U.S. patent application number 11/978990 was filed with the patent office on 2008-09-25 for tracking surgical implements with integrated circuits.
Invention is credited to Bruce Levin.
Application Number | 20080231452 11/978990 |
Document ID | / |
Family ID | 46279022 |
Filed Date | 2008-09-25 |
United States Patent
Application |
20080231452 |
Kind Code |
A1 |
Levin; Bruce |
September 25, 2008 |
Tracking surgical implements with integrated circuits
Abstract
A system and method of tracking medical products provides for
associating a group of medical products with a group location based
on a group radio frequency identification (RF ID) device signal,
where the group includes a first unit and a second unit. The first
unit is associated with a first remote location based on a first
unit RF ID device signal. The method further provides for
associating the second unit with a second remote location based on
a second unit RF ID device signal. The signals uniquely identify
the units and the group.
Inventors: |
Levin; Bruce; (Philadelphia,
PA) |
Correspondence
Address: |
LAW OFFICE OF MORRIS E. COHEN
1122 CONEY ISLAND AVENUE, SUITE 217
BROOKLYN
NY
11230
US
|
Family ID: |
46279022 |
Appl. No.: |
11/978990 |
Filed: |
October 30, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11824281 |
Jun 29, 2007 |
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11978990 |
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11048339 |
Jan 31, 2005 |
7256696 |
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11824281 |
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10106183 |
Mar 27, 2002 |
6861954 |
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11048339 |
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09883991 |
Jun 20, 2001 |
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10106183 |
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60280206 |
Mar 30, 2001 |
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Current U.S.
Class: |
340/572.1 |
Current CPC
Class: |
A61F 13/44 20130101;
G06K 17/00 20130101; A61B 90/98 20160201; G06K 17/0029 20130101;
G06K 17/0022 20130101; A61B 90/90 20160201 |
Class at
Publication: |
340/572.1 |
International
Class: |
G08B 13/14 20060101
G08B013/14 |
Claims
1. An assembly comprising: a first unit of one or more products
including a first unit radio frequency identification (RF ID)
device; a second unit of one or more products including a second
unit RF ID device; and a packaging combining the first and second
units together into a group, the group including a group RF ID
device including information usable to identify at least one of the
first unit and the second unit.
2. The assembly of claim 1, further comprising: a first
supplemental RF ID device removably attached to the first unit; and
a second supplemental RF ID device removably attached to the second
unit.
3. The assembly of claim 2, wherein the first and second
supplemental RF ID devices are configured to be reattached to
another item.
4. The assembly of claim 3, wherein the another item is at least
one of a medical container, a patient chart, an IV apparatus, an
injection apparatus, and a patient bracelet.
5. The assembly of claim 1, wherein at least one of the first unit
RF ID device is integral with the first unit and the second unit RF
ID device is integral with the second unit.
6. The assembly of claim 1, wherein at least one of the first unit
and the second unit are medical products.
7. The assembly of claim 1, wherein the first unit and second unit
include at least one of: (a) a pharmaceutical product, (b) a blood
product, and (c) a tissue product.
8. The assembly of claim 1, wherein the first and second RF ID
devices include at least one of source data and unit number
data.
9. The assembly of claim 1, wherein the information itself directly
identifies both the first unit and second unit.
10. The assembly of claim 1, wherein at least one of the first RF
ID device, second RF ID device, and the group RF ID device include
information usable to determine at least one of: (a) an origination
point of at least one of the first unit, the second unit, and the
assembly, (b) verification information regarding at least one of
the first and second units, (c) the identity of an intended
recipient of at least one of the first unit, second unit, and the
assembly, (d) drug indications, (e) drug contra-indications, and
(f) drug interactions.
11. The assembly of claim 1, wherein at least one of the first RF
ID device, second RF ID device, and the group RF ID device include
information usable to determine verification information, regarding
at least one of the first and second units, including data
indicating the authenticity of at least one of the first unit and
second unit.
12. The assembly of claim 1, wherein the group RF ID device
includes information usable to determine the number of units
contained in the packaging.
13. The assembly of claim 1, wherein the group RF ID device further
includes all information on the first RF ID device and the second
RF ID device.
14. The assembly of claim 1, wherein at least one of the first and
second units are pharmaceutical products and at least one of the
first RF ID device and the second RF ID device include information
usable to determine at least one of: (a) drug-type data, (b)
drug-name data, (c) drug formulation data, (d) interaction data,
(e) dosage data, (f) expiration data, (g) batch number data, (h)
indication data, and (i) contra-indication data.
15. The assembly of claim 1, wherein at least one of the first RF
ID device, the second RF ID device, and the group RF ID device are
configured to emit a signal when a predetermined date is
reached.
16. The assembly of claim 1, wherein at least one of the first RF
ID device, second RF ID device, and the group RF ID device include
information usable to determine at least one of: (a) blood donor
data, (b) blood type data, (c) antigen data, and (d) antibody data.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 11/824,281 filed Jun. 29, 2007, which is a
continuation of U.S. patent application Ser. No. 11/048,339, filed
Jan. 31, 2005, which is a continuation of U.S. patent application
Ser. No. 10/106,183, filed Mar. 27, 2002 and issued as U.S. Pat.
No. 6,861,954, which is a continuation-in-part application of
abandoned U.S. patent application Ser. No. 09/883,991, filed Jun.
20, 2001, which claims the benefit of U.S. Provisional Patent
Application Ser. No. 60/280,206, filed Mar. 30, 2001.
FIELD OF THE INVENTION
[0002] The present invention relates to devices, labels, methods,
and systems to monitor and track medical implements and products
containing integrated circuits. Specifically, embodiments of the
present invention relate to preventing these medical implements
from being inadvertently left within a human or animal following
completion of medical procedures. In addition, embodiments of the
present invention are meant to decrease errors resulting from
sub-optimal production, processing, distribution, and
administration of medical products, including but not limited to
pharmaceuticals and blood products. Embodiments of the present
invention also pertain to managing medical products, medical
devices and disposables, such as medications, blood, and tissue
products, and more particularly to the use of electronic means such
as radio frequency identification (RF ID) devices to assist in the
management process from point of origin to end use.
