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Medical Device Adverse Events: You Dont Know What You Dont Know - PowerPoint PPT Presentation

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Medical Device Adverse Events: You Dont Know What You Dont Know This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  1. Medical Device Adverse Events: You Don’t Know What You Don’t Know This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  2. Madris Tomes, MBA Founder and CEO, Device Events (current) Adverse Events Sub-group Lead, AHA’s Learning UDI Community FDA Public Health Analyst, Unique Device Identification (UDI), and Subject Matter Expert for Adverse Event Reporting Co-author, UDI Demonstration Abstract (cardiac stents) with Mercy, Mayo, Boston Scientific, Duke, Medtronic, Abbott, and the FDA FDA Device Liaison to CMS for SunshineAct Broadcast Public Relations for Firestone Tire Recall (2000) Featured in: New York Times (front page business section), CNN, Washington Post Magazine, CNBC Power Lunch, Reuters, NBC NY www.linkedin.com/in/madris This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  3. *95% of the medical devices on the market have not gone through clinical trials. Most people, doctors included, do not know this. It takes 2 months to 2 years for medical device patterns/signals to be identified, investigated, and reported by the FDA. “Today, we do not track medical device adverse effects reported by physicians before an actual recall is issued.” VP at the second largest Group Purchasing Organization (GPO) In the US *National Center for Health Research

  4. Recent Headlines Demonstrate the Cost of Impenetrable Data

  5. With over 6 million reports in Public MAUDE , the data is impenetrable, unusable and not timely. What You See in Public MAUDE This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  6. Over 1300 Variations of the Name “Medtronic” Have Been Submitted to the FDA in the last 2 years alone. Without Matching and Cleansing, True Adverse Event Counts are Inaccurate This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  7. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  8. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  9. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  10. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  11. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  13. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  14. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  15. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  16. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  17. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  18. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  19. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  20. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  21. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  22. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  23. The Current State of Adverse Events This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  24. Although duodenoscopes and heater-coolers have received the most attention by the media, peritoneal dialysis machines, bronchoscopes, colonoscopes and cystoscopes are also testing positive for drug resistant, dangerous bacteria. Patterns Across Device Types This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  25. Scenario: Your hospital is named in a lawsuit for use of a device. View when the device company knew of the issues. Search on Contaminations in Olympus scopes

  26. Searching for Contaminations • Positive for b(6): 1083 reports • Mycobacteria, NTM: 146 reports then; 1,077 now • CRE, ESBL: 140 reports then; 302 now • Pseudomonas, klebsiella: 324 reports then; 380 now • Candida lipolytica: 31 reports then; 38 now • MRSA: Critical Events Reports are redacted more often than they are not This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  27. Questions? This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

  28. Questions? This material is confidential and proprietary to Device Events. Recipient may not distribute, copy, print or repeat information in the document without prior written consent.

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