Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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SYSTEM AND METHOD FOR PREVENTING WRONG-SITE SURGERIES
TECHNICAL FIELD
The present invention relates generally to
surgical devices and procedures and, in particular, to
surgical devices and procedures for preventing wrong-site
surgeries.
BACKGROUND OF THE INVENTION
A great deal of attention has recently been
given to the unacceptable rate of avoidable patient
injuries, or so-called medical mistakes, in the United
States. Estimates of the number of medical mistakes per
year in the United States is difficult to ascertain, but
a recent publication, To Err is Human, by Dr. Lucian
Leape, suggests that the avoidable death rate for medical
mistakes are between 48,000 and 96,000 patients per year.
As defined by the Joint Commission on
Accreditation of Healthcare Organizations (JCAHO), wrong-
site surgery includes wrong side or site of the body,
wrong procedure, and wrong-patient surgeries.
Prevalence of Wrong-Site Surgery
From January 1995 to March 2001, JCAHO reviewed
voluntary reports of 1,152 "sentinel events." Wrong-site
surgery accounted for 114 cases (9.9%) and included
procedures in neurosurgery, urology, orthopedics, and
vascular surgery. Despite the high profile of JCAHO's
Sentinel Event Policy, under-reporting by healthcare
organizations likely affects these statistics. Only 66%
of the 1,152 total events were "self-reported" by the
institutions involved; the balance coming from patient
complaints or media stories. Using a mandatory reporting
system, the New York State Department of Health received
46 reports of wrong-site surgery from April 1, 1998
through March 31, 2000, compared with 114 cases JCAHO
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received nationally over a period 3 times longer. This
suggests that voluntary incident reporting may grossly
underestimate the true incidence of wrong-site surgery by
a factor of 20 or more.
The Physician's Insurance Association of
America (PIAA) reviewed the claims data from 22
malpractice carriers representing 110,000 physicians from
1985 to 1995. There
were 331 cases of wrong-site
surgery. The
complete PIAA database documents almost
W 1,000 closed malpractice claims involving wrong-site
surgery. However, this figure also likely underestimates
the prevalence of wrong-site surgery. Since most wrong-
site surgeries involve relatively minor procedures
(arthroscopy, rather than limb amputations or major
neurosurgical procedures), sequelae are minimal and may
not result in a claim.
Consequently, estimates of the
incidence of wrong-site surgery derived from litigation
data likely underestimate the true prevalence of this
problem, as do estimates based on incident reports.
Factors Identified as Contributing to Wrong-
Site Surgery
Several factors have been identified that may
contribute to an increased risk of wrong-site surgery.
These risk factors include:
= More than one surgeon involved in the case,
either because multiple procedures were contemplated or
because the care of the patient was transferred to
another surgeon;
= Multiple procedures were conducted on the
same patient during a single trip to the operating room,
especially when the procedures were on different sides of
the patient;
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= Unusual time pressures related to an unusual
start time or pressure to speed up the preoperative
procedures; and
= Unusual patient characteristics such as
physical deformity or massive obesity that might alter
the usual process for equipment set-up or positioning of
the patient.
The root causes identified by hospitals were
most often related to communication, preoperative
assessment of the patient, and the procedures used to
verify the operative site. Communication issues fall into
two major categories:
= Failure to engage the patient (or family,
when appropriate) in the process of identifying the
correct surgical site, either during the informed consent
process or by the physical act of marking the intended
surgical site; and
= Incomplete or inaccurate communication among
members of the surgical team, often through exclusion of
certain members of the team (e.g., surgical technicians)
from participation in the site verification process, or
through reliance solely on the surgeon for determining
the correct operative site.
The completeness of the preoperative assessment
of the patient was a frequent contributing factor, often
through failure to review the medical record or imaging
studies in the immediate preoperative period. The
procedures for verifying the correct operative site were
found to be flawed in many cases due to:
= No formal procedure;
= No final check in the operating room;
= The absence of any oral communication in the
verification procedure;
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= All relevant information sources not
available in the operating room;
= No checklist to ensure all relevant
information sources were checked;
= Some members of the surgical team were
excluded from the verification process and felt they were
not permitted to point out a possible error; and
= Total reliance on the surgeon for verifying
the surgical site.
JCAHO Strategies for Reducing Wrong-Site
Surgery
The Joint Commission offers the following
possible strategies for reducing the risk of wrong-site
surgery:
= Clearly mark the operative site and involve
the patient in the marking process to enhance the
reliability of the process;
= Require an oral verification of the correct
site in the operating room by each member of the surgical
team;
= Develop a verification checklist that
includes all documents referencing the intended operative
procedure and site, including the medical record, X-rays
and other imaging studies and their direct observation of
the marked operative site on the patient;
= Personal involvement of the surgeon in
obtaining informed consent;
= Ensure through ongoing monitoring that
verification procedures are followed for high-risk
procedures; and
= "Time out" immediately before starting the
procedure. (Source: Joint Commission on Accreditation of
Healthcare Organizations. Sentinel Event Alert, issue
six, August 28, 1998.)
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Despite the implementation of strategies to
prevent wrong patient, wrong site, wrong side surgery,
regrettably this seemingly most preventable of
complications still occurs. (The
aforementioned
statistics do not address the number of times in which
implants or instrumentation is going to be placed as a
part of the procedure, and are not available when the
surgeon is ready for them. In these
instances, the
surgeon must either change plans, or wait while the
W surgical team attempts to locate the appropriate implants
or instrumentation, sometimes located at another
hospital.) The
fraudulent assumption of a medical
professional's infallibility, coupled with organized
medicine's focus on the individual's medical mistakes
rather than a systems approach have contributed to this
problem. In an attempt to improve patient safety,
"[e]ffective July 1, 2004, compliance with the Universal
Protocol for Preventing Wrong Site, Wrong Procedure,
Wrong Person Surgery will be required of all Joint
Commission accredited organizations." As a part of the
universal protocol, a "pause" or "time out" is required.
This serves as a final verification of: (1) the correct
patient; (2) the correct procedure, site and side; and as
applicable, (3) the availability of implants or
instrumentation, prior to making incision. This is a
time when all members of the surgical team are supposed
to pause to review the case, and agree that the correct
procedure is being done on the correct patient, at the
correct site, and on the correct side. In
theory, this
would ensure that any errors that had been made could be
detected prior to incision. In
reality, the "time out"
seldom occurs; and when it does, not in any uniform or
regular manner. The universal protocol does not specify
a particular time for the pause to occur, and it does not
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specify a protocol as to what should happen during the
pause, that is to say, what information should be
communicated by whom, and to whom.