BACKGROUND OF THE INVENTION
[0003] During surgery it is necessary to place surgical implements,
such as sponges, scalpels, needles, gauzes, and the like near or
into a wound cavity. Even though thorough manual counts are
conducted following the completion of surgery, this method is time
consuming, tedious and error prone. Indeed, surgical implements are
too frequently left inside patients resulting in complications
including trauma, pain, infection or death.
[0004] A number of conventional methods exist to make sure that all
surgical implements have been removed from a patient, but all have
drawbacks. The most well known method is to use X-rays. In this
procedure, the surgical implements have radio opaque material
embedded within them. Following the completion of surgery and
suturing of the patient, an X-ray machine is moved over the patient
and an X-ray is taken of the wound area to determine whether radio
opaque materials are present in the patient. However, some
materials may be too small to be easily seen on X-ray, or they may
be otherwise obscured by bone or tissues within radio dense areas.
If any surgical implements are found on the X-ray within the
sutured area, then the patient is reopened to retrieve the retained
materials. This way, implements left within a patient are removed.
However, each time this procedure is performed, expensive operating
room time is wasted and other patients may have their surgeries
delayed. Furthermore, the patient is subjected to more anesthesia
time and otherwise unnecessary radiation.
[0005] Another method suggested by U.S. Pat. No. 4,193,405 to
Abels, detects a radio-frequency ("RF") transponder embedded in a
surgical sponge. In this method, tagging of surgical articles with
ferrite or other semiconductor material is done such that when they
are exposed to two selected frequencies the material will resonate.
This resonance can then be detected by a RF receiver. However, this
method merely relates to a transponder, no data is recorded as to
type of object, time rank of object, nor does it allow for master
categorization which would alert the user that an object is in fact
missing, even in the absence of a detected failure. Hence, this
level of safety is easily breached.
[0006] In U.S. Pat. No. 4,658,818 to Miller, a miniature
battery-powered oscillator is attached to each surgical implement
and activated prior to its initial use. The output of each
oscillator is in the form of a low powered pulse which is coupled
to the body's fluids and tissue. After the surgery is completed,
but prior to suturing, a detection system is used to sense for any
pulses generated within the body. However, this system also does
not provide information as to object type, rank timing or master
categorization, and merely serves as a pulse alarm.
[0007] Another system that has recently been devised is disclosed
in U.S. Pat. No. 5,931,824 to Stewart. This system is drawn to
placing machine-readable information on individual surgical
sponges. In addition, each sponge has X-ray detectable material
embedded within it. This system requires that each sponge is
scanned which is tedious, and allows for neither non-orientational
registration nor perimeter scanning.
[0008] Additionally, sub-optimal logistics result in medication and
other errors, which have resulted in significant morbidity and
mortality.
[0009] Furthermore, tracking and distributing medications and blood
or tissue products from their points of origin to their appropriate
administration to patients requires a very major commitment of
dedicated resources to maintain acceptable safety and efficiency.
Unfortunately, commonly utilized methodologies can be expensive,
wasteful, and potentially hazardous as they rely heavily on human
input and require sustainable levels of efficiency that may be
unrealistically high. As any breach of vigilance resulting from
suboptimal visual or other input, stress, fatigue, repetition or
distraction can have dire consequences at multiple points, risk
exposure is significant. Medications may be poorly tracked leading
to shortages in inventory or inappropriate use of outdated
medications. Inappropriate formulations or concentrations of drug
may be found in improper locations in the hospital, clinic or other
patient care facility and this can result in improper dosing.
[0010] Furthermore, allergies or other adverse medication
reactions, as well as hazardous drug interactions may go
unrecognized or ineffectively addressed by patient care providers
or other ancillary medical staff. Blood product preparation is an
expensive and complex endeavor and current procedures for tracking
blood products at the point of collection through the point of
distribution can be suboptimal. Additionally, the procedures can be
subject to hazard as human error at several points can lead to
fatalities. For example, one concern is the potential for busy
clinicians to misread one or more of a series of numbers and
letters on a patient ID bracelet or unit of packed red blood cells
during a severe bleeding episode in an operating room. Hence, there
is a need for effective and safe methodologies for tracking
medications and blood and other tissue products from the point of
production to the point of administration.
[0011] A number of tracking devices have been well documented. For
example, U.S. Pat. No. 6,130,613 shows a radio frequency
identification stamp (10) having a substrate (24) with a first
surface (12) and a second surface (18). The first surface (12) is
printed with indicia indicating at least a postage value. An
antenna (16) is formed on the second surface (18) and a radio
frequency identification circuit chip (20) is secured to the second
surface (18) and coupled to the antenna (16). A layer (22) of
adhesive is also disposed on the second surface (18). A mailing
label (600) includes indicia (614) printed on a first surface, and
an antenna (616) coupled to a radio frequency identification
circuit chip (620) on a second surface (618). A layer (622) of
adhesive covers the second surface. The layer bonds the circuit
chip (620) to the second surface and couples the circuit chip (620)
to the antenna (616). The circuit chip (620) may retain a tracking
number, and more preferably, retains sender information (601),
recipient information (602), service type information (603) and
billing instructions (604).
SUMMARY OF THE INVENTION
[0012] The present invention provides devices, methods, and systems
that monitor and track medical materials, including surgical
implements.
[0013] In an embodiment of the present invention, a surgical
implement including at least one integrated circuit that uniquely
identifies the surgical implement by a unique identifier is
provided.
[0014] In another embodiment of the present invention, a method for
monitoring and tracking surgical implements is provided. The method
includes identifying at least one surgical implement including an
integrated chip, where each surgical implement is uniquely
identified. Another method of the present invention provides for
monitoring and tracking medical materials. This method includes
uniquely identifying at least one medical material by a unique
identifier, each medical material including at least one integrated
circuit having the unique identifier programmed therein and
monitoring each medical material by its unique identifier. In
another embodiment of the present invention, a method for
monitoring surgical implements in conjunction with a surgical
procedure is provided. The method includes initializing at least
one surgical implement where each surgical implement includes an
integrated circuit, registering the surgical implement prior to a
surgical procedure by programming a unique identifier in the
integrated circuit, and accounting for the surgical implement at
the completion of the surgical procedure by receiving the unique
identifier from the surgical instrument.
