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Key Learning Segments
Medical device reprocessing policy is developed, implemented and overseen by infection preventionists (IPs). Developing these policies can be difficult when medical technologies, such as ultrasound probes, are used across multiple health delivery settings and departments. Ensuring evidence-based practices are implemented in line with federal and national standards and guidelines is paramount to both patient and staff safety, and to facility risk and quality management.
This session reviews key considerations and strategies for IPs developing policies in compliance with federal and national standards and guidelines. An expert in regulatory and accreditation standards shared practical knowledge about how standards are developed and audited. The ANSI/AAMI national standards are also reviewed, including the collaborative approach to their development and how national standards can support IPs in practice decision making.
Leave this session armed with frameworks and practical strategies for improving patient safety through the development of ultrasound probe reprocessing policies.
- Describe the importance of device reprocessing policy, compliance with federal and national standards and guidelines, for patient and staff safety
- Recognize challenges infection preventionists can face when identifying standards and guidelines to inform device reprocessing policy
- Discuss guidance, strategies and solutions for developing policies, based on practical experience from an expert in the regulatory and accreditation standards
- Identify AAMI and ANSI as the bodies that develop American national standards, that they are recognized by the FDA, and how they can inform policy and practice across a facility
Lisa Waldowski, DNP, CIC
Lisa Waldowski is an expert Infection Prevention and Control specialist and nurse consultant with over 30 years of experience in the healthcare industry. An expert in the accreditation and regulatory standards, Lisa knows how to develop and implement comprehensive infection prevention and control programs and education.
Damien Berg, BA, BS, CRCST, AAMIF
Damien Berg, BA, BS, CRCST, AAMIF is the Vice President of Strategic Initiatives for IAHCSMM. Berg is an IAHCSMM Past-President of the board of Directors (2018-2019) and a veteran Sterile Processing leader who most recently served as regional manager for UC Health in Northern Colorado. He has over 28 years of Sterile Processing and OR experience. He has extensive experience working closely with healthcare organization leadership and with various regulatory bodies and standards-making groups such as the American National Standards Institute and the Association for the Advancement of Medical Instrumentation (ANSI/AAMI) and the International Standards Organization (ISO). Additionally, he has spent many years as chair of the IAHCSMM Advocacy Committee.
Daniel Lightfoot, PhD
Daniel Lightfoot is the Medical Director of the Americas for Nanosonics. He received his doctorate in Developmental Cellular and Molecular Biology from the Karolinska Institute in Stockholm, Sweden, researching aberrant genetic contributions and their effect on stem cell and early embryonic initiation and development. He continued his research at The Scripps Research Institute, but focusing on fetal organ development, specifically fetal brain formation and cephalic cellular differentiation.
After leaving academic research, Daniel has held a lab director position in a hospital, science director roles for various disease state organizations that include mammalian cloning, autism, rare and ultra-rare genetic diseases and as a medical director within the pharmaceutical industry.