Download Final BMEIdea Project Submission

University of Pittsburgh Dept. of Bioengineering
Intravenous Infusion Simulation
BMEIdea Project Submission
Russell Bregman, Jon Grasman, Craig Lehocky, Adam Scharl
Advisor: Dr. Joseph T. Samosky
April 22, 2008
Revision 4
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Contents
3..……………………………………………………….….…………..Executive Summary
3………………………………….………….…………………….…………..Problem
3………………………………….………………………………….…………Solution
4………...……………………..……………..…….Competition and Differentiation
4………………………………………...……..…..Regulatory and Reimbursement
4…………………………………………….…………….……..Sales and Marketing
5...………………………………………...………………….………….…….……Motivation
5…………………………………………………………………….…..…..Project Objective
6….……………………………………………...…..…..Applicable Standards and Risks
6….……………………………………………….…………………Initial Design Prototype
6…...………………………..…Computation Center and Drug Selection Software
7……..…………………………………………………Flow Measurement Hardware
8……………………………….Flow Measurement Software and Visual Feedback
9...…………………………………………….………………….Verification and Validation
10…...……………………………………………Drug Selection System Verification
10…...………………………………..…Verification of Infusion Rate Measurement
12…...……………………………………….……..…Simulated Clinical Use Testing
16…………………………………………………….Patent and Prior Art Considerations
17……………………………………………..…..……...Anticipated Regulatory Pathway
18..…………………………………………....…….…….Estimated Manufacturing Costs
19...………………………………………….……Marketing Analysis and Sales Strategy
20…..……………………………………………….....…………….…………...…References
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EXECUTIVE SUMMARY
Problem
Iatrogenic, or physician-induced, errors are rampant in the hospital setting and
consistently rank as one of the top three leading causes of death in America. In the year 2000,
nearly 225,000 deaths were attributed to medical errors. One of the major sources of error is
from drug delivery. It is estimated that nearly 1.5 million patients are injured due to improper
drug delivery each year1. Common drug delivery errors include use of the incorrect drug and
injection of a bolus of medication into an intravenous (IV) line at an incorrect rate. The former
error poses the obvious risks of aberrant reactions to the wrong medication, while the latter can
cause an overdose due to the specific medication’s diffusive properties within tissue.
Administration of the incorrect drug can often be a result of hasty procedure. However, the
requirement for medical staff to accurately gauge correct infusion rates for medication is an
insufficiently trained skill.
Medical simulation training offers healthcare workers the opportunity to practice and
improve day-to-day procedures without the chance of harming human beings. Currently, there
is no combination drug selection and infusion rate sensor system that accurately mimics the
clinical setting.
Solution
The Intravenous Infusion Simulation (IVIS) was developed to allow current and future
hospital staff the chance to develop the muscle memory and intuition for infusing drugs at
different rates. The IVIS is a self-contained drug infusion rate sensor for various drugs which are
required to be infused at different rates. The main goals of the IVIS are to allow an
administrator to select the drug being administered, provide real-time feedback to the user on
the accuracy of the injection rate, and store data such as infusion rate and dosage amount from
the procedure offline for post-simulation analysis.
The IVIS utilizes a drug database that can be expanded by the user to store information
on drug infusion parameters. In conjunction with an infusion rate measurement system, the
IVIS uses this information to compare the real-time infusion rate with recommended values of
administration for the specific drug being simulated. These calculations are performed within a
LabVIEW virtual instrument to provide an easily understood user interface for the system. The
IVIS essentially relies on two flow “sensors”. The first is an actual Pelton wheel flow sensor
downstream from the infusion site. The second is the infusion pump, the value of which is
entered into the IVIS program as the background flow rate, in essence acting as another sensor.
In addition to comparing drug delivery performance of the user at a computer terminal,
the IVIS provides an intuitive user feedback system that is integrated with the IV equipment.
The simulation includes a RGB LED element which provides real-time visual feedback to the
user based on current drug delivery performance, allowing for the development of the correct
muscle memory. This real-time feedback, along with the storage of drug administration data
offline for post-simulation analysis, provides a strong educational tool for the medical simulation
industry.
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Competition and Differentiation
Current drug recognition systems, including those used by leading simulation company
Medical Education Technologies Incorporated (METI), rely on barcode scanning. Individually
labeled syringes with unique barcodes for each drug are scanned when the user introduces the
syringe to an injection site equipped with a scanner. The METI package comes with a software
database in which many drug identities are pre-programmed.
The barcode approach was considered for IVIS drug recognition. However, personal
consultation with clinicians has revealed that active drug recognition, such as scanning a
barcode before injection, introduces another step to the IV injection procedure that is not
clinically realistic. Additionally, several errors may result, such as improperly labeling the
syringe or drug vial. The IVIS relies on drug selection in the virtual instrumentation by the
administrator of the simulation. This is to ensure the integrity of the flow sensor, to keep the
simulation as realistic as possible, and to avoid introducing unnecessary steps.
The METI model also measures rate of injection at the infusion site of direct injections,
but does not for an IV apparatus simulation. Thus, many design alternatives were considered
before deciding upon the current model. Directly measuring the infusion rate at the injection site
with extremely sensitive flow sensors would provide the most accurate recordings. Also, adding
a third flow sensor to the other two sensors at the bag and patient sites could allow for a second
confirmation of the infusion rate through calculation at the IVIS computing center. Once again,
the cost-benefit analysis combined with the budget of the project proved the current two-sensor
system to be the best option.
The combination of drug selection and accurate flow measurement in a self-contained,
affordable package makes the IVIS an attractive option for medical simulation centers.
Regulatory and Reimbursement
As a medical simulation device, and not necessarily a clinically operable device, the IVIS
does not specifically fall within Food and Drug Administration (FDA) regulatory guidelines.
However, if it were to be considered for future clinical use, it would follow analogous FDA
regulations for similar products. The IV flow measurement system could be compared to similar
IV medical devices. In order to prevent restriction of flow at any site within the apparatus, a
passive flow sensor would be required at the patient site. Assuming these conditions are met,
the IVIS would fall into an FDA Class II regulated device, as do common IV components such
as infusion pumps and IV administration sets. Such a device would require pre-market
notification [501(k)] before being introduced to the hospital environment. With the necessary
risks and human factors identified, human trials would be conducted to verify the safety of the
device.
Sales and Marketing
The IVIS will initially be marketed as a medical simulation. Medical simulation training is
increasingly becoming more popular in the United States as a method to quell medical errors.
Roughly 45 US medical schools, 8 international medical schools, 26 international anesthesia
sites, and 1 government training center have their own medical simulation environment. In
addition to medical training centers, health insurance providers are the target customers for the
IVIS. This population directly benefits from a better trained healthcare staff, which in turn not
only saves money, but more importantly saves lives.
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MOTIVATION
Drug delivery is a prevalent problem in the modern world of medicine. The Committee
on Identifying and Preventing Medication Errors estimates that as many as 1.5 million patients
are injured annually due to drug delivery errors.1 Indeed, in 2000, drug delivery errors alone cost
hospitals $3.5 billion.2 These healthcare providers, as well as their insurers, stand to directly
benefit from the reduction of these errors.
Most drug administration errors have been attributed to incorrect injection rates of a
bolus of medication. A drug such as furosemide can be delivered to the patient too quickly, in
which case it may cause serious harm. Conversely, a drug such as adenosine can be delivered
too slowly and thus will not achieve the desired effect. In addition, use of the wrong drug in IV
administration can lead to drastic complications for the patient.
These errors can be alleviated by use of a drug delivery simulation system, which
provides a means to educate healthcare workers and avoid careless errors that can occur in the
clinical setting. Currently, there is no such simulation system that can both measure the rate of
infusion and compare that measurement to known optimal rates without a complete redesign of
the administration equipment. A system that resembles a typical IV administration set allows
the simulation training to more easily translate into the clinical setting.