Accordingly, it can be seen that a need exists
for improvements to surgical procedures and devices to
prevent or at least reduce wrong-site surgeries. It is
to the provision of meeting these and other needs that
the present invention is primarily directed.
SUMMARY OF THE INVENTION
Generally described, the present invention
provides a system and method for preventing wrong-site
surgeries by imposing a pause just before the surgery
starts, during which time the surgical team conducts a
pre-operative assessment to confirm that correct site of
the surgery about to be performed. By imposing the pre-
operative assessment, the surgical team gets one last
chance to catch any avoidable mistake that would
otherwise lead to a wrong-site surgery.
In a first example embodiment of the present
invention, the system includes a container that holds one
or more surgical implements, a lock mechanism for
securing the container closed, and a removable
confirmation label that blocks or at least impedes access
to the lock mechanism. The surgeon cannot readily open
the container to get the surgical implements until the
correct surgical site has been confirmed and the label
has been removed. The surgical implements include one or
more scalpels or other blades, a syringe loaded with a
local anesthetic, a needle, a scope, and/or other
surgical implements needed at the outset of the surgery.
The label includes, for example, a checklist for
confirming surgery-related information and one or more
fields for signatures.
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In one aspect of the invention, the lock
mechanism includes a lock member that fits through two
openings in the container that align when the container
is closed.
Preferably, the container includes a bottom
and a top that slides off the bottom, with one lock
opening being through the top, and the other lock opening
formed into an internal divider wall that also defines
compartments for the surgical implements.
In another aspect of the invention, the
container bottom has one or more dedicated compartments
for surgical needles. In use,
the bottom may be
positioned beside a surgical team member for storing
surgical needles after they have been used in the
surgery. Then, at
the conclusion of the surgery, the
container may be closed and the surgical sharps all
safely disposed of at once.
In yet another aspect of the invention, the
container top can be removed from the bottom and
positioned between the surgeon and a surgical team member
to define a neutral zone where hands do not meet. With
the neutral zone clearly defined, the incidence of
stickings when passing the surgical sharps back and forth
is reduced.
In another aspect of the invention, the
container can be adapted to be tracked and/or monitored
using, for example, a data capture and/or display device,
system or technology secured to at least one portion of
said container.
In another aspect of the invention, the
container can be adapted to provide a quick and easy
visualization mechanism to relate to the surgical team
the correct site, i.e. left side or right side, the
surgical procedure should occur.
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In use, the system forces a surgery team to
pause prior to initiating the surgery, after the patient
is draped and the surgeon and surgical technician are
both sterilely gowned, when all members of the surgical
team pause to make sure that they have the correct
patient, the correct operation is being performed, on the
correct site and side, and all necessary surgical
instrumentation or implants are physically available.
Once that information is confirmed, which might require
the surgeon to review the medical record or the imaging
studies; the surgeon removes a dual-tipped pen from the
top of the container and uses the ink side to sign the
label on the box. The label is then removed and placed in
the medical record, and the surgeon now has access to the
lock to open the container and remove the surgical
implement(s). The
surgical marking pen side of the pen
can be used to mark the incision. The container top is
then turned upside down and serves as the surgical
neutral zone, which defines a hands-free "neutral zone"
where sharp instruments can be traded between the surgeon
and surgical technician without the actual passing of
sharp instruments from hand to hand. In
addition, the
container may also have pre-loaded local anesthetic with
a needle and syringe, to further expedite the starting of
the operation. Furthermore, compartments in the container
will have foam padded areas, with printed numbers, for
the counting and storage of suture needles, as well as
other sharps, and at the end of the surgical case the
container can be reclosed securely, with all the sharps
in the container accounted for, and safely disposed of as
one unit.
In a second example embodiment, the container
bottom has four compartments with a shorter syringe
compartment. In a third example embodiment, the label is
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attached to the top and bottom of the container to lock
it closed, so that the label doubles as the lock. In a
fourth example embodiment, the lock member is provided by
a tie member that fits through aligned openings formed by
two external tabs on the container, and the label covers
the lock member. In a fifth example embodiment, the lock
member is provided by a wrapper that encloses the
container, and the label is removably attached to the
wrapper or to a pull tab for opening the wrapper. And,
in still other embodiments, the container does not
include a lock mechanism, or it does include a lock
mechanism and the label does not cover it, but the label
impedes access to opening the container by being
prominently positioned so that it is hard not to notice
it, which prompts a pause for the surgical team to
conduct the pre-operative assessment to confirm the
correct site of the surgery.
The method of preventing wrong-site surgery
comprises the steps of providing a container that holds a
surgical implement and has a label for confirming
surgery-related information, with the label removably
attached to the container; using the label to conduct a
pre-operative assessment confirming a correct surgical
site; removing the label from the container; opening the
container and removing the surgical implement; and using
the surgical implement at the outset of the surgery. In
this way, the pre-operative assessment confirming that
the correct surgical site has been identified is done
before making an incision and starting the surgery.
Preferably, the container is provided with a lock
mechanism securing it closed, and the label is positioned
blocking access to the lock mechanism so that the label
must be removed to open the container.
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In one aspect of the method, the container
includes a top that is removed to open the container.
The method further includes the steps of positioning the
removed container top between a surgeon and a surgical
team member to define a neutral zone where hands do not
meet; and exchanging surgical sharps between the surgeon
and the surgical team member without sticking each other.
The exchanging is done by the surgeon placing the
surgical sharps into the container top and the surgical
team member then picking them up, and vice versa.
In another aspect of the method, the container
includes a bottom with at least one compartment that
holds the surgical implement and with one or more
additional compartments for surgical needles, and
positioning the removed container bottom beside a
surgical team member. The
method further includes the
steps of, after the surgical needles have been used in
the surgery, storing the used surgical needles in the
dedicated compartments in the container bottom. In
addition, the method includes replacing the top on the
container to close the container at the conclusion of the
surgery; and disposing of the container with the used
sharps safely inside.
The specific techniques and structures employed
by the invention to improve over the drawbacks of the
prior devices and accomplish the advantages described
herein will become apparent from the following detailed
description of the example embodiments of the invention
and the appended drawings and claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Fig. 1 is a perspective view of a container for
surgical sharps according to a first example embodiment
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of the invention, showing the container in a closed and
locked position;
Fig. 2 is a left side view of the container of
Fig. 1;
Fig. 3 is a plan view of the container of Fig.
