nov 27]. Available from: http://blogs.fda.gov/fdavoice/index.php/2015/06/a-global-fight-against-dangerous-counterfeit-and-unapproved-medical-products-from-operation-pangea-to-fdas-global-strategic-framework/
  • Migliore A, Mertens R, Almazán C, et al. Petition; [cited 2016 Nov 27]. Available from: https://www.uni-wh.de/fileadmin/media/u/news/2013/2._Quartal/28_11_2012_Open_letter_Medical_Devices_FINAL_corrigendum_pdf.pdf
  • European Commission. Press Release: restoring confidence in medical devices. Action Plan after the PIP scandal tightened control in Europe; [cited 2016 Nov 27]. Available from: http://europa.eu/rapid/press-release_IP-14-699_en.htm
  • European Commission. PIP Action Plan; [cited 2016 Nov 27]. Available from: http://ec.europa.eu/growth/sectors/medical-devices/pip-action-plan/index_en.htm
  • Eldessouki R, Peeters R. Therapeutic and diagnostic device regulatory requirements in Europe. In: Ackerman J, Smith M, Ehreth J, et al., editors. Therapeutic and diagnostic device outcomes research. South Lawrenceville (NJ): International Society for Pharmacoeconomics and Outcomes Research; 2011. p. 55–62.
  • Sorenson C, Drummond M. Improving medical device regulation: the United States and Europe in perspective. Milbank Q. 2014;92:114–150. Epub 2014/03/07.
  • Boriani G, Maniadakis N, Auricchio A, et al. Health technology assessment in interventional electrophysiology and device therapy: a position paper of the European Heart Rhythm Association. Eur Heart J. 2013;34:1869–1874.
  • GKV Spitzenverband. Medizinprodukte - mythen und wahrheit [Myths and Truths]; 2013; [cited 2016 Nov 27]. Available from: https://www.gkv-spitzenverband.de/media/dokumente/presse/presse_themen/innovationszentren/SpiK-GKV-SV-Argumentationspapier-Medizinprodukte_MythenWahrheit-final-d___.pdf [German].
  • International Society for Pharmacoeconomics and Outcomes Research. ISPOR Patient Registry Special Interest Group; [cited 2016 Nov 27]. Available from: http://www.ispor.org/sigs/pr_operations_bg.asp
  • Niederländer C, Wahlster P, Kriza C, et al. Registries of implantable medical devices in Europe. Health Policy. 2013;113:20–37. Epub 2013/10/01.
  • Black N, Tan S. Use of national clinical databases for informing and for evaluating health care policies. Health Policy. 2013;109:131–136. Epub 2012/11/03.
  • Valzania C, Torbica A, Tarricone R, et al. Implant rates of cardiac implantable electrical devices in Europe: a systematic literature review. Health Policy. 2016;120:1–15. DOI:10.1016/j.healthpol.2015.11.001 Epub Nov 10.
  • Dreyer NA, Bertagna M, Gliklich RE. Designing and assessing registries to evaluate the safety of medical products. Monitor. 2007 Aug;21:47–50.
  • Drolet BC, Johnson KB. Categorizing the world of registries. J Biomed Inform. 2008;41:1009–1020. Epub 2008/03/11.
  • Centre for Reviews and Dissemination. Systematic reviews: CRD’s guidance for undertaking reviews in health care. York: University of York; 2009; [cited 2016 Nov 27]. Available from: http://www.york.ac.uk/crd/SysRev/!SSL!/WebHelp/SysRev3.htm
  • Moher D, Liberati A, Tetzlaff J, et al. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Int J Surg. 2010;8:336–341. Epub 2010/02/23
  • Alings M, Vorstenbosch JM, Reeve H. Automaticity: design of a registry to assess long-term acceptance and clinical impact of Automatic Algorithms in Insignia pacemakers. Europace. 2009;11:370–373. Epub 2009/02/26.
