U.S. patent application number 13/110520 was filed with the patent office on 2012-11-22 for system and method to better assure correct use of pre-programmed medical devices.
Invention is credited to Brian C. Case, Lan T. Nguyen.
Application Number | 20120297255 13/110520 |
Document ID | / |
Family ID | 47175890 |
Filed Date | 2012-11-22 |
United States Patent
Application |
20120297255 |
Kind Code |
A1 |
Case; Brian C. ; et
al. |
November 22, 2012 |
SYSTEM AND METHOD TO BETTER ASSURE CORRECT USE OF PRE-PROGRAMMED
MEDICAL DEVICES
Abstract
Systems and methods are provided for performing a medical
procedure with respect to a subject. A data storage location of the
system is pre-programmed with a plurality of subject data entries,
each having subject-specific information associated with it. A user
interface receives an identity input from a subject, which
corresponds to the identity of the subject. A controller is
associated with the database and the user interface, and is
programmed to compare the identity input to the subject data
entries. If the identity input corresponds to the subject-specific
information of a subject data entry, the controller commands a
treatment device to perform a medical procedure with respect to the
subject. Otherwise, if the identity input does not correspond to
the subject-specific information of any of the subject data
entries, the controller generates an error signal which prevents
the performance of the medical procedure with respect to the
subject.
Inventors: |
Case; Brian C.; (Lake Villa,
IL) ; Nguyen; Lan T.; (Vernon Hills, IL) |
Family ID: |
47175890 |
Appl. No.: |
13/110520 |
Filed: |
May 18, 2011 |
Current U.S.
Class: |
714/47.1 ;
714/E11.024 |
Current CPC
Class: |
A61M 1/3403 20140204;
G06F 21/31 20130101; G16H 10/60 20180101; G08B 3/10 20130101; A61M
1/34 20130101; G16H 40/60 20180101; H05K 999/99 20130101; G08B 5/22
20130101; A61B 34/10 20160201; G06F 19/00 20130101; A61M 2205/33
20130101; A61M 2205/3334 20130101 |
Class at
Publication: |
714/47.1 ;
714/E11.024 |
International
Class: |
G06F 11/07 20060101
G06F011/07 |
Claims
1. A system for performing a medical procedure with respect to a
subject, comprising: a data storage location pre-programmed with
one or more subject data entries, each subject data entry having
subject-specific information associated with it; a user interface
adapted to receive an identity input from a subject; a treatment
device; and a controller associated with the user interface and the
treatment device and configured to compare the identity input to
the subject-specific information of the one or more subject data
entries, and command the treatment device to perform a medical
procedure with respect to the subject if the identity input
corresponds to the subject-specific information of one of the
subject data entries or, if the identity input does not correspond
to the subject-specific information of any of the subject data
entries, generate an error signal that prevents the performance of
the medical procedure with respect to the subject.
2. The system of claim 1, wherein the controller is configured to
command the treatment device to perform a medical procedure based
at least in part on the subject-specific information corresponding
to the identity input if the identity input corresponds to the
subject-specific information of one of the subject data
entries.
3. The system of claim 1, wherein the user interface comprises a
biometric scanner.
4. The system of claim 3, wherein the user interface comprises a
fingerprint reader.
5. The system of claim 3, wherein the user interface comprises a
retina scanner.
6. The system of claim 3, wherein the user interface includes face
recognition software.
7. The system of claim 3, wherein the user interface comprises a
heart rhythm monitor.
8. The system of claim 3, wherein the user interface includes voice
recognition software.
9. The system of claim 3, wherein the user interface includes DNA
recognition software.
10. The system of claim 1, wherein the user interface is configured
to communicate with a subject identification card.
11. The system of claim 10, wherein the user interface comprises an
RFID reader.
12. The system of claim 10, wherein the user interface comprises a
barcode reader.
13. The system of claim 1, wherein the user interface is configured
to communicate with authentication software of an electronic
device.
14. The system of claim 1, wherein the user interface is configured
to receive a personal identification number from the subject.
15. The system of claim 1, wherein the data storage location
comprises a database integrated into the system.
16. The system of claim 1, wherein the data storage location
comprises a removable storage device.
