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Monitoring Medical Devices: Missed Warning Signs Within Existing - PowerPoint PPT Presentation

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Monitoring Medical Devices: Missed Warning Signs Within Existing Data Andrew M. Ibrahim MD, MSc House Officer IV | Department of Surgery Robert Wood Johnson Clinical Scholar INSTITUTE FOR HEALTHCARE POLICY University of Michigan &

  1. Monitoring Medical Devices: Missed Warning Signs Within Existing Data Andrew M. Ibrahim MD, MSc House Officer IV | Department of Surgery Robert Wood Johnson Clinical Scholar INSTITUTE FOR HEALTHCARE POLICY University of Michigan & INNOVATION Academy Health Surgical & Perioperative Care Interest Group June 24 th , 2017 | New Orleans, Louisiana

  2. MONITORING MEDICAL DEVICES Limitations of FDA How HSR Can Rise & Fall of the Device Monitoring Support FDA Gastric Band Device INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  3. MONITORING MEDICAL DEVICES Limitations of FDA How HSR Can Rise & Fall of the Device Monitoring Support FDA Gastric Band Device INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  4. MONITORING MEDICAL DEVICES Limitations of FDA How HSR Can Rise & Fall of the Device Monitoring Support FDA Gastric Band Device INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  5. The Rise of Gastric Band Device… FDA Approval 2001 80,000 Devices Annually INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  6. Gastric-band Complications Requiring Reoperation Slippage Causing Obstruction Erosion into the Stomach Slipped band Myur et al. Obesity Surgery, 2005;(15)207-215 Kumar & Thompson. Clin Gastroenterol Hepatol. 2013;11(4):343-353 INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  7. INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  8. Gastric Band Device Reoperations of Medicare Payments 47 % for the Gastric Band Device were for REOPERATIONS INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  9. Restrict (or even Eliminate) Gastric- Band Use…. INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  10. Why Didn’t Our FDA Monitoring System Detect These Concerns Sooner? INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  11. Limitations of FDA Pre-Market Trials SMALL LIMITED “REAL” SAMPLE SIZE FOLLOW-UP PRACTICE INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  12. FDA Efforts to Improve Post-Market Surveillance INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  13. INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  14. FDA Post-Market Surveillance Limitations 1. Voluntary 2. Time Delays 3. Unknown Frequency INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  15. FDA Post-Market Surveillance Limitations 1. Voluntary 2. Time Delays 3. Unknown Frequency INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  16. FDA Post-Market Surveillance Limitations 1. Voluntary 2. Time Delays 3. Unknown Frequency INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  17. FDA Post-Market Surveillance Limitations 1. Voluntary 2. Time Delays 3. Unknown Frequency Solution? “…require unique device identifiers to be included in insurance claims.” INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  18. Device Specific Reoperation Codes Lap Band Related Reoperations (CPT Codes) Port Removal 43887 Port Revision 43886 Port Replacement 43888 Band Removal 43772, 43774 Band Revision 43771 Band Replacement 43659, 43773 Conversion to RNYGB (Lap) 43644, 43645, 43844 Conversion to RNGYB (Open) 43848 Conversion to Sleeve (Lap) 43775 INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  19. Gastric Band & Administrative Data • Free • Publically Available INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  20. Gastric Band & Administrative Data • National Inpatient Sample, 2006-2014 • 216,781 Gastric Band Procedures • $1.3 Billion – placement of device • $820 Million – revise or remove device INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  21. Annual Number of Gastric Band Device Procedures 40,000 35,000 Number of Procedures 30,000 25,000 20,000 15,000 10,000 GASTRIC BAND PLACED 5,000 TOTAL 151,766 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year Gastric Band Placement INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  22. Annual Number of Gastric Band Device Procedures 40,000 35,000 Number of Procedures 30,000 25,000 DEVICE 20,000 REOPERATIONS TOTAL 15,000 70,932 10,000 GASTRIC BAND PLACED 5,000 TOTAL 151,766 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year Gastric Band Placement Device Reoperation INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  23. Annual Number of Gastric Band Device Procedures 40,000 FDA Expands Indications for Device Use 35,000 Number of Procedures 30,000 25,000 DEVICE 20,000 REOPERATIONS TOTAL 15,000 70,932 10,000 GASTRIC BAND PLACED 5,000 TOTAL 151,766 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year Ibrahim & Dimick. JAMA . June 2017 Gastric Band Placement Device Reoperation INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  24. Annual Number of Gastric Band Device Procedures 40,000 FDA Expands Indications for Device Use 35,000 Number of Procedures 30,000 Reoperations rates as low as 4%... 25,000 DEVICE “provide reasonable assurance of 20,000 REOPERATIONS TOTAL 15,000 safety and effectiveness.” 70,932 10,000 – FDA, Summary of Safety and Effectiveness Report, 2011 GASTRIC BAND PLACED 5,000 TOTAL 151,766 0 2006 2007 2008 2009 2010 2011 2012 2013 2014 Year Ibrahim & Dimick. JAMA . June 2017 Gastric Band Placement Device Reoperation INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  25. Annual Payments for Gastric Band Device Procedures $350,000,000 $300,000,000 $250,000,000 Payments (USD) $200,000,000 DEVICE REOPERATION $150,000,000 TOTAL $820 million $100,000,000 GASTRIC BAND $50,000,000 PLACEMENT TOTAL $1.3 billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device Reoperation Gastric Band Placement

  26. Annual Payments for Gastric Band Device Procedures Reoperations >30% of $350,000,000 Annual Payments $300,000,000 $250,000,000 Payments (USD) $200,000,000 DEVICE REOPERATION $150,000,000 TOTAL $820 million $100,000,000 GASTRIC BAND $50,000,000 PLACEMENT TOTAL $1.3 billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device Reoperation Gastric Band Placement

  27. Annual Payments for Gastric Band Device Procedures Reoperations >30% of $350,000,000 Annual Payments Reoperations >50% of Annual Payments $300,000,000 $250,000,000 Payments (USD) $200,000,000 DEVICE REOPERATION $150,000,000 TOTAL $820 million $100,000,000 GASTRIC BAND $50,000,000 PLACEMENT TOTAL $1.3 billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device Reoperation Gastric Band Placement

  28. Annual Payments for Gastric Band Device Procedures Reoperations >30% of $350,000,000 Annual Payments Reoperations >50% of Annual Payments Reoperations >90% of $300,000,000 Annual Payments $250,000,000 Payments (USD) $200,000,000 DEVICE REOPERATION $150,000,000 TOTAL $820 million $100,000,000 GASTRIC BAND $50,000,000 PLACEMENT TOTAL $1.3 billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device Reoperation Gastric Band Placement

  29. Annual Payments for Gastric Band Device Procedures Reoperations >30% of $350,000,000 Annual Payments $300,000,000 Placement of 104,000 Devices $250,000,000 Payments (USD) ~$1 billion $200,000,000 DEVICE REOPERATION $150,000,000 TOTAL $820 million $100,000,000 GASTRIC BAND $50,000,000 PLACEMENT TOTAL $1.3 billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device Reoperation Gastric Band Placement

  30. Why not track Reoperations� >30%� of� $350,000,000 Annual� Payments Reoperations� >50%� of� Annual� Payments Reoperations� >90%� of� $300,000,000 Annual� Payments every devices in $250,000,000 (USD) $200,000,000 DEVICE� Payments� REOPERATION� $150,000,000 TOTAL administrative $945� million $100,000,000 GASTRIC� BAND� $50,000,000 PLACEMENT� TOTAL claims? $1.3� billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device� Reoperation Gastric� Band� Placement INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  31. Why not track Reoperations� >30%� of� $350,000,000 Annual� Payments Reoperations� >50%� of� Annual� Payments Reoperations� >90%� of� $300,000,000 Annual� Payments every devices in $250,000,000 (USD) $200,000,000 DEVICE� Payments� REOPERATION� $150,000,000 TOTAL administrative $945� million $100,000,000 GASTRIC� BAND� $50,000,000 PLACEMENT� TOTAL claims? $1.3� billion $0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Year Device� Reoperation Gastric� Band� Placement The Codes Don’t Exist INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  32. Health Services Researchers and Monitoring Medical Devices INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  33. INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

  34. Acknowledgements Justin Dimick & the CHOP community. INSTITUTE FOR HEALTHCARE @andrewmibrahim POLICY & INNOVATION

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