1, showing labels on the container, including a
confirmation/signature label covering a lock member so
that the container cannot be unlocked and opened until
the label is removed;
Fig. 4 is a perspective view of the container
of FIG. 1 in an unlocked and open position;
Fig. 5 is a cross section view of the container
of FIG. 1 taken at line 5-5, showing a lock member being
removed from aligned lock openings to unlock the
container;
Fig. 6 is a perspective view of the lock member
of Fig. 5;
Fig. 7 is a plan view of an instructions label
of FIG. 3;
Fig. 8 is a plan view of the
confirmation/signature label of Fig. 3;
Fig. 9 is a plan view of a surgical pen-
covering label of Fig. 3;
Fig. 10 is a plan view of the container of Fig.
1, ready for use, showing compartments holding a local
anesthetic-loaded syringe and surgical blades for use in
the surgery, and empty compartments for used suture and
syringe needles;
Fig. 11 is a perspective view of the container
bottom of Fig. 10 in use, showing the used surgical
suture and syringe needles stored in their dedicated
compartments;
Fig. 12 is a schematic diagram of the container
shown in FIG. 10 in use, showing the container bottom
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holding the surgical sharps and the container top
inverted and defining a neutral zone between the surgeon
and the surgical technician;
Fig. 13 is an exploded perspective view of a
container for surgical sharps according to a second
example embodiment;
Fig. 14 is a plan view of the bottom of the
container of Fig. 13;
Fig. 15 is a perspective view of a container
for surgical sharps according to a third example
embodiment, showing the container in a closed and locked
position;
Fig. 16 is a perspective detail view of a
container for surgical sharps according to a fourth
example embodiment, showing a label being removed to
expose a lock;
Fig. 17 is a side view of a container for
surgical sharps according to a fifth example embodiment,
showing a label positioned on a sterile inner wrapping
enclosed by an outer wrapping;
Fig. 18 is a plan detail view of the container
of Fig. 17, showing an opener strip and pull tab of the
sterile inner wrapper;
Fig. 19A is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention, showing the container in a
closed position;
Fig. 19B is a perspective view of an
alternative embodiment of the container for surgical
equipment, illustrating an outer container.
Fig. 20 is a top view of the container of Fig.
19;
Fig. 21 is a perspective view of a container
for surgical equipment according to an alternative
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embodiment of the invention, showing the container having
an RFID transponder;
Fig. 22 is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention, showing the container having
a data storage device;
Fig. 23A is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention; showing the container having
W a central control unit;
Fig. 23B is a schematic diagram of the
components of an illustrative example of a central
control unit;
Fig. 24 is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention, showing one embodiment of a
surgical site visual indicator;
Fig. 25 is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention, showing an alternative
embodiment of a surgical site visual indicator;
Fig. 26 is a perspective view of an embodiment
of the locking pin member containing a data capture
and/or display device;
Fig. 27 is a top view of an embodiment of the
locking pin member containing an alternative embodiment
of a data capture and/or display device;
Fig. 28 is a perspective view of an embodiment
of the locking pin member containing a data capture
and/or display device and flash drive;
Fig. 29A and 29B illustrate a flow chart
describing an representative embodiment of a method of
preventing a wrong-site error during surgery in
accordance with the present invention;
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Fig. 30 is a schematic illustration of a
surgical system which utilizes a surgical container in
accordance with the present invention;
Fig. 31 is a perspective view of a container
for surgical equipment according to an alternative
embodiment of the invention;
Fig. 32 is an alternative perspective view of
the container illustrated in Fig. 31;
Fig. 33 is a top view of the container
W illustrated in Fig. 31;
Fig. 34 is a bottom view of the container
illustrated in Fig. 31;
Fig. 35 is side view of the container
illustrated in Fig. 31;
Fig. 36 is an alternative side view of the
container illustrated in Fig. 31;
Fig. 37 is a front view of the of the container
illustrated in Fig. 31; and
Fig. 38 is a back view of the container
illustrated in Fig. 31.
DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS
Referring to the drawing figures, the present
invention includes a surgical system and a method of
using the surgical system to impose a pre-operative
assessment to prevent wrong-site surgeries. The system
includes a container that holds one or more surgical
implements needed for the surgery, a lock mechanism that
secures the container in a closed position, and a
confirmation and/or signature label in a position that
prevents or at least impedes access to the lock. In this
way, the surgical team is forced to pause to deal with
the label in order to access the surgical implements
needed to start the surgery.
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Referring to FIGS. 1-11, where is illustrated a
surgical system 10 according to a first example
embodiment of the present invention. FIGS. 1-4 show the
surgical container 12, the lock mechanism 14, and the
confirmation and signature label 16 of the surgical
system 10. The container 12 has a bottom 18 and a top 20
that can be positioned in the closed position of FIG. 1
or the opened position of FIG. 4. In the
depicted
embodiment, the top 20 and the bottom 18 slide relative
W to each other to open and close the container 12. For
example, the container 12 may include a lip-and-groove
arrangement 22 to permit the top 20 to be slid off of the
bottom 18. In
addition, the container 12 may include
detents or other structures for snapping closed the top
20 and bottom 18 so that the container cannot freely
slide open when it is unlocked. In
alternative
embodiments, the container has a hinge for a pivotal
opening motion, preferably with the hinge permitting the
top to be separated from the bottom. The size
of the
container 12 is selected based primarily on the intended
contents and may be customized for different types of
surgeries and/or different surgeons. In general, though,
the container 12 is not too large to be obtrusive or too
small to escape notice. In a
typical commercial
embodiment, the container 12 is about 1-2 inches high,
about 4-6 inches wide, and about 8-10 inches long. In
addition, the container 12 is preferably generally
rectangular with scalloped top edges for ease of
gripping, and is preferably made of a plastic material,
though other materials may be suitably employed.
Preferably, the bottom surface of the bottom 18
and the top surface of the top 20 are provided with
gripping features so that they will not slip on a
substantially horizontal surface they are resting upon.
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For example, the gripping features may include a layer 13
of frictional material such as rubber or soft plastic
inlayed or applied onto the top surface (or a portion
thereof) of the top 20, and an adhesive-backed pad 15 of
frictional material such as rubber or soft plastic
attached to the bottom surface of the bottom 18. In this
way, the bottom 18 and the inverted top 20 are held in
place during use, as described in detail below.