17. A method of performing a medical procedure with respect to a
subject, comprising: storing one or more subject data entries, each
having subject-specific information associated with it; receiving
an identity input from a subject; comparing the identity input to
the subject-specific information of the one or more subject data
entries; and performing a medical procedure with respect to the
subject if the identity input corresponds to the subject-specific
information of one of the subject data entries or, if the identity
input does not correspond to the subject-specific information of
any of the subject data entries, generating an error signal that
prevents the performance of the medical procedure with respect to
the subject.
18. The method of claim 17, wherein said performing a medical
procedure with respect to the subject includes performing a medical
procedure based at least in part on the subject-specific
information corresponding to the identity input if the identity
input corresponds to the subject-specific information of one of the
subject data entries.
19. The method of claim 17, wherein said receiving the identity
input from the subject includes receiving biometric data from the
subject.
20. The method of claim 19, wherein said receiving the identity
input from the subject includes reading a fingerprint of the
subject.
21. The method of claim 19, wherein said receiving the identity
input from the subject includes scanning a retina of the
subject.
22. The method of claim 19, wherein said receiving the identity
input from the subject includes analyzing the face of the
subject.
23. The method of claim 19, wherein said receiving the identity
input from the subject includes monitoring a heart rhythm of the
subject.
24. The method of claim 19, wherein said receiving the identity
input from the subject includes analyzing the voice of the
subject.
25. The method of claim 19, wherein said receiving the identity
input from the subject includes analyzing the DNA of the
subject.
26. The method of claim 17, wherein said receiving the identity
input from the subject includes communicating with a subject
identification card.
27. The method of claim 26, wherein said receiving the identity
input from the subject includes reading an RFID signal.
28. The method of claim 26, wherein said receiving the identity
input from the subject includes reading a barcode.
29. The method of claim 17, wherein said receiving the identity
input from the subject includes communicating with authentication
software of an electronic device.
30. The method of claim 17, wherein said receiving the identity
input from the subject includes receiving a personal identification
number from the subject.
Description
BACKGROUND
[0001] 1. Field of the Disclosure
[0002] The present subject matter relates to systems and methods
for controlling the performance of a medical procedure on a
subject.
[0003] 2. Description of Related Art
[0004] It is axiomatic that the parameters under which an at least
partially automated medical procedure is performed, including
without limitation blood donations and apheresis, should correspond
or be appropriate to the characteristics of the donor or patient
upon which the procedure is being performed. For example, when
performing a blood donation procedure, it may be advantageous for a
number of parameters, such as the sex and weight of the donor or
patient, to be taken into consideration. If the incorrect
operational parameters are used, the procedure may be less
efficient than it would otherwise be and/or in certain
circumstances could possibly be harmful to the donor or patient.
Accordingly, care should be taken that the operational parameters
correspond to the unique characteristics of the donor or
patient.
[0005] Typically, information regarding the donor or patient is
present in a datasheet or written prescription and entered into the
automated device or system via a user interface by the operator of
the system (e.g., a nurse, doctor, or technician) at the beginning
of the procedure. The operator confirms the settings of the system
and the identity of the subject and then instructs the system to
initiate the medical procedure. By relying on manual data entry,
there is of course a risk of operator error, resulting in
operational parameters which do not correspond to the unique
characteristics of the donor or patient. Thus, systems and methods
which reduce the risk of data entry errors would be
advantageous.
SUMMARY
[0006] There are several aspects of the present subject matter
which may be embodied separately or together in the devices and
systems described and claimed below. These aspects may be employed
alone or in combination with other aspects of the subject matter
described herein, and the description of these aspects together is
not intended to preclude the use of these aspects separately or the
claiming of such aspects separately or in different combinations as
set forth in the claims appended hereto.
[0007] In one aspect, a system is provided for performing a medical
procedure with respect to a subject. The system includes a
database, a user interface, a treatment device, and a controller.
The database is pre-programmed with one or more subject data
entries, each subject data entry having subject-specific
information associated with it. The user interface is adapted to
receive an identity input from a subject. The controller is
associated or in communication with the database, the user
interface, and the treatment device, and is configured to compare
the identity input to the subject-specific information of the
subject data entries. If the identity input corresponds to the
subject-specific information of a subject data entry, the
controller commands the treatment device to perform a medical
procedure with respect to the subject. If the identity input does
not correspond to the subject-specific information of any of the
subject data entries, the controller generates an error signal that
prevents the performance of the medical procedure with respect to
the subject.
