The extremely elevated temperatures during the summer months and unexpected colder temperatures in southern states during the winter have increased the cost of energy usage with some states asking customers to limit their consumption. Therefore, power consumption of medical institutions is under scrutiny. In this session, we will focus on medical imaging as these devices are commonly the highest power consumers in the facility. We will detail the types of imaging devices that use the most energy, how to determine the consumption the devices, what institutions can do to reduce power use, what vendors should be doing, and effective mitigation strategies.

A regional clinical engineer is asked to step in for a 120-day detail as Chief Healthcare Technology Manager of a medium sized VA Hospital with about 15-staff. This case study offers guidance and tips for acting as a temporary manager, while also juggling being a manager for the first time. Hear the perspective of a developing clinical engineer leading a struggling department, and how it was able to improve through positivity, persistence, and engagement.

Health care systems can potentially reduce healthcare-associated infections (HAIs) using cognitive science-based programs. For central line-associated bloodstream infections (CLABSIs), there are 250,000 occurrences in the U.S. every year and on average it costs $48,108 to treat. CLABSI increases patient mortality by 12 %-25 %. Since the COVID-19 pandemic began in 2020, there has been a significant increase in hospital-associated infections, including CLABSIs. Using case studies from several health systems we will share how the use of this training approach has assisted in reducing many HAIs.

Your clinicians have just told you they want a new AI-enabled technology. What questions should you be asking them, your administration, and your vendor to ensure that (1) your facility defines what they expect to gain from the new technology and (2) the new technology will meet these expectations given your population, culture, and infrastructure.

Virtual Instructor-led trainings (VILTs) are a necessary and effective part of any HTM professional development program. This session covers the basics of delivering effective virtual trainings. With years of experience in training development, Kilda Group offers real-world examples from working with HTM professionals at hundreds of Veterans Affairs facilities across the United States to highlighting concepts that are broadly applicable and actionable for HTM managers at any healthcare facility. Content focuses on maximizing the strengths of VILTs while avoiding common challenges. Concepts covered include enabling technologies, feedback mechanisms, measurement and assessment, and participant engagement.

The Children's National Medical Center created a formal program for medical device security. This program addresses the collective goals of the clinical mission and the IT Security initiatives of organizations. To achieve programmatic goals, the Medical Device Cybersecurity Working Group was established. The Medical Device Cybersecurity Working Group is composed of the technology teams from healthcare departments, such as, Radiology, the Cardiology, lab, Telemedicine, Pharmacy & HTM, and the nursing leaders. The technology teams include the administration of asset management, security risk assessments, vendor expectations, vulnerability management, and a patch management strategy within the program.

The instability of cybersecurity in healthcare is a threat to public health. News headlines of cybercrimes in healthcare are a daily occurrence. Government leaders have generated a flurry of regulatory and policy activity to maintain some level of awareness. In this session, we explore recent legal and regulatory actions aimed at improving the resilience of healthcare. We discuss the following: How will this activity improve cybersecurity healthcare networks?; What does it mean to those on the front lines of protecting critical infrastructures?; What should HTM staff know about the legal and regulatory landscape?; What should HTM staff know about the profound operational, financial, and regulatory challenges with cybersecurity?

Errors in processing instruments and equipment by Sterile Processing Department (SPD) staff has a significant impact on both operating room (OR) and SPD operations. In this session, we take a Lean Six Sigma approach to identifying causative issues and the costs to both patients and hospitals from these errors. Information presented is from the study sponsored with the University of Michigan Industrial Engineering Division and a subsequent study at a major Midwest hospital. Participants learn about the need for a robust Event Reporting System, the size, scope, and cost of the events, and lean-based strategies for improvement.

ISS Solutions has developed tools within our Computerized Maintenance System (CMMS), using dashboards, scripts, and custom reports, to delve into CMMS data and gain insights into the equipment managed. For example, we can gain insights into risks related to cybersecurity, by integrating medical device discovery data into the CMMS and using that to target the riskiest models. The Prostate Health Index (PHI) screening of devices captures data from the completion of medical exams for automation to ensure compliance with policies. Preventive maintenance compliance (PMC) tracks real-time and displayed in the Biomed shop, as well as trended in monthly reporting.

