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Information systems change the way we deliver health care and change how health care will work in the future. The benefits that health information technology already have delivered demonstrate clear progress. The promise of creating even more effective systems to exchange clinical data among providers, if done well, should improve patient outcomes and patient satisfaction.

Nine years ago, I was in an emergency department watching my 9-year-old daughter writhing in postsurgical pain and dehydration, while I tried to get the resident and nurse to find the clinical and drug record of what had been done for her by different caregivers just two days before — in the same ED — to deal with this same problem. I wanted them to understand what solved the problem, because what they had proposed was counter to what had been done two days earlier. It took several arguments and two hours. It should have taken two minutes with no argument. Fortunately, we finally got it right, and my daughter was fine. Nonetheless, it was frightening and frustrating.

Health care IT has solved this problem for most situations and, in the future, this disconnect should not exist. However, this progress comes with a catch: interconnectivity creates complexity, and complexity creates chaos if not carefully controlled.

Convergence Begins

The worthy goal of IT interconnectivity has led ECRI Institute to focus on one particular consequence that often is not considered as carefully as it should be. It stems from the connections we want between medical devices and information systems. For the past 10 years or more, we have been tracking the integration of medical devices with information systems, and the pace of this trend recently has accelerated. Over time, medical devices have grown more software-based with network capability. The challenge is the increasing desire to connect medical devices to health IT networks.

To give a specific example, connecting physiologic monitoring systems to a hospital's enterprise network allows patient data to be exchanged with an electronic health record. It also enables importing radiologic images from picture archiving and communication systems or data from laboratory information systems to bring needed information directly to the point of care to support clinical decisions. Such convergence of medical device technology with health IT has the potential to affect clinical workflow. From our vantage point, this trend is accelerating with many different devices and IT systems, and we believe that its implications warrant careful consideration by those managing hospitals and health systems.

New Threats

In simple terms, this convergence has four basic consequences.

The first consequence. Patient safety looks different. For many decades, we have researched medical device safety, including thousands of on-site medical device accident investigations and laboratory evaluations to learn firsthand of device safety risks. Our work in medical device safety enables us to see that patient safety issues occur now that never existed before and that proactively addressing these hazards has become central to operating a safe clinical environment.

The earlier example of placing physiologic monitoring systems on the hospital network has led to several types of problems, including those involving change management. A change made to the hospital's wireless network could cause the physiologic monitoring devices that ran on the network to "reboot" periodically, which could lead to gaps in critical monitoring and the potential for alarms to be inactive or not heard. So, a new threat becomes evident: Trouble with a main network can spill over to trouble with the clinical devices connected to it, which can spill over to trouble with your patients.

The second consequence. Critical management and staff skills look different. Both IT staff and the clinical engineering staff must recognize that both professions have entered a new era. It takes considerable knowledge and understanding to appreciate the ways in which a hospital network communicates data to and from medical devices and their associated safety risks. When an infusion pump becomes part of the hospital network for the purposes of updating drug libraries, that convergence leads to a need for IT staff to understand the criticality and patient safety issues of infusion pumps. When spreadsheet software freezes and reboots, it's frustrating; when a physiologic monitor providing real-time alarms reboots, it's frightening. Consequently, biomedical technology and clinical engineering staff must grasp the complexity of networking to ensure the reliability of their medical devices. For instance, is it now possible for someone to maliciously or unintentionally hack into a hospital network and shut it down along with critical medical devices? Suddenly, making sure those security patches are installed becomes a patient safety issue. Conversely, is it possible to bring the entire hospital network down if a virus is introduced through a medical device linked to that network? An information network is in many ways like a chain — it is only as strong as its weakest link. Does that chain now include the remote intensive care unit?

The third consequence. Assessing the performance of technology looks different. In the past, when a hospital sought to buy the best infusion pumps, it looked for those that infused the best. Now, when an organization wants to buy the best infusion pumps, it must look at how the pump infuses and how it will interface and function with the pharmacy information system, electronic medication administration record, computerized provider order entry system and, increasingly, the EHR.

I had dinner last year with a hospital CEO who lamented that staff were incredibly frustrated because they could not get new infusion pumps to interface properly with the new EHR. "Let the finger pointing begin … " is how she phrased it. This means that when reviewing new clinical technology for acquisition, whether it is an infusion pump or linear accelerator, connectivity requirements and capabilities are crucial to the decision.

A quick point about interfaces: just because an interface between a device and an IT system exists does not mean it actually works well. We suggest talking with users who have the same systems connected — though, in truth, even that is no guarantee because many integrated systems are configured uniquely.

The fourth consequence. Quality looks different. Improving the quality of care will depend increasingly on our collective ability to manage and take advantage of the convergence of medical devices and information systems. Improving quality is not simply about avoiding problems, but also about exploiting opportunities. Convergence provides numerous opportunities to make things work better. Whether it is telehealth that can send ICU data to a specialist 500 miles from a remote patient or it is providing the right drug allergy information at the bedside infusion pump, the possibilities for improvement are right there for the picking.

Start Now

This takes us back to my daughter. The opportunity from the convergence of medical devices and information systems, if done well, will lead to faster, better diagnoses and treatment. Speed makes a difference. Getting the right information to the right place — whether it is patient histories or medical device data — will improve quality. Why are we still waiting for days on that radiology report? Why are we still expecting patients to remember not only their medications but the exact dosages? Why are patients still hand-delivering clinical data from specialists in one location to specialists in another location because they are not connected? We all are asking the same questions, and we all know we can and should make these connections to improve care.

We also know that the faster we get on with it, the better. Just ask my daughter.

Anthony J. Montagnolo, M.S. (amontagnolo@ecri.org), is executive vice president and chief operating officer of ECRI Institute, Plymouth Meeting, Pa.