[0008] In another aspect, a method is provided for performing a
medical procedure with respect to a subject. One or more subject
data entries are stored, with each having subject-specific
information associated with it. An identity input is received from
the subject. The identity input is compared to the subject-specific
information of the subject data entries. If the identity input
corresponds to the subject-specific information of a subject data
entry, a medical procedure is performed with respect to the
subject. If the identity input does not correspond to the
subject-specific information of any of the subject data entries, an
error signal is generated to prevent the performance of the medical
procedure with respect to the subject.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIG. 1 is a schematic view of a medical device according to
an aspect of the present disclosure; and
[0010] FIG. 2 is a flowchart which shows the process undertaken by
the medical device of FIG. 1 when receiving identity information
from a subject and then performing a medical procedure with respect
to the subject.
DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
[0011] The embodiments disclosed herein are exemplary only, and the
subject matter described herein may be embodied in various forms.
Therefore, specific details disclosed herein are not to be
interpreted as limiting the subject matter as defined in the
accompanying claims.
[0012] FIG. 1 diagrammatically illustrates a system 10 for
performing a medical procedure with respect to a subject. The
system 10 of FIG. 1 includes a data storage location (such as a
database 12), a user interface 14, a treatment device 16, and a
controller 18. The system may be configured and used for carrying
out any particular medical procedure. More particularly, the system
may be configured for carrying out automated or semi-automated
apheresis or blood collection procedures on a healthy donor or
patient.
[0013] The data storage location may be variously configured and
positioned without departing from the scope of the present
disclosure. For example, the data storage location may be
integrated into the system 10 and associated with the controller
18, as is the case with the database 12 of FIG. 1. In other
embodiments, the data storage location may be remote from the
system 10, for example, being located at or in a central server or
storage facility of the owner of the system 10. If the data storage
location is remotely located, it may communicate with the system 10
by any of a number of known or novel remote access means such as,
but not limited to, wireless Internet access. In another
embodiment, the data storage location is a removable storage
device, such as an encoded identification card, which may be
brought into association with the system 10 by a subject or
operator. Other configurations of the data storage location may
also be employed without departing from the scope of the present
disclosure.
[0014] The data storage location may store a wide variety of data
and information. In the embodiment of FIG. 1, the data storage
location (in the form of a database 12) stores one or more subject
data entries 20, with each subject data entry 20 corresponding to a
subject (i.e., a donor or patient) upon which a medical procedure
is to be performed using the system 10. The database 12 is
pre-programmed with the subject data entry 20 for a particular
subject at a time prior to the system 10 carrying out a medical
procedure on that particular subject. Each subject data entry 20
includes subject-specific information 22, such as name, weight,
sex, age, birth date, address, unique password, fingerprint, facial
or retinal data, and/or answer(s) to security questions. The
subject-specific information 22 corresponds to the identity of the
subject and is compared to identity input 26 which is entered into
the system by the subject, as will be described in greater detail
below.
[0015] In addition to the subject-specific information 22, each
subject data entry 20 may include one or more parameters 24 or such
parameter(s) may be calculated or determined by the controller 18
based on the medical procedure and/or a combination of the
procedure and subject-specific information 22. The nature of the
parameter 24 may vary depending on the nature of the medical
procedure to be performed. Also, the parameter 24 may relate to or
be derived based on the sex of the subject, the weight of the
subject, the acceptable rate at which fluid may be drawn from
and/or returned to the subject (e.g., a citrate infusion rate),
etc.
[0016] The user interface 14 includes a display for receiving
commands and information from an operator or subject and displaying
instructions for the operator or subject to perform. The display
may be variously provided, such as in the form of a touch screen
or, alternatively, a screen with an associated device which allows
an operator or subject to interact with the user interface 14
(e.g., a keypad or keyboard). The user interface 14 also includes
an input device for receiving an identity input 26 from the
subject, which corresponds to the identity of the subject. As will
be described in greater detail below, there are a variety of ways
in which a subject may identify him- or herself, so the input
device may be variously configured. In some embodiments, the
display serves as an input device, while in other embodiments, the
input device is separate from the display.
[0017] The principles of the present disclosure may be employed in
a wide variety of devices and in a wide variety of procedures.