[0015] The present invention also includes systems. In one
embodiment of the present invention a system for monitoring and
tracking surgical implements is provided. The system includes at
least one surgical implement, each surgical implement including an
integrated circuit that stores a unique identifier of the surgical
instrument and a detector that detects the surgical implement by
detecting the unique identifier from the integrated circuit.
Another embodiment of the present invention includes a system for
monitoring and tracking surgical implements including at least one
surgical implements, including at least one integrated circuit and
a sensor for sensing the surgical implements based on a signal
received from each integrated circuit. In another embodiment of the
present invention, a system for monitoring surgical implements used
in conjunction with a surgical procedure is provided. This system
includes at least one surgical implement comprising an integrated
circuit, the integrated circuit associating a unique identifier
with each of the surgical implements and emitting a signal
containing the unique identifier, a detector that detects the
signal emitted by the surgical implement, and an output device to
process information provided by the detector. The present invention
also provides another embodiment of a system, including at least
one surgical implement comprising an integrated circuit, the
integrated circuit associating a unique identifier with each of the
surgical implements and emitting a signal containing the unique
identifier, a platform with a detector that detects the signal and
determines a placement and removal of each of the surgical
implements from the platform based on the detected signal, and an
output device that receives and processes information provided by
the detector. Another embodiment of the present invention provides
a system for monitoring patients including at least one medical
material, each medical material including a first integrated
circuit, at least one patient identification tag, each patient
identification tag including a second integrated circuit, and a
sensor that monitors the medical materials and patient
identification tags based on signals received from the first and
second integrated circuits.
[0016] The present invention also provides a medical label
including at least one integrated circuit, where the integrated
circuit uniquely identifies a medical product the medical label is
attached to. In another embodiment of the present invention, a
blood product label is provided, which includes a label attached to
a blood product, the label including at least one integrated
circuit that uniquely identifies the blood product. The present
invention also provides a blood product container including the
blood product label. Finally, the present invention provides
medical product including at least one integrated circuit that
uniquely identifies the medical product by a unique identifier.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] FIG. 1 shows a block diagram of the sensor system and two
integrated circuits to be used in surgical implements.
[0018] FIG. 2 shows a block diagram of the sensor system and two
integrated circuits to be used in surgical implements.
[0019] FIG. 3 shows an embodiment of a database table for the
sensor system.
[0020] FIG. 4 shows an embodiment of a database table for the
sensor system.
[0021] FIG. 5 shows a flow chart of registration instructions for
the sensor system.
[0022] FIG. 6 shows an embodiment of the sensor system in a patient
ID bracelet and integrated circuits in blood bags and syringes.
[0023] FIG. 7 shows a diagram of an example of a medical product
infrastructure utilizing an assembly of medical products in
accordance with one embodiment of the invention.
[0024] FIG. 8 shows a diagram of an example of a health care
facility utilizing an assembly of medical products in accordance
with one embodiment.
[0025] FIG. 9 shows a flow chart of an example of a method of
tracking medical products in accordance with one embodiment of the
invention.
DETAILED DESCRIPTION
[0026] Embodiments of the present invention relate to methods,
devices, labels, and systems for monitoring medical implements
products containing integrated circuits, microchips, or Radio
Frequency Ids (RFID). Prior to a medical procedure, each of the
implements to be used is registered with a sensor system such that
the implement is uniquely identified. Following the medical
procedure, each of the implements that was registered is then
accounted for.
[0027] FIG. 1 shows an example of one embodiment of the present
invention. Like elements are labeled with like numbers. In FIG. 1,
two surgical implements 10 and 11 are shown and a sensor system
100. Surgical implements, as used herein, include, but are not
limited to, sponges, needles, scalpels, gauze, forceps, and
scissors and the like.
[0028] Also, the scope of the term surgery or surgical is not to be
limited, but should include all types of medical procedures and is
used herein interchangeably with the term medical.
[0029] In FIG. 1, surgical implement 10 includes an integrated
circuit 20, and surgical implement 11 includes an integrated
circuit 21. The integrated circuit 20 includes an analog front-end
50, which could, for example, be a LC circuit; a memory 40; and a
controller 30. In the memory 40 of surgical implement 20 there can
be stored a programmable surgical implement identifier 65. This
programmable surgical implement identifier is used as a unique
identifier for each surgical implement. This particular
illustration is but one example of how the present invention could
be practiced and is not meant to limit the scope in any way.
[0030] The integrated circuits 20 and 21 are powered through radio
frequency ("RF") signals generated by the sensor system 100.
However, the integrated circuits may also be powered by any known
source of energy, including, but not limited to, a battery,
exposure to air, moisture, certain chemicals or substances, changes
in temperature, pH, or motion. Additionally, the integrated
circuits may be powered by induction, EMF, other radiation or by
the potential, chemical, or electrical gradients, or micro-electric
currents of the body.
[0031] The integrated circuits 20 and 21 are encapsulated in
plastic and then incorporated into surgical implements. Generally,
the integrated circuits are incorporated into each of the different
surgical implements or materials natively. Therefore the integrated
circuits are incorporated in such a way as to be encapsulated,
hermetically sealed, flexible, heat, shock and water resistant and
sterilized or sterilizable. The integrated circuits are also
incorporated in a manner that does not impede or hinder the normal
function of the medical implement. Because the surgical implements
include many different instruments, incorporation of the integrated
circuits into each different implement needs to be individualized
to that implement and this can be done by those of skill in the
art. Also, the integrated circuits can be incorporated into or
structurally associated with x-ray opaque material.
[0032] FIG. 1 also shows a sensor system 100. The sensor system 100
includes a processor 120, a memory 130, and a transmitter 110. The
memory 130 of the sensor system includes registration instructions
135 and registration data 140. The processor 120 can be a
Pentium.RTM. III manufactured by Intel of Santa Clara, Calif., an
Application Specific integrated circuit ("ASIC"), a
microcontroller, etc. The registration instructions 135 will be
explained more fully with reference to FIG. 5 and the registration
data 140 will be explained more fully with reference to FIG. 3 and
FIG. 4. The sensor system 100 may also include an interface
consisting of a computer terminal or terminals (not shown). In
addition, there may be additional auxiliary sensory systems used in
conjunction with the main sensor system throughout an operating
room. Operating room as used herein, includes, but is not limited
to, an operating theater, an operating room, an operating suite, or
any other room where surgery or any invasive procedure of any type
is performed on humans or animals.
