All Systems Go: How Systems Engineering Can Improve Healthcare Technology

Abstract

By education and training, clinical engineers and other healthcare technology management (HTM) professionals are problem solvers. But today's problems are markedly different than they were in the past—a trend that is accelerating as information technology (IT) becomes increasingly complex, connected, and crucial in healthcare. Tried and true tools and protocols for managing stand-alone equipment are proving insufficient for dealing with systems issues.Right now, most healthcare technology managers inhabit an in-between world—one that straddles the “break–fix” mentality of the past and the systems thinking that experts believe is the future for improving patient safety and clinical practices.“Over the past 10 years, my job as a clinical engineering director has changed from managing the majority of medical systems as stand-alone devices or isolated systems to, today, these same systems are either integrated or in the process of integration with other systems,” says Gregory Herr, director of clinical engineering at the Christ Hospital Health Network in Cincinnati, OH.Donald Armstrong, a certified biomedical equipment technician with GE Healthcare, sees “a huge difference” in his responsibilities because of the growing systems dynamic. “We spend a lot more time these days tracking where the failure lies, instead of just fixing the immediate problem,” he says.Pat Baird, an engineering director with Baxter Healthcare Corporation, sees real value in embracing systems thinking in healthcare. “The motivation that I have for bringing more systems theory to the health-care environment is that I see the people constantly reinventing the wheel in healthcare. Many of the challenges in healthcare are the same challenges other industries have faced decades ago. Healthcare needs to catch up and I think that ‘systems thinking’ could help speed the process.”Getting to the practical side of systems thinking in healthcare first requires a journey through abstraction, because a system is “a whole bunch of levels of abstraction,” in the words of Lane Desborough, a product strategist with Medtronic.Participants at the 2012 AAMI-FDA Interoperability Summit emphasized that people are an integral part of any system, because people interact with technology. Summit participants urged the use of the term “sociotechnical” to describe—and guide the design and life cycle of—systems in healthcare.Recently, the phrase “system of systems” has been in vogue, and yes, there's an acronym for that: SoS. Purists say that term is meaningless, however, and that “system” suffices and says it all.Regardless of the terminology, the interaction of individual components is the key differentiator for true systems, or systems of systems, in healthcare technology, according to Ken Maddock, vice president of facility support services at Baylor Health Care System. “We have had networked medical devices tied to a back-end database for years,” he says. As an example, he cited electrocardiogram (ECG or EKG) systems. “You'd send an EKG cart out, and you'd run a 12-lead EKG on a patient. And you were able to hook those up to a network and download the studies. The devices connected, but they didn't really interact.“Most people are considering the device and the backend database to be a system of systems now,” Maddock adds. “A lot of people are confusing just connecting devices to a network and feeding data into an electronic health record [EHR] to be a system of systems. Even with the EHR, that is still basically one-way communications. To me the real system of systems is when you have live or close-to-live communication back and forth that impacts the setup of the device and the way the device interacts in some way with the patient. It's not just a dumb device anymore. It's a device that knows who you are and is going to customize what it is doing based on who you are and what your condition is. The device has context.”For Maddock, the use of infusion pumps provides a good way to understand how well designed and functioning systems can turn “dumb devices” into smart ones. In most applications, networks push out periodic drug library updates to infusion pumps—a one-way communication. For the few healthcare delivery organizations that are using systems to apply the “five rights” of drug administration (right patient, right drug, right dose, right route, right time), many connected systems interact back and forth to make that possible.When a broad system is designed with an intended behavior such as the five rights built into it, it can contribute to improved patient care and clinical practices. Consider the care of a patient in a critical care unit. Baird sees three systems at work: The treatment for that patient involves a system of devices that are delivering drugs; another system of monitors that keeps tabs on the patient's condition; and an EHR system to handle the patient's medical history.“If there's a sudden change in the patient's vitals, the nurse might need to refer to the medical records to check for allergic reactions or other complicating medical conditions before deciding on what changes need to be made to the drugs being delivered. So the clinician actually is working with three different systems every day, even with this simple example.”The challenge of any system is that desired behaviors, emergent properties, and interactions can go awry. In short, there are often unintended consequences.