Referring additionally to FIGS. 5 and 6, the
lock mechanism 14 secures the container 12 in the closed
position. The lock mechanism 14 preferably includes a
lock member that is received in locking engagement
through two aligned lock openings in the top and bottom
of the container. For example, in the depicted embodiment
the lock member 24 linearly slides into a first lock
opening 26 in the top 20 and a second lock opening 28 in
the bottom 18 when the container 12 is in the closed
position. The lock member 24 preferably includes a lock
pin 32 that is received in the aligned openings 26 and 28
and a tab 34 for ease of grasping by hand. The top 20
may have a recess 36 configured to at least partially
receive the tab 34 to provide a low profile, with the
first lock opening 26 positioned within the recess. The
second lock opening 28 is preferably formed into one or
more divider walls 38 that define compartments in the
bottom 18, so that the opening is out of the way and so a
separate upstanding structure is not required for
defining the opening. The lock member 24 can be made of
a plastic, metal, or other material. It will
be
understood that other types of lock mechanisms may be
used to accomplish the herein-described purposes.
Referring additionally to FIGS. 7-9, the
confirmation and signature label 16 is removable and
covers the lock member 24 so it cannot be accessed to
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unlock the container 12 until the label is removed. In a
typical commercial embodiment shown in FIG. 8, the
confirmation and signature label 16 has a front side that
can be written upon and that includes a checklist to be
filled out by the surgical technician, and fields where
surgical team members sign after confirming that the
information entered in the checklist is correct. For
example, the checklist preferably provides for confirming
the correctness of the patient name, the type/name of the
W surgical procedure, the laterality of the incision (left,
right, or midline), and the laterality of the pathology
(left, right, or midline), and for confirming that the
proper instrumentation and any surgical implants are
present and accounted for. It will
be understood that
the confirmation and signature label 16 may be customized
for the same or other surgical uses, and thus is not
limited to the specific representation depicted herein.
Thus, in alternative embodiments, the checklist may call
for the same surgery-related information of the depicted
embodiment, only some of this information, or additional
information.
Preferably, the confirmation and signature
label 16 is adhesive-backed and has a pull tab so that it
can be easily removed from the container 12 and, if
desired, placed in the medical record (the patient's
record/chart/file) after it has been signed and removed.
In addition, the container 12 preferably has
instructions for use prominently displayed on it. For
example, in the depicted embodiment the instructions are
marked on an adhesive-backed label 40 that is applied to
the container top 20. Alternatively, the instructions
may be printed or otherwise marked directly on the
container 12 or elsewhere, or they may be omitted.
Referring additionally to FIG. 10, the
container 12 preferably has an adhesive-backed label 42
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applied to the container top 20 to cover and hold a pen
44 within a recess 46 formed in the container top 20.
The pen 44 preferably has two marking tips 48 and 50 at
opposing ends. A
writing tip 48 is similar to a
conventional ink pen for filling in and signing the
confirmation and signature label 16. And a surgical tip
50 is similar to a conventional surgical pen with
indelible ink for pre-operatively marking the surgical
site on the patient's body, and optionally for the
W signature of the surgeon. In alternative embodiments, the
pen 44 may be removably attached to the container 12 by
hook-and-loop fasteners or other conventional attachment
structures; the pen 44 may be a conventional one-tipped
ink or surgical pen, or it may be omitted. In addition,
a small measuring ruler may be included in the recess 46
or provided (e.g., etched, printed, or otherwise applied)
on the container, for example, at location 52 (FIG. 4).
The bottom 18 of the container 12 preferably
includes a number of internal compartments (collectively
referred to as the compartments 54) defined by the
internal divider walls 38. The size, shape, and
configuration of the compartments 54 are selected for the
surgical implements desired to be held in the container
12, and as such may be customized depending on the
surgery and the surgeon. In the depicted embodiment, the
container 12 has a first compartment 54a that is pre-
loaded with a syringe 56 containing a local anesthetic
such as lidocaine, and a second compartment 54b that is
pre-loaded with one or more surgical blades 58, such as
Number 10 and 15 scalpels. It will be
understood that
the container 12 may be provided with both the syringe 56
and the blades 58, with only one of these, and/or with
other surgical implements such as packets of surgical
needles. In
alternative embodiments, the compartments
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are sized, shaped, and configured for including other
types of blades, handles for the blades, disposable
single-unit scalpels, a syringe with another local
anesthetic, arthroscopic probes, and/or other surgical
implements needed to start the case. In
addition, the
second compartment 54b for the blades 58 may have a sheet
of foam lining.
Referring additionally to FIG. 11, the depicted
container 12 has a third compartment 54c and a fourth
compartment 54d that are sized, shaped, and configured
for storing used syringe and suture needles 60 and 62
after they have been used in the surgery. The
compartments 54c and 54d are preferably each lined with
an attachment sheet 64 and 66 that holds the used needles
in place and that has numbered spaces for ease in
counting the used needles. For
example, the attachment
sheet 64 and 66 may be made of a foam and/or magnetic
material.
In addition, the first compartment 54a can be used for
miscellaneous purposes such as holding unused suture
packages 68 so they are readily accessible as needed
during the surgery. Thus, it
will be noted that the
container bottom 18 of FIG. 10 is shown just opened and
ready for use, and the container bottom 18 of FIG. 11 is
shown in the midst of use during the surgery.
A method of using the system 10 to prevent
wrong-site surgeries will now be described. The
container 12 is provided in the closed, locked position
of FIGS. 1 - 3, preloaded with one or more surgical
implements needed to start the surgery. The confirmation
and signature label 16 prevents accessing the lock member
24, so the surgical team must deal with the label before
it can unlock and open the container 12 to start the
surgery. This
effectively forces a pause or "time out"
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before the surgery can commence, thereby prompting the
pre-operative assessment. At this
time, the surgical
technician who is starting the case fills out the
checklist on the label 16. For
example, when using the
confirmation and signature label 16 of FIG. 8, the
surgical technician checks for the correct patient being
present, the correct type/name of the surgical procedure,
the correct laterality of the incision (left, right, or
midline), the correct laterality of the pathology (left,
right, or midline), and the presence of the proper
instrumentation and/or needed surgical implants. The
attending surgeon then confirms all the information
written on the confirmation and signature label 16 by the
surgical technician and signs his name to indicate that
he/she has personally reviewed and confirmed the
information to be correct. Then the
surgeon (or the
technician) removes the confirmation and signature label
16 from the container 12, removes the lock member 24 (or
otherwise actuates the lock mechanism to unlock the
container), and opens the container 12 (see FIG. 4) to
access the surgical implements in the container. The
removed confirmation and signature label 16 can be placed
in the medical record to document that the "time out" and
confirmation was performed. At this
point, the surgery
start time is recorded, and surgery is considered
started.
The individual hospital's operating room policy
preferably requires the operating/attending surgeon to
open the box him/herself, and/or to sign his/her name
prior to making incision. In this
way, the system 10
forces the surgical team to pause at the same time in
every case (namely, just prior to incision), to ensure
that the correct surgery is being done, on the correct
side, to the correct patient, and that all needed
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surgical instrumentation or implants are available. It
will be understood that other surgical systems that
include a container for surgical implements and a
confirmation and/or signature label that is positioned to
block or impede opening of the container to force a pause
just before the start of a surgery, but not specifically
described herein, may be used with the system to
accomplish the functionality described herein. It should
also be noted that the system 10 is not meant to replace
W current pre-operative measures to prevent wrong-site
surgery (Le., all of JHACO's advice/recommendations),
though it could, but rather it is designed to supplement
those measures by providing a last chance to prevent
wrong-site surgery by forcing the pause just before the
incision.
The uniqueness of the system 10 provides
additional safety features. One of these safety features
relates to the "neutral zone," which is generally
considered to be the area between the surgeon and the
surgical technician, where the surgeon's hands and the
surgical technician's hands are supposed to never meet.
But in practice, this is a general and undefined area,
and it can expand, shrink, and shift as the surgeon and
technician lean over, turn slightly to one side, and/or
shift their weight during the course of the surgery.
Because of this, and because of the focus on the patient
and the surgical procedure, occasionally the surgeon and
technician stick each other when passing sharp
instruments back and forth.
Referring additionally to FIG. 12, after the
container 12 has been opened to start the surgery, the
container top 20 may be inverted and placed on a cart or
other horizontal surface between the surgical technician
70 and the surgeon 72 as they face the operating table
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74. As described above, the top surface of the container
top 20 and the bottom surface of the container bottom 18
preferably have gripping features so that they do not
slip and move during the surgery. In this position, the
container top 20 defines a clearly demarcated, lateral
neutral zone 76 where hands are not allowed to meet. When
the surgeon 72 is done with a sharp instrument, he can
simply place it in the neutral zone, that is, in the
upside-down container top 20. The surgical technician 70
can likewise add or remove sharp instruments to or from
the inverted container top. By the
surgeon 72 and the
surgical technician 70 never actually handing each other
sharp instruments, but instead having a clearly defined
neutral zone 76 for indirectly passing sharps to each
other, the incidence of needle sticks can be reduced.
Furthermore, the container bottom 18 may be
placed on a cart or other horizontal surface beside the
surgical technician 70 (e.g., on the opposite side of the
container top 20) or elsewhere in a position that is
convenient for the technician. With the container bottom
18 accessible to the technician 70, he/she can use the
container bottom during the surgical case to store all
the used sharps (e.g., scalpels, needles), as shown in
FIG. 11, similarly to how the technician would normally
use a conventional sharps box or needle holder or
counter. The container 12 or at least its top 20 may be
red in color, similar to a conventional sharps box, to
help minimize the likelihood of needle sticks.
Alternatively, another color such as purple or opaque may
be used.
Moreover, at the end of the case, all the
sharps used during the surgery can be put in the
container 12, and the container can be closed and safely
disposed of. The detents or other snapping structures of
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the container 12 hold the container closed. In addition,
the lock mechanism 14 may be provided with detents or
other snapping structures so that the lock member can be
reinserted to secure the container 12 closed. This way,
all of the surgical sharps used during the case can be
safely disposed of as a single unit.
Turning now to FIGS. 13 and 14, there is
illustrated a surgical system 110 according to a second
example embodiment of the present invention.
Similarly
W to the system 10 of the first example embodiment, the
system 110 includes a container 112 with a bottom 118 and
a top 120, a lock mechanism having a lock member 124 that
is received in alignable first opening 126 (not shown)
and second opening 128, and a number of divider walls 138
forming compartments 154 for the surgical implements. In
this embodiment, however, compartment 154b extends all
the way across the container bottom 118, and compartments
154a, 154c, and 154d each have the same length. In
addition, the foam sheet inserts 64 and 66 for the
compartments are configured for the different arrangement
of the compartments.
Turning now to FIG. 15, there is illustrated a
surgical system 210 according to a third example
embodiment of the present invention. The
system 210 is
similar to that of the above-described embodiments,
having a container 212 with a bottom 218 and a top 220
and a confirmation and signature label 216. In this
embodiment, however, the label 216 is positioned
extending across the bottom 218 and top 220 of the
container 212 to hold it closed. In this
way, the label
216 also functions as the lock mechanism, so a separate
lock mechanism is not included. In use, after the label
216 is filled out, signed, and removed from the container
212, the container can be opened to start the case
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without additionally having to remove a separate lock
member.
Turning now to FIG. 16, there is illustrated a
surgical system 310 according to a fourth example
embodiment of the present invention. The system
310 is
similar to that of the first embodiment, having a
container 312 with a bottom 318 and a top 320, and a lock
mechanism 314 with a lock member 324 received in two
alignable lock openings 326 and 328. In this embodiment,
however, the lock member is a plastic tie wrap or a
twisty tie, and the alignable lock openings 326 and 328
are defined in tabs extending from the exterior of the
container. In
addition, the system 310 may include a
spare tie 324 for relocking the container 312 after use
for safe disposal. In an
alternative embodiment, the
lock mechanism is provided by a conventional slide-lock
or snap-lock mechanism similar to that of commercially
available surgical sharps boxes.
Turning now to FIG. 17 and 18, there is
illustrated a surgical system 410 according to a fifth
example embodiment of the present invention. The system
410 is similar to that of the second embodiment, having a
container 412 for surgical implements and a confirmation
and/or signature label 416 for use and removal just prior
to starting the surgery. In this
embodiment, however,
the lock mechanism is provided as a wrapper 414 with the
label 416 on it. The wrapper 414 is preferably made of a
clear plastic material and has a circumferential opener
strip 415a with a pull tab 415b formed into it, similar
to the wrapper, opener strip, and red pull tab on some
conventional compact disc cases. The
label 416 is
preferably positioned on the wrapper 414 over the pull
tab 415 so that when the label is peeled off, the pull
tab 415b is pulled and the opener strip 415a is pulled to
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partially open the wrapper. The
label 416 can be sized
and shaped so that it wraps all the way, or most of the
way, around the container 412, so that in order to remove
the wrapper 414, the label must first be removed, thereby
prompting the pause for the pre-operative assessment.
In the embodiments described herein, all of
these components are sterilized so that the surgeon can
sign the label at the operating table immediately prior
to starting the surgery. To
maintain the wrapper in
sterile condition, a removable outer wrapper 478 is
preferably provided that encloses the sterile components,
as shown in FIGS. 17 and 18.
