SCENARIO:
A patient is newly admitted to an intensive care unit from the emergency
department at a suburban hospital. The patient is placed ona
physiologic monitor and a ventilator in the ICU. The nurse associated the
patient to the monitor so that she could automatically chart vital signs in
the EHR. The patient has labs drawn and resulted every two hours via a
POC (Point-of-Care) device. The patient had radiology exams in the ED
prior to arriving in the ICU. An interactive infusion pump (Smart Pump)
administers medications intravenously and interacts with the EHR to
record titration of the medications automatically in real time. Twenty-six
miles away, at a remote monitoring center (tele-ICU) stationed in a large
metropolis hospital is also monitoring the patient.SCENARIO:
An alarm sounds from the physiologic monitor at the
bedside while a secondary alert sounds within the tele-ICU
unit alerting staff at the patient’s bedside as well as in the
tele-ICU that the patient has gone into VT (Ventricular
Tachycardia), a lethal heart arrhythmia that requires
immediate intervention. While the care givers at the
bedside start advanced cardiac life-saving measures, the
remote clinician can begin searching the electronic health
record for the patient’s most recent lab results, pertinent
medical history, medication history, as well as radiology
results.SCENARIO:
The remote clinician has special software that enables the
remote clinician to review real-time vital signs, track and
review trends, and recognize changes. The remote clinician
can view the activities occurring in the patient room via a
two-way camera with audio as well as call a code for the
bedside, thus allowing the bedside clinician to remain at the
bedside providing direct patient care. The bedside and
remote clinicians methodically work together to resolve the
issue, convert the patient, and stabilize the patient....According to Medical Strategic Planning, Inc., over
the last decade the number of devices that need to
be interfaced has grown from a handful to over 400
major devices (MSP Industry Alert, 2009). Medicat
device connectivity is expected to increase
efficiency and productivity, improve clinical
workflow, lower costs while improving patient
quality and safety.MEANINGFUL USE
The HITECH ( Health Information Technology
for Economic and Clinical Health) Act allows
eligible providers and eligible hospitals to qualify
for the Center for Medicare Medicaid Services
(CMS) incentive payments if they achieve
“meaningful use” of certified EHR technology to
provide patient care (Center for Medicaid and
Medicare Services, 2013).The Centers for Medicare & Medicare
Services (CMS) and the Office of the National
Coordinator for Health Information Technology
(ONC) are providing meaningful use criteria for both
acute care (hospital/ER) and provider practices
(clinic) settings. Eligible providers and eligible
healthcare facilities that comply will receive
incentive payments. In time, those failing to comply.
will be penalized.Meaningful Use is a three-phased
approach building upon each other. HITECH
does not provide incentives specifically for
medical device connectivity in itself but
connectivity drives the adoption of EHR use
and thereby meaningful use adoption.According to HIMSS, “interoperability
describes the extent to which systems and
devices can exchange data, and interpret
that shared data. For two systems to be
interoperable, they must be able to exchange
data and subsequently present that data
such that it can be understood by a user”
(HIMSS, 2013).HL7 or Health Level Seven
According to Interface, HL7 is by definition “an ANSI
(American National Standards Institute) standard for
healthcare specific data exchange between computer
applications. The name comes from ‘Health Level 7,’ which
refers to the top layer (Level 7) of the Open Systems
Interconnection (OSI!) layer protocol for the health
environment. The HL7 standard is the most widely used
messaging standard in the healthcare industry around the
world” (Interfaceware, 2013).Middleware enables integration of
data between two or more programs,
devices, or information Systems:it
facilitates communication and data
sharing.MATT
aNIntegration engines use HL7 to
characterize their ability to manage all
interfaces. The engines aggregate and
share data regardless of the
transmission protocol. They are
responsible for message routing and
translation.Data can also be transferred through a
device gateway. These are usually
transferred through a central server that
consolidates and collates data and then
forwards the information to the EHR.Medical Device Data Systems (MDDS)
are hardware or software products that
transfer, store, convert formats and
display medical device data, and it does
not by itself control the functions or
parameters of any other medical
devices.Examples of MDDS include:
: Software that stores patient data such as
blood pressure readings for review at a later time
y/ Software that converts digital data generated
by a pulse oximeter into a format that can be printed
. Software that displays a previously stored
electrocardiogram for a particular patientA Class II medical device used-for
active monitoring is utilized in the
aforementioned ICU scenario as the
software that allows the remote
clinicians to review real-time vital signs,
track and review trends, and recognize
changes.The POC solution serves as middleware
where the POC device or component
associates the patient to the medical
device and compiles the information
from the medical device to send to a
server (DiDonato, 2013)POC devices generally link to the
medical device via a wired serial
connection or wirelessly.Periodic or episodic devices are those
that obtain a single set of
measurements from a patient at single
points in time or spot checks (DiDonato,
2014; ECRI Institute, 2012).Examples of common episodic devices
are portable vital sign monitors, glucose
meters, pulse oximetry, and ECG
machines.CONTI ONS
NETWORKEDContinuous devices are divided into
stand-alone or networked devices.
Continuous networked devices are
commonly stationed in a patient room to
treat a single patient over a continuous
time span.CONTI ONS
ST ee TNTContinuous stand-alone medical device
solutions are used to continuously
monitor a single patient over a period of
time but the device is portable and not
hardwired or networked to a vendor-
specific server, thereby requiring a POC
component within the patient room or
attached to the medical device itself.Ay
DEVICE
teenThe linking of the medical device data
with the right patient is referred to as
patient association. There are
historically two approaches to patient
association: patient centric and location
centric (ECRI Institute, 2012).Patient-centric identification involves
associating a medical device with-a
patient based on a unique patient {BD
number, often the patient’s unique
medical record number.In location-centric association
the patient is typically identified
by a location such as a room or
bed.Auto-ID technologies such as bar code
scanning and passive RFID is becoming
increasingly useful and available as a
means to assist with mobility and
periodic device use (McAlpine, 2011).Radio Frequency Identification (RFID) refers
to a wireless system comprised of two
components: tags and readers. The reader is
a device that has one or more antennas that
emit radio waves and receive signals back
from the RFID tag. Tags, which use radio
waves to communicate their identity and
other information to nearby readers, can be
passive or active.USES:
«Inventory control
*Equipment tracking
*Out-of-bed detection and fall detection
*Personnel tracking
Ensuring that patients receive the
correct medications and
medical devicesData are continuously being sent to the
EHR, the nurse must validate which
data are accurate and should be
recorded within the permanent patient
medical record. This process of manual
verification of data and recording them
into the medical record is known as
data validation.Device connectivity solutions were
unidirectional, or the flow of information
was from the medical device to the EHR
only; this is also often referred to as
classic or one-way connectivity.Smart pumps use drug libraries which
allow infusion pumps to perform
functions that assist with programming
and calculating dose and rate delivery
as adapted by a healthcare institution
and to patient care areas (Cummings &
McGowan, 2011).Soft limits can generally be overridden
after a clinician acknowledges a safety
alert whereas hard limits are generally
set for high-risk medications (Cummings
& McGowan, 2011).The clinicians were identified when entering
the room by ultrasound-enabled badges
identifying them to the patient and families.
Each patient room has a patient- and family.
centered screen that can be used to identify
caregivers, provide a schedule of the day
activities for the patient, as well as access
to. view educational programs.The rooms include a direct care touch
screen which aids in documentation
and provides important clinical
attributes such as allergies, labs, and
meds (Cerrato, 2011; Hagland, 2011).Alarms are intended to alert a
caregiver when an immediate or
potentially adverse event occurs or
could occur.Considering our scenario of the patient/in
the ICU, alarms could be emitted not only
from the physiologic monitor, infusion pump;
and ventilators but the nurse must also
respond to call lights, bed-exit devices,
feeding pumps, sequential compression
devices, telephone calls, texts/pages, etc.
(Cvach, 2012).Due to the aforementioned issues, many
caregivers become immune or desensitized
to the alarms and are not as timely to
respond to alarms (Sentinel Event Alert,
2013).Medical device companies are exploring
technology to develop safer and more
effective alarm management. Medical
device vendors are seeking to improve
parameter acquisition techniques as well as
improve alarm and alert designs to reduce
nonclinically significant alarms (ACCE
Healthcare Technology Foundation, 2013).1
aa teHealthcare institutions’ information
systems transmit and store a great
deal of sensitive and protected
information; therefore, mitigating risks
and safely securing the information are
as important as safely caring for the
patient.Device vendors and healthcare providers
must work together to continue development
of automation that will enhance patient care,
safety, and workflows.
When new types of technology or devices
are introduced in the healthcare setting, it
must increase efficiency or adoption will not
occur.From a vendor standpoint, it is timely.and
costly to research and develop devices,
device drivers, and software.
From a structural standpoint, it can be very
costly to add network components after a
structure is constructed so as healthcare
facilities expand or rebuild.SCENARIO REVISTED
The patient recovered from her life threatening
arrhythmic event and is ready for discharge from
the hospital. Due to having a life threatening
cardiac event, she will be discharged with a wireless
home holter monitor and pulse oximetry. A visiting
nurse will visit and download the information from
the holter monitor and oximetry weekly. In the
meantime, the patient will record all her activity,
rest, and recovery.