PROJECT OBJECTIVE
The goal of the Intravenous Infusion Simulation (IVIS) is to provide current and future
healthcare employees with a realistic intravenous drug infusion simulation in order to better train
these workers and decrease drug administration errors in the clinical setting. Specifically, the
IVIS aims to improve users’ ability to administer the correct drug at its recommended rate of
infusion. The IVIS provides real-time visual feedback to the user indicating optimal or
unacceptable drug delivery. This instantaneous feedback trains the user’s neuromuscular
facilitation, or muscle memory, to recognize desirable flow rate administrations. In addition, the
IVIS records several parameters offline such as identity of the drug simulant administered, total
volume administered, IV bag drip rate, and drug infusion rate across the entire trial. These
offline data also include the optimal infusion rate and tolerances for the respective drug
simulant.
To facilitate the most realistic training environment possible, the IVIS avoids interfering
with the common IV drug administration routine. The entire system is designed to resemble a
typical IV administration set as closely as possible. This allows the IVIS to record the infusion
rate without obtrusively modifying the IV apparatus, therefore providing a realistic simulation.
The IVIS allows healthcare professionals and pre-professionals to accurately attempt
drug infusions at variable rates before attempting these procedures on live patients. Through
medical simulation training with the IVIS, it is predicted that incidents of incorrect drug
administration and improper infusion rate will decline.
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APPLICABLE STANDARDS AND RISKS
FDA guidance highlights four main risk considerations in typical IV administration sets:
device malfunction, adverse tissue reaction, infection, and improper use. These risks are in
relation to the patient being treated with an IV administration set, and deserve consideration in a
cohesive simulation of drug delivery.
However, manufacturing and design practices
implemented with the IVIS have focused on user risk and causes of improper training rather
than direct patient injury.
The IVIS has been developed under the FDA Quality System Regulations (QSR). These
controls require complete documentation of the design process, the identification of risk posed
to the user, and any other considerations that relate to the safety and efficacy of the device.
These regulations have been adhered to through the creation and updating of a product design
specification, initial hazards analysis, verification and validation plan, and additional human
factors analysis.
The main source of risk for the IVIS stems from the effects of medical simulation training.
This type of training must present a realistic simulation device to the user, with which they
perform the tasks that they are learning or improving. An improperly designed device which
creates additional steps in the simulated medical procedure can not only result in poor training
performance, but can also result in a negative training effect that may be carried over to the
clinical setting. The design of an IV infusion simulation must, therefore, resemble a typical IV
administration set as much as possible, and preserve the conventional drug delivery method.
The measurements of the simulation system may also translate into a negative training
effect for the user. Each sensor and data acquisition unit that the system uses has been
verified and validated to the original product specifications. FDA guidance recommends bench
testing for mechanical components within IV equipment, which carries over to the mechanical
sensing equipment used in the IVIS as well as the software tools implemented within the
simulation.
INITIAL DESIGN PROTOTYPE
Computation Center and Drug Recognition Software
The IVIS comes equipped with a laptop computer (Dell Ension, Round Rock, TX), on
which the IVIS software is preinstalled. The program was developed using LabVIEW software
(National Instruments, Austin, TX). The drug selection software utilizes a database of drug
identities and their corresponding range of conductance values. The drug database also
contains pertinent information regarding each drug including nominal dosage parameters, such
as volume and rate of injection. The database was designed in Excel (Microsoft, Redmond,
WA), a widely used spreadsheet application, so that users may update the database at their will.
The user selects the drug to be simulated within the LabVIEW virtual instrument (Figure
1), which then refers to the supplied drug database (Table 1). This establishes the parameters
for proper drug infusion, and allows the system to compare these values to the measured rates.
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Flow Measurement Hardware
The injection rate of drugs at the injection port (F-site) is crucial for both the efficacy of
the drug as well as the well-being of the patient; optimal infusion rates vary depending on the
identity of the drug. For example, furosemide should be injected at a maximum rate of 20 mg
min-1, while haloperidol’s recommended injection rate is 2 mg min-1.