Today’s medical professional is immersed in technology more than ever before. You’re being asked to operate IoT devices, log in to cloud-based systems, interpret info, and understand both the security and privacy implications of decisions you make every day. As the medical profession continues to stampede into the 4th industrial revolution, it’s time to take a few deliberate steps concerning how we use technology today. One of those steps is to empower medical professionals with a foundational knowledge of the we use every day. That might seem daunting. But it really isn’t. You just need to know where to start. Join Dr. James Stanger, CompTIA’s Chief Technology Evangelist, as he discusses ways that medical professionals can get their start into the world of digital fluency. If you’re interested in moving beyond the typical “hunt and peck” approach to todays tech and become truly fluent, join Dr. Stanger to learn more.

What are the real costs of a XR program? Can you save money with assistance through AR, should HTM be supporting this type of equipment? What makes sense, and what do we know.

The success of Healthcare Technology Management (HTM) professionals often hinges on their ability to communicate with and influence their non-technical colleagues and/or leaders. In this session, learn processes and techniques for communicating complex information, problems, and/or solutions in terms that will resonate with less technical audiences.

This session focuses on practical aspects of assuring safe and secure implementation of interoperable medical systems and maintaining continued safety and security over their life cycle. The panelists will review the interoperability management life cycle model based on the AAMI-UL 2800 series of standards. They will also discuss practical aspects of implementing the model, including identifying appropriate safety and security objectives, collaborating with multiple stakeholders in the interoperable medical system, and appropriate points of information exchange and types of information to be exchanged.

Medical device manufacturers have been requiring water quality levels on their instructions for use (IFU) materials to assure a safe reprocessing of their device, and the anticipated release of American National Standards Institute (ANSI) AAMI ST108, Water for the processing of medical devices helps to determine the water quality requirement used throughout the Sterile Processing Department (SPD). This session will identify the water quality requirement for the most common areas in an SPD using the current standards and manufacturers IFU.

FDA will be issuing the final guidance document on remanufacturing of medical devices soon. This guidance is likely to have significant impact on manufacturers, servicers, healthcare delivery professionals and organizations, and ultimately, the patients who depend on medical devices for their care and wellbeing. This session will give the audience an opportunity to gain experience with FDA mandates and how it will be implementing and enforcing the mandate. This will help HTM professionals know how to comply with those requirements.

“HTM Insight: Longitudinal Analysis of Maintenance & Repair Contracts” presents useful data from a new study that quantifies factors impacting cost, quality, and productivity. This analysis includes U.S. health systems data, an observational survey from more than 100 hospitals, time and motion studies, and a data warehouse analysis (100K service contracts and 500K service events and over 35M data points). This educational presentation includes a discussion regarding implications on portfolio complexity, time consumption, cost variability, vendor monitoring, and risk management. Participants learn how their organization compares against these benchmarks and identify opportunities to improve financial and operational performance.

The Internet of Medical Things (IoMT) cybersecurity is a growing concern in the healthcare industry. The healthcare industry remains the most vulnerable of targets. Healthcare providers are suffering an average of $100M loss due to unexpected security breaches affecting the integrity of patient data, confidentiality of sensitive information, and the availability of critical information systems. This session provides an overview of critical components of incident response as described by IoMT and HTM/CE experts. The session discusses the mechanisms used for proactive detection of suspicious activities, unauthorized vendor and employee access, and forensic analysis. Session speakers provide insights to conducting tabletop exercises with key stakeholders to ensure effective incident response management.

Massachusetts General Hospital is replacing its obsolete visual alarm distribution system with innovative technology. The clinical units rely on light emitting diode (LED) sign alerts for a quick visual of alarms and bed notifications. While the innovative technology provides an opportunity to expand the platforms for alarm notifications, the initial phase was to maintain the current alarm visual capability for a smoother clinical transition. Beginning in 2019, the process included risk assessments, product evaluations and selection, collaboration with stakeholders on the design, provisioning, configuration, and implementation of the system, as well as troubleshooting issues encountered during the process.

