POINT OF CARE ENGINEERING AND TECHNOLOGY

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CMBEC29


Vancouver, BC; June 1
-
3, © 2006





1

POINT OF CARE ENGINE
ERING AND TECHNOLOGY

Blake W. Podaima,
1, 2, 3

and Robert D. McLeod

2, 3

1.

Virtuistix Inc., Winnipeg, Manitoba, Canada, R2G 0P5

2.

TRLabs,

100
-
135 Innovation Dr., Winnipeg, Manitoba, Canada, R3T 6A8

3.

Department of Electrical and Computer Engin
eering, University of Manitoba
, R3T 2N2

E
-
mail:
Bpodaima@virtuistix.ca
;
McLeod@ee.umanitoba.ca

ABSTRACT

Currently there is a heightened demand for
improvements in patien
t point of care (POC). Errors
and other incidents are inevitable in complex systems,
and hence, the goal of this work is in mitigating
medical errors through the use of technology and
protocols via systems engineering. Over the past
several years there has

been increased emphasis on
the reporting and analysis of POC errors. Some of the
more prominent errors are erroneous patient
identification, drug administration, and medication
administra
tion recording. T
his paper addresses
specific

s
mart Radio Frequency
Identification (RFID)
enabled
technology for improving
patient
POC
.

Keywords
: RFID enabled devices, patient point of
care, adverse drug events, and medical compliance

1. INTRODUCTION

It is estimated that approximately 36% of adverse
drug events occur at th
e patient POC while only
2%
are intercepted
[3]
. In addition to POC errors, there are
other sources of errors including prescription,
transcrip
tion, and dispensing
[1]
. Although this paper
addresses

specific technology for improving POC, it is
recognized that any effective system will need to be
integrated within the context of a complete patient care
management system.

The benefits
to

modernization
of health
management
through
information
technology

are often
easil
y seen only once adopted
[2]
.
A
n electronic
records system

(ERS)
introduces consistenc
y into the
process and
with sufficient standards

decreases errors
in information gathering

[4]
.
Practitioners

like the fact
that if

they write a prescription


the

prescription is
auto
matically recorded
.
Furthermore, their
PDA
software
can

refer to the system’s database and list
any
potential
interactions between the prescribed
medication and other m
edications

that the patient may
already be taking
.

Advancements in information and communication
technology
(ICT)
and their adoption in health
care
ne
cessitate a “s
ystem

s

a
pproach.”

System

s
approaches include human factors engineering
(HFE)
as well as tec
hnology engineering
[12]
. HFE
attempt
s

to identify s
ituations that give rise to human

errors and
implement

“system changes”

to reduce their
occurrence and min
imize their impact on patients.

This
perspective
,

which strives
to ca
tch human errors
before they occur
,

or block them from causing harm
,

is
argued to be more effective
and realizable
than
attempting to create

an error free or flawless system
[5]
.
In this regard
,

technology engineering can be us
e
d
in conjunction with HFE

to improve the accuracy and
efficiency of protocols and practice with a similar
objective of reducing errors

[11]
,

[21]
. Systems
E
ngineering implies the increased use of t
ools such as
those for failure mode and effects analysis and root
cause analysis (FMEA and RCA)
[14]
.

There are a number of
mobile devices and
wireless communication
technologies that will play a
major role in moderni
zing medic
al and health systems

[19]
.
Security is also an issue that
needs to be
addressed thoroughly and implement
ed properly to be
effective as Clinical Grade N
etworks are developed
and deployed
[10]
.

2. SM
ART RFID
IN HEALTHCARE


Smart”
RFID
(
devices
) is

another technology that
has

the
potential to improve
patient
safety and quality
of
care. Promising technologies and methodologies for
improving
patient
POC and reducing errors include
those based on barcodes

and
RFID

[15]
,

[16]
. These
technologies are not new and have been in
commercial use for well over twenty years. They

are
however becoming more main
-
stream as both
supporting electronic technology i
mproves and
connectivity
protocols become standardized

[8]
. One
of the problems with early adoption of both RFID
and
barcodes is that they are inherently submissive
,

allowing for identification with little or no support for
int
eractivity and automation.