Figure 1. IVIS computer interface, designed in LabVIEW. At the top left is the drug selection database.
Selecting a drug brings online the optimal flow rate, which is displayed as a green line on the center
visual feedback area. The red line (maximal rate) and blue line (minimal rate) are controlled by the
tolerance input value. The white line displays the user’s infusion in real time.
Table 1. IVIS drug database.
Drug Name
Furosemide
Haloperidol
Famotidine
Hydrocortisone
Digoxin (undiluted)
Digoxin (diluted)
Optimal Flow Rate (mL min-1)
2
0.5
1
2.5
0.2
0.8
Optimal Dosage (mg)
30
10
50
20
1
1
Concentration (mg mL-1)
10
4
10
1
1
0.2
To avoid obtrusive modifications to the F-site, it was necessary to record flow rate above
and below the infusion site (refer to Figure 2). The first flow measurement is recorded at the IV
bag, and is controlled by an Alaris Infusion Pump (Cardinal Health, OH). The user manually
enters the flow rate of deionized water from the IV bag (QIV).
The second flow measurement is located at the patient site, which is downstream from
the injection site. This flow measurement records the combined flow of the drip rate and the
infused drug. A Pelton wheel flow sensor, Model 101 FLO-SENSOR (McMillan Company,
Georgetown, TX), is used to measure the total flow into the patient (Qpatient). These values are
collected in real-time and sent to a data acquisition device (USB-6009, National Instruments),
which relays the electrical pulses from the flow sensor to the computer.
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Figure 2. Diagram of the IVIS setup. Gray lines indicate electrical flow and black lines indicate fluid flow.
Flow Measurement Software and Visual Feedback
The IVIS computing center also contains flow calculation software, where the desired
output is the volumetric rate of injection of the drug (Qdrug). Using the continuous inputs of the IV
drip rate (QIV) and the amount of flow entering the body site (Qpatient), the flow measurement
software calculates the rate of drug injection. Assuming that solutions in deionized water are
incompressible and that fluid flow is continuous, the IV apparatus is modeled as a simple
electrical circuit in the sense that the drug and IV fluids are flowing into a node, with one output
to the patient. Kirchhoff’s Current Law states that all currents flowing into a node must equal the
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currents flowing out of a node, thus the rate of drug infusion is calculated by subtracting the IV
drip bag flow rate from the total flow rate into the patient (Equation 1):
[1].
As the trial progresses, each of these flow rates is recorded in an Excel data file for postsimulation analysis. Additionally, the IVIS calculates the total injected amount of drug. After the
drug is identified by the user, the initial concentration of drug, Ci, in the vial is brought online
from the drug database. The IVIS records the elapsed time of the injection, and integrates the
flow rate over time to determine the volumetric amount of drug injected, V (Equation 2). This
value is then multiplied by the initial concentration of the drug to determine the mass of the drug
injected, m (Equation 3).
[2]
[3]
The final component of the IVIS is the injection rate visual feedback. The drug selection
software and flow measurement software communicate together to implement this feature. As
mentioned previously, when the drug is identified by the user, parameters such as the drug’s
initial concentration and recommended injection rate are brought online. While the IVIS is
continuously calculating the injection rate at the F-site, it compares each value to the
recommended range of values for the drug being delivered. This difference is defined by the
IVIS in one of three ways: the infusion rate is within an acceptable range, below the acceptable
range, or above it. This range is drug simulant specific, based on the consequences of an
improper infusion rate for the specific drug type. The range, or tolerance, is controlled by the
administrator on the virtual instrument.
Based on this assigned value, the
IVIS provides a real-time visual feedback
feature consisting of a green, blue, or red
LED element located at the infusion site
(Figure 3). The green LED represents an
acceptable drug delivery rate, while the
red and blue lights indicate an infusion
that is above or below the acceptable
range of infusion rates, respectively.
Stereolithography
apparatus
(SLA)
prototyping was used to create a housing
for the LED at the infusion site (Figure 4).
The smaller hole of the housing is used to
hold the LED, while the second attaches
directly to the F-site.
