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

What Makes a Good Medical Device Adverse Event Report?

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

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?

What Happens to Adverse Event Reports Submitted to the FDA?

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

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

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

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

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

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

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

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

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