Accordingly, the treatment device 16, which actually performs (at
least part of) a medical procedure on the subject, may be variously
configured. In one embodiment, the treatment device 16 may be an
apheresis system, for example, a centrifuge system configured to
draw blood from a subject, separate it into its constituents, and
return at least one of the components to the subject. Exemplary
centrifuge systems include those currently marketed as the
ALYX.RTM. and AMICUS.RTM. systems by Fenwal, Inc. of Lake Zurich,
Ill., as described in greater detail in U.S. Pat. No. 6,325,775 and
U.S. Pat. No. 5,868,696, respectively, which are hereby
incorporated herein by reference. Other treatment devices may also
be employed without departing from the scope of the present
disclosure, including (without limitation) dialysis systems,
parenteral nutrition systems and others.
[0018] The controller 18 is associated with or in communication
with the database 12, the user interface 14, and the treatment
device 16. The controller 18 may be configured or programmed with a
plurality of functions or procedures, and has various functions,
including (but not limited to) receiving data from the various
other components of the system 10, issuing commands to the various
other components of the system 10, and monitoring the performance
of the various other components of the system 10. In one
embodiment, the controller 18 is configured to compare the identity
input 26 which is provided by the subject to the subject data
entries 20 stored in the database 12. If the identity input 26
corresponds to the subject-specific information 22 stored in one of
the subject data entries 20 (i.e., if the system 10 "recognizes"
the subject), the controller 18 will command the treatment device
16 to perform a medical procedure with respect to the subject. This
may include determining or accessing the parameter(s) 24 associated
with that particular subject data entry 20 (if provided) and
sending the parameter(s) 24 to the treatment device 16 for use in
performing the medical procedure.
[0019] If the identity input 26 does not correspond to the
subject-specific information 22 stored in any of the subject data
entries 20, the controller 18 may initiate any of a number of
responses. In one embodiment, the controller 18 generates an error
signal that prevents the performance of the medical procedure with
respect to the subject. The error signal may trigger audible and/or
visual alarms and alerts, including commanding the user interface
14 to show an error message (e.g. "Unable to confirm individual")
on the display. In another embodiment, the controller 18 optionally
commands the treatment device 16 to perform the procedure on the
subject using default operational parameters instead of parameters
uniquely suited to the subject.
[0020] FIG. 2 illustrates an exemplary manner of using a system 10
according to the present disclosure. Prior to a medical procedure
being performed on the subject, a subject data entry 20 is
pre-programmed into the database 12 for the subject. This may be
done remotely or by using the user interface 14. A medical
personnel is prompted to enter a variety of information, including
at least the subject-specific information 22 which will be used to
identify the subject. The medical personnel may also be prompted to
enter one or more parameters 24 to be used when performing the
medical procedure with respect to the subject. Depending on the
nature of the identity input 26, the nature of the subject-specific
information 22 and, hence, the manner and form in which it is
entered into the database 12 may vary. For example, the information
may be retrieved from another database, such as a central or remote
database by direct interrogation and download, or in response to
subject or medical personnel input. Further, the nature of the
parameter(s) 24 may depend on the nature of the medical procedure
to be performed with respect to the subject. When the
subject-specific information 22 and optionally parameter(s) 24 (if
provided) have been entered into the system 10, the medical
personnel may confirm the data entered, thereby generating a
subject data entry 20 which is stored in the database 12 and is
unique to the subject.
[0021] At some later time, the subject is brought into the vicinity
or proximity of the system 10 or an operable portion of the system
10. The subject may be connected to the treatment device 16 upon
being brought into the vicinity of the system 10 or may be
connected to the treatment device 16 at a later time (e.g., after
the system 10 has confirmed the identity of the subject). While in
the vicinity of the system 10, the subject attempts to identify
him- or herself to the system 10 by providing an identity input 26
via the input device of the user interface 14. The identity of a
subject may be expressed in any of a number of ways, so the system
10 may include one or more different input devices for receiving
the identity input 26.
[0022] In one embodiment, the identity input 26 may take the form
of biometric data, in which case the input device of the user
interface 14 is provided as a biometric scanner or reader. For
example, the input device may be provided as a fingerprint reader
to receive and analyze the fingerprint of a subject. In another
embodiment, the input device is provided as a retina scanner to
view and analyze the retina of a subject. In yet another
embodiment, the input device includes face recognition software to
view and analyze the face of a subject. In another embodiment, the
input device is provided as a heart rate monitor to consider the
heart rhythm of a subject. In yet another embodiment, the input
device includes a microphone or comparable audio device to receive
and analyze the voice of a subject. In another embodiment, the
input device is configured to receive a blood sample from a subject
and analyze the DNA of the subject. Other biometric identifiers may
also (or additionally) be provided by a subject to express his or
her identity.