Figure 3. Visual LED feedback at the injection site, as
shown during simulation training.
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Figure 4. Schematic drawing of customized LED Housing, designed in SolidWorks.
VERIFICATION AND VALIDATION
In order to verify the safety of the IVIS to end users, the device underwent the following tests.
These tests attempted to minimize the hazards listed in the device risk management summary
to a satisfactory level, as well as ensured that the device met or exceeded the device
performance characteristics detailed in the design specifications.
Drug Selection System Verification
The drug selection software is integral to the entire feedback system. Therefore, the
drug database and corresponding LabVIEW code were developed with absolute specifications.
The database contains the correct nominal infusion rates for each drug, and was obtained from
www.clinicalpharmacology-ip.com. These data were then validated by doctors of pharmacy in
order to ensure their accuracy.
LabVIEW code was developed in order to read from this database, and needed to
correctly translate the drug that is selected on the virtual instrument into the proper nominal
infusion rate. This code underwent 50 trials of selecting a drug at random, and verifying that the
correct infusion rate was returned to the LabVIEW code; all trials resulted in the proper
translation of the database into the virtual instrument. In addition, the virtual instrument includes
a display box for the nominal rate to serve as a last-minute check by the administrator.
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Verification of Infusion Rate Measurement
The frequency measurement algorithm developed in LabVIEW was first verified by using
a signal generator (CFG 253, Tektronix, Richardson, TX). The signal generator produced
signals at a range of 10 to 250 Hz, which were then confirmed as being similarly recorded by
the algorithm.
To verify proper performance of the flow sensor system, it was introduced to a constant,
known flow rate for 1 minute intervals. The trials included flow rates ranging from 10 to 20 mL
min-1, with 1 mL min-1 increments, and involved 5 trials for each flow rate. The resultant pulse
frequency generated by the McMillan flow sensor, and recorded with LabVIEW code at each
infusion rate, was plotted against the known infusion rate being delivered to the system as
confirmed by the Alaris infusion pump. These data verified the linearity of the flow sensor, and
provided a calibration curve with which to translate pulse frequency into a reportable
measurement of mL min-1 (Figure 5).
Figure 5. Calibration curve for background flow rates controlled by the infusion pump.
The calibration curve was fit with a linear trend line, and yielded the equation used for
determining infusion rate when recording pulse frequencies (Equation 4):
[4].
In addition to verification of the flow sensor accuracy, the system was evaluated for
sensitivity. Testing, once again, involved delivering a known, constant infusion rate to the
sensor. This test, however, used flow rates ranging from 13 to 13.25 mL min-1 at increments of
.02 mL min-1; each flow rate was evaluated 5 times. The resultant generated frequencies for
each flow rate were once again plotted against the known rate (Figure 6), and the resolution of
the system was obtained by determining the smallest range of rates that had non-overlapping
95% confidence intervals (p-value < 0.05); the resolution of the system was determined to be
.17 mL min-1. In essence, this means that we can be sure of our measurement within .17 mL
min-1 of the reported value.
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Figure 6. Sensitivity testing of the IVIS’ flow measurement capabilities determined
that the smallest increment that can be discriminated is 0.17 mL min -1 (error bars are
95% confidence intervals, p-value < 0.05).
A third aspect of IVIS verification involved the calculation of the dosage volume. A
syringe was used to infuse volumes ranging from 1 mL to 20 mL, with 3 trials at each volume.
The average of each volume measurement was taken, and a percent error was calculated (see
Table 2). While low volume amounts resulted in almost 10% error, larger volumes were not as
unreliable. However, error can also be attributed to the method of volume measurement, which
was performed with a syringe.
Table 2. Comparison between actual volume of fluid injected and
measured volume from the IVIS.
Calculated Volume (mL)
1.09
2.10
2.95
4.07
6.16
1.23
20.15
Actual Volume (mL)
1
2
3
4
6
10
20
Percent Error
9.2
5.1
1.8
1.8
2.7
2.3
0.8
Simulated Clinical Use Testing
Initial validation of the system occurred at a medical simulation center. The system was
used during simulation in-services with a selection of 10 nurses. Each situation was observed
in order to validate the safety and efficacy of the system. Characteristics of the system that
were considered included proper visual feedback and overall realism of the system.
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The visual feedback system was utilized by all nurses involved with the in-services, and
validated the placement of the RGB LED. Comments made by the nurses further justified
location of the feedback: using the infusion site for placement of the feedback, being as close to
the patient as it normally is, allowed the nurses to undergo their normal drug delivery process.
In addition, the brightness of the visual feedback allowed the nurses to use their peripheral
vision and still have the benefit of the color-coded guide. Figures 7 and 8 show the infusion rate
data for 2 nurses involved in the trials. In Figure 7, the nurse can be observed initially
overshooting the furosemide, and then attempting to hover near the optimal flow rate after
making adjustments. The nurse then performed slightly better on the famotidine trial. Figure 8
shows a contrasting method of drug infusion, which the Department of Pharmacy is actually
attempting to dissuade. As seen in the furosemide trial, the nurse injects a bolus, waits a short
period of time, injects another bolus, and continues this pattern. The IVIS allowed the
administrator of the simulation to observe these differing techniques between nurses.
All the nurses involved with the in-services and the instructor conducting the simulations
were asked for validation of the system’s realism. Comments included: the infusion pump did
not have additional ports for tubing, and therefore reduced the type of drug deliveries that could
be made within the simulation; the location of the infusion site, when used in conjunction with
the simulation mannequin, closely resembled the location of a central venous catheter; the
visual feedback LED, while adding an extra component to the system, did not significantly alter
the drug-delivery process.
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Figure 7. Subject 1 in-service infusion data for drugs furosemide and famotidine. This subject
attempted to hover around the optimal green rate throughout injection.
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Figure 8. Subject 3 in-service infusion data for drugs furosemide and famotidine. This subject
initially injected with the bolus method for furosemide that the Department of Pharmacy is trying to
deter.
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PATENT AND PRIOR ART CONSIDERATION
After searching through the patents currently on file with the United States Patent and
Trademark Office, a few patents have been revealed which pertain to the development of the
Intravenous Infusion Simulation. There are two patents in particular which each encompass a
particular facet of the IVIS system. The first patent is for an Anesthesia Drug Monitor, which
allows for representation to the person administering a drug, in this case some form of
anesthesia, with real time feedback regarding their performance.3 The IVIS is designed to be
able to give real time feedback performance to the person using the device to administer drugs,
but is not limited to only anesthesia. Also, the IVIS visual feedback system, especially the LED
embedded at the F-site, allows for a passive visual feedback system. This passive system
makes the IVIS a unique device in the field of medical simulations in that it combines a teaching
element into the simulation structure directly.
The IVIS also comes with an easily expandable drug database, and thus any
user can add new drugs or modify the existing entries should information become available that
the dosage rates currently used are incorrect. Also, this allows for the IVIS to work for nonstandard patients, who have different dosage requirements. Though there are several devices
with drug databases and systems which utilize them, the IVIS is the first with one that can be
simply modified by the end user and thus rapidly updated and customized without any additional
effort on the production end.4 This type of highly editable drug database system has clear
advantages, especially if the ability to modify the values is given to the respective drug
companies, who would then have an interest in making sure that their drug comes to market
with data suggesting dosage rates.
The administration set simulation also deserves patent consideration. Previously issued
patents describe a simulation based on weight to determine the amount of fluid delivered to a
simulated patient.5,6 The patented simulation systems use this measurement to determine
proper physiological responses of the mannequin. These simulations focus on patient effects
resulting from improperly administered drugs, rather than the real-time training of medical
personnel in proper drug delivery.
Additionally, U.S. Patent 5873731 describes a novel solution to drug delivery simulation.