This session connects new or aspiring team leads, department leads, site leads, managers, etc. highlighting best practices, lessons learned, and common expectations for those assuming leadership roles in HTM. This session covers leadership roles and responsibilities, tips, and tricks for ensuring team engagement, and the pitfalls that new leaders encounter when assuming the role.

Part one of this session explores how the audience can develop a career growth mindset. Giving key insights for adapting more chances of success by creating a growth mindset and staying open and receptive to growing and learning new skills. With effort, perseverance, and drive, you can develop your skills, take responsibility for your success, and overcome any obstacle. Part two profiles personal stories and words of wisdom from two established HTM leaders. Through this lively Q&A, the audience learns to triumph over challenges they could never have predicted.

This session discusses how the Computerized Maintenance Management System (CMMS) database and Microsoft Power BI can provide useful information for future capital equipment replacements. It is geared towards the Clinical Engineering Management Teams and key stakeholders for capital equipment planning. The Equipment Planning Tool allows end-users to access reporting tools 24X7 with a Power BI refresh from the data add or edited within the CMMS. The tool tracks oversight of age of the equipment, purchase price, depreciation values and end of support dates that assist key stakeholders in planning for future inventory replacement needs to support the patient population.

While innovation in healthcare is not new, access to innovation initiatives by non-physicians is a more contemporary approach to proving value to organizations that chose to pursue it. In this session, we will discuss the applications and the effects of collaboration between clinical engineering and Innovations in the successful development of solutions to problems presented by clinical, administrative, and technical stakeholders. We will demonstrate the importance of a formalized innovations program and the benefit of partnering clinical engineering and innovations in engineering solutions to complex healthcare problems.

We will discuss why, when, and how to accelerate a medical device cybersecurity program. Every organization has challenges, whether with resources, strategy, or direction. In collaboration with University Health System, we were able to identify limitations to enhance maturity and partnered with First Health Advisory to radically uplift UHS's security posture while integrating people, processes, and technology. Join us as the speaker shares challenges, overcoming challenges, and how collaborating with First Health helped support a business case and map/integrate appropriate technologies to enhance the program.

This topic provides the audience with an overview of The Joint Commission Survey. The survey discusses the following: survey summary, preparation, organization survey differences, general preparation, common findings, hot topic areas, other applicable standards, national patient safety goals, resources.

In 2022, ECRI released the “Top 10 Patient Safety Concerns in Healthcare,” and telemetry monitoring was listed as #10 in the ranking. Among the common problems, ERCI called out poor safety culture, infrastructure failures, and the lack of emergency outage planning. Telemetry systems may have built in redundancy that can mask multiple failures allowing staff to continue to function for weeks or months until a complete outage occurs. This session covers how to build a life cycle management strategy for telemetry and clinical network infrastructures to prevent unplanned downtime, expenses, and potential risk to patients.

This presentation shares recent available research to explore the viability and antimicrobial features of novel materials used in medical devices. More specifically, this research is exploring the performance of polymers infused with copper nanoparticles to reduce the microbial load and prevent or reduce the formation of biofilms in long and narrow channels. These channels, often found on arthroscopes and endoscopes, pose a significant health risk to patients across multiple care settings. This research is partially sponsored by an AAMI-Kilmer Foundation Grant. Note - Research was done as part of Mr. Leiva's PhD thesis, which are separated from his work with 3M Healthcare.

Hospitals are increasingly finding value in and uses for surgical video. This ranges from basic, including EMR documentation, to futuristic, using massive amounts of video to develop predictive AI algorithms. Other uses include QA, training, and research. At MGH we capture video from OR integration systems, OEM and multi-vendor recorders, and more. Video can be archived, exported to the EMR, routed to research servers, and other applications. To achieve this we created a media repository capable of performing these functions while providing clinicians access to editing and management tools. We will discuss the challenges and successes of implementing this system.

