How can we get high quality routine data to monitor the safety of devices and procedures?

BMJ (Online)

Volumn 346, Issue 7907, 2013, Pages

  Campbell, Bruce ^a   Stainthorpe, Andrew C ^a   Longson, Carole M ^a  

^a NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CODING; DATA COLLECTION METHOD; DEVICE APPROVAL; DEVICE SAFETY; ELECTRONIC MEDICAL RECORD; GOVERNMENT REGULATION; IMPLANT REGISTRY; INFORMED CONSENT; INTERNATIONAL COOPERATION; PATIENT SAFETY; POSTMARKETING SURVEILLANCE; PRIORITY JOURNAL;

EQUIPMENT AND SUPPLIES; EQUIPMENT SAFETY; GREAT BRITAIN; HUMANS; MEDICAL DEVICE LEGISLATION; PATIENT SAFETY; REGISTRIES;

EID: 84878327988     PISSN: None     EISSN: 17561833     Source Type: Journal    
DOI: 10.1136/bmj.f2782     Document Type: Article

References (20)

1. McCulloch P. EU's system for regulating medical devices. BMJ 2012;345:e7126.
2. Cohen D, Billingsley M. European patients are left to their own devices. BMJ 2011;342:d2748.
3. Dhruva S, Bero L, Redberg R. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA 2009;302:2679-85.
4. Heneghan C, Thompson M, Billingsley M, Cohen D. Medical-device recalls in the UK and the device-regulation process: retrospective review of safety notices and alerts. BMJ Open 2011;1:e000155.
5. Dent T, Wortley S, Campbell B. New interventional procedures. BMJ 2004;329:3-4. (Pubitemid 38869991)
6. European Commission. Proposal for a regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009. http://ec.europa.eu/health/medical-devices/files/revision-docs/ proposal-2012-542-en.pdf.
7. EU Business. EU regulatory framework for medical devices and in vitro diagnostic medical devices. 26 September, 2012. www.eubusiness.com/topics/ health/medical-devices-2.
8. Plumb J, Lyratzopoulos G, Gallo H, Campbell B. How guidance on the use of interventional procedures is produced in different countries: an international survey. Int J Technol Assess Health Care 2009;25:124-33.
9. Bristol Royal Infirmary Inquiry. Learning from Bristol: the report of the public inquiry into children's heart surgery at the Bristol Royal Infirmary 1984-1995. 2001. http://webarchive.nationalarchives.gov.uk/+/www.dh.gov.uk/en/ Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH-4005620.
10. Downs SH, Black NA, Devlin HB, Royston CM, Russell RC. Systematic review of the effectiveness and safety of laparoscopic cholecystectomy. Ann R Coll Surg (Engl) 1996;78:241-323.
11. NICE. Interventional procedures. http://www.nice.org.uk/IP.
12. British Orthopaedic Association. Metal-on-metal hips. www.boa.ac.uk/PI/Pages/Metal-on-Metal.aspx.
13. Campbell B, Patrick H, REGISTER Group. International collaboration in the use of registries for new devices and procedures. Br J Surg 2012;99:744-5.
14. Baum M. Making best use of unique device identification. Health Manage Technol 2011;32:24.
15. International Health Terminology Standards Development Organisation. SNOMED CT. www.ihtsdo.org/about-ihtsdo/snomed-ct.
16. National Joint Registry. Funding. www.njrcentre.org.uk/njrcentre/ AbouttheNJR/Howweoperate/Funding/tabid/79/Default.aspx.
17. Sveriges Kommuner och Landsting. Quality registries. www. kvalitetsregister.se/om-kvalitetsregister/quality-registries.
18. Cabinet Office. Open data measures in the Autumn statement. Press release, 29 November, 2011. www.cabinetoffice.gov.uk/news/open-data-measures- autumn-statement.
19. Food and Drug Administration. Medical devices. 2012. www.fda.gov/ MedicalDevices/ScienceandResearch/EpidemiologyMedicalDevices/ MedicalDeviceEpidemiologyNetworkMDEpiNet/ucm296425.htm.
20. McCulloch P, Altman D, Campbell B, Feldman L, Flum D, Glasziou P, et al. No surgical innovation without assessment: the IDEAL recommendations. Lancet 2009;374:1105-12.