Plug and pray?

Medical device connectivity is the integration of medical devices with information systems, which automates the workflow surrounding the medical device. This workflow automates data analysis or acquires and communicates data generated by devices to other information systems or users. Common workflows include:
• Admitting, discharge, and transfer functions;
• Managing patient context—which data goes with what patient and when;
• Routing data, such as nurse-to-patient assignments;
• Data export to other systems;
• Data analysis;
• Alarm and alert generation; and
• Message delivery and escalation.

Some of the first examples of medical device connectivity were Apple IIs with graphics tablets connected to the serial output of hemodynamic recorders in the catheterization (cath) lab. Like many connected devices, these systems automated data acquisition and analysis to improve the diagnostic reporting process. Many of these early connectivity solutions have disappeared into a broader “redefined” medical device. In the cath lab example, separate hemodynamic recorders and personal computers merged into systems like Marquette Electronics’ MACLAB hemodynamic monitoring system—a system that allowed Marquette to enter and, for a time, dominate a new medical-device category.

Connectivity Drivers
Perhaps the biggest driver for medical device connectivity today is electronic medical record (EMR) adoption, according to Julian Goldman, MD, program leader of the Medical Device Plug-and-Play (MD PnP) interoperability program, departments of anesthesia and biomedical engineering at Massachusetts General Hospital (Boston). “Without medical device connectivity, the benefits of EMR adoption will be held back by manual data-transcription errors and workflow problems as clinicians struggle to incorporate medical device data into the patient record,” Goldman says.

Workflow automation at the point of care is also driving medical device connectivity. Many hospitals are looking to improve communications on nursing units and improve patient safety through better alarm notification. This workflow automation entails interoperability between nurse call systems, communications systems, and medical devices to coordinate the delivery of care and respond better to significant events.

While the potential benefits of medical device connectivity are well-known, the best way to implement connectivity solutions are less clear. Challenges with connecting devices include legacy devices that were not designed with connectivity in mind. Some newer devices provide built-in network connectivity used with the vendor’s proprietary end-to-end connectivity system. There are also third-party solutions that offer very different approaches to connectivity.

Connectivity Methods
Medical devices currently targeted for connectivity include spot vital signs monitors, continuous patient monitors, infusion pumps, and ventilators. The goal of device standardization by hospitals is helpful here, but no single vendor can provide all of these devices. And while patient monitoring lends itself to standardization, some devices (like ventilators) are hard to standardize. The result is a heterogeneous environment with devices of different vintages from multiple vendors.

Medical device connectivity requires a connection between the device and the target information systems. Legacy devices use a serial connection to a terminal server that converts the RS-232 signal to a network connection. Both wired and wireless local-area networks are used to connect devices to information systems. Older device-connectivity systems run on “private” networks that are physically or logically separate from the wider hospital network. The resulting proliferation of these “islands of information” is giving way to integrating devices into the hospital network. Because health care is inherently mobile, with patients moving throughout their stay and highly mobile caregivers, wireless networks offer the most flexible and least obtrusive network connection.

With the exception of diagnostic imaging modalities and some clinical lab equipment, the data that comes out of medical devices is in a proprietary format. Devices with end-to-end connectivity systems aggregate data from devices at a server, which converts the data into a standard—typically Health Level Seven (HL7) or SOAP/XML—and passes it on to another system. Devices that have only an RS-232 output must convert the serial interface to a network connection, where the data from multiple devices is aggregated in a server, which also converts the data into a standard for use by other systems.

Efforts of the Integrating the Healthcare Enterprise patient care device workgroup, standards bodies like the Institute of Electrical and Electronics Engineers Inc 1073 workgroup, and HL7 are working to improve the plug-and-play capabilities of medical devices. Goldman’s MD PnP group is also driving connectivity with use case development and a new verification lab. But it will probably be years before medical devices like those mentioned above achieve the ease of connectivity currently enjoyed in radiology with digital imaging and communications in medicine.

Proprietary end-to-end vendor systems include a variety of “smart” infusion-pump systems, spot vital signs systems, and continuous patient-monitoring systems. Third-party vendors like Capsule Technologie (Boxborough, Mass) and Cain Medical, (London), offer connectivity to legacy devices with serial outputs; they convert proprietary serial protocols to HL7 and XML. Another group of third parties, represented by Sensitron and Care Fusion, acquire data from spot vital signs monitors using nurse-carried personal digital assistants (PDAs). A final group of third-party vendors provide enterprisewide connectivity and messaging infrastructures supporting medical devices; these companies include Emergin, GlobeStar Systems, and Ascom (also a wireless phone vendor). At the point of care, wireless communications vendors like SpectraLink, Vocera, and Ascom offer varying levels of workflow automation along with application programming interfaces to third-party connectivity solutions. Nurse call vendors are also getting into workflow automation with their own patient flow, messaging, and nurse-to-patient assignment software.

Connectivity Planning
How one finds their way through this bewildering sea of competing choices is a challenge. The interrelated nature of the devices, users, and workflows means that any one connectivity choice will inevitably impact subsequent decisions down the line. “With many connectivity projects you don’t find all the hidden costs until after the project is complete,” says Craig Bakuzonis, director of clinical engineering, Shands Hospital (Gainesville, Fla). “Detailed planning and experience have been our best project-management tools.”

Perhaps the most important part of connectivity planning and execution is needs assessment. Unlike many projects in health care, connectivity crosses multiple organizational silos in a hospital and must sync up multiple moving targets. These moving targets are changes that occur in care delivery methods, medical device upgrade and purchase plans, and information technology (IT). Any resulting solution must fit today’s environments and support future changes planned across overlapping areas. Even seemingly unrelated projects are interrelated—will nurses want to carry a PDA for spot vital signs capture and another PDA for the Baxter “smart” pump system budgeted for next year? Probably not. Can we run both applications on the same PDA? Good question; probably not.

