medical device adverse events you don t know what you don
play

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

Mar 24, 2023 •193 likes •490 views

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.

Download Presentation
Download Policy: The content available on the website is offered to you 'AS IS' for your personal information and use only. It cannot be commercialized, licensed, or distributed on other websites without prior consent from the author. To download a presentation, simply click this link. If you encounter any difficulties during the download process, it's possible that the publisher has removed the file from their server.

Recommend

Disclosure of Adverse Jane McKay Events Adverse Events Adverse events will happen through

Disclosure of Adverse Jane McKay Events Adverse Events Adverse events will happen through

Disclosure of Adverse Jane McKay Events Adverse Events Adverse events will happen through out your medical career . You must be able to discuss this with your patients . Lets outline a strategy to do this Disclosure of Adverse Events

444 views • 17 slides
Overview of SG2 SG2 Terms of Reference Examine the requirements for the reporting of medical

Overview of SG2 SG2 Terms of Reference Examine the requirements for the reporting of medical

Overview of SG2 SG2 Terms of Reference Examine the requirements for the reporting of medical device adverse incidents involving medical devices, Recommend ways to harmonize: Reporting requirements of medical device adverse events

470 views • 14 slides
Development of common terminology and code related to adverse event of medical device - NWIP

Development of common terminology and code related to adverse event of medical device - NWIP

Development of common terminology and code related to adverse event of medical device - NWIP September, 2014 Purpose and goal Common terminology and code related to adverse event of medical device will developed. 2 Expectation

159 views • 5 slides
Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease

Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease

Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease Healthcare Costs Physician-Patient Alliance for Health & Safety Crittenden Medical Conference ScottsDale, AZ (April 16, 2012) Cost of Adverse Events

378 views • 16 slides
Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease Healthcare

Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease Healthcare

Put Peer Review & Quality Assurance into Practice: Reduce Adverse Events, Decrease Healthcare Costs Physician-Patient Alliance for Health & Safety Crittenden Medical Conference ScottsDale, AZ (April 16, 2012) Cost of Adverse Events

444 views • 18 slides
Case Presentation: Immune related adverse events Dr. Ronwyn van Eeden Medical Oncologist

Case Presentation: Immune related adverse events Dr. Ronwyn van Eeden Medical Oncologist

Case Presentation: Immune related adverse events Dr. Ronwyn van Eeden Medical Oncologist Some principles irAEs are generally manageable and low grade Can also cause severe morbidity & mortality Vigilance and immediate

760 views • 42 slides
PRO CTCAEs The 2017 update PROs: context Usual description of adverse events with the

PRO CTCAEs The 2017 update PROs: context Usual description of adverse events with the

PRO CTCAEs The 2017 update PROs: context Usual description of adverse events with the 790-items CTCAE (Common Terminology of Adverse Events) criteria under-detects symptomatic, though significant events Patients reports better

521 views • 9 slides
MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM

MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM

MEDICAL DEVICE REW a clinicians perspective INTERNATIONAL MEDICAL DEVICE REGULATORY FORUM (IMDRF) 2017 Harindra Wijeysundera MD PhD FRCPC Vice President Medical Devices & Clinical Interventions, CADTH Associate Professor, Department of

750 views • 37 slides
Medication Reconciliation and Reducing Adverse Drug Events Regional Learning & Action Network

Medication Reconciliation and Reducing Adverse Drug Events Regional Learning & Action Network

Medication Reconciliation and Reducing Adverse Drug Events Regional Learning & Action Network Meetings 2017 Importance of Getting Medication Management Right Pharmaceuticals are the most common medical intervention, and their potential

1.13k views • 26 slides
Safety Immune Related Adverse Events (irAE) Focus on NSCLC Aaron Hansen, BSc, MBBS, FRACP

Safety Immune Related Adverse Events (irAE) Focus on NSCLC Aaron Hansen, BSc, MBBS, FRACP

Safety Immune Related Adverse Events (irAE) Focus on NSCLC Aaron Hansen, BSc, MBBS, FRACP Division of Medical Oncology and Hematology Bras Drug Development Program Princess Margaret Cancer Centre, Toronto, Canada Overview Mechanisms

662 views • 23 slides
Current Regulatory Landscape for Medical Device 3D-Printing Elizabeth McGrath Director, Medical

Current Regulatory Landscape for Medical Device 3D-Printing Elizabeth McGrath Director, Medical

Current Regulatory Landscape for Medical Device 3D-Printing Elizabeth McGrath Director, Medical Device Reforms and Emerging Technology Therapeutic Goods Administration Department of Health 30 March 2019 Medical device 3D printing - This talk

589 views • 22 slides
1 Donors who react may not come back Donors who react may not come back Adverse Events WB

1 Donors who react may not come back Donors who react may not come back Adverse Events WB

Adverse events Adverse events Side effects of blood donation by apheresis Side effects of blood donation by apheresis Adverse events of blood collections Whole blood collections Apheresis collections Hans Vrielink, MD, PhD

336 views • 8 slides
Recent Developm ents in Medical Device Softw are Overview of Mobile Medical Apps and

Recent Developm ents in Medical Device Softw are Overview of Mobile Medical Apps and

Recent Developm ents in Medical Device Softw are Overview of Mobile Medical Apps and Medical Device Data System s February 14, 2016 John Grimes, Ph.D. U.S. Food and Drug Administration Center for Devices and Radiological Health Office