Electrical contacts are designed into each connection of the IV administration set which transfer
drug information from the syringe used for delivery to the IV equipment directly. This system
requires labeling of the drug delivery equipment prior to the simulation. The IVIS allows for a
more realistic simulation by requiring the user to manually take up fluid to the syringe rather
than providing this type of pre-labeled medication. Currently the IVIS employs a manual drug
selection system; however, this system can be used by the instructor running the simulation,
and insures that the process of obtaining a drug from a vial is kept, as well as the use of
standard medical syringes and equipment.
The unique take on the medical simulation market, integrated with a real time passive
feedback system, makes the IVIS a unique solution within the very limited IV administration
simulation market. These systems provide ample reasoning to distinguish this solution from
previously patented ideas.
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ANTICIPATED REGULATORY PATHWAY
In the hopes of introducing this product into the clinical setting, FDA guidance and the
quality system regulations have been followed through every step of the design process. The
physical measurement aspects of the IVIS will require further development to be employed in
the healthcare environment. In addition, the flow rate measurement at the body site will need to
be taken with a passive sensor that has a wider range of operability over low-flow conditions,
and has no chance of impeding fluid flow.
Further design considerations involve the sourcing of materials and equipment from
vendors that are FDA approved for medical device manufacturing, as well as the
implementation of design controls laid out in the Code of Federal Regulations, section
21.820.30. These controls require the planning and documentation of all design processes, the
identification of all risks posed to users of the device along with documentation of the steps
taken to reduce these errors, as well as the recognition of any additional information pertaining
to the safety and efficacy of the device. This documentation will describe substantial
equivalence to predicate devices in the market based on associated risks to the user.
Once these conditions are met, the IVIS will resemble a typical IV administration set
currently used in the clinical setting. The passive sensors represent a system that will be
external to the flow path of the drug, and therefore substantial equivalence between the IVIS
and typical IV administration sets in terms of physical characteristics. Using these products as
predicate devices provides for the use of FDA guidance on these Class II devices. “Class II
devices are those for which general controls alone are insufficient to assure safety and
effectiveness, and existing methods are available to provide such assurances.”7
The clinical, Class II device will require a premarket notification submission [510(k)]
before the device can be introduced to the healthcare industry. This submission will require a
detailed description of the device, its intended use, and the device design specifications. This
introduction to the device must then be supplemented with an identification of the risk analysis
method used to assess the device, as well as a discussion of the device’s characteristics, its
performance characteristics, and any standards that were relied upon during development of the
product.8
In order to avoid any risks to patient health, the FDA also recommends verification
testing of the system’s connections, the number of injection port accesses to failure, and the
pressure and leak tolerances for pre-slit septa under extreme conditions of use.8 A further, but
not inclusive, list of testing would include biocompatibility testing of all equipment, simulated
clinical use testing, and labeling of the equipment to avoid improper use of the administration
set. Specifics of proper labeling techniques for IV administration sets can be found in the FDA
guidance previously mentioned.
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ESTIMATED MANUFACTURING COSTS
The custom LED housing was initially developed using rapid prototyping techniques.
This was for the initial prototype of the IVIS, which was SLA prototyped. The final versions will
be formed of medical grade polypropylene in order to conform to standards set forth by the
FDA.
The IVIS device will be custom assembled per order. This should take no longer than a
few hours for assembly of the full device, which must be constructed, and run with deionized
water. Assuming there are no leaks or other errors and that the system output matches the
known input, the device must be disassembled and shipped to the customer. This system of
production allows for minimal overhead in pre-purchased materials; this is particularly valuable
given the expenses faced in creating the IVIS system, detailed in Table 3. In addition, the
option of not including a laptop computer and simply installing the IVIS software on the client’s
own computer can be a more affordable option.
Table 3. Itemization of product’s components and their costs.
