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FLUID VERIFICATION SYSTEM AND
METHOD FOR INFUSIONS
BACKGROUND OF THE INVENTION
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The invention is related to the verification of the contents of a fluid, and more particularly, to the analysis of a medical fluid for verifying the existence of a pharmaceutical drug or drugs to be infused into a patient through a fluid infusion channel. 10
Physicians and other medical personnel apply intravenous ("IV") infusion therapy to treat various medical complications in patients. IV infusion therapy typically involves infusing medical fluids, such as pharmaceutical drugs, from a fluid source through the tubing of a fluid administration 15 set, and to a cannula inserted in a patient's blood vessel.
In a typical facility, a physician enters an order for a medication for a particular patient. This order may be handled either as a simple written prescription slip, or it may be entered into an automated system, such as a physician 20 order entry ("POE") system. The prescription is routed to the pharmacy, where the order is filled. Typically, the prescribed drug is prepared and inserted into a bag at the pharmacy. A pharmacist also identifies the contents of the bag and the patient for whom the bag is intended, with, for example a 25 human-readable label and a bar coded label. The prepared medication is then delivered to a clinician's station for subsequent administration to the patient.
For safety reasons, and in order to achieve optimal results, the pharmaceutical drug is administered in accurate amounts 30 as prescribed by the doctor, and in a controlled fashion such as by using an infusion pump. An infusion pump moves fluid from the medical fluid bag through a fluid infusion channel and into the patient. The infusion pump is programmed by a medical clinician according to the particular pumping or 35 infusion parameters prescribed by the doctor. The pumping parameters programmed into the pump by the clinician are drug and patient specific. That is, the pumping parameters are selected by the doctor based on the particular drug prescribed and the specific patient for whom it is intended. 40 It is the clinician's responsibility to match the prescribed drug with the correct patient and with the properly programmed pump.
Hospitals and other institutions continually strive to provide quality patient care. A medical error, such as when a 45 patient receives the wrong drug, is a significant concern for all heath care facilities. In some cases, a single patient may be prescribed simultaneous multiple infusions, sometimes four or more, of different drugs. Typically, multiple infusions involve different infusion parameters for each drug. 50 Further, such multiple infusions may involve multiple pump channels; e.g., one channel for each infusion; or a secondary to a primary infusion. Some pump systems include four or more pumping modules, each of which comprises an infusion pump operating on a separate fluid tubing to form a 55 separate pumping channel. Regardless of whether a system has multiple channels or multiple systems each having only one channel, it is important that each channel be correctly programmed to infuse the right drug into the patient. Installing the tubing from a pharmaceutical bag into an incorrect 60 pumping module could result in the wrong drug being pumped into the patient, regardless of correct drug labeling.
Prior attempts have been made to assure that the right drug is administered to the right patient through the right channel. In one example, a bar code label identifying the 65 drug and patient is applied to the bag at the pharmacy. After a clinician manually programs the pump, a bar code scanner
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connected to the pump is used to read the bar code label on the bag to verify that it identifies the same medication as that programmed. In another example, a bar code label is applied to the bag and the label is read with a bar code scanner to automatically program the pump, thus avoiding manual programming entirely. While doctors are more assured that the doses and infusion rates that they prescribe can be delivered to the patients accurately by the pumps available today, such as via the MEDLEYTM patient care system operating the GUARDRAILS® safety system, there remains a concern that the right drug is mounted to the right pump.
Even though the pump systems of today provide significant advances in the art to avoid medication errors, there is a desire to more reliably determine that the correct drug is being infused. For example, the pharmacist may have made a mistake in mixing the component fluids for the bag, or the pharmacist may have applied the wrong bar code label to the bag. The bar code could also contain incorrect information or the clinician could scan the bar code label of the correct bag, but become distracted especially during emergency situations or MEDVAC (helicopter transport for example), and connect the tube from the bag to the wrong pumping channel.
Hence, those skilled in the art recognize that a need exists to more accurately ensure that the correct drug or combination of drugs is properly infused into the correct patient. More particularly, those in the art have recognized a need to more definitely ascertain that the particular pharmaceutical drug a pump is infusing into the patient is the correct drug in the correct concentration. The present invention fulfills these needs and others.
INVENTION SUMMARY
The present invention is directed to a system and method for verifying the contents of a fluid in a conduit. With more particularity, an apparatus is provided for verifying the composition of a fluid contained within a fluid infusion conduit, wherein the conduit includes a conduit wall and an interior through which the fluid is conducted, the apparatus comprising a source of light located and configured so as to direct light through the fluid contained within the conduit, a light sensor located so as to receive the light that was directed through the fluid contained within the conduit after it has passed through the fluid, the light sensor providing light sensor signals representative of a spectrum of the actual composition of the fluid contained within the conduit, and a processor that is adapted to compare the spectrum of the actual composition of the fluid with a spectrum of an expected composition of the fluid contained within the conduit.
In further aspects, a memory is provided in which is stored the spectrum of the expected composition of the fluid contained within the conduit wherein the processor accesses the memory to obtain the spectrum of the expected composition of the fluid contained within the conduit. An input device is also provided with which an indication of the expected composition of the fluid is input to the processor. In a further aspect, the conduit is operated on by a pumping mechanism of an infusion pump wherein the source of light and the light sensor are disposed at locations on the infusion pump upstream from the pumping mechanism.
