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

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

Sep 12, 2023 25 likes •398 views

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 &

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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 University of Michigan

INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Academy Health Surgical & Perioperative Care Interest Group June 24th, 2017 | New Orleans, Louisiana

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SLIDE 2 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

MONITORING MEDICAL DEVICES

Rise & Fall of the Gastric Band Device Limitations of FDA Device Monitoring How HSR Can Support FDA

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SLIDE 3 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

MONITORING MEDICAL DEVICES

Rise & Fall of the Gastric Band Device Limitations of FDA Device Monitoring How HSR Can Support FDA

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SLIDE 4 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

MONITORING MEDICAL DEVICES

Rise & Fall of the Gastric Band Device Limitations of FDA Device Monitoring How HSR Can Support FDA

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SLIDE 5 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

The Rise of Gastric Band Device…

FDA Approval 2001 80,000 Devices Annually

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SLIDE 6 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Gastric-band Complications Requiring Reoperation

Erosion into the Stomach

Kumar & Thompson. Clin Gastroenterol Hepatol. 2013;11(4):343-353

Slippage Causing Obstruction

Myur et al. Obesity Surgery, 2005;(15)207-215

Slipped band

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SLIDE 7 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION
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SLIDE 8 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Gastric Band Device Reoperations

47%

  • f Medicare Payments

for the Gastric Band Device were for REOPERATIONS

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SLIDE 9 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Restrict (or even Eliminate) Gastric-Band Use….

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SLIDE 10 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Why Didn’t Our FDA Monitoring System Detect These Concerns Sooner?

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SLIDE 11 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Limitations of FDA Pre-Market Trials

SMALL SAMPLE SIZE LIMITED FOLLOW-UP “REAL” PRACTICE

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FDA Efforts to Improve Post-Market Surveillance

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SLIDE 14 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

FDA Post-Market Surveillance Limitations

  • 1. Voluntary
  • 2. Time Delays
  • 3. Unknown Frequency
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SLIDE 15 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

FDA Post-Market Surveillance Limitations

  • 1. Voluntary
  • 2. Time Delays
  • 3. Unknown Frequency
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SLIDE 16 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

FDA Post-Market Surveillance Limitations

  • 1. Voluntary
  • 2. Time Delays
  • 3. Unknown Frequency
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SLIDE 17 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

FDA Post-Market Surveillance Limitations

  • 1. Voluntary
  • 2. Time Delays
  • 3. Unknown Frequency

Solution? “…require unique device identifiers to be included in insurance claims.”

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SLIDE 18 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

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
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  • Free
  • Publically

Available

Gastric Band & Administrative Data

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  • National Inpatient Sample, 2006-2014
  • 216,781 Gastric Band Procedures
  • $1.3 Billion – placement of device
  • $820 Million – revise or remove device

Gastric Band & Administrative Data

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

Annual Number of Gastric Band Device Procedures

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

Annual Number of Gastric Band Device Procedures

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SLIDE 23 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 2006 2007 2008 2009 2010 2011 2012 2013 2014 Number of Procedures Year Gastric Band Placement Device Reoperation GASTRIC BAND PLACED TOTAL 151,766 DEVICE REOPERATIONS TOTAL 70,932

FDA Expands Indications for Device Use

Annual Number of Gastric Band Device Procedures

Ibrahim & Dimick. JAMA. June 2017
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SLIDE 24 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION 5,000 10,000 15,000 20,000 25,000 30,000 35,000 40,000 2006 2007 2008 2009 2010 2011 2012 2013 2014 Number of Procedures Year Gastric Band Placement Device Reoperation GASTRIC BAND PLACED TOTAL 151,766 DEVICE REOPERATIONS TOTAL 70,932

FDA Expands Indications for Device Use

Annual Number of Gastric Band Device Procedures

Ibrahim & Dimick. JAMA. June 2017

Reoperations rates as low as 4%... “provide reasonable assurance of safety and effectiveness.”

–FDA, Summary of Safety and Effectiveness Report, 2011

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SLIDE 25 $0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Payments (USD)

Year Device Reoperation Gastric Band Placement DEVICE REOPERATION TOTAL $820 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

Annual Payments for Gastric Band Device Procedures

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SLIDE 26 $0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Payments (USD)

Year Device Reoperation Gastric Band Placement Reoperations >30% of Annual Payments DEVICE REOPERATION TOTAL $820 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

Annual Payments for Gastric Band Device Procedures

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SLIDE 27 $0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Payments (USD)

Year Device Reoperation Gastric Band Placement Reoperations >30% of Annual Payments Reoperations >50% of Annual Payments DEVICE REOPERATION TOTAL $820 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

Annual Payments for Gastric Band Device Procedures

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SLIDE 28 $0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Payments (USD)

Year Device Reoperation Gastric Band Placement Reoperations >30% of Annual Payments Reoperations >50% of Annual Payments Reoperations >90% of Annual Payments DEVICE REOPERATION TOTAL $820 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

Annual Payments for Gastric Band Device Procedures

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SLIDE 29 $0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

Payments (USD)

Year Device Reoperation Gastric Band Placement Reoperations >30% of Annual Payments DEVICE REOPERATION TOTAL $820 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

Annual Payments for Gastric Band Device Procedures

Placement of 104,000 Devices ~$1 billion

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Why not track every devices in administrative claims?

$0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Payments (USD) Year Device Reoperation Gastric Band Placement Reoperations >30%
  • f
Annual Payments Reoperations >50%
  • f
Annual Payments Reoperations >90%
  • f
Annual Payments DEVICE REOPERATION TOTAL $945 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion
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SLIDE 31 @andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION

Why not track every devices in administrative claims?

$0 $50,000,000 $100,000,000 $150,000,000 $200,000,000 $250,000,000 $300,000,000 $350,000,000 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Payments (USD) Year Device Reoperation Gastric Band Placement Reoperations >30%
  • f
Annual Payments Reoperations >50%
  • f
Annual Payments Reoperations >90%
  • f
Annual Payments DEVICE REOPERATION TOTAL $945 million GASTRIC BAND PLACEMENT TOTAL $1.3 billion

The Codes Don’t Exist

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Health Services Researchers and Monitoring Medical Devices

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Acknowledgements

Justin Dimick & the CHOP community.

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Thank You

THANK YOU

@andrewmibrahim INSTITUTE FOR HEALTHCARE POLICY & INNOVATION
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Questions

Email: iandrew@umich.edu @andrewmibrahim www.SurgeryRedesign.com

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