Conventional

applications of RFID technology
in
healthcare
are
primarily
those based upon
identification. These enable systems to be built around
inventory tracking a
nd control.
Extensions

include
pharmaceutical supp
ly chain inve
ntory and tracking for
medical reconciliation.

Tied into a hospital
management system
,

they

have considerable potential
to reduce
adverse drug events at the patient POC.

This is accomplished through

corroboration of the
patient ID with the drug prescribed
by the physician.

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Figure
1
: Medical Compliance Platform


POC
Interaction Components

This paper presents
an overview of RFID
technology within a medical context and introduces
novel designs

using enhanced RFID devices
(system
a
nd methodology) for

integration within
evolving

and
leg
acy POC systems.
Figure

1 illustrates a conceptual
overview of the point of care interacting components
within the medical reconcil
iation and compliance
platform.

A smart

medical device

and its
system
of
deployment
include

methods of identification and
control

for medical compliance
. Identification is
accomplished with the aid of RFID
,

while control is
enabled through a mechanism that can be activated to
prevent improp
er or unauthorized access.

Smart RF
ID
devices attempt to facilit
ate error
-
free
dispensing and
administration
(
of medication and/or
medical supplies
), and other
clinical practices,

to
reduce
or prevent
adverse medical events,
near
misses, or sentinel events.
They

incorporate an RFID
enabled
electromechanical lock o
r latch controlling
access and
include
smart medical containers
,
smart
pumps
,

smart clamps
,
smart valves
,

smart syringes
and pipettes
, and
smart
bandages

.

The RFID tags
on
these

devices can be eithe
r active or passive, and the
cont
rol and

communication can be derived from the
interaction of an RFID reader and tag in conjunction
with the associated electronics and overseeing
medical information management system.

RFID enabled devices come with an associated
overhead, but are not supe
rfluous in deployment, an
d
can be used within the framework

of an engineered





Smart Devices under development at
Virtuistix I
nc.




http://www.virtuistix.ca

POC system

[9]
,
[17]
. The designs discussed here
in

offer seamless integration with purposeful function,
and an evolutiona
ry path to improved overall medical
compliance.

Future RFID devices will ext
end beyond traditional
uses


ev
en the “smart”

applications discussed here.
Such

RFID devices will incorporate various sensors
and will be widely a
vailable as implantable devices
[18]
.

3
. RFID
METHODOLOGY

RFID te
chnology utilization is gaining momentum
and is being tailored to a number of applications
.
Although there are a
variety

of RFID

tags and

systems
,

those best suited to health
care have a
number of

di
fferentiating characteristics.
More
specifically
,

an RFID transponder
or tag
in a medical
application will require data capacities that range from
a few b
ytes to several kilobytes. In contrast
,

there are
1
-
b
it transponders which
provid
e information only

on

their presence
. Although inexpensive
,

and likely to be
widely applied in commercial environments
,

they are
less likely to find mu
ch utility in a health setting.

RFID transponders that allow for sufficient data
require an integrated circuit and have mor
e stringent
power requirements.
This power can be derived
through an

interrogating
electromagnetic

field

of a
n
RFID R
eader
, or supplied by a
n on
-
board battery.
Typically
,

an RFID transponder

will interact w
ith a
reader in one of two ways:

either sim
ultaneo
usly
interacting (with a

reader
)

over a modulated channel
,

or in a sequential manner
,

where the reader switches
off the interrogating field allowing for the transponder
on the tag to respond during a quiescent period.

In addition

to requiring data storag
e
, a health
related RFID system

will also require security beyond
that found in many commercial applications. Security
protocols and their processing imply an additional
constraint upon the energy requirements of the RFID
device

itself
.
M
any medical RFID de
vices will
also
be
required
to interact with a sensor, activate

a
solenoid
or motor

(
or other electromechanical device
)

thereby
increasing the power requirements still further.

