Why I Fight to Improve the FDA, and          You Should Too    Diana Zuckerman, PhD, PresidentNational Research Center for...
Unsafe Medical Products       in the NewsMedtronic Agrees to                     With Warning, a$23.5 Million Settlementin...
Defective Medical Devices     Hit Prime Time
Low Risk Devices
Moderate Risk (510k)
95+% are Reviewed as 510(k)IOM: No evidence of safety or efficacyMust be Substantially Equivalent to  “predicate device or...
High Risk Medical Devices(pacemaker, heart, infusion pump)
Highest Risk Devices: PMAPremarket Approval Reasonably Safe Reasonably EffectiveBased on one clinical trial (not double ...
FDA Approval of         Drugs and Devices              Does NOT mean Nobody will die or be harmed This product is safe f...
510k Substantial Equivalence Similar “intended use” Similar material or mechanism of  action Similar risk: benefit ratio
Are these substantially              equivalent?                              =                              ?Vitek (teflo...
Are these substantially      equivalent?         =         ?
GAO Report  510(k) Reviews in 2003-2007 FDA Cleared 90% of 13,000+ medical devices
More Recalls     Almost  half a billion 510(k) devices were     recalled as high risk in late 2010 and     early 2011, in...
More Recalls     GAO’s estimates that 3,000+ recalls from     2005 through 2009 were high-risk or     moderate-risk recal...
Deaths reported on FDA web site     4,556 deaths for medical devices in     2009 (increased 60% compared to     2006).1
Improving Safety Clinical trials Inspections Any flaws can be caught   sooner with  post-market studies, registries,  s...
Conclusions Can’t have evidence-based medicine with no evidence IOM says that over 95% of new   medical devices have no ...
Consumers Should Care Half billion             510(k) devices were recently recalled as high risk Approx 15% of regulate...
Diana Zuckerman, PhD            PresidentNational Research Center for Women &               FamiliesCancer Prevention and ...
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Zuckerman cue june 2012

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Zuckerman cue june 2012

  1. 1. Why I Fight to Improve the FDA, and You Should Too Diana Zuckerman, PhD, PresidentNational Research Center for Women & Families Cancer Prevention and Treatment Fund
  2. 2. Unsafe Medical Products in the NewsMedtronic Agrees to With Warning, a$23.5 Million Settlementin Kickback Case Hip Device Is Trial of Synthetic Withdrawn Mesh in Pelvic Surgery Ends Early
  3. 3. Defective Medical Devices Hit Prime Time
  4. 4. Low Risk Devices
  5. 5. Moderate Risk (510k)
  6. 6. 95+% are Reviewed as 510(k)IOM: No evidence of safety or efficacyMust be Substantially Equivalent to “predicate device or devices” No clinical trials No inspections No studies are required post-market Can’t be rescinded
  7. 7. High Risk Medical Devices(pacemaker, heart, infusion pump)
  8. 8. Highest Risk Devices: PMAPremarket Approval Reasonably Safe Reasonably EffectiveBased on one clinical trial (not double blind ) with smaller sample than required for prescription drug data
  9. 9. FDA Approval of Drugs and Devices Does NOT mean Nobody will die or be harmed This product is safe for long-termuse This product is more effective than other products on the market
  10. 10. 510k Substantial Equivalence Similar “intended use” Similar material or mechanism of action Similar risk: benefit ratio
  11. 11. Are these substantially equivalent? = ?Vitek (teflon) TMJ implants Dow silicone sheet
  12. 12. Are these substantially equivalent? = ?
  13. 13. GAO Report 510(k) Reviews in 2003-2007 FDA Cleared 90% of 13,000+ medical devices
  14. 14. More Recalls  Almost half a billion 510(k) devices were recalled as high risk in late 2010 and early 2011, including contaminated alcohol swabs that killed this 2-year old boy and then infected others.1
  15. 15. More Recalls  GAO’s estimates that 3,000+ recalls from 2005 through 2009 were high-risk or moderate-risk recalls  Divide 3000 by the device industry’s estimate of 20,000 device submissions.1  RESULTS: 15% were recalled!
  16. 16. Deaths reported on FDA web site  4,556 deaths for medical devices in 2009 (increased 60% compared to 2006).1
  17. 17. Improving Safety Clinical trials Inspections Any flaws can be caught sooner with post-market studies, registries, surveillance
  18. 18. Conclusions Can’t have evidence-based medicine with no evidence IOM says that over 95% of new medical devices have no clinical trials and are not proven safe or effective Clinical trials are less stringent for devices than for prescription drugs
  19. 19. Consumers Should Care Half billion 510(k) devices were recently recalled as high risk Approx 15% of regulated devices are recalled as high or moderate risk
  20. 20. Diana Zuckerman, PhD PresidentNational Research Center for Women & FamiliesCancer Prevention and Treatment Fund www.center4research.org www.stopcancerfund.org
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