  • Beckmann A, Hamm C, Figulla HR, et al. The German Aortic Valve Registry (GARY): a nationwide registry for patients undergoing invasive therapy for severe aortic valve stenosis. Thorac Cardiovasc Surg. 2012;60:319–325. Epub 2012/08/04
  • Boswell CCB, Young LY. PSEF Set Up Registry to Gather Breast Implant Data. 2014; [cited 2016 Oct 30]. Available from: http://www.breastimplantsusa.com/plastic-surgery-articles/psef-set-up-registry-to-gather-breast-implant-data-425.htm.
  • Campolo L, Pantaleo P, Barattoni MC, et al. Coronary angioplasty in the real world: the RESTEM registry. Outcome of patients treated with sirolimus-eluting stents. G Ital Cardiol (Rome). 2008;9:270–279. Epub 2008/06/12
  • Campolo L, Pantaleo P, Barattoni MC, et al. RESTEM: a percutaneous coronary intervention ‘real world’ registry in the drug-eluting stent era. Coron Artery Dis. 2007;18:653–662. Epub 2007/11/16
  • Dugas M, Hoffmann E, Janko S, et al. Complexity of biomedical data models in cardiology: the Intranet-based AF registry. Comput Methods Programs Biomed. 2002;68:49–61. Epub 2002/03/12
  • Galli M, Bartorelli A, Bedogni F, et al. Italian BiodivYsio open registry (BiodivYsio PC-coated stent): study of clinical outcomes of the implant of a PC-coated coronary stent. J Invasive Cardiol. 2000;12:452–458. Epub 2000/09/06
  • Goldberg SL, Berger P, Cohen DJ, et al. Rotational atherectomy or balloon angioplasty in the treatment of intra-stent restenosis: BARASTER multicenter registry. Catheter Cardiovasc Interv. 2000;51:407–413. Epub 2000/12/07
  • Healey JS, Dorian P, Mitchell LB, et al. Canadian Registry of ICD Implant Testing procedures (CREDIT): current practice, risks, and costs of intraoperative defibrillation testing. J Cardiovasc Electrophysiol. 2010;21:177–182. Epub 2009/10/07
  • Hubler S, Potapov EV, Loebe M, et al. Development of a database of patients supported by ventricular assist devices. ASAIO Journal. 2003;49:340–344.
  • Hye RJ, Inui TS, Anthony FF, et al. A multiregional registry experience using an electronic medical record to optimize data capture for longitudinal outcomes in endovascular abdominal aortic aneurysm repair. J Vasc Surg. 2015;61:1160–1166. Epub 2015/03/03
  • Kawaguchi AT, Suma H, Konertz W, et al. Partial left ventriculectomy: the 2nd International Registry Report 2000. J Card Surg. 2001;16:10–23. Epub 2001/11/21
  • Kline-Rogers E, Share D, Bondie D, et al. Development of a multicenter interventional cardiology database: the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) experience. J Interv Cardiol. 2002;15:387–392. Epub 2002/11/21
  • Lam CS, Anand I, Zhang S, et al. Asian Sudden Cardiac Death in Heart Failure (ASIAN-HF) registry. Eur J Heart Fail. 2013;15:928–936. Epub 2013/04/10
  • Lazarus A. Remote, wireless, ambulatory monitoring of implantable pacemakers, cardioverter defibrillators, and cardiac resynchronization therapy systems: analysis of a worldwide database. Erratum Appears in Pacing Clin Electrophysiol. 2007 Nov;30(11):1424. Pacing & Clinical Electrophysiology. 2007;30 Suppl 1:S2–S12.
  • Lee DS, Birnie D, Cameron D, et al. Design and implementation of a population-based registry of Implantable Cardioverter Defibrillators (ICDs) in Ontario. Heart Rhythm. 2008;5:1250–1256. Epub 2008/09/09
  • Ludman PF. British Cardiovascular Intervention Society Registry for audit and quality assessment of percutaneous coronary interventions in the United Kingdom. Heart. 2011;97:1293–1297. Epub 2011/07/02.
  • Maisel WH. Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. JAMA. 2005;294:955–958. Epub 2005/08/25.
  • Proclemer A, Ghidina M, Cicuttini G, et al. The Italian Implantable Cardioverter-Defibrillator Registry. A survey of the national activity during the years 2001-2003. Ital Heart J. 2005;6:272–280. Epub 2005/05/07
  • Proclemer A, Ghidina M, Gregori D, et al. Trend of the main clinical characteristics and pacing modality in patients treated by pacemaker: data from the Italian Pacemaker Registry for the quinquennium 2003-07. Europace. 2010;12:202–209. Epub 2009/11/12
  • Proclemer A, Ghidina M, Gregori D, et al. Impact of the main implantable cardioverter-defibrillator trials in clinical practice: data from the Italian ICD Registry for the years 2005-07. Europace. 2009;11:465–475. Epub 2009/01/13
  • Proclemer A, Ghidina M, Facchin D, et al. Use of implantable cardioverter-defibrillator in inherited arrhythmogenic diseases: data from Italian ICD Registry for the years 2001-6. Pacing Clin Electrophysiol. 2009;32:434–445. Epub 2009/04/02
  • Riambau V, Zipfel B, Coppi G, et al. Final operative and midterm results of the European experience in the RELAY Endovascular Registry for Thoracic Disease (RESTORE) study. J Vasc Surg. 2011;53:565–573. Epub 2010/11/30
  • Ricci RP, D’Onofrio A, Padeletti L, et al. Rationale and design of the health economics evaluation registry for remote follow-up: TARIFF. Europace. 2012;14:1661–1665. Epub 2012/05/01
  • Saxon LA, Boehmer JP, Neuman S, et al. Remote Active Monitoring in Patients with Heart Failure (RAPID-RF): design and rationale. Journal of Cardiac Failure. 2007;13:241–246.
  • Sciahbasi A, Pendenza G, Romagnoli E, et al. The PREHAMI (PREsillion in high-risk acute myocardial infarction) registry: in-hospital and long-term outcomes. Catheter Cardiovasc Interv. 2011;77:608–614. Epub 2010/09/09
  • Barsoum WK, Higuera CA, Tellez A, et al. Design, implementation, and comparison of methods for collecting implant registry data at different hospital types. J Arthroplasty. 2012;27:842–850 e1. Epub 2012/01/31
  • Berry DJ, Kessler M, Morrey BF.Maintaining a hip registry for 25 years. Mayo Clinic experience. Clin Orthop Relat Res. 1997;344:61–68. Epub 1997/12/31.
  • Bohm ER, Dunbar MJ, Bourne R. The Canadian Joint Replacement Registry-what have we learned? Acta Orthop. 2010;81:119–121. Epub 2010/02/23.
  • Diel P, Reuss W, Aghayev E, et al. SWISSspine-a nationwide health technology assessment registry for balloon kyphoplasty: methodology and first results. Spine J. 2010;10:961–971. Epub 2009/10/13
  • Havelin LI. The Norwegian Joint Registry. Bull Hosp Jt Dis. 1999;58:139–147. Epub 2000/01/22.
  • Heinz BC. Arthroplasty registries and their contribution to the safety of patient care in joint replacement. Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz. 2009;52:589–593.
  • Henricson A, Skoog A, Carlsson A. The Swedish Ankle Arthroplasty Register: an analysis of 531 arthroplasties between 1993 and 2005. Acta Orthop. 2007;78:569–574. Epub 2007/10/30.
  • Hyer CF, Portera WB, Haglund EM. Lower extremity implant registries: has the time come in the United States? Foot Ankle Spec. 2010;3:148–152. Epub 2010/04/22.
  • Jang B, Walsh NA, Bruce WJ. Verification of the Australian Orthopaedic Association National Joint Replacement Registry using a surgeon’s database. J Orthop Surg (Hong Kong). 2013;21:347–350. Epub 2013/12/25.
  • Knutson K, Robertsson O. The Swedish Knee Arthroplasty Register (“http://www.knee.se). Acta Orthop. 2010;81:5–7. Epub 2010/02/23.
  • Labek G, Todorov S, Iovanescu L, et al. Outcome after total ankle arthroplasty-results and findings from worldwide arthroplasty registers. Int Orthop. 2013;37:1677–1682. Epub 2013/07/09
  • Labek G, Bohler N. The European Arthroplasty Register (EAR), development and rationale for supranational cooperation of arthroplasty registers. Zeitschrift Fur Orthopadie & Unfallchirurgie. 2009;147:151–157.
