title: Medical device regulation in Australia: safe and effective?
abstract: OBJECTIVE
  To describe the frequency, characteristics and outcomes of reports of possible harms related to medical devices submitted to the Australian Therapeutic Goods Administration (TGA) using data made publicly available on the TGA website.
  
  
  METHODS
  A retrospective analysis, conducted in January 2012, of data made publicly available on the TGA website from January 2000 to December 2011.
  
  
  METHODS
  The number and nature of reports of medical device incidents, recalls and alerts.
  
  
  RESULTS
  Up to December 2011, 6812 incidents involving medical devices were reported to the TGA, although there were several periods where data were unavailable. Incidents were reported more frequently in later years, most often by device sponsors, and were often attributed to mechanical problems. 295 deaths and 2357 serious injuries have been related to incidents, with serious injury (597) highest in 2009. Most incidents involving medical devices were not investigated (47.5%), or, after investigation, no further action was taken (25.0%). During the same time period, there were 35 medical device recalls and 34 medical device alerts issued by the TGA, with no consistent increase over time.
  
  
  CONCLUSIONS
  Despite TGA reform proposals, greater transparency is still needed. Issues that have not been addressed include patchy and conflicting data in the public domain and lack of explanations for the large proportion of uninvestigated reports. To maintain public confidence in the national regulatory system these problems need to be resolved.
authors.affiliation: Sydney School of Public Health, University of Sydney, Sydney, NSW. richard.mcgee@sydney.edu.au
authors.forename: Richard G
authors.initials: RG
authors.lastname: McGee
authors.forename: Angela C
authors.initials: AC
authors.lastname: Webster
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Rogerson
authors.forename: Jonathan C
authors.initials: JC
authors.lastname: Craig
mesh_terms: D001315:Australia; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D016208:Databases, Factual; D004867:Equipment Design; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005260:Female; D006801:Humans; D008297:Male; D057052:Medical Device Recalls / Q000331:legislation & jurisprudence*; D019300:Medical Errors / Q000706:statistics & numerical data; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies