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 24x7), 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.
Plug and pray?
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