  • Malchau H, Garellick G, Eisler T, et al. Presidential guest address: the Swedish Hip Registry: increasing the sensitivity by patient outcome data. Clin Orthop Relat Res. 2005;441:19–29. Epub 2005/12/07
  • Myers S, Kaimal S, Springsteen J, et al. Development of a National TMJ Implant Registry and Repository– NIDCR’s TIRR. Northwest Dent. 2007;86:13–18. Epub 2008/02/05
  • Patel M, Haren MC. Disease registries and managed care. Managed Care Interface. 2007;20:52–56.
  • Paxton EW, Inacio MC, Khatod M, et al. Kaiser Permanente National Total Joint Replacement Registry: aligning operations with information technology. Clin Orthop Relat Res. 2010;468:2646–2663. Epub 2010/07/24
  • Paxton EW, Inacio MC, Kiley ML. The Kaiser Permanente implant registries: effect on patient safety, quality improvement, cost effectiveness, and research opportunities. Perm J. 2012;16:36–44. Epub 2012/06/30.
  • Pedersen SS, Lambiase P, Boersma LV, et al. Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD: design and rationale of the EFFORTLESS S-ICD Registry. Pacing Clin Electrophysiol. 2012;35:574–579. Epub 2012/03/01
  • Puolakka TJ, Pajamaki KJ, Halonen PJ, et al. The Finnish Arthroplasty Register: report of the hip register. Acta Orthop Scand. 2001;72:433–441. Epub 2001/12/01
  • Robertsson O. Knee arthroplasty registers. J Bone Joint Surg Br. 2007;89:1–4. Epub 2007/01/30.
  • Röder C, El-Kerdi A, Frigg A, et al. The Swiss Orthopaedic Registry. Bull Hosp Jt Dis. 2005;63:15–19. Epub 2006/03/16
  • Röder C, El-Kerdi A, Grob D, et al. A European spine registry. European Spine Journal. 2002;11:303–307. Epub 2002/08/24
  • Sadoghi P, Leithner A, Labek G. Overcoming boundaries of worldwide joint arthroplasty registers: the European Arthroplasty Register minimal dataset. J Arthroplasty. 2013;28:1327–1328. Epub 2013/04/02.
  • Schluessmann E, Aghayev E, Staub L, et al. SWISSspine: the case of a governmentally required HTA-registry for total disc arthroplasty: results of cervical disc prostheses. Spine (Phila Pa 1976). 2010;35:E1397–E1405. Epub 2010/10/30
  • Schluessmann E, Diel P, Aghayev E, et al. SWISSspine: a nationwide registry for health technology assessment of lumbar disc prostheses. Eur Spine J. 2009;18:851–861. Epub 2009/03/21
  • Serra-Sutton V, Allepuz A, Espallargues M, et al. Arthroplasty registers: a review of international experiences. Int J Technol Assess Health Care. 2009;25:63–72. Epub 2009/01/08.
  • Eisenmann-Klein M. European breast implant registry–plastic surgery center: European strategic coaching. J Cosmet Laser Ther. 2003;5:231. Epub 2004/01/27.
  • Henriksen TF, Holmich LR, Friis S, et al. The Danish Registry for Plastic Surgery of the Breast: establishment of a nationwide registry for prospective follow-up, quality assessment, and investigation of breast surgery. Plast Reconstr Surg. 2003;111:2182–2189. discussion 90-1
  • Renner C, Neuhann-Lorenz C. International Breast Implant Registry: a user report. Aesthetic Plast Surg. 2006;30:616–621.
  • Shakespeare PG, Bazire N, Whitworth IH. The UK breast implant registry-ten years on. Br J Plast Surg. 2005;58:283–285. Epub 2005/03/23.
  • Lum F, Schachat AP, Jampel HD. The development and demise of a cataract surgery database. Jt Comm J Qual Improvement. 2002;28:108–114.