727 views • 47 slides
And the Verdict Is...: Recent Trends in Drug and Device Litigation Presented by: James Beck

And the Verdict Is...: Recent Trends in Drug and Device Litigation Presented by: James Beck

And the Verdict Is...: Recent Trends in Drug and Device Litigation Presented by: James Beck Steven Boranian Stephen McConnell Agenda Personal jurisdiction Preemption Innovator liability Duty to report adverse events

447 views • 31 slides
The Convergence of The Convergence of Software in the Medical Software in the Medical Device

The Convergence of The Convergence of Software in the Medical Software in the Medical Device

The Convergence of The Convergence of Software in the Medical Software in the Medical Device Industry Device Industry Joseph Azary 203-944-9320 Info@azarytech.com FDA Regulations & Quality Requirements Clinical Sterilization FDA

872 views • 68 slides
How Business Management Platforms Improve Medical Device Manufacturing Operations Medical

How Business Management Platforms Improve Medical Device Manufacturing Operations Medical

How Business Management Platforms Improve Medical Device Manufacturing Operations Medical Devices Rose Wolfe Medical Device in The Connected World Account Manager Conference Keynote Presentation TOPICS MD Business MD ERP Management

257 views • 14 slides
Patient Safety: A Quality System Approach To POCT QC/QA Ellis Jacobs, Ph.D., DABCC New York

Patient Safety: A Quality System Approach To POCT QC/QA Ellis Jacobs, Ph.D., DABCC New York

Patient Safety: A Quality System Approach To POCT QC/QA Ellis Jacobs, Ph.D., DABCC New York University School of Medicine Coler-Goldwater Specialty Hospital & Nursing Facility New York, New York Point-of-Care Testing Characteristics A

999 views • 54 slides
Syntax-centered and semantics-centered views of discourse. Can they be reconciled? Matthias

Syntax-centered and semantics-centered views of discourse. Can they be reconciled? Matthias

Introduction: The Copenhagen Treebank Attribution: a Discourse-Syntax Mismatch? Resolving the Syntax-Discourse Conflict Conclusion Syntax-centered and semantics-centered views of discourse. Can they be reconciled? Matthias Buch-Kromann, Daniel

559 views • 27 slides
Equity of accessibility to dialysis facilities Richard JB, Aldigier JC, Le Mignot L, Glaudet F,

Equity of accessibility to dialysis facilities Richard JB, Aldigier JC, Le Mignot L, Glaudet F,

Equity of accessibility to dialysis facilities Richard JB, Aldigier JC, Le Mignot L, Glaudet F, Ben Sad M, Landais P. Paris Descartes University Assistance Publique Hpitaux de Paris Department of Biostatistics and computer sciences hpital

382 views • 25 slides
Alisha Birk B.S.H. 19; Mark Buckup B.S.H. 19; Eleanor Glockner B.S. 21; Janelle Kaneda

Alisha Birk B.S.H. 19; Mark Buckup B.S.H. 19; Eleanor Glockner B.S. 21; Janelle Kaneda

Alisha Birk B.S.H. 19; Mark Buckup B.S.H. 19; Eleanor Glockner B.S. 21; Janelle Kaneda B.S.H. 19, M.S. 21 Stanford University, Department of Bioengineering Introduction 195,000 PD patients worldwide 1 continuing to rise

495 views • 14 slides
Transforming Participation in Chronic Kidney Disease Long term conditions - facts Over 15m

Transforming Participation in Chronic Kidney Disease Long term conditions - facts Over 15m

Valuing Individuals - Transforming Participation in Chronic Kidney Disease Long term conditions - facts Over 15m people living with an LTC in England Multiple LTCs are set to rise - 1.9m (2008) to 2.9m (2018) Consultations for

712 views • 35 slides
CHRONIC KIDNEY DISEASE FINANCIAL AND ECONOMIC COSTS DR. P. G. MAHIPALA MBBS, MSC, MD, MBA,

CHRONIC KIDNEY DISEASE FINANCIAL AND ECONOMIC COSTS DR. P. G. MAHIPALA MBBS, MSC, MD, MBA,

CHRONIC KIDNEY DISEASE FINANCIAL AND ECONOMIC COSTS DR. P. G. MAHIPALA MBBS, MSC, MD, MBA, FCMA,DED, DM, DBS, DPM DIRECTOR GENERAL OF HEALTH SERVICES MINISTRY OF HEALTH DECEMBER 10, 2013 Common causes es of CRF W Worldwi wide e

838 views • 46 slides
Prevalence Evaluation and Management of All types of cough Cough 3.6% of visits to

Prevalence Evaluation and Management of All types of cough Cough 3.6% of visits to

Prevalence Evaluation and Management of All types of cough Cough 3.6% of visits to primary care 29.5 million visits per year Karen Wood, MD and Arick Forrest, MD Chronic Cough One of the most common reasons for Ohio State

478 views • 17 slides
Collaboration Renal MRI Creating room and momentum through facilitation Registered

Collaboration Renal MRI Creating room and momentum through facilitation Registered

Collaboration Renal MRI Creating room and momentum through facilitation Registered charity no. 252892. Scottish charity no. SC039245. Patient survey on research priorities Weighted Score for research priorities 0 1000 2000 3000 4000

615 views • 13 slides

More recommend