Since its mainstream adoption by GE, Motorola, and others, Lean Six Sigma has been credited with saving hundreds of millions of dollars for manufacturing and service organizations worldwide. Lean Six Sigma combines the best of the Toyota production system focus on waste elimination with a rigorous process of optimization using statistical tools and its infrastructure of “belt” project leaders. Lean Six Sigma has been criticized for being too complicated and taking too much time and resources to achieve sustained improvements. See how Norton Healthcare developed “Rapid Cycle” to streamline this quality methodology to deliver impactful and sustainable improvements.

This presentation provides a leadership development opportunity for those who wish to motivate others: executive leaders, front line managers, service professionals, customer service, and human resource professionals who would like to understand how to use basic neuroscience to influence others and deliver consistently outstanding service outcomes more effectively. During this presentation, the speaker introduces learners to the neuroscience of the brain as it relates to service professionals and leadership development. Expectations are to become aware of the five (5) domains of social threats and rewards that impact motivation.

The Health Information Technology for Economic and Clinical Health (HITECH) Act, updated in 2021 to provide a “Safe Harbor” for the protection against Office for Civil Rights (OCR) violations to include fines, fees, and post-breach oversight costs. To be considered for protection, Health Delivery Organizations (HDOs) must document compliance with specific recognized security practices, such as the 405(d) Health Industry Cybersecurity Practices (HICP) originally created in 2018 and Medical Device Security practices. As a directive from the 405(d) chair to work with the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health and Human Services (HHS), the speaker is currently updating the Medical Device Security section and best practices approach to compliance. The finalized release of this update is pending release the end of 2022.

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This session is for professionals who want to take control of their career. We will discuss the importance of the right mentorship, and pathways into other aspects of the HTM business, such as educational pathways, including college degrees, certifications, webinars, and leadership courses. This conversation will leave you confident, clear, and in control of the path forward. We also discuss running an HTM program: customer service, uniformity, and consistency (creating success), program rigor (what works and what doesn’t work), and customer service (perception vs. reality and key communications).

Since 2020, the healthcare industry has been impacted significantly by the alarming rate of cyberattacks. With minimal understanding of the full extent of those impacts, patient data is at risk. The Ponemon/Cynerio release of “The Insecurity of Connected Devices in Healthcare” has significantly clarified the cyberattack landscape. From the financial impact to compromised patient care, the report represents the voices of healthcare leaders from 517 hospitals. This talk focuses on report findings, provides critical data, and introduces modern approaches to combat cyberattacks.

The FDA is proposing to amend the current good manufacturing practice (cGMP) requirements of 21 CFR Part 820 Quality System Regulation (QSR) to align more closely with the requirements of the internationally recognized ISO 13485:2016, Medical devices - Quality management systems - Requirements for regulatory purpose. This session addresses the Quality System Regulation, the effects of quality management systems, and identifies organizations impacted by the amendments.

Infusion pumps are one of the most frequently used medical devices in healthcare organizations. Unfortunately, they are often associated with adverse events, which can cause significant patient harm. ECRI continues to conduct infusion pump related incident investigations, which are the most common investigation for our accident and forensics investigation group. A thorough investigation into an infusion pump incident often requires meeting legal and regulatory obligations. However, it can also provide invaluable information about how to prevent reoccurring incidents. This session examines insights from ECRI's incident investigations and outlines best practices for conducting a thorough pump investigation.

AI is becoming increasingly adopted in the healthcare industry and is enabling several scientific breakthrough such as better diagnoses of diseases resulting in more accurate treatment. However, AI brings its own security and privacy concerns. When not managed properly, AI could cause harm to the patient. This session provides an overview of the emergent AI applications in medicine and an outline of emergent AI threats to security as well as risks associated with privacy. It concludes with how to safely and securely adopt AI in patient care settings.

HTM groups focus on the “equipment” side of healthcare technology, including software. The disposables and accessories attached to the medical equipment also deserve attention. Industry professionals must consider HTM when changes to disposables and accessories are involved. Clinicians need the entire technology system to function smoothly. When they have a problem, they need HTM to determine every root cause and help solve the problem. HTM must build bridges, in advance, to the professionals procuring these products.