  • Lum F, Schein O, Schachat AP, et al. Initial two years of experience with the AAO National Eyecare Outcomes Network (NEON) cataract surgery database. Ophthalmology. 2000;107:691–697. Epub 2000/04/18
  • Berrettini S, Arslan E, Baggiani A, et al. A registry for the collection of data in cochlear implant patients. Acta Otorhinolaryngol Ital. 2011;31:328–340. Epub 2012/01/31
  • Sanderson G, Ariyaratne TV, Wyss J, et al. A global patient outcomes registry: cochlear paediatric implanted recipient observational study (Cochlear™ P-IROS). BMC Ear Nose Throat Disord. 2014;14:10. Epub 2014/10/16.
  • Gliklich R, Dreyer N, Leavy M, editors. Registries for evaluating patient outcomes: a user’s guide. 3rd ed. 2 Volumes (Prepared by the Outcome DEcIDE Center [Outcome Sciences, Inc., a Quintiles company] under Contract No. 290 2005 00351 TO7.) AHRQ Publication No. 13(14)-EHC111. Rockville (MD): Agency for Healthcare Research and Quality; 2014. Available from: http://www.effectivehealthcare.ahrq.gov/registries-guide-3.cfm.
  • Blömer W, Steinbrück A, Schröder C, et al. A new universal, standardized implant database for product identification: a unique tool for arthroplasty registries. Arch Orthopaedic Trauma Surg. 2015;135:919–926.
  • Choi JS, Lee JH, Park JH, et al. Design and implementation of a seamless and comprehensive integrated medical device interface system for outpatient electronic medical records in a general hospital. Int J Med Inform. 2011;80:274–285.
  • Sagbo S, Blochaou F, Langlotz F, et al. A semi-automatic orthopedic implant management tool for Computer Assisted planning, navigation and simulation: from XML implant database to unified implant access interface. Conf Proc IEEE Eng Med Biol Soc. 2005;1:890–893. Epub 2007/02/07
  • Sagbo S, Blochaou F, Langlotz F, et al. New orthopaedic implant management tool for computer-assisted planning, navigation, and simulation: from implant CAD files to a standardized XML-based implant database. Computer Aided Surgery. 2005;10:311–319.
  • FDA. Device classification panels. 2014; [cited 2016 Nov 27]. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051530.htm
  • Khan W, Muntimadugu E, Jaffe M, et al. Implantable medical devices. In: Domb AJ, Kahn W, editors. Focal controlled drug delivery. New York: Springer US; 2014. DOI:10.1007/978-1-4614-9434-8
  • The Norwegian Arthroplasty Register. The Norwegian arthroplasty register; [cited 2016 Nov 27]. Available from: http://nrlweb.ihelse.net/eng/
  • Kaiser Permanente. Cardiac Device Registry; [cited 2016 Aug 13]. Available from: http://www.kpimplantregistries.org/Registries/Cardiology.htm
  • IBIR. International Breast Implant Registry; [cited 2016 Aug 13]. Available from: http://www.ibir.org/
  • Black N, Barker M, Payne M. Cross sectional survey of multicentre clinical databases in the United Kingdom. BMJ. 2004;328:1478.
  • Office for Human Research Protections. Federal Policy for the Protection of Human Subjects (‘Common Rule’). 2016; [cited 2016 Nov 27]. Available from: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/
  • Pangalos G. Draft secure medical database standard. Stud Health Technol Inform. 2002;69:49–110. discussion 229-37.
  • Innovation in Medical Evidence Development and Surveillance. OMOP common data model; [cited 2016 Nov 27]. Available from: http://imeds.reaganudall.org/OMOPCDM
  • Center for Devices and Radiological Health, U.S. Food and Drug Administration. Strengthening our National System for Medical Device Postmarket Surveillance; 2012; [cited 2016 Nov 27]. Available from: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM301924.pdf
  • ICOR. International Consortium of Orthopaedic Registries. 2012; [cited 2016 Nov 27]. Available from: http://www.icor-initiative.org/
  • Arts DG, De Keizer NF, Scheffer GJ. Defining and improving data quality in medical registries: a literature review, case study, and generic framework. J Am Med Inform Assoc. 2002;9:600–611. Epub 2002/10/19.
  • Mendelsohn AB, Dreyer NA, Mattox PW, et al. Characterization of missing data in clinical registry studies. Ther Innovation Regul Sci. 2015;49:146–154.
