The Association for the Advancement of Medical Instrumentation Podcast - AAMI

In this episode we continue our discussion with three human factors experts: Kate MacNamee, MaryBeth Privitera, and Michael Wiklund.

Kate is a senior human factors engineer and program manager at Farm, a Flex Company.

MaryBeth is principal of human factors and research at HS Design, Inc., and a professor and the director of the Medical Device Innovation & Entrepreneurship Program at the University of Cincinnati.

Michael Wiklund is general manager of human factors engineering at EMERGO by UL.

With us today are three human factors experts: Kate MacNamee, MaryBeth Privitera, and Michael Wiklund.

Kate is a senior human factors engineer and program manager at Farm, a Flex Company.

MaryBeth is principal of human factors and research at HS Design, Inc., and a professor and the director of the Medical Device Innovation & Entrepreneurship Program at the University of Cincinnati.

Michael Wiklund is general manager of human factors engineering at EMERGO by UL.

If water or moisture remains in the internal channels of flexible endoscopes, an overgrowth of bacteria can appear in a short period of time, presenting serious health risks to patients. In this episode, Mary Ann Drosnock, director of clinical education at Healthmark Industries, and Damien Berg, regional manager for UCHealth and direct manager for the Medical Center of the Rockies and Poudre Valley Hospitals, discuss key guidance (including that found in ANSI/AAMI ST91) for ensuring that endoscopes are dried appropriately, as well as overcoming other challenges facing sterile processing departments. This podcast is sponsored by Healthmark.

Staying ahead of mounting healthcare cybersecurity threats will require a unified approach on the part of healthcare technology management (HTM) and information technology (IT) professionals. In this episode, Cory Brennan, a medical device security consultant for CynergisTek, discusses HTM-IT collaboration, developing a new generation of HTM professionals, risk assessments for medical devices, and establishing a unified regulatory approach to medical device security.

The inaugural AAMI & TRIMEDX John D. Hughes Iconoclast Award makes it official: Binseng Wang, a self-described rebel, is a master at challenging norms and assumptions. With congenial resolve and authority, Wang has made significant contributions in rallying the HTM field to pursue the most important outcome, improving the delivery of patient care. In this episode, Wang discusses how challenging practices that are not firmly grounded in objective evidence is vital toward improving HTM.

Artificial intelligence (AI) and machine learning are poised to transform healthcare delivery by providing earlier diagnosis and targeted treatments while driving greater efficiencies. AI will enhance the delivery of care in a variety of ways, but according to Pat Baird, head of global software standards at Philips, it won't require a new regulatory paradigm. Instead, the challenge will be taking what we already about standardization and applying it to AI and machine learning.

For more information, check out the new AAMI/BSI position paper on supporting the governance and regulation of AI and machine learning in healthcare.

Advances in technology have helped patient care to move outside the confines of the hospitals and into the patients' homes. However, moving technology into less controlled environments brings a myriad of complications, and navigating the transition effectively requires communication, caregiver and patient preparation, and a standardized process. In this episode, Mary Weick-Brady and Jason Amaral, members of the AAMI Foundation's home infusion group, share insights on successfully transitioning infusion therapy from the hospital to the home.

For more information, check out the new AAMI Foundation report, From Hospital to Home: A Process Map for Successful Infusion Therapy Transition.

Similar to the way pilots are using virtual reality (VR) to simulate piloting an aircraft, healthcare technology management (HTM) professionals can use VR to practice performing medical device maintenance activities, such as troubleshooting a virtual telemetry board, while increasing understanding and knowledge retention in the process. In this episode, Rick Sidlo and Aaron Goryl from GE Healthcare discuss the advantages of using VR to train HTM and other professionals, how the experience compares with a vendor's traditional classroom training, and where VR is headed in terms of its ease of use, access, and affordability.

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The literature suggests that if patients had their breathing monitored continuously rather than every several hours, as is the current practice, then a major portion of the injuries and deaths caused by opioid-induced respiratory depression could be avoided. In this episode, Dr. Frank Overdyk, a professor of anesthesiology and internationally recognized expert in the field, shares his insights, including reasons for the slow implementation of this technology and strategies to help build the business case for the practice.

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Recognized by many jurisdictions around the world, the standard ANSI/AAMI/ISO 13485:2016, Medical Devices; Quality management systems; Requirements for regulatory purposes, provides structured guidance to help organizations meet regulatory requirements. In this episode, international quality and regulatory compliance consultant Eamonn Hoxey describes the major differences between the 2003 and 2016 editions of 13485. As we near the end of a three-year transition period for medical device developers and manufacturers to comply with requirements set forth in the 2016 edition of the standard, Hoxey discusses how the new updated version clarifies expectations for manufacturers, providing a much more global, comprehensive, and harmonized approach to meeting requirements.

Learn more at AAMI.org