[0033] One example of an integrated circuit and corresponding base
station that a person of ordinary skill in the art could use to
practice the present invention is TEMIC Semiconductors TK5552
transponder integrated circuit and base station, as described in
TEMIC Semiconductors, "TK5552", Rev. A4, 26, Apr. 2000, which is
hereby incorporated by reference, in its entirety. TEMIC
Semiconductors' TK5552 integrated circuit transponder is a
programmable read/write transponder with an operation range of up
to 10 cm powered by a RF field generated by the base station.
[0034] Other embodiments of the integrated circuit can be made of
molecular switches using nanotubes as wires, such as described by
Rotman in "Molecular Computing" Technology Review 103: 52-58
(May-June 2000), or molecular conductors such as benzine dithol as
described by Reed et al. in "Computing with Molecules" Scientific
American, 282: (June 2000), both of which are hereby incorporated
by reference in their entirety.
[0035] In addition, the integrated circuit can be a RFID. The RFID
may be readable only or readable and writeable. One example of an
RFID that could be used in the present invention is disclosed in
U.S. Pat. No. 6,249,227, hereby incorporated by reference, in its
entirety.
[0036] Embodiments of the present invention relate to tracking and
monitoring surgical implements. To that end, as can be seen in FIG.
1, data is read and written to and from the sensor system 100 and
integrated circuits 20 and 21. The sensor system 100 assigns the
programmable surgical implement identifier 60 to the surgical
implement 10 and surgical implement identifier 61 to surgical
implement 11 while collecting various data to compile the
registration data 140 in the sensor system 100 and memory 130.
[0037] An example set of registration instructions 135 stored in
the memory 130 of the sensor system 100 is shown in FIG. 5. In the
first step 200, the sensor system 100 scans a first surgical
implement and receives the surgical implement identifier of the
first surgical implement. At step 210, the surgical implement
identifier of the first surgical implement is stored in the
registration data 140 in the memory 130 of the sensor system 100 in
a first data record. In step 220 the sensor system 100 scans a
second surgical implement and receives a surgical implement
identifier of the second surgical implement. At step 230 the
surgical implement identifier of the second surgical implement is
stored in a second data record in the registration data 140. In
step 240 the sensor system 100 re-scans the first surgical
implement and re-receives the surgical implement identifier of the
first surgical implement. In step 250 the first data record is
updated based at least in part on the re-received surgical
implement identifier of the first surgical implement.
[0038] The registration data 140 can be a relational database 170
shown in FIG. 3. Database 170 includes records 184-190, which are
accessible using a suitable database management system software.
Each record 184-190 of database 170 contains six fields 172-182.
Field 172 holds the surgical implement identifier, which can be any
unique identifier, for example a number(s), letter(s), a
combination of numbers and letters, a frequency, or the like. In
this embodiment, the memory 40 of the integrated circuit 20 is
programmable, so the surgical implement identifier 60 is
programmable. Therefore, field 172 can be programmed by the sensor
system. Field 174 indicates the initial time of registration, for
example when the sensor system first senses the surgical implement
and is associated with a registration identifier. Field 176
indicates when the given surgical implement was checked out to be
used in a surgery and is associated with a checked-out identifier.
Field 178 holds information about when the given surgical implement
was checked back in following it use and is associated with a
checked-in identifier. Field 180 holds information about the
check-in location within the operating room and field 182 indicates
what the actual surgical implement is, for example, a sponge, a
scalpel, gauze, or the like. This particular arrangement of fields
is but one illustration of how the invention may be practiced. For
example, certain fields can be omitted, additional fields can be
provided, or the arrangement of fields can be changed. For example,
additional fields for the check-in or check-out location can be
added. Also, a field could be added that indicated the count of
each implement. For example, that a particular sponge was sponge
five of twenty-5/20 or that a scalpel was two of five-2/5.
[0039] Each record 184-190 of database 170 associates a surgical
implement identifier with time of check-out and time of check-in.
In addition, other information is associated with each surgical
implement, for example, the actual surgical implement and the
location of its check-in. By compiling this information it becomes
possible to monitor each individual surgical implement.
[0040] FIG. 2 shows a similar embodiment as FIG. 1, except that the
data is only shown being read by the sensor system 100. The memory
40 of the integrated circuit 22 has a pre-programmed surgical
implement identifier 65 as compared to the programmable surgical
implement identifier 60 of FIG. 1, and integrated circuit 23 has a
pre-programmed surgical implement identifier 66.
[0041] FIG. 4 shows database 150, which could be used with the
embodiment of the present invention shown in FIG. 2. Database 150
includes records 160-166, which are accessible using a suitable
database management system software. Each record 160-166 of
database 150 contains three fields 152-156. Field 152 contains the
surgical implement identifier, which is pre-programmed in the
surgical implement. The pre-programmed identifier could be
programmed, for example, in such a way as to indicate the hospital,
the type of implement, the number of the implement, or other
parameters desired to be associated with the implement. This
particular programming is one illustration of how the invention may
be practiced. Field 154 corresponds to a check-in "flag" if the
surgical implement has been taken to be used, while field 156
corresponds to a check-out "flag" when the surgical implement is
brought back after being used. This is a simplified version of the
database shown in FIG. 3.
[0042] Prior to surgery, each surgical implement having an
integrated circuit in it is placed on or near the main sensor
system. The sensor system assigns an individual surgical implement
identifier to each surgical implement and records initial data
(e.g., initial time of registration). In order to make sure that no
unregistered implements are located within the operating room, the
sensor system will note all incomplete implement integrated circuit
data profiles and alert upon such sensing. When the surgery begins
and the surgical implements are used, the sensor system records the
time each surgical implement is checked-out/used. When the surgical
implement is done being used and the surgical implement is replaced
either on or near the main sensor system or in an auxiliary sensory
system, the time and optionally, the location, of check-in for each
surgical implement is recorded. Following surgery, a comparison is
completed of surgical implements checked-out and surgical
implements checked-in and a list is generated to identify which
surgical implements are missing, if any. An output device, such as
a computer can be used to display the list. In addition, an alarm
will sound if any surgical implements are checked-out but not
checked back in from the sensor or the output device.
Alternatively, the sensor system can keep a running comparison of
the surgical implements that have been checked-out and the ones
checked-in. In this manner the sensor system can be programmed to
alert at particular times during the procedure in order to track
the surgical implements throughout the procedure.
[0043] The functions of the sensor system include, but are not
limited to, sensing, tracking, marking, managing, monitoring,
setting, controlling, checking, dating, timing, billing inventory
control and comparing with protocol. When the implements are placed
on, in, or near the main or auxiliary sensor system, each is
detected and assigned a unique and individual identifier by the
associated sensor system. The identifier used herein includes, but
is not limited to, information regarding the product, numbers,
strings of letters and numbers, strings of letters or other codes,
or a frequency. The sensor system and the auxiliary sensor systems
as used herein include, but are not limited to, handheld devices,
perimeter systems, entry/exit systems, tables, trays, shelves or
stands.
[0044] In another embodiment, a backup system could be incorporated
into the surgical implements using a second integrated circuit, or
tag, which would generate an error message when read by a sensor
system if there was a problem with a primary integrated
circuit.
[0045] In another embodiment, the initial assigning of surgical
implement identifiers is performed when the surgical implements
enter the operating room.
[0046] FIG. 6 shows another embodiment of the present invention. A
patient 299 wearing an identification bracelet 300 is receiving
fluids, medication, or blood 318, through tubing 315, intravenously
312. The identification bracelet 300 contains a sensor system 310,
which includes information about the patient 299, including
allergies, medical orders, medication orders, and the like. Each of
the bags 318 and 320 include integrated circuits 317 and 319
respectively, which may be placed directly on the bags 318 and 320
or incorporated into a label and then placed on each bag 318 and
320. The integrated circuits 317 and 319 indicate what is in the
bags, either blood, medication, fluids, etc. Likewise, syringe 325
contains medication and includes an integrated circuit 324, which
indicates what medication is in the syringe 325. If the contents of
bag 320 or syringe 325 are harmful, potentially harmful, or
inappropriate in any way for patient 299, then when the integrated
circuits 319 or 324 come near the sensor system 310 located in the
patient's identification bracelet 300, an alarm/alert (not shown)
will sound. In an alternative embodiment, the sensor system can be
located elsewhere in the patient's room. In addition, more than one
integrated circuit can be located on or around the patient. In
another embodiment one or more integrated circuits can be sensed by
a sensor system and then the associated information from each
integrated circuit is compared to the other or alternatively to
stored information. If the information does not match a given set
of parameters, an alert or alarm will sound.
[0047] In another embodiment of this invention, medical orders,
such as for medical procedures, laboratory studies, or the like,
are tagged with one or more integrated circuits-integral or
removable, and a sensor system is located on or near the patient or
in the patient record, card, chart, or hand held, or other
computing platform. In another embodiment, the sensor system or
sensor auxiliary device is located in the patient identification
bracelet, dog tag, or other suitable appliance.
[0048] The patient sensor system is preprogrammed with patient
information, including, for example, allergies, current
medications, medical problem list, patient requests, consents, date
of birth, name, insurance, next of kin, contact information, and
the like, and may be programmed with status updates or orders. If
an inappropriately tagged blood product or drug is brought in
proximity to the patient, the sensor will trigger an alert or alarm
which can take many forms for easy identification. Similarly, if a
disposable integrated circuit card, for example, a 2'' by 3''
plastic card (i.e. credit card size) in which an integrated circuit
was embedded, for each procedure is generated, should an orderly
carrying this card approach the wrong patient for transport, an
alert will be generated. The integrated circuit can be, for example
a flash memory card or a smart card.
[0049] In another embodiment, a second integrated circuit can be
located in the patient identification bracelet or dog tag. If both
the medical orders and the patient identification bracelet contain
integrated circuits, then the sensor system can monitor and track
whether two integrated circuits move too close together. For
example if the wrong medical orders were about to be placed in a
patient's chart or the wrong medicine was to be given to a patient.
In this embodiment, the sensor system can indicate a conflict
between two integrated circuits visually or audibly. In addition,
an output device, such as a monitor, can display which devices are
in conflict.
[0050] In yet another embodiment of this invention, pharmaceutical
products have one or more integrated circuits attached to the
containers, bottles, bags, or labels which may be integral or
removable for attachment to inventory lists, patient charts or
intravenous ("IV") or injection apparatus as noted above. Remote
sensors on hand held devices, located in cabinets where
pharmaceuticals are stored, or situated elsewhere, can quickly
identify expired or misplaced or otherwise inappropriate drugs.
Effective tracking of inventory with appropriate software is
improved and appropriate ordering, billing and analysis of other
information are enhanced.
[0051] In another embodiment of the present invention, a medical
label includes at least one integrated circuit. The medical label
can also be just the integrated chip. In addition, there can be
more than one label on a given medical product. The medical label
can be used to label any type of medical material or product,
including pharmaceutical products and blood products, for example
as shown in FIG. 6. The medical label can also be placed on medical
containers, such as boxes, boxes that contain medical products,
crates that contain medical products, bottles, ampoules, bags,
syringes, or the like. The integrated circuit within the medical
label can include information about the origination of the medical
product, verification information about the medical product, the
destination of the medical product, what the medical product is,
which patient is to receive the medical product, indications,
contra-indications, interactions, or similar medically or
logistically relevant information. The verification information can
include data that indicates the authenticity of the medical
product. In addition, there can be more than one medical label on a
given medical product. For example, an integrated circuit as
described (either in a label or as the label itself) can be used
and at least one additional label in the form of a written
description of the medical product can be also located on the
medical product.
[0052] In another embodiment where the medical label is used to
label blood products, the integrated circuit can include
collection, processing, storage, distribution, usage, and patient
delivery information. Collection, processing, storage information,
usage and the like can include, information about the blood donor,
the blood type, blood recipient, expiration date, unit number,
antigens, antibodies, logistical information, delivery
distribution, or combinations thereof.
[0053] In addition, the label can have certain physical and
chemical properties. For example, the label can be temperature
resistant, water resistant, shock resistant, and flexible. The
integrated circuit within the label can be hermetically sealed so
that the environmental conditions experienced by the label do not
effect the integrated circuit. For example, such environmental
conditions can include the blood container containing the label
being frozen and then thawed for storage purposes. The blood
products referred to in these embodiments can include, but are not
limited to, whole blood, platelets, packed red blood cells, and
plasma.