Medical RFID devices could also be

programmable and reusable.
The reuse implies

an
additional cons
traint that may require the device

to be
subject to
temperature,
chemical
,

and/
or electronic
processes
,

not otherwise needed in less sterile
environments.
As with other medical devices,

Clinical
G
rade
Smart
M
edical
R
FID devices
will be r
equired
to
meet the stringent standards of various governing
bodies and institutions of

the health
care

industry.
Clinical grade RFID devices will also be required to
meet rigorous EMI and EMC (electromagnetic
interference and compatibility) guidelines
[20]
.

Pharmacy

Hospital

Information

System

Central Medical

Processing

Unit

Disposal +

Sterilization

RFID

Reader

Patient

(RFID)

Overseeing

Physician

(RFID)

Smart Medical Device

Medical

Content/

Apparatus

RFID +

Interface

(RFID)

Care

Provider

Mobile PDA

RFID

Reader

Central Medical

Supply Unit

RFID Reader

RFID Reader

Monitoring

Preparation

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The frequency of operation for RFID devices fall
into several broad ranges
reflecting that of the reader.
These range from RF (MHz) to microwave (GHz). The
physical
operating proximity

of devices is also an
important issue in

a medical setting. It i
s likely that
close coupling (<
1
cm) would contravene the existi
ng
protocol of a POC

practitioner
. Remote coupling (0
-
1
m) would allow for the functionality of the RFID
device without compromising the
protocol of the
practitioner who
may be wearing the reader
/

transceiver

on his or her

wrist or

belt.

4
.
SMART RFID
DEPLOYMENT

For the purpose of discussion here
,

we will
introduce a
n

RFID smart device and its
method

of
deployment
.
The
following “Smart Valve”
extends

the

basic valve princi
ple however
it
offers much greater
capability and purpose by including
an RFID

tagging
device and
microcomputer
interface with bi
-
directional
communication.
The capability therein incorporates a
controller that authorizes the operation of a manual or
autom
atic mechanical valve with lockable
-
latch and
pinch
-
off regulating mechanism



thereby modulating
flow through a

tube
.
T
he smart valve incorporates an
RFID tag and accompanying interf
ace (
in situ

and/or
external)
in

a method and system to control the
mecha
nical operation of a valve: i) manually enabling
or precluding an instance of user operation of the
valve regulating mechanism; or ii), automatically
enabling or precluding an instance of
power assisted
(e
g., ele
ctromechanical)
operation of the valve
regul
ating mechanism. Hence,
in addition to facilitating
flow by activating a

valve regulating mechanism
(opening, closing, or modulating), this smart valve

assembly

incorporates a lockable
-
latch which will
prevent unauthorized, erroneous, or in
advertent
operat
ion
. In the field, information will be available as
to the status of operation (metrics, performance),
maintenance, and serviceability

(replacement)
.

The RFID smart valve can be identified with an
RFID reader (in the manifestation of a mobile or
stationary

communicating electronic computing device)
and used to “interrogate” valve status. The
communication and electromechanical control can be
derived from the interaction of the RFID tag (and
associated electronics) and the RFID reader


and, in
some instance
s, an overseeing information
management system. Upon identification,
corroboration, and authentication,
t
he interrogating
RFID reader could be used to activate or preclude the
latch and/or pinch
-
off re
gulating mechan
ism.

In effect, the smart valve assembly
, method and
system, is used for both identification and as a means
of control for the enabling or preclusion of flow through
a passageway. The manual user operated valve pinch
-
off regulation mechanism inherently offers a high
degree of application flexibi
lity and simplicity in design
without necessarily compromising functionality. This
approach can therefore be particularly attractive in
many instances since it may well capitalize on a
concomitant reduction in overhead, ease of fabrication,
and increased m
echanical reliability. On the other
hand, offering an automatic RFID triggered valve
pinch
-
off regulating mechanism offers the potential for
ease of field deployment and robustness.
This
implementation, as shown in Figure

2
,

incorporates an
electromechanic
al solen
oid

(latch) and

servo
(
motor
)


acting upon a shaft

fixed to a plunger in the form of
a gate

or
cylinder

in a sealed housing or chamber.

