Three clinical engineers discuss the challenges of managing connected medical devices, from troubleshooting and cybersecurity to the skills and strategies departments will need in the years ahead.
By Alyx Arnett
When a connected medical device stops working, the problem might not be with the device itself. It could involve the hospital network, a software application, or another system outside HTM’s direct control. Identifying the cause—and determining who’s responsible for fixing it—is just one of the challenges facing clinical engineering (CE) departments as medical technology becomes more interconnected.
In this 24×7 roundtable, three clinical engineers—Patrick C. Headley, MSc, CHTM, CISSP, manager of clinical engineering professional services at UVA Health; Samantha Jacques, PhD, FACHE, AAMIF, FACCE, vice president of clinical engineering at McLaren Health Care; and Michelle Falk-Nixon, clinical engineer at WakeMed—discuss the changing responsibilities, the challenges they’re encountering, and what CE and HTM departments can do to prepare for what’s ahead.
The American College of Clinical Engineering has described CE as evolving from traditional device maintenance toward stewardship of interconnected “cyber-physical systems.” Does that description reflect what you’re seeing?
HEADLEY: Absolutely. CE departments are stewards, but maintenance is still required. It is the scope of maintenance that is expanding to include endpoint security management. At UVA, we treat patching as a CMMS-tracked maintenance activity and each vulnerability as a recall. Each issue receives a unique work order for each affected medical device. We have added two dedicated medical device cybersecurity staff members to resource these efforts. Additionally, we steward the devices through their lifecycle from risk assessment, through ongoing monitoring, and factoring in cybersecurity considerations into lifecycle replacement planning.
JACQUES: This transition has been underway for at least the last 10 years. The movement of technology from standalone devices to interconnected systems including servers (both physical and virtual), software applications, and integrations to myriads of other systems and interconnected workflows changes the way individual pieces are procured, installed, upgraded, managed as well as how planning for downtime is handled.
FALK-NIXON: Absolutely. We’re seeing a shift from managing individual devices to managing connected systems. Our technicians are frequently challenged with capturing and maintaining accurate cyber and asset data, which becomes increasingly important as healthcare organizations face evolving cybersecurity threats. Today, success depends not only on keeping devices operational, but also on understanding how they connect to networks, software applications, and other systems throughout the environment.
As medical devices become increasingly dependent on hospital networks, software, cloud services, and other connected systems, where are you seeing the biggest operational challenges?
HEADLEY: Because HTM departments manage so many different makes and models of medical equipment, capturing the manufacturer-approved patching methodology in inventory and actually applying patches is a significant and highly variable undertaking. Patches often have to be applied in-person, although sometimes they can be completed remotely, but they always must be coordinated to ensure there is minimal disruption to clinical operations.
JACQUES: Clear roles and responsibilities for support of these complex systems is critical. Ownership for network, hardware, software, application, integrations, and overall system lifecycle is ideal to identify and document. Teams also have to plan for failures in each portion of the solution so that clinical impacts can be identified and operational teams can identify and implement downtime procedures.
FALK-NIXON: The biggest operational challenge is that connected medical devices no longer exist in isolation. HTM is responsible for the device, but network infrastructure, cybersecurity, software applications, and cloud services are often managed by other departments. As a result, troubleshooting and support require a much more collaborative approach. At the same time, HTM is increasingly expected to understand and manage risks beyond traditional equipment maintenance, making strong cross-functional partnerships essential.
How has the growth of connected medical devices changed the relationship between CE and IT/cybersecurity at your organization?
HEADLEY: At UVA, awareness of the need for medical device cybersecurity has been a catalyst from which CE’s relationship with IT Security has blossomed into a strong partnership. IT Security participates in our CE-run medical device governance meetings, and we share tooling. CE has access to enterprise tools that apply to medical devices, and we grant access to our passive network monitoring solutions. We collaborate on risk assessments, policy development, incident response, tabletop exercises, and audit response.
JACQUES: This differs device by device and system by system. The largest gap is those systems where responsibilities aren’t defined and documented well and have to be negotiated during an event.
FALK-NIXON: The growth of connected devices has made collaboration between HTM, IT, and cybersecurity a necessity. The biggest area of overlap is ownership during troubleshooting. When a device isn’t functioning properly, it’s not always clear whether the issue originates with the device, the network, an application, or another connected system. Those gray areas can slow resolution, which is why strong relationships and clearly defined escalation paths have become increasingly important.
When should CE/HTM become involved when a hospital is considering purchasing a new connected medical device? What questions should the department be asking?
HEADLEY: HTM should be consulted from the start. CE teams often serve as the “connective tissue” bringing together all the resources required to make a medical technology implementation successful. In terms of connectivity and cybersecurity, there are several factors to be identified before a device is purchased. What connections and integrations are needed? Who will be the application owner and how will users be administered? What is the future supportability of the device and all its software subcomponents? How will this device be patched, by whom and how often?
JACQUES: This does not change from normal lifecycle management of equipment typical HTM departments. At the ideation state, or RFP stage, all operational and support departments should be included to provide requirements and assess vendors to ensure all needs are meet.