Quality initiatives in healthcare has been around for a long time, but a quality management system (QMS) is still relatively new to the industry. In this session, we review the history of quality, the current regulatory landscape, and changes likely to occur in the future. We take a broader view as to why an HTM service department should embrace a QMS. We break down the overall program into smaller chunks, review key concepts and benefits to an HTM department, and how implementing a QMS improves patient and staff satisfaction.

In the early 20th century, leaders were taught to manage their team so that the individual contributors performed essentially as robots taking inspiration from the introduction of the assembly line.  As generations have come and gone, Leadership has stagnated and not leveraged many changes in culture or work style. AAMI proposed that between 2020 and 2025 75% of the leaders in HTM would retire / be replaced.  With such an influx of new talent, there is an opportunity to share Leadership Techniques for the 21st century, where people are appreciated for both who they are today and who they can be tomorrow. Join us in this round-table discussion as we share the foundations of successful leadership of our HTM/CE teams.

JSMI has revised the Guidelines for Sterilization Assurance in Healthcare Settings by 2021, and has developed and published an evaluation tool this year. In this session, we will explain the efforts for standardization of sterilization in healthcare setting in Japan.

This session touches on the current USA drought of Biomedical Equipment Technicians (BMETs) and looks at ways to engage newly educated HTM professionals. Specifically, this session addresses how to hire and attract BMET graduates from Canada and Mexico under United States-Mexico-Canada Agreement (USMCA) (the new North America Free Trade Agreement (NAFTA)). The goals are to show managers that talent is available outside of the USA, how to attract the talent available, and how to get local human resources (HR) teams to keep resumes from highly talented students who are interested in a career in the BMET field! Specifically, this will address the requirements of the nonimmigrant NAFTA Professional (TN) visa.

The session highlights the benefits of using a closed-loop process for alerts/recalls management within an HTM department. It covers a step-by-step walkthrough of the process used by the Department of Veterans Affairs Medical Center nationwide. This process starts from the initial point of awareness of the alert/recall and includes searching inventory for affected equipment; contacting the manufacturer; investigating the issue and root causes; determining the amount of risk posed to patients and staff (risk score); and clearly defining, completing, and documenting all corrective actions within a reasonable timeline to maintain clinical safety.

This program assists Biomedical (Biomed) and Sterile Processing Department (SPD) to understand how each department is dependent on the other to provide safe patient products. It offers guidance in developing a multi-disciplinary team to collaborate in mitigating risks associated with product failures.

Hospitals are constantly faced with devices operating outside of their secure network facilities. There are more devices than ever before that need to be secured remotely and require remote management as they are no longer protected by the traditional hospital network environment. To address potential risks, clinical engineers must understand the impact of telehealth delivery and remote monitoring on the hospital's security strategy. This session looks at a security engineering approach to healthcare and discusses the growing need for telehealth solutions and devices that are secure by design.

This program details the seven-month process a multi-hospital system undertook to standardize the future procurement of capital equipment for all locations to a single vendor for each of fourteen different imaging modalities. During the presentation, we detail the request for proposal (RFP) process undertaken, stakeholder engagement, and how the selection process ended to the satisfaction of all concerned. We discuss the capital cost savings realized, which for this project was approximately $20M over a 10-year period. In addition to the actual cost savings, efficiencies have improved in training and clinical engineering expenses have decreased.

The speaker loves the healthcare field with all his heart! This session covers ways to use resources in the HTM industry to help grow the pipeline and engage healthcare professionals in a progressive career in HTM. This session explores how we can bring greater awareness about the HTM profession and how to retain professionals within the field. Tips will be provided on how to customize information for a range of potential professionals from new entrants that are starting their first career to those who are changing careers to new technicians just starting out.

International Organization for Standardization (ISO) initially developed its ISO 13485 standard to provide a quality management system (QMS) for medical device manufacturers to regulate industry compliance. HTM contractors, in-house service providers, and distributors are seeking.