EXAMPLE
[0054] A patient is prepped for a surgical procedure and brought
into the operating room. The operating room team comprising, for
example, three operating room nurses, two doctors, and an
anesthesiologist are also present in the operating room. The
operating room nurses are responsible for, among other things,
tracking the sponges, scalpels, gauze, forceps, clamps, and other
medical implements used during the surgery or surgical procedure.
To this end, each surgical implement to be used in this surgery
includes an integrated circuit. As the nurses prepare for the
surgery, they place each of the surgical implements on or near a
sensor system, which is located near to the operating table upon
which the patient lies. This sensor system registers each of the
implements. As each of the implements is registered, the nurses
watch the information appear on a screen of the sensor system,
(e.g., a display of a computer) for each of the implements: 1) what
each implement is; 2) the time the implement is placed on the
sensor system; 3) the place where the implement is being
registered; and 4) a unique identifier assigned to each implement
is shown. Once all of the implements have been registered, the
surgery can begin.
[0055] The doctors begin the surgery and each implement is used in
turn. As each implement is used by the doctors, it is removed from
the proximity of the sensor system. For example, when one of the
nurses hands a scalpel to a doctor, the sensor system senses that
the scalpel has been "checked-out" at a certain time. When the
doctor has finished with the scalpel, a nurse can either put the
scalpel back near the sensor platform it was removed from or place
the scalpel on or near an auxiliary sensor system (e.g., a sharps
container). When, for example, the auxiliary sensor system senses
the scalpel, the scalpel is registered as "checked-in" and the
location and time of check-in is also noted.
[0056] For each surgical implement, each of these steps can be
performed. However, if at the end of the surgery, there are
implements that have not been checked-in, then the sensor system
indicates which implements are missing (e.g., not checked-in). In
addition, prior to the doctors suturing the patient, a nurse checks
the sensor system (e.g., the display of the computer mentioned
earlier). In another embodiment, the sensor system can sound an
alarm to remind the operating room team that there are implements
missing.
[0057] Once the operating room team is aware that there are items
missing and what items are in fact missing by looking at the
information provided by the sensor system (e.g., the display of the
computer again) as to the description of the item, the check-out
time, and the like, a doctor can use an auxiliary sensor system in
the form of a portable sensor system to locate the implement. For
example, if the implement is still within the patient, a portable
sensor system comparable to sensor system 100 but portable in
nature is used to locate the missing implements.
CONCLUSION
[0058] Embodiments of devices, methods, systems to surgical
implements and other medical products, including integrated
circuits have been described. In the foregoing description, for
purposes of explanation, numerous specific details are set forth to
provide a thorough understanding of the present invention. It will
be appreciated, however, by one skilled in the art that the present
invention may be practiced without these specific details. In other
instances, structures and devices are shown in block diagram form.
Furthermore, one skilled in the art can readily appreciate that the
specific sequences in which methods are presented and performed are
illustrative and it is contemplated that the sequences can be
varied and still remain within the spirit and scope of the present
invention.
FURTHER EMBODIMENTS
[0059] Other embodiments of the present invention are directed to
electronic devices and their use for tracking medical products such
as medications, blood, and tissue to improve patient safety. The
embodiments utilize electronic devices including but not limited to
RF ID (radio frequency identification) devices which are attached
to the medical products to assist in their safe production,
distribution, and administration to patients. These devices may be
programmed with information which is pertinent to the proper
identification, routing, and administration of the medical
products. The information may subsequently be read at any time
during the life cycle of the medical product. In a particular
embodiment, the information is routed to computing systems where it
may be processed.
Medications:
[0060] One embodiment of the invention uses RF ID devices such as
labels or tags for medications. The devices may be placed by any
known process on containers, vials, ampules and the like. In one
embodiment, commonly used labeling information is visibly readable
on each label or tag. At the point of manufacture, the labeling
process involves applying one or more labels having RF ID devices
to the unit dose container. Ideally, one or more of these RF ID
devices will be adhesive and removable for subsequent attachment to
IV bags, syringes, patient charts, smart cards and the like. In one
embodiment these devices are very thin, flexible, resistant to
extremes of temperature, moisture, trauma and have a shelf life
greater than four years. The devices may be readable and/or
printable and may, for example, contain certain data which may
include but not be limited to, drug type, name, formulation,
interactions, dosages, expiration date, batch number, location of
manufacturing facility and contraindications. As the individual
unit doses are packaged, each packaged grouping also includes one
or more labels having RF ID devices attached to its larger
subpackage with all the information found in each individual unit
dose and with the number of individual units contained in each
package or subpackage. Hence, a large package or shipment of drug
can have multiple RF ID devices arranged in such a way that each
subpackage is accounted for individually and sequentially with the
RF ID device of larger units accounting for the next level of
smaller units. This pyramid design provides consistency and better
tracking ability as the units are easily referenced to larger
master RF ID units.
[0061] After the application of the devices to the pharmaceutical
products, sensors note the distribution of the products through the
facility and their exit as they are shipped to wholesalers or
distributors, or to healthcare facilities. Appropriate data is
recorded and stored centrally. As the products reach their
destination they are data scanned and this information is again
centrally processed. The products are then routed to the
appropriate final locations, where they are kept in the pharmacy or
sent to patient care areas. While there, essential data is recorded
locally and centrally. The use of scanners, which may be portable
or fixed, within storage cabinets or other fixtures keeps track of
inventory and notes the presence of outdated drugs for easy
disposal. Further, the presence of nonformulary products or
concentrations as well as other inappropriate medications can be
made known to responsible parties in a timely and effective manner.
The presence of an LED, which could be programmed to emit light
when expiration has occurred, or which could be induced to emit
light when an external field is applied to an RF ID device on an
expired drug package, would make identification even easier.
[0062] When an order for drug is received this too can be
programmed electronically such that the correct drug is
automatically selected from a central distribution center or from a
local drug access center. Here, the RF ID device could also assist
in correct drug selection. When the correct package is chosen,
relevant data is recorded for billing, inventory, and related
referencing and for comparison with patient data to avoid allergic
reactions, redundancy, and possible adverse interactions.
