Ofstead & Associates, Inc.
Uncovering device adverse events to improve safety for patients and personnel
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Eligible for 1.0 contact hour | HSPA | CBSPD | RN |
Have you experienced surgical stapler misfires, burns from laparoscopic insulation failures, or robotic surgery cables snapping during procedures? Do you want to learn more about potential problems with medical devices in your facility? Anyone can submit adverse event reports to the FDA MAUDE database and use it to find reports of malfunctions and patient harm caused by damaged or defective medical devices. In this webinar, two researchers will walk participants through the process for submitting reports and provide strategies for searching the database. They will present case studies of adverse events reported to the FDA related to ultrasound probes, surgical staplers, robotic surgical systems, laparoscopic instruments, and endoscopes. Participants will learn how MAUDEs can be used to guide decision-making and improve patient safety.
By the end of this one-hour webinar, participants will be able to:
- Explain the purpose and value of Medical Device Reports in the Manufacturer and User Device Experience (MAUDE) database maintained by the US Food and Drug Administration (FDA)
- Conduct searches, interpret search results, and submit reports to the MAUDE database
- Understand the implications of reporting requirements for manufacturers, health care providers, institutions, and patients
- Discuss device malfunctions and exposures/injuries related to the use of common medical devices (e.g., endoscopes, ultrasound probes, staplers, and robotic surgical systems)
- Background on FDA medical device reports and the MAUDE database
- How to conduct searches in the MAUDE database and interpret search results
- Strategies to maximize the value of database searches
- Case studies: Identifying relevant MAUDE reports for common problems
- Leveraging MAUDE reports to improve patient safety
- How to submit an adverse event report to the FDA
- Key takeaways and recommendations
- Sponsor acknowledgement (Supported by an educational grant from Healthmark)
Cori L. Ofstead, MSPH
President & CEO, Ofstead & Associates
Cori L. Ofstead, MSPH, is an epidemiologist with 30 years of experience designing and conducting studies about the impact of clinical processes on patient outcomes. She has served as the Principal Investigator on numerous studies related to infection prevention, instrument reprocessing, and vaccination against infectious diseases. Ms. Ofstead is nationally recognized for her groundbreaking research, and her studies have been published in peer-reviewed journals including CHEST, AJIC, ICHE, Journal of Hospital Infection, Gastroenterology Nursing, and Vaccine. She currently serves as a reviewer for AJIC, Endoscopy, and the Journal of Urology, and is an active member of the editorial board for AJIC. She has presented the findings of her studies at national and international conferences sponsored by the CDC, APIC, IAHCSMM, AORN, SGNA, AGA, and several universities. In addition, she currently serves as a preceptor for epidemiology students in the School of Public Health at the University of Minnesota.
Brandy L. Buro, MS, RDN
Research Associate, Ofstead & Associates, Inc.
Brandy Buro is a research associate at Ofstead & Associates, where she supports the team in conducting real-world research by leading surveillance of scientific literature and translating key findings for diverse audiences in industry and healthcare. Ms. Buro has an MS in public health and research methods and is a registered dietician with a strong background in biology, health behaviors, and education methodology. She has research experience in a variety of settings, including hospitals, long-term care facilities, and in the community. Her research has been published in AJIC, Journal of Wound Care, and the Journal of Nutrition Education and Behavior. Prior to joining Ofstead in 2017, Ms. Buro worked as a clinical dietitian in various healthcare settings and led nutrition education programs at the University of Minnesota.