In other example embodiments, the system is
provided with a container for surgical implements and a
confirmation and/or signature label removably attached to
the container, but without a lock mechanism for the
container or with a lock mechanism that is not covered by
the label. Instead,
the label is positioned directly or
indirectly on the container to merely impede opening the
container; that is, the label is in a prominent position
so that it is not easily overlooked and it thereby
prompts the surgical team to conduct the pre-operative
assessment. Such
embodiments are provided by the first
example embodiment modified without the lock mechanism,
and the fourth example embodiment modified with the label
on the container top only.
In still other alternative embodiments, the
system includes a container with a scalpel (or other
surgical implement) in it, with another way of forcing a
pause without filling out a label. For
example, the
system can include a .lock mechanism for the container
that by itself forces the pause. The lock can be a small
combination lock, with a combination that only the
circulating nurse knows. The
doctor and scrub tech
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confirm that they have the right patient and the right
operation, and relay that information to the circulating
nurse, who then confirms the information and gives them
the code to open up the combination lock.
Referring to Figures 19A-25, an alternative
embodiment of a surgical system in accordance with the
present invention is described. The surgical system 500
has many similarities to that of the above-described
embodiments. The
surgical system 500 contains a
container 512 which is preferably adapted to be trackable
and/or can electronically communicate with other
components of the system 500. The
ability to be
trackable and/or electronically communicate with other
components of the system 500 allows the users of the
surgical procedure the ability to continuously monitor
and check that the scheduled surgical procedures for a
patient is correct, thereby extending the prevention of
wrong site surgeries to multiple patient-medical
representatives interactions.
The container 512 has a top 514 and a bottom
516 secured together to provide an interior compartment.
The interior compartment is designed to hold surgical
instruments, such as described in Figures 4, 10, or 11.
The interior compartment is designed to hold pre-loaded
surgical instruments specific for each surgical
procedure. As part
of the system 500, one or more
labels, similar to the labels as described previously,
for example label 16 described and illustrated in Figure
8. The label
must allow at least the surgeon, or other
surgical team members, to fill in the surgical-site
information within an input field of the label, i.e. the
surgical-site information to conduct a pre-surgery
assessment confirming the correct surgical site.
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The container 512 has a locking mechanism,
illustrated herein as a pin member 518 sized and shaped
to slidably engage and/or be positioned within the top
514 where at least a portion of the pin member 518 is
secured within an opening positioned within the bottom
516, as described in Fig. 4-6.
Alternative mechanisms
for locking the container 512 may include conventional
slide-lock or snap-lock mechanism similar to that of
commercially available surgical sharps boxes or other
previously described mechanisms. Whatever
mechanism
locks the container 512, the label must cover and/or
prevent the locking mechanism from opening prior to the
removal of the label. To aid
the user in signing the
label, the top 514 of the container 512 may contain a
recessed holding area 520 sized and shaped to hold a
writing utensil, such as a pen 522. To retain
the pen
522 within the recessed holding area 520, a writing
utensil locking member, illustrated herein as two
parallel and spaced apart finger-like extensions 524 and
526, are secured to the bottom surface 527 of the
recessed holding area 520. The
finger-like extensions
524 and 526 have some elasticity so that when the pen 522
is inserted between the two finger-like extensions 524
and 526, both move apart. Once the
pen 522 is fully
inserted within, the finger-like extensions 524 and 526
snap back to their original position, securing the pen
522 in place.
To allow for monitoring and/or tracking,
positioned on or with the container 512 is a tracking
and/or monitoring mechanism using, for example, a data
capture and/or display device or system or other digital
information options, illustrated herein as a bar code (an
optical machine-readable representation of data) 528
preferably a Universal Product Code (UPC). The UPC can
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be programmed with various patient identifying
information similar to that of the labels described
previously, including the patient name or other
identification means, type of surgery, site of surgery,
and physician name. As such, when a physician or medical
support team member scans the bar code 528 with a bar
code reader or scanner, they will be able to view the
information. Alternatively, the container may use a two
dimensional bar code, such as a Quick Response Code (QR
code), which is adapted to be read by an imaging device,
such as a camera.
Referring to Figure 21, the container 512 is
shown using an alternative embodiment of a tracking
and/or monitoring mechanism using, for example, a data
capture and/or display device or system, illustrated
herein as a radio-frequency identification (RFID)
transponder 530. The RFID
transponder 530 generally
comprises a chip for storage and/or processing, an
antenna for transmitting and receiving information, and
an inlay for supporting the chip and antenna. While any
RFID transponder known to one of skill in the art may be
used, the RFID transponder 530 may be an active tag
having a battery which runs the microchip circuitry, or a
passive tag without a battery and using a RFID reader
which is designed to send electromagnetic waves to induce
the tag's antenna to power the microchip circuitry. The
transponder 530 may be a read-only tag which contains
data pre-written thereon, a write-once tag which allows
the user to write data to the tag one time, or a full
read and write tag which enables the user to write new
data to the transponder as needed.
The inlay may be a substrate film which can
support and hold the chip and antenna.
Alternatively,
the inlay can be a label or tag having self adhesion
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coating to ensure that the RFID chip and antenna adhere
to a surface. The
inlay may be embedded in plastic
castings or casted in polyurethane resin coatings.
Figures 22-25 illustrate examples of the
container 512 having additional features. Figure 22
shows the container 512 having an additional recessed
storage area 532 adapted to store a data storage device,
illustrated herein as a flash drive 534. The flash drive
534 preferably contains information relating to the
patient that can be transported wherever the container
512 travels, i.e. from the initial pre-op discussion to
the surgical room. Figure
23A and 23B illustrates a
container 512 converted to a "smart" container. The top
514 is adapted to include a central control unit 536
including, for example, a processor 538, memory 540,
graphic processing unit 542, GPS functioning 544, and
Bluetooth wireless capability 546. The
central control
unit 536 can be powered by a battery 550 and electrically
connected to a display unit 552, such as an LED screen
554, see Figure 23A. Data input devices, such as buttons
558 or a keyboard (not shown), may be included to allow
the user to input data. The
container 512 may also
contain a connection point, illustrated herein as a USB
port 560 to allow for transfer of data from the central
control unit 536 to a flash drive or a computer system
via cables.
Figures 24 and 25 illustrate rapid
identification features of the container 512. As part of
the overall surgical system 500, the containers are
designed to provide easy and rapid visualization using a
visual indicator to alert the surgical team as to which
side (left or right), sometimes referred to as
"laterality", of the patient a surgical procedure is to
take place. As shown in Figure 24, the container 512
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includes all or at least a portion of the top 514, the
bottom 516, and the locking pin 518 having a color coding
of some shade of red, illustrated herein as pink/rose
color hash markings, to indicate a right side surgical
procedure. The
locking mechanism is preferably colored
as well. Figure
25 illustrates the container 512, and
locking pin 518, having a left side surgical procedure
indicator, illustrated as a purple based color, see
broken line hatchings, preferably a lavender color.