[0023] In another embodiment, the subject is provided with a unique
subject identification card, badge, or removable storage device
which is analyzed by the input device to attempt to identify the
subject to the system 10. For example, the input device may
comprise a bar code reader, with the subject being provided with a
subject identification card having personal information encoded
into a bar code which can be read by the input device. In another
example, the subject may have a subject identification card encoded
with personal information and having a built-in radio-frequency
identification ("RFID") circuit. The input device comprises an RFID
reader which is capable of reading the personal information on the
card for subsequent analysis by the controller 18. The card may
serve as a data storage location, as described above, being further
encoded with one or more of the subject's unique operational
parameters 24, rather than pre-programming the parameter(s) 24 into
the database 12 or deriving/calculating them by the controller 18.
In this case, the identity input 26 and the parameter(s) 24, if
any, will be read by the input device and, if the identity input 26
corresponds to the subject-specific information 22 in one or more
of the subject data entries 20, the controller 18 will send the
parameter(s) 24 from the card to the treatment device 16.
Furthermore, the card may be encoded with a multiple-treatment
regimen, with the result of each treatment being tracked by the
system 10 over time.
[0024] In one or more embodiments, the controller 18 may be
programmed to require certain one or more of the subject-specific
information 22 in the subject data entries 20 to correspond to the
identity input 26. For example, the system 10 may require a
combination of correct subject-specific information 22 before
proceeding with the medical procedure. Specifically, the system 10
may require two or more subject-specific information 22 to be
consistent with the identity input 26 and/or with each other. As
non-limiting examples, the system 10 may require consistency among
a name and sex; a name and password; a name and fingerprint and
medical condition; a fingerprint and facial recognition; or such
other combination as may be selected.
[0025] In yet another embodiment, the input device of the user
interface 14 is programmed to recognize and read authentication
software running on an electronic device, such as a mobile phone or
laptop computer.
[0026] In another embodiment, the user interface 14 is programmed
to receive a personal identification number, code, or password from
the subject. If the display of the user interface 14 is a touch
screen, the personal identification number may be directly entered
using the display (thereby allowing the display to serve as the
input device). Alternatively, an input device comprising a keypad
or keyboard may be provided to allow the subject to enter the
personal identification number.
[0027] When the subject has provided the identity input 26 to the
system 10, the controller 18 compares the identity input 26 to the
subject data entries 20 stored in the database 12. As described
above, if the identity input 26 corresponds to the subject-specific
information 22 stored in one or more of the subject data entries
20, as required by the system 10 (represented in FIG. 2 as a "YES"
response to the "if-then" diamond containing the words "Medical
Device confirms individual's authentication"), the system 10 has
successfully identified the subject. The controller 18 will then
command the treatment device 16 to perform a medical procedure with
respect to the subject, which may include the controller 18
computing, retrieving, or accessing the parameter(s) 24 associated
with that particular subject data entry 20 and sending it/them to
the treatment device 16 for use in performing the medical
procedure.
[0028] If the controller 18 is unable to match the identity input
26 to the subject-specific information 22 stored in any of the
subject data entries 20 (represented in FIG. 2 as a "NO" response
to the "if-then" diamond containing the words "Medical Device
confirms individual's authentication"), the system 10 has failed to
identify the subject. In the embodiment of FIG. 2, the controller
18 responds by disabling or declining to proceed with the medical
procedure and may generate a signal that prevents the performance
of the medical procedure with respect to the subject. The subject
may then be given one or more additional opportunities to express
his or her identity using the same or a different identity input
26. As described above, different responses to a failed
identification may also be initiated without departing from the
scope of the present disclosure.
[0029] It will be understood that the embodiments described above
are illustrative of some of the applications of the principles of
the present subject matter. Numerous modifications may be made by
those skilled in the art without departing from the spirit and
scope of the claimed subject matter, including those combinations
of features that are individually disclosed or claimed herein. For
these reasons, the scope hereof is not limited to the above
description but is as set forth in the following claims, and it is
understood that claims may be directed to the features hereof,
including as combinations of features that are individually
disclosed or claimed herein.
* * * * *