Finding qualified staff is an ever-growing challenge in the healthcare field, but qualified staff are indispensable to delivering the level of service your clinical caregivers need. How can you continue to deliver the level of service your clinical caregivers need? A major part of the solution lies in adopting lean practices to eliminate waste and non-value-added work, automating workflows and processes, and increasing the time for professionals to perform core functions. In this session, attendees gain understanding of time-motion studies conducted by HTM leaders, along with the processes and methods that can be employed to optimize staff productivity and efficiency.

AAMI standards development is important to improving best practices and patient care. In this session, the speakers share their experiences participating in standards development. This includes how published standards improve best practices, compliance, and recognition within healthcare (HC) organizations. The speakers describe how rewarding standards development is, the benefits to the participant's professional development, and how their influence within their organizations contribute to the goals of providing safe and effective medical devices for patient care. The Q&A session focuses on how HTMs can join the development of standards by becoming involved with AAMI’s Medical Equipment Management Committee (EQ)-related standards activities.

Are you using the performance data from your medical devices to make smart fleet management decisions? How do you know if devices are working and collecting data to perform maintenance and repairs before they fail? Learn about the different types of datasets available, how to use analysis tools for connected IoT and the impact on staff, equipment manufacturers, and service providers.

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Top 10 things we wish we knew at the beginning of our careers! Learn from the experiences of two life-long biomed professionals in a lively discussion about professional and life lessons learned over the past 40 years. For the experienced HTM professional, we will refresh your memory of the lessons you have likely learned along the way and help you build your own list of lessons learned. If you are early in your career, join us to benefit from 40 years of HTM experience as you navigate this exciting field.

Hospitals across the world face an increase of cyberattacks that often lead to severe and long-lasting consequences for healthcare organizations. Today's healthcare facilities need to focus on improving their technical and organizational cyber-capabilities and assure the integrity of their medical device ecosystem. But… no two organizations are alike. This session describes how organizations find the right-fit based on understanding their risks, capabilities, and resources. The session also reviews common organizational models, offers guidance on how to implement cross-functional touch points, and provides an update on available educational resources and evolving regulations and standards.

Join the speaker as he describes his transition from an “in-house” HTM manager to an “outside” HTM consultant. He describes the sometimes bumpy and frustrating yet rewarding differences from working as an in-house HTM manager where he had considerable “command and control” compared to being an outside consultant where he could only offer “advice and suggestions.” Also, learn the benefits and limitations of working as an independent consultant at both large and small consulting organizations. The lessons learned from this presentation will better prepare you for the next step in your career.

During the past few years, the frequency of reported vulnerabilities that affect medical devices has significantly increased. There is an increasing urgency to patch vulnerabilities faster, but vulnerability requirements require a broad strategy. Within an active patient care environment, stopping everything to patch devices is not a viable option. Some medical devices are not available for patching due to FDA regulations. A patch may not be available for devices running outdated operating systems. In this session, Keith Whitby, Section Head, HTM at Mayo Clinic and Greg Murphy, CEO of Ordr describes best practices to streamline vulnerability management.

The advent of COVID-19, along with the onset of patient care shifting from acute care to non-acute care, environments have led to the adoption of varied monitoring technologies to keep a track of non-critical patients. Join us as we present a landscape of technologies that move beyond traditional bedside monitoring: right from telemetry and virtual patient observation to telehealth solutions. Pulling from ECRI’s research and market trends data, we provide a set of questions and best practices for aligning technical solutions to clinical expectations and patient needs.

UL2930 is a new safety standard that addresses the current shock-risk in patient care areas that utilize power strips (relocatable power taps). This panel of industry experts provide their perspectives on the patient safety benefits of UL2930 and its need for universal adoption as soon as possible.

Many different survey organizations, such as the Center for Medicare & Medicaid Services (CMS), Joint Commission (JC), and Det Norske Veritas (DNV) survey hospitals to ensure regulatory compliance practices are in place. In preparation for each survey, HTM teams need to perform several actions, like, proper categorization to give managers the ability to quickly identify high-risk devices, manage devices on an Alternative Equipment Management (AEM) program, identify utility equipment, and identify devices removed from the maintenance program. Those details, including location and schedule need to be clearly addressed on a day-to-day basis and documented in the Computerized Maintenance System (CMMS) for accurate reporting, dashboard viewing, and other means of capturing data.