Alternative visual indicators may include symbols,
letters, words or phases. In any embodiment, the surgeon
or surgical team member can easily ensure that the
position of the surgical site or laterality aligns with
the color of the container 512.
Figures 26-28 illustrate the pin member 518
adapted to contain additional features that enhance the
tracking and/or can electronic communication with other
components of the system 500. As
illustrated in Figure
26, the tab 560 contains a bar code 528 secured to the
side surface 562. Figure 27
illustrates a top view of
the pin member 518 showing an RFID transponder 530
secured to the top surface 564. Figure 28 illustrates the
pin member 518 having a tab recessed receiving area 566
sized and shaped to receive a data storage device such as
flash drive 534.
With the ability to track and/or communicate
with other components of the surgical system, the
container 512 can be used in multiple time periods within
the entire surgical procedure, including pre-
hospitalization/surgical period, the day of pre-surgical
procedure in the pre-op holding area, and the actual
operating room. The
systems, devices and methods in
accordance with the present invention are designed to
prevent wrong patient, wrong site, wrong side surgery by
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providing multiple steps of protection at multiple time
points when the patient is passing through the surgical
procedure environment, see Figs 29A and 29B. As
described herein, the use of the term "surgical procedure
environment" or surgical procedure" defines any period
when the patient is interacting with his/her medical team
or medical team associates including but not limited to
office personnel, nurses, medical technicians, surgeons.
The time period of interaction includes pre-
hospitalization and hospitalization, including pre, post
and during a surgical operation.
Pre-Surgical Booking
Ensuring the prevention of wrong site surgeries
begins as early as the initial steps of the surgical
procedure. At the time of surgical booking, errors can
be initiated and perpetuated all the way through the
actual surgical procedure. The system and methods of the
present invention start when the surgeon's office
schedules the surgery with the patient, see step 610. At
the time the surgery is scheduled by the hospital, the
patient's name and information are associated with a
container, preferably a trackable one such as container
512.
The container 512 may be provided with a unique
container identification number, similar to a vehicle
identification number (VIN) used for automobiles. The
container identification number (CIN) may be established
at the time of manufacture and remains with a particular
container. This number is unique to the container in
that the number is never reused and never applied to
different containers. The
unique identification numbers
can be integrally formed into the container or may be
attached to the container as part of a separate label, or
part of the QR/Scan codes. Once the
unique number is
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assigned to a container and/ or is then further
correlated or associated to a particular patient, the
container as well as the patient information coupled to
it is serialized. This
allows for the container to be
tracked and analyzed as it moves through the medical
system. In cases in which a patient has been determined
to have wrong information, i.e. the patient should have a
right side surgery, but the box is coded for a left side
surgery, the container is destroyed and the reason(s) for
its destruction is electronically attached to the unique
number. This
allows for hospitals or manufactures to
review all containers manufactured or scheduled for a
medical procedure to determine how many were actually
used in such surgical procedures. For
those containers
not used, reasons as to why containers failed to be used
in a medical procedure, potential errors
(incorrect/inaccurate manual inputs), or wrong site
surgeries/never events can be reviewed, providing insight
as to when, where, and why surgical mistakes were made.
Periodical reviews of such data allows hospitals an
ability tom identify areas that need improvement.
If the patient is undergoing a surgical
procedure which requires the surgeon to perform a
procedure on a particular side, a color coded container
512, such as those described in Figures 24 and 25, is
associated with the patient, see 614. For
surgical
procedures that do not require laterality, the container
512 will be a neutral color, such as gray.
Alternative embodiments of the medical system
500 may include the use of a non-sterile outer box 521,
see Fig. 19B having an upper portion 523 securable to a
lower portion 525 which houses the container 512.
Preferably, the outer box contains tracking and/or
electronic communications mechanisms, such as a bar code
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or RFID tag. The outer box 521 may also be color coded
to match the color of the container 512. In this manner,
the container 512 can be transported to various locations
and/or handled by the surgical team while on route to the
operating room without concerns of contamination. In
addition to color coding or matching, various patient
related information, such as for example the patient's
name, history, surgical procedure, side of surgery,
associated color coding is encoded to an identifying
W label or tag label, such as a bar scan.
At the time of the surgical procedure, the
container 512 is delivered to the patient at the pre-
operation holding area, see 618. At this point, numerous
opportunities are available to confirm that the patient
will undergo the correct surgical procedure at the
correct site, see 620. When the surgeon visits with the
patient to discuss the surgery, and possibly mark the
site of surgery, the surgeon 622A and the patient 622B
and will confirm the site of surgery.
Additional
surgical team members may also perform surgical procedure
checks. For
example, the prep nurse 6220, and the
operating room nurses 622D, may confirm the patient's
information is correct by matching the patient
information to the information of the scan bar. As such,
the surgeon 622A, prep nurse 6220, and the operating room
nurses 62D may scan the bar code using a bar code reader.
If the information matches, the patient
continues with the medical procedure process. As part of
the system 500, when a scan of the bar code is performed,
the information may be displayed (i.e. surgical procedure
for right side would be displayed with at least a rose
color that matches the rose color of
the container 512)
with a matching color background so that the medical
professionals can easily, quickly visually confirm
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laterality.
Determining or confirming surgical
procedures and/or location at this point prevents any
mistakes made at the surgeons' office or by the hospital
scheduler when scheduling the procedure. In
addition,
all members of the surgical team are aware of what
procedure needs to be performed on the correct patient,
and on what side the procedure is to occur. If the
surgeon or surgical team member determines the surgery
was not scheduled correctly, a new container 512 with the
correct information will be ordered and brought back to
the pre-operation holding area, see 624.
Once the patient information has been
determined to be correct, he/she will be transferred to
the operating room. At this point, the patient will be
checked in, see 626. At check in, patient information is
verified and may be checked against the bar code
information of the container 512, see 628. The operating
nurse will put in the information in the electronic
health record, see 630. This information must match the
information already in the electronic health records. If
any information is incorrect, the electronic health
record can be put on hold, or on "freeze" so that any
individual accessing the record would know that the
patient must not undergo any surgical procedures, see 632
and 634.