“The reason why this word ‘emergent’ is so attractive to me is that oftentimes the system properties don't emerge until the system emerges,” Desborough adds. “In fact, by definition, an infusion pump sitting in a warehouse somewhere is doing no harm nor good until it's purchased by a hospital and brought into a particular clinical setting and attached to a certain patient with a certain drug being infused through it. It does nothing until it's part of a broader system.”David Stiles, CBET and director of biomedical engineering and central equipment services at Long Beach (CA) Memorial Medical Center, has first-hand experience with system-propelled emergent properties and unintended consequences. “An example of our new challenges is the process of drug library revisions on our infusion devices that rely on quick broadcast to nursing, pharmacy, and information systems,” he says. “This new ‘system’ may not react or implement as designed—and this requires quick and unscheduled intervention.”Desired behaviors such as patient safety and clinical decision support could emerge from medical technology and health IT systems. But experts say these kinds of behaviors are unlikely to emerge unless systems engineering principles and tools are applied, beginning in the design stage, to produce them. Worse, failure to attend to potential unintended consequences could compromise patient safety—a prospect that is increasing as more components and systems are connected.That's where systems engineering will be valuable. “In my mind, systems engineering is as simple as balancing what you're trying to achieve versus what are the potential unintended consequences of connecting all of these things together,” Desborough says. “How do we understand what the positive and negative effects are before we put them into the overall system, so that we aren't surprised when something bad happens?”For the U.S. Department of Defense, systems engineering means “planning, analyzing, organizing, and integrating the capabilities of a mix of existing and new systems into an SoS capability greater than the sum of the capabilities of the constituent parts.” Note that according to the Defense Department's definition, a system doesn't really manifest itself in its true sense—in terms of producing desired behaviors—without systems engineering.“Systems engineering has been practiced with intent in industries like defense and power generation for decades,” says Rick Schrenker, a systems engineering manager with the Department of Biomedical Engineering at Massachusetts General Hospital in Boston. “The drivers for their earlier adoptions in those domains included rapidly increasing complexity in deployed systems, rapidly increasing rates of change in these complex systems, and costs that spiral out of control in the absence of intentional and formal control. It is so obvious to me that healthcare can learn from these domains. Frankly, anyone in a systems development role in healthcare who doesn't at least see the need to familiarize themselves with work in other domains needs to get out of healthcare management. Now.”What could be the practical value of a system, or system of systems, approach in healthcare? Fewer risks to patients, a reduction in costs for healthcare facilities, and greater efficiencies would top the list, according to experts.“Medical professionals can receive data from the system of systems and perform a more extensive trending analysis of a patient or hospital—predicting issues that could arise for a hospital floor during a particular season or when cases have similar data,” says Kathleen Whanger, quality assurance manager with the vascular division at Teleflex Arrow International. Prediction, she explains, is key to reducing risk and cost. More accurate forecasts could help determine, for example, “how many gauzes to order or how many times a catheter will have to be changed.”And what does this move toward systems thinking mean for HTM professionals in the field? At the very least, it underscores the changing nature of their jobs and highlights the need for new skills and knowledge.“At the clinical engineer director level, advanced project management skills become necessary,” says Dan DeMaria, director of Bio-Medical Services & Communications with Olathe Medical Center in Olathe, KS. “The ability to manage an interdisciplinary project is critical to success.”The move toward a systems dynamic also opens the door to HTM professionals playing even greater roles in their facilities.