[0063] At this point, one RF ID device may be taken from the unit
package and placed on the patient record, chart, or smart card. A
second RF ID device which also has written drug data as to drug
name, date of administration and concentration should be adhered to
a syringe or IV bag. In a preferred embodiment, a smart card,
chart, or ID band would have an RF ID or other device containing
relevant patient history, treatment, orders and other data and
would be updated real-time or on a frequent basis. A
sensor/processor unit compares the data from the ID devices of the
drug and the patient. This helps ensure that compatibility exists
and the therapy is appropriate. In one embodiment, an enabling
signal precedes therapy, and a failsafe signal is generated to
alert appropriate parties that a level of patient safety is
breached. The sensor processor unit can be integral with the
patient RF ID tag, for example on the patient ID bracelet, with the
ability to transmit to a central computer or processor, or it may
be physically separate as a stand alone device or one receiving and
relaying data to a central location. The sensor/processor device
may be linked to central data and computer systems by wireless or
other commercially available means.
Blood/Tissue Products:
[0064] Other embodiments of the invention disclose the use of RF ID
devices in processing and administering blood products and the
transplantation of tissue products to human patients. At the point
of collection, one or more RF ID devices are appended to the
collected blood. Relevant data is encoded on them as to collection
time and date, typing or other essential data, method of viral
inactivation and the like. Alternatively, a radio frequency bar
code may be used. If the blood is fractionated, one or more RF ID
devices are attached to each derived unit of product. This is done
in such a way that all the data contained in the first RF ID
application are contained in all subsequently written RF ID labels
with the relevant new data for the derived products encoded or
written subsequently. Hence, products can be tracked easily back to
the original donor and source. The RF ID devices are able to
withstand the processes required for the preparation of safe blood
products and their derivatives. Hence, the RF ID devices are water
resistant, resistant to physical stresses and the extreme cold used
in the storage of blood products. They generally have long shelf
lives, but this is unnecessary for packed red blood cells.
Encapsulation may be used to add to their durability, and the RF ID
devices can be thin, flexible, adherent and easily removable and
reattachable. One of the series of applied RF ID devices serves as
the master RF ID and is undetacheable except through removing the
RF ID device from the adherent portion allowing its inclusion to a
master database after use. A central sensor is able to distinguish
among the units stored in a single location and individually track
their data. Hence, real-time inventory is achieved.
[0065] When units and products are distributed, their routes and
destinations are noted and recorded. On arrival to a hospital or
other healthcare facility, a sensor confirms their arrival and
records the data. This can be relayed back to the place of origin
for confirmation. Once again, a sensor distinguishes among the many
different units stored in one location and that information is
stored centrally. If other typing is done, that data is added to
the RF ID labels on the appropriate units. When the hospital types
or screens a patient for the receipt of the product, that
information is centrally stored and the chosen units have their RF
ID tags updated and further encoded with that additional patient
data.
[0066] Alternatively, a second series of RF ID tags can be
generated and applied to the appropriate units. Electronic or other
mechanical or functional linkage can be used. When a unit of
product is ordered, the information is recorded centrally. When the
unit of the product arrives at its destination, it is again sensed
and appropriate data is displayed. When the unit is taken for
patient administration, this is noted by the local sensor and
relayed centrally. When the unit is taken to the patient, another
patient specific RF ID, or other device, on a patient ID bracelet,
smart card or chart or nearby allows for comparison between the
patient data and the product data. The sensor/processor can be
integral to the patient specific RF ID device or separate in a
local or central locale as noted above. Before administration,
positive enablement can be achieved. A failsafe mechanism signals
an alarm if any incompatibility is present, providing passive
security. This process facilitates processing, distribution, record
keeping, inventory, billing, and improves patient safety and
decreases product waste.
[0067] FIG. 7 shows an infrastructure 410 in which the principles
described herein can be useful. Generally, it will be appreciated
that throughout the life cycle of a medical product, a number of
entities/facilities may be involved. For example, a source facility
412 such as a drug manufacturer or blood bank may transport the
medical product to a distributor facility 414, where the
distributor facility 414 distributes the medical product to one or
more health care facilities 416. As will be discussed in greater
detail below, each facility maintains a central database 418 of
source data and/or patient, where each database 418 may be accessed
by the other facilities in the infrastructure 410 via network
420.
[0068] By way of example, it can be seen that an assembly 422 of
medical products includes a first unit 424 and a second unit 426.
The first unit 424 of the medical product includes a first unit RF
ID 428, which may be incorporated into a label as discussed above.
The first unit RF ID 428 uniquely identifies the medical product
and the first unit 424. Similarly, the second unit 426 of the
medical product has a second unit RF ID device 430 where the second
unit RF ID device 430 uniquely identifies the medical product and
the second unit 426. It can further be seen that packaging 432 such
as shrink wrapping, box or crate, combines the first unit 424 and
the second unit 426 into a group. Furthermore, the packaging 432
has a group RF ID device 434, where the group RF ID device 434
uniquely identifies the medical product, the first unit 424 and the
second unit 426. It will be appreciated that the medical product
can include pharmaceutical products, blood products, tissue
products, or any combination thereof. It should also be noted that
the group identified by the group RF ID device 434 typically
includes many more units than the two illustrated.
[0069] It will further be appreciated that a first supplemental RF
ID device 436 may be removably attached to the first unit 424,
where the first supplemental RF ID device 436 also uniquely
identifies the first unit 424. This allows the first supplemental
RF ID device 436 to be subsequently reattached to other containers
such as vials, syringes, etc. if the first unit 424 is
fractionated. Similarly, a second supplemental RF ID device 438 may
be removably attached to the second unit 426. The second
supplemental RF ID device 438 uniquely identifies the second unit
426. The supplemental RF ID devices may be applied at the source
facility 412, the distributor facility 414 or anywhere else in the
distribution chain of the medical product.
[0070] As already discussed, the RF ID devices may include source
data and unit number data. In the case of pharmaceutical products,
data may include but is not limited to drug-type data, drug-name
data, formulation data, interaction data, dosage data, expiration
data, batch number data, indication data, cartron indication data,
or combinations thereof. In the case of blood products, data may
include, but is not limited to blood donor data, blood type data,
expiration data, antigen data, antibody data, or combinations
thereof.