Once a determination has been made the
information matches, i.e. it is the correct patient, it
is the correct surgery and correct surgical site,
container 512 is presented to the surgeon, see 636. If
the container 512 is placed in an outer box, the surgeon
simply removes the outer box and opens container 512. In
either case, once the patient is prepped and draped, a
formal and final timeout is performed by the members of
the surgical team, see 638. The
surgeon fills in the
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label, see 640, either a label such as 16 or scans the
bar code 530, placed over the locking mechanism of
container 512 and pulls it off, see 642. The system 500
can be adapted to allow the surgeon to perform electronic
signatures, which can then be transferred to the
patient's chart. If the
container 512 contains a flash
drive or other memory storage device, the surgeon or
nurses could use such device to match the patient
information in the electronic health record. If any
information does not match, a freeze could ensue, warning
those involved with the surgery to stop any further
proceedings. He/she
can now open the container 512 to
gain access to the surgical equipment therein and begin
surgery, see 644.
Referring to Figure 30, the present invention
is shown linked to a smart surgery room. For
example,
the container 512 located in a surgical room 700 may
contain a container control panel such as control panel
554. Within
the surgical room 700, an information
reader, such as a RFID reader 702 is located to read the
RFID tag 530. The
container control panel 554 is
preferably electronically connected, via wired or
wireless technology, to a hospital or central control
unit 704 having one or central computers 705 outside the
surgical room 700. The control
unit could be a manned
station functioning similar to a flight control tower.
Alternatively, or in addition to, the container control
panel 554 may be in electronic communication with a
surgical room control unit 706 having at least one
computer 707 located within the room. Individuals
manning the control unit 704 may provide the surgeon
within the surgical room 700 clearance to proceed with
opening the container 512 based on the information
received from the container, using, for example, a
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radiofrequency device. Based on
the information
received, the container may be opened remotely using an
electronic lock 710 on the container 512. Preferably, the
lock would be electrically coupled or in communication
with the hospital control unit 704 and/or the surgical
room control unit 706.
Additional features of the system may include
container 512 and/or the surgical equipment having LEDs
attached thereto to allow for tracking by optical or
camera guided navigation systems. In addition
to the
above described features, it is understood that the
container 512 may include or be adapted to include one or
more features described previously, whether as part of a
system or as a feature of a container embodiment.
In addition to providing a timeout, the medical
system 500 allows for tracking of errors from pre-
hospitalization to the actual surgical procedure. This
provides a hospital valuable data as to where errors or
possible errors may have occurred.
Accordingly, the present invention provides a
number of advantages. In particular, the system and
method of the invention insure a final confirmation of
the correct patient, procedure, site, and as applicable,
implants or instrumentation, is performed thoroughly and
consistently, immediately prior to allowing incision to
be made. The marking of the surgical site, the required
use and removal of the confirmation checklist before
accessing the surgical blades needed to start the
surgery, and the resulting open communication between the
patient, the surgeon, and the operating team, all
contribute to reducing wrong-site medical errors. In
addition, the surgical container provided by the
invention can be used as a needle box for sharps disposal
at the end of the case, and as a neutral zone during the
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case to decrease the incidence of needle sticks or
lacerations from the surgeon and the surgical technician
handing each other sharp instruments such as scalpels or
needles. Furthermore, use of the invention can actually
be extended to other areas of the hospital where an
incision might be made, such as in the interventional
radiology suite, the intensive care unit, or the
emergency room.
Referring to Figures 31-38, an alternative
embodiment of a container 810 is shown. The
container
810 has a top 814 and a bottom 816 secured together to
provide an interior compartment. The
interior
compartment is designed to hold surgical instruments,
such as described in Figures 4, 10, or 11. The interior
compartment is designed to hold pre-loaded surgical
instruments specific for each surgical procedure. One or
more labels, similar to the labels as described
previously, for example label 16 described and
illustrated in Figure 8, can be secured to the container
810. The label must allow at least the surgeon, or other
surgical team members, to fill in the surgical-site
information within an input field of the label, i.e. the
surgical-site information to conduct a pre-surgery
assessment confirming the correct surgical site.
The container 812 has a locking mechanism,
illustrated herein as a pin member 818, similar to pin
518, sized and shaped to slidably engage and/or be
positioned within the top 514 where at least a portion of
the pin member 818 is secured within an opening
positioned within the bottom 516, as described in Figs.
4-6. A ring
819 is secured to or integrally formed to
the pin member 818, acting as a mechanism for grabbing
and pulling the pin member 818 out.
Alternative
mechanisms for locking the container 812 may include
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conventional slide-lock or snap-lock mechanism similar to
that of commercially available surgical sharps boxes or
other previously described mechanisms. Whatever
mechanism locks the container 812, the label must cover
and/or prevent the locking mechanism from opening prior
to the removal of the label.
To aid the user in signing the label, the top
814 of the container 812 may contain a recessed holding
area 820 sized and shaped to hold a writing utensil, such
as a pen 822. To retain the pen 822 within the recessed
holding area 820, a writing utensil locking member,
illustrated herein as two parallel and spaced apart
finger-like extensions 824 and 826, are secured to the
bottom surface 827 of the recessed holding area 820. The
finger-like extensions 824 and 826 have some elasticity
so that when the pen 822 is inserted between the two
finger-like extensions 824 and 826, both move apart.
Once the pen 822 is fully inserted within, the finger-
like extensions 824 and 826 snap back to their original
position, securing the pen 822 in place. A plurality of
vents, 828, are used to allow for release substances,
such as heat/steam when the device is sterilized.
Adjacent to the recessed area 820, is a second or
extended recessed area 830 which contains a securing
mechanism, illustrated herein as a compression member 832
which may be used as a compression point for surgical
equipment, such as surgical blades stored thereunder.
In addition to the above described features, it
is understood that the container 810 may include or be
adapted to include one or more features described
previously, whether as part of a system or as a feature
of a container embodiment including but not limited to
monitoring and/or tracking or color coding features.
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It is to be understood that this invention is
not limited to the specific devices, methods, conditions,
or parameters described and/or shown herein, and that the
terminology used herein is for the purpose of describing
particular embodiments by way of example only. Thus, the
terminology is intended to be broadly construed and is
not intended to be limiting of the claimed invention. For
example, as used in the specification including the
appended claims, the singular forms "a," "an," and "the"
W include the plural, the term "or" means "and/or," and
reference to a particular numerical value includes at
least that particular value, unless the context clearly
dictates otherwise. In addition, any methods described
herein are not intended to be limited to the sequence of
steps described but can be carried out in other
sequences, unless expressly stated otherwise herein.
While the invention has been described with
reference to an example embodiment, it will be understood
by those skilled in the art that a variety of
modifications, additions and deletions are within the
scope of the invention, as defined by the following
claims.
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