“Healthcare technology managers will be using the information from practical applications of systems engineering to improve their infrastructures within a particular hospital unit and throughout the entire hospital,” Whanger says. “With this information they can engage in discussions about improving data trending and communication between devices so as to improve overall healthcare to a patient or patients as well as ease the burden on nurses writing information into charts. This will also allow for improved communication between nurses during shift changes as well as better communication between other healthcare professionals at the hospital.”Raymond Zambuto, president of Clinical Engineering Concepts, LLC, says that what he calls “clinical systems engineers” will need to take on new, specialized roles, in collaboration with other stakeholders, such as IT professionals, clinicians, and manufacturers, in these areas:Systems thinking advocates believe there is an emerging, but largely unfilled, need for systems integrators in hospitals and other healthcare delivery organizations. That role entails bringing big-picture thinking to sociotechnical systems. Moreover, if clinical engineers and other HTM professionals do not step into these new roles, they risk being marginalized by others who can evolve to meet technology needs, Zambuto says.New skills are required at the technician level as well, DeMaria says. In addition to working closely with or as a part of IT, “we must understand basic networking and have a ‘big picture’ understanding of the entire data flow from medical device to the network to the electronic medical record.”Plus, he says, biomedical professionals are often in a position of “triaging” reported problems and engaging appropriate subjectmatter experts, including network engineers, systems analysts, or communications engineering staff. While HTM staff may not actually resolve problems, they do take ownership of them and ensure resolution.“It is my expectation that HTM technicians will be more involved in initial trouble analysis of complex interdisciplinary systems,” DeMaria says. “I can envision a day in which HTM will become a tier 2 help desk function. I expect we will be providing resources to a unified help desk, which will further blur the lines between HTM, IT, and even communications.”Some HTM professionals are beginning to use systems engineering principles and tools more deliberately. “I have seen more and more collaboration in working with IT and risk management as we further develop our EMR, medical device integration, and new electronic adverse event reporting systems,” Stiles says. “As we introduced these new systems, we have followed new and unknown implementation and validation processes developed by our informatics groups based on new and different established standards. We are developing workflow strategies now that include our other major support groups—IT, nursing practice councils, pharmacy—during medical equipment management and support activities.“An acute example,” Stiles adds, “is that we can no longer just take a system down without advance notice to clinicians and IT support. Our actions performed on medical devices now can make a real-time effect on data reaching the EMR interface.”A complicating factor to the systems evolution is the fact that more healthcare is moving outside the hospital setting and involves issues as complex as EHR implementation and alarm management. The systems dynamic will go with that migration. “We are assuming support of physician offices, outpatient clinics, and other nonhospital care areas as the hospital builds its healthcare network,” Herr says.Systems engineering, architecting, and integration are increasingly relevant to manufacturers in designing and developing health IT equipment.“There are a number of companies today that have developed or are building competencies in these areas, whereas before there might've been functional engineering departments like electrical or mechanical or software engineering,” Desborough says. “It's a recognition that these things are all part of a broader system and we need to be thinking about these different aspects proactively.”In Desborough's own work developing an artificial pancreas, model-based design and simulation are powerful tools. Models and simulations allow designers and developers to accurately predict desired behaviors and unintended consequences of a system—and tweak the system to weed out negative effects—in early stages of design and development.With such tools, manufacturers can get more “proactively engaged” in designing products to fit into a broader system, Desborough says. Models and simulations are applicable as well to healthcare delivery organizations that are engineering or re-engineering systems. Some healthcare systems, in fact, have created simulation centers for this purpose.“I also think that many companies are going to have to think defensively about their designs,” Baird says. “Think about when you learned to drive a car. There is a style of teaching that is called ‘defensive driving techniques’ where you anticipate that things will go wrong, and your behavior is to minimize the impact of things going wrong—things like maintaining a safe distance between you and the car in front of you.”