In yet further aspects, the apparatus further comprises a reference element indicative of a spectrum of the conduit wall, a source of light is located and configured so as to direct light through the reference element, and a light sensor is located so as to receive light that was directed through the
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reference element after it has passed through the reference element, the light sensor providing light sensor signals representative of a spectrum of the actual composition of the reference element wherein the processor is further adapted to adjust the spectrum of the actual composition of the fluid 5 within the conduit with the spectrum of the actual composition of the reference element.
In further aspects, a predetermined spectrum is representative of the composition of the conduit wall wherein the processor is further adapted to adjust the spectrum of the 10 actual composition of the fluid within the conduit with the predetermined spectrum representative of the conduit wall. In other aspects, the apparatus further comprises a memory in which is stored a plurality of spectra of possible expected fluid compositions contained within the conduit, an input 15 device with which the expected composition of the fluid contained within the fluid conduit is input to the processor, wherein in response to the input device the processor accesses the memory to obtain the spectrum of the expected composition of the fluid contained within the conduit. In 20 another aspect in accordance with the invention, the processor is adapted to access additional spectra in the memory in the event that the spectrum of the expected composition does not match the spectrum of the actual composition and make further comparisons of spectra from the memory to the 25 spectrum of the actual composition, and in the event that a match is detected, indicates the spectrum that matched. In a further aspect, the processor is further adapted to synthesize a spectrum for the expected fluid composition from spectra in the memory. 30
In another aspect, the processor is further adapted to provide an alarm signal in the event that the spectrum of the actual composition does not match the spectrum of the expected composition. Yet further, the processor controls the pumping mechanism and is adapted to prevent the pumping 35 mechanism from operating in the event that the spectrum of the actual composition does not match the spectrum of the expected composition. The processor is further adapted to permit an operator of the pump to override the processor in the event that the spectra do not match. The apparatus further 40 comprises a memory wherein the processor is further adapted to store in the memory an override of the processor. The processor is further adapted to communicate with a hospital server located remotely from the processor events relating to comparisons of spectra. 45
In more detailed aspects, the apparatus further comprises a reader device in communication with the processor adapted to read an identification device related to the fluid, the identification device including an indication of expected composition of the fluid. The identification device contains 50 a spectrum of the expected composition of the fluid. The identification device contains an indication of the expected fluid composition and the processor is adapted to retrieve a spectrum consistent with the expected fluid composition. The identification device comprises a bar code and the 55 reader comprises a bar code scanner. In another aspect, the identification device comprises an RFID tag and the reader comprises an RFID reader. In yet further detailed aspects, the identification device comprises a wireless information device and the reader comprises a compatible reader of the 60 wireless information device.
In accordance with the method in accordance with aspects of the invention, there is provided a method for verifying the composition of a fluid contained within a fluid infusion conduit, wherein the conduit includes a conduit wall and an 65 interior through which the fluid is conducted, the method comprising directing light through the fluid contained within
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the conduit, sensing the light that was directed through the fluid contained within the conduit after it has passed through the fluid and providing light sensor signals representative of a spectrum of the actual composition of the fluid contained within the conduit, and comparing the spectrum of the actual composition of the fluid with a spectrum of an expected composition of the fluid contained within the conduit.
In more detailed aspects, the method further comprises storing the spectrum of the expected composition of the fluid contained within the conduit in a memory, and accessing the memory to obtain the spectrum of the expected composition of the fluid contained within the conduit. In other detailed aspects, the method comprises directing light through a reference element, receiving light that was directed through the reference element after it has passed through the reference element, the received light being representative of a spectrum of the actual composition of the reference element, and adjusting the spectrum of the actual composition of the fluid within the conduit with the spectrum of the actual composition of the reference element.
In other aspects, the method further comprises receiving a predetermined spectrum representative of the expected composition of the conduit wall, and adjusting the spectrum of the actual composition of the fluid traveling through the conduit with the predetermined spectrum representative of the conduit wall. The method additionally may comprise storing a plurality of spectra of possible expected fluid compositions contained within the conduit, inputting the expected composition of the fluid contained while within the fluid conduit, and accessing the spectrum of the expected composition of the fluid contained within the conduit from the plurality of spectra. Further, the method comprises accessing additional spectra in the event that the spectrum of the expected composition does not match the spectrum of the actual composition and further comparing spectra to the spectrum of the actual composition, and in the event that a match is detected, indicating the spectrum that matched. Additionally, the method comprises synthesizing a spectrum for the expected fluid composition from spectra to identify a drive.
In yet other detailed aspects, the method further comprises providing an alarm in the event that the spectrum of the actual composition does not match the spectrum of the expected composition. The method further comprises reading an identification device related to the fluid, the identification device including an indication of expected composition of the fluid. The method further comprises reading an identification device that contains a spectrum of the expected composition of the fluid. The method further comprises reading a bar code identification device with a bar code scanner. The method further comprises reading an RFID tag with an RFID reader. The method further comprises reading a wireless information device with a compatible reader.
Other aspects and advantages of the invention will become apparent from the following detailed description and the accompanying drawings, illustrating by example the features of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of a system in accordance with aspects of the invention showing a medical instrument having four medical fluid infusion pumps connected to respective fluid sources and a single patient through respective fluid administration sets. A programming module is connected to all pumps and is shown as having a connection to a remote
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