Hospitals spend hundreds of millions of dollars purchasing new equipment every year. They follow a structured format to purchase, install, and maintain their equipment. But for most, that structure ends when the equipment becomes obsolete or no longer usable. This course teaches how to manage the process, save time and money while helping others, ensure transparent reporting and gain a new-found space within the department or warehouse; it teaches how to implement a no-cost program of re-homing working equipment and avoiding disposing equipment into landfills. Equipment Disposition must become holistic in all hospitals.

Big data presents an opportunity to integrate massive volumes of clinical data which can provide critical information for treatment providers and helps improve quality of health care. To be useful at the point of care, key information in clinical decision-making tools need rapid scanning within a fast-paced clinical treatment environment. Using deductive content analytic methods to synthesize participant feedback, the team designed specific algorithms to examine and summarize terabytes of data by applying evidence-based analytics into a clinically meaningful construct (e.g., episodes of care, medication trials, service settings), resulting in a succinct clinical summary.

Safety is important for all sorts of electrical devices, but it becomes extra critical for patient safety when it comes to electrical medical devices. In this session, we will discuss electrical safety testing to regional standards and provide tips and best practices to allow you to do more with your electrical safety device administration.

In April 2022, the FDA released new Premarket Draft Guidance, revealing the most critical requirements for manufacturers to build secure devices. This session explores what this means for clinical engineers and how the FDA guidance will positively impact devices of the future. How can hospitals prepare their organizations for the shifts necessary and assure that the devices they are buying are indeed more secure? Developing a long-term security strategy will ensure secure future devices by design and remain secure throughout the device life cycle. This strategy includes aspects of contracting, security assessments, staff education, and technical security controls.

Health Technology Assessment (HTA) is a broad term used to describe the evaluation of medical equipment and other technologies in various settings. HTM professionals play an important role in HTA in hospitals but are not always fully included in the process. HTM professionals can offer insights into serviceability, total cost of ownership, and other technical factors. We also bring an unbiased and objective perspective to the process. This session reveals new findings into how HTA is occurring in U.S. hospitals and offers strategies for continuing to enhance the role of HTM professionals in this area.

Intravenous smart pumps (IVSP) deliver medications for approximately 90% of hospitalized patients yet remains high-risk for intervention. This session focuses on how IVSP technology design leads to dosing errors related to flow rate inaccuracies. Session content is based off a large body of research done by the speakers and collaborators spanning laboratory study, mathematical modeling, bedside observation, and surveying practicing clinicians. To support patient safety, HTM managers and clinical engineers must be familiar with the safety implications of this technology.

When it comes to managing medical devices, efficiencies in clinical asset management translates to improvements in patient safety, cybersecurity, and hospital operations. In this session, discover how Baptist Health and Ordr Inc. found ways to optimize clinical asset management and operationalize device insights to deliver value in (1) automated device discovery and classification to reduce manual efforts, (2) real-time device insights (make, model, system configuration, software levels, location) for patching and operational efficiencies, (3) full-life cycle vulnerability management to prioritize and mitigate risks, and (4) device utilization insights to support procurement decisions.

This session reviews the data from a validation study of a qualitative cleaning verification test to detect residual protein in channels of lumened medical devices after manual cleaning. The researcher conducted three subset studies: (1) a coupon testing study to establish the limit of detection (LOD), (2) channel testing study to determine extraction efficiency, and (3) in-use clinical testing to demonstrate the efficacy of this test in clinical use. The overall results of the study demonstrate that this test method is a useful cleaning verification tool for sterile processing professionals to check for residual proteins in the channels of lumened devices after manual cleaning.

What are good documentation practices (GDP)? What do they look like? What is objective evidence? Am I doing enough? Am I doing it right? These are questions HTM professionals encounter across the span of their careers. In this session, we cover the core practices of good documentation, how to define objective evidence, and understand how this plays a role in the overall quality of an HTM program. We also discuss best practices, worst practices, and everything in-between, as well as how these practices align with a quality management system (QMS).

