1. Patient Safety and Medical Devices Sonia 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. What Happens to Adverse Event Reports Submitted to the FDA?

6. Demographics
100, ,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

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

8. 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

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

10. 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

11. 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

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

13. 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

14. 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