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. www.aami.org

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. Learn more ate AAMI.org

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

What's the optimal way to perform device maintenance? Although implementing an AEM program can save healthcare facilities time and money, the concept has caused confusion for many in the healthcare technology management community. To start, the Centers for Medicare & Medicaid Services defines AEM as "alternate equipment management," whereas The Joint Commission uses "alternative equipment maintenance. Through the recent publication, AEM Program Guide: Alternative PM for Patient Safety, author Matthew Baretich seeks to cut through the confusion by offering practical, real-world guidance for implementing a well-crafted AEM program and remaining compliant with applicable standards and regulations.

How are hospitals doing with sterile processing, and what's the biggest challenge to effective sterilization today? Sterile processing expert and author Rose Seavey shares her insights, offering tips to both healthcare facilities and the makers of medical devices. She also talks about ST79, a widely used standard for steam sterilization, which has just been released with a major update. This podcast is sponsored by Healthmark.

With cybersecurity attacks on the rise in healthcare and a growing appreciation for the threats posed to patients, patch management is more important than ever—yet it remains a challenge for most hospitals. Why? "I don't think there's any other industry that has such a diversity of different devices from different manufacturers run in an environment where the pieces are so dependent on each other. That makes it difficult to, for example, take one device down, patch it and reboot it without affecting other devices" said Axel Wirth a distinguished technical architect for Symantec Corporation and a member of the BI&T Editorial Board. A cybersecurity expert, Wirth shares his tips for patch management and his "defense in depth"; framework that he believes all healthcare facilities should adopt. This podcast is sponsored by Nuvolo.

What’s the biggest mistake hospitals make in introducing and implementing wireless technologies? “Not appreciating the complexity,” says Shawn Jackman, co-chair of AAMI’s Wireless Strategy Task Force and founder and CEO of Clinical Mobility Inc. In a conversation with host Terry Baker, Jackman explains what HTM professionals can do to educate themselves about wireless technologies and provides suggestions for what hospitals must do now to achieve wireless success. Produced by: The Association for the Advancement of Medical Instrumentation

The clinical engineering team at Intermountain Healthcare has a success story to share about its initiative to safeguard its medical equipment from viruses and cyberattacks. Two members of the team, Mike Busdicker and Priyanka Upendra, describe how they conducted a systemic review of all network-connected devices and, working with other departments, came up with a plan to address potential vulnerabilities. They share their tips and lessons learned, and advise all healthcare facilities to embrace cybersecurity management as an ongoing priority. Produced By:The Association for the Advancement of Medical Instrumentation

Just a few months on the job, new AAMI President and CEO Robert Jensen describes his vision for the association, how his time as a Marine officer helped to prepare him for this job, and the opportunities (and challenges) he sees for the healthcare technology community. A crucial part of AAMI's mission, Jensen said, is to help provide "visionary ideas" so that the professionals on the frontlines of healthcare technology can "craft the future that will actually serve the patients and the full community." Jensen shares with podcast host Terry Baker his idea of what success at AAMI will look like under his leadership. Sponsored by: Healthmark Produced By: AAMI and Healthcare Tech Talk

Medical imaging technology has advanced considerably in modern times, with the rise of computed tomography (CT) and magnetic resonance imaging (MRI). Factor in the growth of 3D and 4D imaging, along with the integration of imaging with computers and software, and it’s easy to understand why imaging is one of the most exciting areas in healthcare technology. Glen McQuien, director of operations at Modern Biomedical and Imaging Inc., talks about the changes he’s seen in his career and those that are on the horizon. And McQuien, a member of the BI&T Editorial Board, has some advice for hospitals trying to figure out how to make smart purchasing decisions when it comes to imaging technology. Produced By: AAMI and Healthcare Tech Talk

Hospitals are under pressure to draft and implement comprehensive policies that show they have a handle on the crucial patient safety issue of alarm fatigue. There’s been an explosion in the number of medical devices with alarms and alerts, resulting in a noisy healthcare setting and desensitizing clinicians to the meaning or importance of alarms. With more alarms going off, the intended goal of alerting clinicians to true emergencies has been diminished, and patient safety has been imperiled. Ronald Wyatt, MD, the patient safety officer and medical director at The Joint Commission and Maria Cvach, DNP, CCRN, director of policy management and integration for the Johns Hopkins Health System in Baltimore, MD, talk about what hospitals should be doing—and how they can make a positive difference with effective clinical alarm management. Sponsored by Spacelabs Healthcare. Clinical Alarm Management Compendium Produced By: AAMI and Healthcare Tech Talk

What does it take to develop and support a culture of safety in hospitals and other healthcare facilities? AAMI President Mary Logan and Connie Barden, RN, the chief clinical officer at the American Association of Critical-Care Nurses talk about the keys to success and identify the obstacles to allowing such a culture to flourish. "Safety is not automatic in healthcare," Barden noted, adding that changing culture starts with changing behaviors and moving away from a fixation on blame and punishment. Sponsored by: Healthmark Produced By: AAMI and Healthcare Tech Talk

How can healthcare facilities ensure that the right drug is going to the right patient, through the right route, with the right dose, at the right time? These five “rights” of medication administration get to the heart of infusion system safety. Marilyn Neder Flack, senior vice president of patient safety initiatives at AAMI and director of the AAMI Foundation, and Deborah Pasko, director of medication safety and quality at the American Society of Health-System Pharmacists (ASHP), talk about the incredible progress that’s been made on this front—and how more work is needed in areas such as drug library management and user-friendly design practices. Sponsored by Smiths Medical. Learn more at AAMI Hot Topics Produced By: AAMI and Healthcare Tech Talk