This session focuses on three key points of reference: (1) To understand the test and measurement requirements from International Electrotechnical Commission (IEC) and Association for the Advancement of Medical Instrumentation (AAMI) Standards. (2) To understand U.S. Food and Drug Administration (FDA) and other regulatory roles in defibrillator/pacer testing. (3) To understand the basis for manufacturers' preventive maintenance.

The National Cybersecurity Center of Excellence (NCCoE) Healthcare team has been developing the project Mitigating Cybersecurity Risk in Telehealth Smart Home Integration, which provides Health Delivery Organizations (HDOs) with practical solutions for securing an ecosystem that incorporates consumer-owned smart home devices into an HDO-managed telehealth solution. The purpose of this project is to identify unique cybersecurity and privacy risks when patients use Internet of Medical Things (IoMT) devices such as smart speakers to interact with healthcare information systems.

Healthcare professionals reprocess robotic surgical instruments using manual and automated cleaning. Robotic surgical instruments (daVinci Xi 8mm instruments) require manual pre-cleaning steps before placement in a washer-disinfector and a specialized robotic cleaning cycle (RAS cycle) to clean and disinfect robotic instruments during automated cleaning. A robotic surgical instrument manufacturer (Intuitive) has worked on several projects to improve the reprocessing workflows. These projects were done in collaboration with washer-disinfector manufacturers, ultrasonic bath manufacturers, and cleaning validation laboratory to develop and validate a fully automated cleaning processes for robotic surgical instruments using a generic MIS washer-disinfector cycle. Thus, resulting in the reduction of labor costs, variability reduction, cycle time reduction, fully automated and integrated cleaning processes, and sustainable cycle.

Virtual reality, augmented reality, and mixed reality are increasingly pervasive in both healthcare and education. Organizations around the globe are rapidly adopting these technologies to drive measurable training and performance results among employees. In this session, we analyze current and future landscapes of extended reality (XR) applications, hardware, and services available in the market. We evaluate successful enterprise strategies and determine their applicability to the HTM industry, explore the benefits of immersive simulations to employee training, and share how HTMs can leverage XR technology and data to drive performance within their departments and institutions.

A fundamental objective of medical technology management is to make safe and effective medical technology available for patient care, and to do so economically. A proven technique is monitoring device failures to identify performance improvement opportunities. The 2020 AAMI White Paper, “Optimizing the Computerized Maintenance System (CMMS) Failure Code Field” describes a method adopted by a growing number of HTM programs. This presentation reviews the extent of adoption and how HTM programs are using it to improve performance.

The two major stakeholders in medical device cyber security management are IT and clinical engineering. Both require a deep subject matter expertise, often with a higher-level of technology focus from IT and greater clinical focus from clinical engineering. Depending on the institution, medical device cybersecurity management could be led by IT, clinical engineering, or a team approach from both groups. This session addresses the advantages and disadvantages of each approach and will, in part, be based on lessons learned from a series of interviews of hospitals on the effectiveness of their medical device cybersecurity program leadership.

Attendees will get a rare opportunity to meet a leader from the Joint Commission in an interactive session. Herman McKenzie, director of the Department of Engineering in the Standards Interpretation Group, leads the team responsible in developing and interpreting the Life Safety and Environment of Care Standards. Come with questions and have them answered in real time!

Herman McKenzie is currently the Director, Department of Engineering in the Standards Interpretation Group at The Joint Commission. In this role, he leads the standards interpretation and customer support activities relative to the Life Safety and Environment of Care standards. Mr. McKenzie also manages all activities associated with the daily operations of the Engineering department, provides standards interpretation and education to The Joint Commission’s Surveyors and accredited organizations, reviews equivalency requests and survey reports, conducts surveys and Intracycle Monitoring conference calls, serves as faculty for educational programs, and is a speaker for national, regional, state, and local audiences.

Speaker: Herman A. McKenzie, MBA, CHSP