Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

1. Patient Safety and Medical DevicesSonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

2. What Makes a Good Medical Device Adverse Event Report?

3. Complete Device Narrative Information Device Identifier data Device Type • e.g. Infusion Pump • Implantable insulin • Patient controlled analgesia Brand Name • e.g. Kleenex brand of tissues Model Number • e.g. 123 or ABC defibrillator Manufacturer Name • e.g. Check for name on device label

4. Complete Device Narrative Information • User Demographics • Who is using the device? • healthcare professional • patient • Patient Diagnosis • Any presenting or underlying condition that may have contributed to the reported adverse event • Circumstances of Use • Anything unusual or unexpected about the device use in the reported adverse event?

5. Demographics • 100,000 - 120,000 medical device adverse event reports per year • 95% from manufacturers • about half of these are summary reports • 5% from health care practitioners, consumers, and user facilities

6. Reports are Evaluated • The FDA’s CDRH relies on backgrounds in: • Nursing • Biology • Radiology • Dentistry • Public health • Chemistry • Biomedical engineering

7. Adverse Event Evaluation • High-Risk Reports receive priority review • Pediatric deaths • Multiple patient deaths or serious injuries • Fire , explosion, electrocution • Burn, anaphylaxis, exsanguination • Manufacturer initiates remedial action • Unusual events flagged by a reviewer

8. Adverse Event Evaluation • High volume, well-known, events are reviewed in the aggregate through summary reporting • Breast Implants • Surgical Sutures • Intravascular Catheters

9. Adverse Event Evaluation • Reports are reviewed against other data • FDA regulatory data such as pre-market submissions and product recalls • Literature reviews • Previously submitted adverse event trends • similar problems with similar devices • similar problems with other manufacturers • similar patient or use scenarios

10. Adverse Event Evaluation • Analysts may request additional information to assess the cause of a reported event by: • telephone • fax • letter • user facility visit • manufacturer inspection • consult with other FDA Centers

11. FDA Recommendations • Public Health Notification • Post-market Studies • Regulatory Action • Recalls, Standards • Education and Outreach • Peer-Reviewed Articles • Websites • Conferences, Partnerships with professional organizations

12. Unanswered Questions in the Post-market Period • Long Term Medical Device Safety Data • Condition of approval studies • Post-market studies • Device Performance in the Larger Post-market Patient Population • Epidemiological Studies • Registries • Use Error Related to New and Complex Technology • Changing User Demographics, i.e. professionals and lay consumers • Variety of Use Locations, i.e. hospital and home • Evolution of Multiple Function-Multiple Indication Devices, i.e. blood pressure monitors, fluid delivery systems

13. Medical Product Surveillance Network (MedSun) • Data from a sample of medical facilities is anticipated to: • Provide information on emerging medical device problems • Provide information on changes in device use • Promote communication between FDA and the clinical community • Lead to improved safety and efficacy of medical device use