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to “predicate device or devices” No clinical trials No inspections No studies are required post-market Can’t be rescinded
High Risk Medical Devices(pacemaker, heart, infusion pump)
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
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
510k Substantial Equivalence Similar “intended use” Similar material or mechanism of action Similar risk: benefit ratio
Are these substantially equivalent? = ?Vitek (teflon) TMJ implants Dow silicone sheet
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, including contaminated alcohol swabs that killed this 2-year old boy and then infected others.1
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!
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, surveillance
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
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
Diana Zuckerman, PhD PresidentNational Research Center for Women & FamiliesCancer Prevention and Treatment Fund www.center4research.org www.stopcancerfund.org
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