HCMDSS November 16-17, 2004 Arlington, VA Victoria L. Rich, PhD, RN Chief Nursing Officer Hospital of the University of Pennsylvania Assistant Dean of Clinical Practice University of Pennsylvania, School of Nursing

What are the emerging technical and scientific issues in medical devices? Interoperability of information sources Examples Patient identification a. health information b. care and treatment in all venues II.Human Factors a. cognition science b. aging population c. environments

What are the major obstacles in innovative design and accelerated certification? How can information and software technology help? Prepared device specific knowledge workers with multidisciplinary tutelage e.g. informatics, evidence based medicine, biomedical engineering and translational research e.g. informatics, evidence based medicine, biomedical engineering and translational research What are key obstacles to the development and certification of medical device software and systems? What are key obstacles to the development and certification of medical device software and systems? Organize numerous data sources into usable assessable information. Complex Simplicity!

Bio Victoria L. Rich, Ph.D., R.N. is the Chief Nursing Officer at the University of Pennsylvania Hospital (HUP) and is the Assistant Dean of Clinical Practice at the University of Pennsylvania, School of Nursing, where she is helping redesign patient care in oncology units to decrease chemotherapy errors and clarification of discharge instructions. As Vice President of Patient Care at the University Community Hospital (UCH) in Tampa, she helped develop statewide patient safety initiatives for both inpatient and outpatient care delivery systems. She is a leader in patient safety culture development for the nursing profession, and an expert in root cause analysis and development of corrective action plans for state and Federal agencies. Rich consults for Alaris Medical Systems, Inc. and Eclipsys where she provides advice in human factors design for safe processes in nursing practice, and is an expert witness for several law firms. She developed a corkscrew model of complex circularity to encourage a culture of systemic mindfulness in error reduction. She is co-developer and speaker at an annual Patient Safety Conference for Nursing, patient safety peer reviewer for the American Journal of Nursing, contributor to patient safety pamphlets and books, co-investigator on an Agency for Healthcare Research and Quality (AHRQ) Proposal for Nurse Medication Safety, and is part of a team of thought leaders in medicine, nursing, and informatics to create an evidence-based patient care unit of the future.