“Similarly,” Baird says, “in other industries that have successfully connected systems together, there are defensive design techniques that minimize the effects of a network that is down, or of a connected component that has failed,” so that no single point of failure takes down a whole system.Whanger says manufacturers need to broaden their perspective and communicate even more with stakeholders outside their own facilities. “Manufacturers should think about how their device can improve the health of the patient and work with other companies developing other supporting medical devices to develop and define integration points,” Whanger says. Companies also should improve communication between the hospital environments and the company for postmarket surveillance, she says. “They should also realize there could be a market for simpler devices but with the same communication capabilities for hospitals without the technology infrastructure—and also for in-home devices. There are lots of great possibilities by thinking beyond one device.”In a sign that industry is beginning to recognize these possibilities, the CEOs of nine device makers (Cercacor, Cerner, Dräger, GE Healthcare Systems, Masimo, Smiths Medical, Sonosite, Surgicount, and Zoll) announced in January 2013 that they would work together to make their devices interoperable. Specifically, they will work toward sharing information across different devices to improve patient care—a systems-thinking approach.Managing the life cycle of equipment will require a systems perspective as well. This begins even before purchasing decisions are made. “Obviously there will be more requirements in the request for proposal (RFP) that need to be thought through,” Baird says. “Healthcare technology managers are going to need to demand more information from their vendors, and will need to work closely with the vendors to ensure that everything works together as intended, without unexpected consequences.”At the purchasing level, there's a growing list of variables to consider. “The purchasing process needs to take account of the environment, work flows, human factors, and other equipment systems it will be interacting with,” Zambuto says. “The design of medical equipment is a much more complex business if it is to be done right. My concern is that not all manufacturers will recognize these factors, making it all the more important for the hospital and its clinical engineers and BMETs [biomedical equipment technicians], whether in-house or contracted, to be aware of the reality of system of systems interaction.”In practice, this means that the clinical engineering job of managing medical systems is not only changing, but expanding. “Our clinical engineering program still follows our basic goals of equipment management, preventive maintenance, repairs, and reporting,” Stiles says. “We still report to facilities, as most other hospitals do, but we have created many shared processes with other system owners such as IT, pharmacy, and risk management.”To work more effectively in this systems environment, Long Beach Memorial Medical Center has adopted different processes to support the acquisition of new equipment, design of medical device integration workflows, and collaboration with new groups and committees, he says:Likewise, with a systems approach, medical and health IT upgrades, repair, and maintenance will increase in scope, at least over the short term.“If there is a software upgrade for one device, this might cause a communication error to other medical devices or cause a communication error to the nurses' station,” Whanger points out.The fact that just about everything is connected in multiple ways in the modern hospital is the main point that healthcare technology experts keep coming back to. Virtually no piece of equipment operates in isolation anymore.“Medical devices are part of a larger electronic data management system,” Zambuto says. “BMETs need to take account of this in their approach to repair and maintenance protocols. For example, the loss of data transfer on a monitoring system could be a hardware problem, a software problem, or a network problem. Coordination needs to be maintained with the IT department. Similarly, when working on a system that supports more than one patient, care must be taken to not disturb the flow of information from other beds while troubleshooting or maintaining a problem area.”Collaborative efforts like these might not be easy—at least at first. “I like to compare this to cleaning out my garage,” Baird says. “I have so much clutter in my garage right now; when I finally decide to reorganize it, during the actual reorganization itself, the garage looks much worse—everything is moved out of place, piled on top of each other, as things are moved around to make room. Eventually, I get one corner organized, then another, and eventually all of the clutter and chaos in the middle of the garage is gone and I have a much more efficient setup.”Ironically, it could well be that more systems will help solve some systems issues. At the Christ Hospital Health Network, Herr says the computerized maintenance management systems (CMMS) incorporates more than traditional clinical engineering devices management. It includes IT information and regulations related to the Health Insurance Portability and Accountability Act (HIPAA). “Systems management is part of this CMMS,” he says.Creating these systems and making them work smoothly won't happen all at once, and it will be challenging. But there are ways to start. “Let's just say that without recognizing that we are dealing with a system of systems, and breaking the delivery of care in today's and tomorrow's hospitals into smaller ‘chunks’ or subsystems, we will never get a handle on how it all really works or how to improve operations and safety,” Zambuto says. “If we try to treat it as a whole, we will drown in a tsunami of unintended consequences.”