  • Larsson S, Lawyer P, Garellick G, et al. Use of 13 disease registries in 5 countries demonstrates the potential to use outcome data to improve health care’s value. Health Aff (Millwood). 2012;31:220–227. Epub 2011/12/14
  • NHS Digital. Breast and Cosmetic Implant Registry.2016; [cited 2016 Nov 27]. Available from: http://content.digital.nhs.uk/bcir
  • Gliklich R, Dreyer NA, Leavy MB, et al. Standards in the conduct of registry studies for patient-centered outcomes research. A guidance document for the patient-centered outcomes research institute. Camebridge (MA): Outcome, A Quintiles Company; 2012.
  • Zbrozek A, Hebert J, Gogates G, et al. Validation of electronic systems to collect Patient-Reported Outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force. Value Health. 2013;16:480–489. Epub 2013/06/26
  • Derrett S, Bevin TH, Herbison P, et al. Access to elective surgery in New Zealand: considering equity and the private and public mix. Int J Health Plann Manage. 2009;24:147–160. Epub 2009/03/27
  • Dunne A, Scriven A, Furlong C. Funding linked to evidence: what future for health promotion? Perspectives in Public Health. 2012;132:109–110.
  • Taylor J, Patrick H, Lyratzopoulos G, et al. Methodological challenges in evaluating the value of registers. Int J Technol Assess Health Care. 2014;30:28–33.
  • The Society of Thoracic Surgeons. STS national database; [cited 2016 Nov 27]. Available from: http://www.sts.org/national-database
  • FDA. Unique Device Identification – UDI; [cited 2016 Nov 27]. Available from: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/
  • Cole JA, Taylor JS, Hangartner TN, et al. Reducing selection bias in case-control studies from rare disease registries. Orphanet J Rare Dis. 2011;6:61. Epub 2011/09/14
  • Yazici H. Beware of registries for their biases. Bull NYU Hosp Jt Dis. 2012;70:95–98. Epub 2012/08/16.
  • Cooter RD, Barker S, Carroll SM, et al. International importance of robust breast device registries. Plast Reconstr Surg. 2015;135:330–336. Epub 2015/01/30
  • Stausberg J, Semler S, Neugebauer EA. A registry of registries and cohorts: recommendations for metadata and policies. Gesundheitswesen. 2014;76:865–873. Epub 2014/12/20.
  • Storz-Pfennig P, Schmedders M, Dettloff M. Trials are needed before new devices are used in routine practice in Europe. BMJ. 2013;346:f1646. Epub 2013/03/20.
  • Commonwealth Fund. DPMI. Dutch Parliament Medical Implant Registries. 2015; [cited 2016 Nov 27]. Available from: http://www.commonwealthfund.org/publications/newsletters/international-health-news-briefing/2013/jan/january-2013/netherlands/new-medical-implant-registry
  • FDA. Next steps: Action Plan 2013. 2013; [cited 2016 Nov 27]. Available from: http://www.fda.gov/medicaldevices/safety/cdrhpostmarketsurveillance/ucm348796.htm
  • Center for Devices and Radiological Health, U.S. Food and Drug Administration. Strengthening our National System for Medical Device Postmarket Surveillance - update and next steps; 2013. [cited 2016 Nov 27]. Available from: http://www.fda.gov/downloads/MedicalDevices/Safety/CDRHPostmarketSurveillance/UCM348845.pdf
  • FDA. Medical Device Epidemiology Network Initiative (MDEpiNet); [cited 2016 Nov 27]. Available from: http://www.fda.gov/MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/MedicalDeviceEpidemiologyNetworkMDEpiNet/default.htm
  • Krucoff MW,  Normand SL, Edwards F, et al. Recommendations for a National Medical Device Evaluation System. New Jersey: Medical Device Registry Task Force & the Medical Device Epidemiology Network, FDA; 2015. Available from: http://mdepinet.org/
  • BVMed - Bundesverband Medizintechnologie. Branchenbericht Medizintechnologien 2016; [cited 2016 Nov 27]. Available from: https://www.bvmed.de/de/branche [German]

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.