Conduit
RFID
Electronics
Electromechanical
Cylinder Valve
Power
Supply
(Valve shown with
throughway open)
Override
Key
Port 1
Port 2
Port 3
Port 1
Port 3
Port 2 (into the
page) not shown
Top
View

Lock/Unlock
Mechanism
[Rotary]

Figure
2
:
Smart
Stop
-
cock Valve (multiport)

There are several in
-
field embodiments of design
pertaining to th
e definitive actuation or modulation of a
smart valve pinch regulating mechanism

(plunger)
: in
one mechanical instance of operation, the smart valve
would simply provide a visual or au
dio status indicator
approving/
disapproving the manual operation

of the
valve regulating mechanism; in another mechanical
instance of operation, the smart valve could physically
unlock a latch mechanism that would permit the
manual operatio
n

of the valve regulating mechanism;
finally, in an electromechanical instance of operat
ion,
the smart valve could physically unlock a latch
m
echanism and provide the actual electromotive force

that would automatically modulate (drive) the valve
regulating mechanism
.

Used in a medical setting,
an RFID smart valve

can

be
deployed
to safely gat
e the release of a fluid as
would be th
e case for Intravenous (IV) or I
nfusion
Therapy.
Furthermore, t
he
RFID smart valve

can

be
used in conjunction

with other RFID devices or tags as
part of an IV administration set
.
This will
,

in
e
ffect
,

facilitate
the m
eans for
medical compliance between

patient RFID, IV RFID, and/or RFID devices used to
sense the rate of drug delivery

[6]
.

By incorporating
i
ndic
ators
(sensors) on the devices
, an RFID reader
can
pole the set and determine the

o
perational efficacy

of the system
.

In another instance of deployment, the
smart valve can be used in
the
handling, preparation,
or management, of
various
pharmaceuticals. Where
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4

regulation and safety standards necessitate proper
handling and mixing protoc
ols, as such, the smar
t
valve could be used in a myriad of

medica
l settings
.

In general,
smart devices can also include
auxiliary sensor information and memory that can be
communicated to the RFID reader or vise versa, and if
necessary, up through the info
rmation management
hierarchy for re
-
programming, time stamping, data
collection, and/or (re)
-
evaluation. This sensor based
acquisition can include information such as
temperature, pressure, flow rate, viscosity, humidity,
chemistry, Ph, etc.

The described
method and system can be
envisaged
to function
within a ubiquitous or p
ervasive
computing environment. In this manner, small
embedded computers would respond to one’s
presence, desires
, and needs, without the health
care
provider necessarily being solely re
sponsible for all
active manipulati
on within one’s environment. A
n
etwork of fixed and wireless devices would allow for
context aware communication

[7]
,
[13]

so as to
seamlessly integrate the health
care provider’s
intentions and even perform tasks automati
cally. This
will rid the health
care provider of the more mundane
and arduous tasks freeing up time necessary to focus
on the primar
y task at hand. T
heir work
should be
made easier
,

while the
ir prese
nce is more transparent.

H
ence
,

this makes

for a less intrusive and in
vasive
practice,
while

delivering
an
improved
quality of
health
care.

5
.
CONCLUSION

This paper outlines a number of areas where POC
engineering and technology are brought to bear on the
m
edical community with the overall goal of improving
patient safety and quality of care. We ascertain the
emerging field of RFID technology has the potential to
improve medical compliance via human factors
protocols and practice at the patient POC. Within a

ubiquitous or pervasive health computing environment,
novel RFID smart devices
,

in conjunction with wireless
PDAs,
are proposed integrating identification, security,
control, and actuation. Various
POC
embodiments
along these lines are currently under dev
elopment.

ACKNOWLEDGEMENT
S

We wo
uld like to extend our thanks

to
Wayne
Johnston,
Dr.
David Gregory

from the F
aculty of
Nursing

at the University of Manitoba
,

and
(
Vasee
)

T.

Vaseeharan

of TRLabs
-
Winnipeg, for their beneficial
comments and insights.

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