[0071] It can further be seen that facilities such as health care
facility 416a may include one more sensing systems 440 in
communication with the RF ID devices 428, 430, 434, 436, 438 and a
central processing unit (CPU) 442. While communication is
illustrated as being implemented via a bus network 444, it will be
appreciated that any appropriate local area networking (LAN),
wireless networking, or other architecture may be used. It can be
seen that the CPU 442 is coupled to the central database 418a and
associates the received data in accordance with any number of
commercially available database approaches.
[0072] Turning now to FIG. 8, health care facility 416a is shown in
greater detail. Specifically, it can be seen that the assembly of
medical products enters the health care facility 416a at receiving
area 446. The group RF ID device 434 is scanned using sensor 448a
in order to log the uniquely identified first unit 424 and second
unit 426 in as being received. This enables unit data and source
data to be associated with any patient data/location data that may
be entered into computing terminal 450a. This information is
transmitted to the CPU 442 for storage in the central database
418a.
[0073] It can be seen that as the units 424, 426 move throughout
the health care facility 416a, the overall system enables tracking
of such movement as well as updating of any relevant patient data.
For example, in the illustrated example, the first unit 424 is sent
to a treatment area 452 and is placed in a pharmaceutical cabinet
454 for temporary storage. Before placement in the cabinet 454, the
first unit RF ID device 428 can be scanned by sensor 448b, where
the treatment area location is associated with the first unit 424.
Additionally, the first unit RF ID device 428 may communicate with
a sensor 448e mounted within the cabinet 454. It can further be
seen that a patient chart 456 has a patient data RF ID device 458.
In the illustrated example, the first supplemental RF ID device 436
may be attached to the patient chart 456 and any conflicts can be
detected and reported as discussed above.
[0074] It can further be seen that second unit 426 is sent to a
pharmacy 460 for storage until an order is placed for the
particular medical product. It can be seen that if the second unit
426 is fragmented to a supplemented container 462, the second
supplemental RF ID device 438 can be attached to the supplemental
container 462 in order to document the fragmentation. Thus, when
the supplemental container 462 is sent to treatment area 464,
sensor 448d and terminal 450d can initiate an update of the central
database 418a.
[0075] Turning now to FIG. 9, a method 467 of tracking medical
products is shown. Processing block 468 provides for receiving the
shipment, which contains the assembly of medical products. A group
of medical products is associated with a group location at block
470 based on a group RF ID device signal. As already discussed, the
group includes a first unit and a second unit. Block 472 provides
associating the first unit with a first remote location based on
first unit RF ID signal. The second unit is associated with a
second remote location at block 474 based on a second unit RF ID
device signal. The signals uniquely identify the units and the
group.
Example Scenarios:
[0076] The following scenarios illustrate by way of example certain
of the principles of the embodiments of the present invention:
Scenario #1:
[0077] A widely used medication is received by a hospital. A
tracking device in accordance with the present invention is affixed
to each vial of the medication, and the vials are distributed to
various locations within the hospital. Prior to distribution,
tracking information such as product type, name, formulation,
interactions dosages, expiration date, batch number, manufacturing
facility, handling and storage information, and distribution
locations are entered into a central computer. At a later date, it
is discovered that the expiration date of the medication is in
error, and that it will shortly expire. Using the information
stored in the central computer, the locations of the medication are
rapidly determined, so that removal and disposal can be achieved.
Alternatively, a sensor in a storage cabinet periodically scans all
medications and directly identifies the presence and location of
the expired drug. It is also possible to have a pre-programmed
timer, clock or a chip or other circuit such that an individual RF
ID device independently emits a signal when a certain date is
reached which may be noted with a passive or active sensor array or
by a characteristic sound, light or electrochemical color change of
part or all of the printed label or package. A battery source set
to expire at or near the expiration date of the pharmaceutical may
also be used, wherein when the battery source expires an alert is
issued.
Scenario #2:
[0078] A patient is to undergo emergency surgery immediately.
Information, including that relating to the patient's allergies or
other drug reactions is written on the patient's RF ID bracelet in
accordance with embodiments of the present invention. In the
operating room just prior to surgery, the anesthetics to be used
during the operation are automatically scanned and this information
was processed with the information on the ID bracelet. It is
discovered that one anesthetic agent would produce a severe
reaction in the patient. A safe substitute anesthetic is suggested
by the system and was subsequently used during the procedure with
good result.
Scenario #3:
[0079] A patient arrives at the ER complaining of vomiting blood. A
type and cross is sent immediately and information is encoded and
written on the central computer and on the RF ID label directly and
immediately placed on the ER patient's sample tube at the point of
blood sampling. This tube arrives at the hospital blood bank where
it is scanned to avoid clerical and other errors involving patient
data. The central computer has already used the patient data to
access previous data from prior hospital or clinic visits, and may
use the internet or other known modality to access confidential and
necessary health information from any hospital, physician, insurer
or other reliable source. In the blood bank, blood typing data is
obtained rapidly and RF ID labels are appropriately written. The
results are automatically compared with those obtained previously
during prior admissions or with data from the city blood bank or
American Red Cross. Differences, such as new antibodies are noted
and the records upgraded throughout. Any obvious clerical or other
errors are also ruled out very effectively by this process of
comparison. the patient deteriorates and undergoes emergency
surgery.
[0080] Suppose blood is ordered and sent to the operating room
(OR). While bringing the blood to the OR, an extra bag that was in
storage for another patient is taken unwittingly. When placed in
the dedicated patient storage container or area, automatic scanning
indicates the presence of this unit of blood. If this should fail a
scanner integral to or near the patient ID bracelet would note the
discrepancy and issue a warning such that the wrong unit not be
given. When each unit is given, the used bags are placed in a waste
area, where the RF ID tags are again scanned. This information is
sent to the blood bank for closure of the loop. This prevents units
from becoming lost or otherwise wasted in a busy OR. This also
allows for real time tracking of blood use in the OR by the blood
bank, which can then better keep up with demands and improve
logistics. This is very important if a nonhospital or city blood
center's resources should become required on short notice. Further,
the blood bank would avoid unnecessary processing of unneeded blood
and blood products which would need to be used quickly or wasted
once prepared.
[0081] In the foregoing detailed description, devices, systems and
methods in accordance with embodiments of the present invention
have been described with reference to specific exemplary
embodiments. Accordingly, the present specification and figures are
to be regarded as illustrative rather than restrictive.
* * * * *