FALK-NIXON: HTM should be involved as early as possible in the evaluation process, not after a purchasing decision has already been made. Before a connected device enters the environment, we need to understand its network requirements, cybersecurity risks, software dependencies, support model, and integration points. Early involvement helps identify potential challenges, clarify ownership among stakeholders, and ensure the organization is prepared to support the technology throughout its lifecycle.
Are CE/HTM departments equipped with the skills needed to support increasingly software-, network-, and cloud-dependent medical devices?
HEADLEY: HTM departments have the capability to support medical device security and to act as application owners for connected medical device systems. HTM is well-positioned to navigate the variety and complexity of medical device technology and to understand the interdependencies that exist in the clinical environment. Practitioners can increase their knowledge by enhancing their foundational skills in cyber domains including data security, networking, patching and vulnerability management.
JACQUES: Not all techs have the appropriate skills, but these are attainable. Most sites have at least a few techs that are knowledgeable enough to help out their departments with things like networking knowledge, basic integration or data transfer workflows, basic cybersecurity requirements, and other IT skills that weren’t historically in the skill set of HTM staff.
FALK-NIXON: HTM professionals have always adapted to new technologies, but the skillset is definitely evolving. Traditional device troubleshooting remains important, but today’s technicians also need a working knowledge of networking, cybersecurity, cloud-based systems, and data management. Many departments are still building those capabilities through training and experience. As medical devices become more connected, the ability to collaborate with IT, cybersecurity, and vendors is becoming just as important as the ability to repair the device itself.
As the number of connected devices grows, how are you approaching visibility and inventory? How confident are you that your organization knows what medical devices are connected, where they are, and what systems they’re communicating with?
HEADLEY: Visibility has to start with an accurate and reliable inventory, which is increasingly challenging to attain. Connected devices being added to the inventory must have their network-identifiable information documented per policy. To assist with identification of devices on the network that may not have been captured, UVA uses Asimily, a passive network monitoring platform. A bidirectional interface between Asimily and our CMMS ensures asset record details are kept in-sync. Asimily also maps device communications inside and outside the organization. The best way to be confident in the security of medical devices communications is to architect your network to only allow expected traffic and connections.
JACQUES: There are tools many hospitals use to monitor network traffic that allow hospitals to match their CMMS data to the data in these tools. These passive network monitoring tools are useful for identifying the location of these devices as well as how they are connected to network and where data is being sent.
FALK-NIXON: We leverage tools such as Medigate to improve visibility into our connected medical devices and support inventory management efforts. While I wouldn’t say we have complete confidence, as this is an evolving and increasingly complex area, we work diligently to maintain accurate information on the devices approved for use within our organization. Platforms like Medigate help us identify device locations, monitor connectivity, and strengthen our overall understanding of the medical device ecosystem.
When a connected medical device experiences a problem, how difficult is it to determine whether the cause is the device itself, the network, software, or another connected system? How has this changed troubleshooting?
HEADLEY: This difficulty in troubleshooting connected medical devices has been present ever since we started connecting medical devices to PACS and the EMR. As we add more connections and leverage cloud environments, there are more system owners who may need to be involved in troubleshooting efforts. It is important to know data flow, permissions, and dependencies from the creation of data to its intended destination as well as to have established partnerships with each applicable system owner to facilitate timely troubleshooting.
JACQUES: This is a challenging problem as the troubleshooting for this issue may take a much larger group of people including team members from HTM, networking, firewall, server, field services, and others testing and troubleshooting steps to understand root cause of issues.
FALK-NIXON: Troubleshooting connected medical devices has become increasingly complex because issues can originate from the device, network, software, integrations, or cloud services. Recently, our department absorbed a Device Integration team, which has improved communication and collaboration across disciplines. Even so, complex problems often require multiple people and departments to resolve. As connectivity continues to grow, HTM professionals must remain diligent throughout the entire device lifecycle, from onboarding and integration to ongoing support and cybersecurity management.
Looking ahead, what development in connected medical devices will have the greatest impact on CE/HTM, and what should departments do now to prepare?
HEADLEY: I think that we will be seeing more medical devices coming to market designed with Secure-by-Design principles. Healthcare delivery organizations are likely to receive devices that are more capable of being secure, but perhaps with more configuration options that must be understood, selected, and implemented in a strategic and coherent way. SBOMs, cryptographic inventories, and enhanced logging and monitoring options will present new challenges of data analysis and monitoring. CE teams should stay abreast of these coming changes, structure their teams (intra- and interdepartmental) and develop a strategy for dealing with many implementation decisions.
JACQUES: The transition to connected medical devices makes the ecosystem much more complex, and so understanding the environment is critical. Changes in the underlying infrastructure will have more impacts on clinical care, uptime, and availability of equipment, and so truly understanding how changes in the ecosystem affect the systems will be critical to ensuring that HTM departments continue to provide value to our health systems.
FALK-NIXON: As medical devices become more connected and cybersecurity expectations continue to rise, HTM departments will face substantial changes in how they manage, support, and secure technology. While technology will continue to evolve, the biggest challenge will be ensuring technicians have the knowledge and skills to support it effectively. Departments should invest now in training focused on networking, cybersecurity, device integration, and data management. Preparing today’s technicians for tomorrow’s technologies will be essential to maintaining safe, reliable patient care.
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