IV administration supplies:
 Arrow International, Inc W20770, which contains “10 Drop NonVented Drip Chamber with 2-Gang Detachable Stopcock, Time Tag
and 1 Pre-Pierced F-site, Rotating L/L; 50/case”
 IV administration Stand
Flow Sensors Subsystem
 McMillan Low Cost Liquid Microturbine FLO-SENSOR 101-3-D-M3
 McMillan Power Adapter and Cables 100-17T
 Cardinal Alaris Infusion Pump*
 Connections to Data Acquisition Device
Data Processing Unit
 Virtual Instrumentation (LabVIEW Academic License)
 Laptop Computer*
 Data Acquisition Unit (National Instruments USB-6009 DAQ)
Visual Feedback Module
 RGB LEDs
 Wiring
Total:
* : Items that were donated and not included in production cost total.
$10.00
$16.00
$330.00
$70.00
*$3000
$10.00
$99.00
*$500.00
$289.00
$2.00
$2.00
$828.00
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MARKET ANALYSIS AND SALES STRATEGY
The IV simulation market is in its infancy, and IVIS is a new conceptualization that
addresses a pressing need in the marketplace. Currently the only alternate system on the
market that deals with the medical simulation of drug administration is the METI drug
recognition system, which comes bundled with proprietary software and a simulation patient.
However, this bundling process means that the entire package must be purchased at a
prohibitive $200,000. This device relies on bar-coded, pre-loaded syringes which must be
carefully aligned in order to be recognized before the drug is delivered. The operation of the
METI device is unlike the actual method of injection used in a clinical setting. It requires preloading of syringes, eliminating the possible error of the wrong drug being infused into the
patient. Also, due to the placement and design of the device, it requires additional steps that
would not be present in the case of an actual hospital setting, and thus may instill incorrect
training of proper drug delivery rates in the user of the device.
The IVIS is meant to, as much as possible, resemble the function and aesthetic of the
actual drug delivery system in the hospital setting, and thus allows for simulated training to be
done with better overall results. This training is applicable to every practitioner in each of the
5,700 hospitals in the United States. However, the true distribution channel that this and other
simulation devices must take is to prove they are as effective in reducing not only the medical
errors suffered by patients but the insurance costs associated with running the hospital. This
differs from the distribution methods employed in the typical medical device industry; instead of
appealing to the hospitals or the doctors, the IVIS is meant to appeal to healthcare insurers as a
method of reducing malpractice and other claims. After development of the IVIS is complete,
there are already plans to test the efficiency of the IVIS in training users in effective drug
delivery techniques. This medical simulation training will hopefully easily cross over into the
hospital setting, where those who underwent the training will exhibit a lower rate of instances
that lead to medical malpractice claims due to drug delivery errors. The target users of the IVIS
device are medical practitioners in the hospital, but the target purchasers of the product are the
insurance companies which cover hospital liabilities.
Considering the cost of those errors comes to be approximately 3.5 billion dollars each
year, and that the IVIS simulation unit, once in place and properly maintained, may be used by
an extensive number of medical practitioners, a price of approximately $1,000 per unit, would be
more than reasonable. We would not be seeking reimbursement from any sort of governmental
body for the device, as there is no direct cost relationship between our device and the patient.
Health and malpractice insurance providers stand to experience the direct monetary benefit
from use of the IVIS in simulation training. Decreased drug injection errors will translate in a
demonstrable way into saved revenue for the hospital as well. The target customers of the
device are these healthcare providers and their insurers.
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REFERENCES
1. Committee on Identifying and Preventing Medication Errors. “Preventing Medication Errors.”
Inst. Of Med. 1996
2. Taxis, K. Barber, N. “Causes of intravenous medication errors: an ethnographic study.” Qual
Saf Health Care 2003; 12:343-348
3. United States Patent 0156143, Anesthesia Drug Monitor
4. United States Patent 5317506, Infusion Fluid Management System
5. United States Patent 4853521, System for Verifying and Recording Drug Administration to a
Patient
6. United States Patent 5882207, Apparatus and Method for Quantifying Fluid Delivered to a
Patient Simulator
7. FDA Device Classes. http://www.fda.gov/cdrh/devadvice/3132.html
8. Guidance for Industry and FDA Review Staff - Intravascular Administration Sets Premarket
Notification Submissions [510(k)]. http://www.fda.gov/cdrh/ode/guidance/1189.html