By Aine Cryts

Sacramento, Calif.-based clinical engineering consultant Ted Cohen, MS, CCE, fACCE, points to the exponential growth of PACS technology about 15 years ago as the starting point in the need to make various health IT systems communicate with each other.

That’s because, in radiology, scanners are connected to an archive where images are stored. Just as MR scanners need to be able to send images to an archive that’s accessible in a digital format for radiologists to interpret the images at their workstations, healthcare leaders need to figure out how to get patients’ blood pressure readings and blood glucose levels into the electronic health record (EHR) so that they’re accessible to clinicians—and all of this must be accomplished in a secure manner.

From a national perspective, Cohen, who previously served as a clinical engineering manager at UC Davis Medical Center, says it was the passage of the Health Information Technology for Economic and Clinical Health Act in 2009 that incentivized healthcare organizations to invest in health IT. Calling it a “game-changer,” he says passage of this law incentivized healthcare facilities around the country to connect medical devices to hospital information systems and EHRs.

Before the law’s passage and healthcare facilities’ concerted focus on increasing interoperability among medical devices and health IT systems, however, nurses across the country were manually entering data about patients’ vital signs into the EHR. This data entry was laborious work, and it took nurses away from the patient’s bedside, notes Cohen. Thus, it was important to automate this information-sharing between medical devices and health information systems, especially given the high volume and frequency of the data.

Paul Sherman, CCE, president of St. Louis-based Sherman Engineering and technical program manager for Integrating the Healthcare Enterprise’s Patient Care Device Domain (IHE-PCD), says that getting a patient’s vital signs documented in the EHR can enable better care, but manually typing in that information is inefficient and ineffective.

The problem can be as simple as this: Nurses get busy. If they’re capturing a patient’s blood pressure and then they get distracted by an alarm or get paged while they’re typing in that information, that patient data gets lost, adds Sherman, who previously served as a senior biomedical engineer with the U.S. Department of Veterans Affairs.

Key Issues in HTM and IT

It’s because of the dramatic increase in medical device connectivity and interoperability that hospitals’ clinical engineering and IT departments are worried about medical device privacy and security, says Cohen. Also on the minds of healthcare leaders is the need for IT and clinical engineering teams to communicate with each other—at both the people and device level, he adds.

And the departments’ differing focuses can create some friction between them, according to Cohen. Case in point: Clinical engineering departments have tended to focus more on patient safety and product performance, whereas IT teams are more concerned with security. The primary job tasks also differ, says Cohen. While clinical engineering teams are more likely to focus on operational tasks, such as repairing, testing, or evaluating medical equipment, IT staff are more project-focused.

In some cases, there can also be cultural differences between these teams, he adds. For instance, some clinical engineering departments are unionized and work on a 24/7 schedule, while IT teams include non-union employees who are likely to work Monday through Friday.

Even so, Cohen has witnessed a trend where clinical engineering teams are increasingly reporting to the hospital’s chief information officer. And there’s a practical reason for this, he says: Most IT departments are 10 times bigger than clinical engineering departments. That strategic shift will also cause changes within healthcare facilities—but Cohen says the most effective way to get these two teams to mesh is to remind everyone of the two overarching priorities: achieving patient safety and enabling ease of use for clinicians.

“[Everyone on a project] has to really pay attention to the patient because the ultimate goal is to help clinicians do their jobs better and have a positive impact on patients,” he adds.

Overcoming Interoperability Challenges

Ensuring interoperability with a hospital’s legacy systems—such as patient monitoring devices in the intensive care unit, dialysis equipment, and telemetry machines—can be a challenge, acknowledges Sherman. Many of these systems function well within hospitals, and that means executives don’t intend to replace them until they stop working.

Fortunately, Sherman says, there are companies that can design mechanisms to capture data from these older systems in a way that can be understood by newer medical devices. Still, as expensive as it is to make legacy systems and newer medical devices interoperable, the option of taking legacy systems offline and replacing them is even more expensive—and potentially disruptive to patient care.

He points out that it’s particularly valuable to capture information about alert alarms within a patient’s record in the EHR. Why? Because, Sherman says, this level of detail helps clinicians determine the most appropriate treatment plan for the patient.

Moreover, since many older systems haven’t been built to enable interoperability, healthcare facilities need to be very specific in their requirements when purchasing new technologies, industry experts say. But before you issue an RFP or RFI, however, you need to first approach the challenge of interoperability with medical devices as a systems issue, says Sarasota, Fla.-based Elliot Sloane, PhD, CCE, an HTM expert; 24×7 Magazine board member; and president, executive director, and founder of the Foundation for Living, Wellness, and Health.

“That starts with a clear requirements definition,” he advises. And as an organization considers this topic, it needs to focus on all aspects of its short- and longer-term needs. For example, for a monitoring system specification, it should clearly identify whether it’s trying to manage alarms, quality, or safety—or all three, or, possibly an even larger set of capabilities.

Sloane adds that, in order to develop the appropriate requirements, you need to catalog and prioritize them. Also important for planning purposes is determining a measurable testing strategy, he maintains. “If you don’t do those things at the outset, your ability to acquire technology or determine if it’s working correctly on installation or in the future is very poor,” says Sloane.

Getting Clarity from Vendors

Some EMR and medical device vendors aren’t necessarily complete or transparent with the documentation they provide to prospects and customers, which can make the RFP/RFI process a challenge, industry insiders say. For instance, Sloane says: If your organization requires Integrating the Healthcare Enterprise (IHE) compatibility or Institute of Electrical and Electronics Engineers (IEEE) 11073 coding, those requirements must be in your procurement document.

“[The requirements in the RFP have] to be clearly a ‘go/no-go’ or a cost penalty,” says Sloane. “There has to be a clear, written statement that the requirements will be included in the quoted cost, and in the installed system, as well as a specified number of months or years of future updates.”

Sloane encourages HTM managers to provide members of their organization’s C-suite with a five-year lifecycle cost when educating them about any new solutions that involve interoperability among medical devices and other mission-critical systems, such as EMRs. Here’s how the case could be presented to a CFO, for example:

  1. Pay $1 million dollars for a system that’s robust and has very low support costs in the next five years.
  2. Pay $500,000 for a system that will cost $250,000 a year over the next five years to upgrade everything to ensure compatibility.

“Break it down into a long-term cost of ownership,” says Sloane, who recommends always including the cost to train staff and potential hardware, telecommunication, and software updates. Resources for determining the long-term cost of ownership include Net Present Value tools—which are readily available for Excel—and lifecycle cost of ownership or total cost of ownership templates, which are widely published, he adds.

“Standardization, while not free, has some actual return on investment,” Sloane says. “If you have all of your devices on the same system and on the same backbone, troubleshooting, diagnosis, replacements, and updates become a conversion cost. If they’re all disparate, [however], you are like the old Ed Sullivan guy, with the plates on the sticks spinning them.”

Unfortunately, Sloane says, that scenario plays out in many HTM departments. “They spend 98% of their time doing fix-it stuff.”

Aine Cryts is a contributing writer for 24×7 Magazine. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at kstephens@medqor.com.