Good planning for connectivity incorporates requirements from nursing, biomedical engineering, and IT into a series of road maps. Each road map starts with current requirements and captures planned clinical and operational changes into the future. A good time horizon would be one that equals the operating life your hospital expects from a new medical device. Each milestone on the road map needs an associated project description and list of requirements. If no one in your hospital can plan out as far as the estimated useful life of your medical devices, make sure constraints posed by keeping those devices are understood by all parties.

In most hospitals, the only department with project managers is IT. This, combined with the increase in information-systems budgets, places IT in a key position. “The day has come when biomeds and IT need to work together on a daily basis,” says Troy Gillette, director clinical engineering and patient equipment, Robert Wood Johnson University Hospital (Brunswick, NJ).

The Biomed/Nurse Interface
According to Elizabeth Wykpisz, vice president, Washington Heart and Vascular (Washington, DC), “Nursing is constantly evaluating the infrastructure, policies and procedures, and staffing models that surround the delivery of quality and effective care.” Many hospitals experience patient-flow bottlenecks. It is anticipated that care delivery models will change and adapt as patient flow is addressed and improved. “Strategies like observation units, rapid response teams, express admission programs, variable acuity nursing units, and moving patients to intermediate care that has traditionally been considered ‘critical care status’ are common responses to improve patient flow and other pressures,” Wykpisz says. These changes impact nursing-unit admissions criteria and staffing, which in turn impact medical-device requirements, alarm notification, communications, and surveillance needs. There is also a need to address surge capacity.

Biomedical, nursing, and IT departments should work together on IT projects that involve medical devices, and this collaboration should start at the beginning of projects. At Shands Hospital, nursing and IT specialists are cross trained in each other’s specialties, and they work together on connectivityprojects. “We’ve found that consistency in people on the  team, and a consistent direction, ensures the best outcomes for device-connectivity projects,” Bakuzonis says.

The biggest challenge to connectivity Gillette has faced is the proliferation of various stand-alone patient-monitoring networks that have accumulated over the past 15 years. “We’ve had to bring all these networks up to the same standard and network design and into a common infrastructure,” Gillette says.

“Clinicians are driving requirements for medical device connectivity at a pace that is challenging,” says Bridget Moorman, clinical systems engineer, biomedical engineering, Kaiser Permanente (Berkeley, Calif). Responding to clinicians’ needs was complicated by vendors who perhaps oversold their connectivity capabilities and placed Kaiser in the unwanted role of systems integrator. About a year ago, Kaiser started including purchase-contract language that Moorman called the “interoperability clause,” where device vendors agree to work toward interoperability with Kaiser’s EMR vendor. “We haven’t selected a definite standard,” Moorman says. “As vendor contracts come up, we negotiate a mutually acceptable connectivity method. And if the medical device connectivity doesn’t occur, then that vendor is obligated to deinstall their system.”

With the increased adoption of wireless medical devices, appoint an active and well-qualified radiofrequency safety officer (see J. Scot Mackeil’s September Soapbox in 24×7), and include him or her in connectivity project teams. In addition to the usual registry and history of medical devices maintained by biomedical engineering, device network infrastructures and software versions should be fully documented. Connectivity road maps will force network design decisions that impact cost and patient safety. Biomedical engineering may also be represented during discussions involving physical plant changes ranging from electrical power, emergency preparedness, and renovation to new construction.

Working With IT
A biomed’s perfect day entails rubbing shoulders with clinicians and responding to life-critical situations as needed, 24/7. The IT person’s perfect day is to resolve all issues and problems from their desktop computer. This dichotomy is reflected in IT departments that are in a constant search for “enterprisewide solutions” to replace the proliferation of different point solutions that are hard to manage and expensive to maintain. This desire for enterprise solutions definitely impacts device connectivity, and especially multiple private networks.

As IT extends further into the clinical realm, it must change its operations to meet a higher level of patient-safety requirements —especially as medical devices are integrated into the hospital IT infrastructure. According to Eric Yablonka, VP, CIO, University of Chicago Hospitals and Health System (Chicago), “We shifted to 24/7 operations when we began implementing our computerized physician order entry system, because any system that is critical to the delivery of patient care requires immediate support whenever there is a problem.” Integrating medical device systems support into the IT help desk and biomed support processes is an important step that many hospitals have already made.

In addition to a traditional IT planning road map that encompasses applications and infrastructure, telecommunications plans—especially any in-house wireless phone systems—must be documented. Just as various consumer electronics are converging into cell phones (PDAs, cameras, mp3 players), wireless phones at the point of care will have to support more than voice calls.

Avoiding Pitfalls
Frequently, biomedical engineering learns about projects late in the game—sometimes too late to avoid rework and other unanticipated costs. To avoid this waste, be proactive and make sure you are involved in the right committees to see connectivity requirements sooner rather than later. If there is no appropriate group or committee, consider starting one and engage your peers in nursing and IT in an effective planning process now. Proliferation of point-of-care computing devices, like wireless phones, PDAs, and computers on wheels, are moving into data acquisition and even alarm notification. Your best opportunity to impact safety and save money is to be involved before requirements are set.

As medical device connectivity has evolved, administrative applications are giving way to those impacting patient care and safety. Systems have evolved from data gathering and export to alarm management. According to Goldman, the next big connectivity application will entail medical device interoperability. “In the future, connectivity will include medical device control that permits the integration of distributed medical devices to produce ‘error-resistant’ systems with safety interlocks between devices,” Goldman says. This error resistance will decrease user errors and provide closed-loop systems to regulate the delivery of medications and fluids, improving patient safety and outcomes.

Tim Gee is a contributing writer for 24×7. Contact him through his Web site: