Education and demonstration – Question or problem eliciting response – Response of plural examinees communicated to monitor or...
Reexamination Certificate
2001-07-02
2003-03-18
Vo, Hieu T. (Department: 3747)
Education and demonstration
Question or problem eliciting response
Response of plural examinees communicated to monitor or...
C434S262000, C434S429000
Reexamination Certificate
active
06535714
ABSTRACT:
FIELD OF INVENTION
The present invention relates to medical device training, and, more particularly, to a method, system, and apparatus for training users in the understanding and use of numerous medical devices, including providing for documentation of competency during the training exercise.
BACKGROUND INFORMATION
Medical devices are an integral and indispensable component of patient care. However, they present a number of unique problems that have not been adequately addressed by device manufacturers or the medical community in general. There is ample evidence that errors in the understanding and use of medical devices are responsible for considerable morbidity and mortality. Recently, government agencies have begun to look more closely at the ability of medical institutions as well as manufacturers to accurately assess the dangers presented by medical devices. Further, the FDA has mandated the use of “human factors” experts in the design of medical devices to reduce the complexity of the device/human interface.
Learning to use various medical devices is often taught through textbooks, manuals, lectures, and videotapes. Obviously, while providing a low cost source for learning theory, these informational resources clearly lack the important benefit that can only be acquired from “hands-on” training and practice with the actual device. A number of manufacturers in other industries have designed interactive training systems (software based) to help users learn their specific systems, especially in the flight industry (e.g., Microsoft Flight Simulator™). For example, a manufacturer may include a video, computer program, or interactive web site to illustrate and present step by step instructions on the proper use. A software program with a simulated image of the device controls may also allow a user to practice using a specific device (e.g., U.S. Pat. No. 6,024,539 to Blomquist which discloses a computer image of an infusion pump with various programs for simulating operation of the manufacturer's pump). Each of these training systems are designed solely for the specific instrument being taught.
In order to teach the use of multiple instruments, especially in the medical arena, there are presently available patient simulator mannequins to provide “hands-on” training to medical personnel in areas such as trauma treatment and anesthesiology. These mannequins typically have significant capabilities including spontaneous breathing, pulse, heart and breath sounds and the ability to monitor vital signs such as ECG, pulse oximetry and end-tidal carbon dioxide by connecting commercial off-the-shelf (COTS) medical devices to the simulator. Various medical devices can be attached to these mannequinsto train users in the proper implementation and use (e.g., endotracheal tube, EKG monitor, blood pressure cuff, pulse oximeter, automatic external defibrillator). These mannequins are typically computer controlled and are programmed for a variety of responses which simulate medical conditions. Examples of such mannequins are disclosed in U.S. Pat. No. 5,941,710 to Lampotang, et. al., U.S. Pat. No. 5,900,923 to Prendergast, et al., U.S. Pat. No. 5,403,192 to Kleinwaks et al., and in U.S. Pat. No. 3,520,071 to Abrahamson et al., the disclosures of which are incorporated herein by reference.
Using patient simulator mannequins such as these, the students, nurses, medical personnel, etc. can develop skills in manual dexterity and proper placement of leads, tubes, etc. without risk. However, learning to use a variety of medical devices by attaching them to such simulator mannequins is not feasible, since access to full-scale patient simulator mannequins is generally not readily available and requires a large capital outlay for the equipment. Moreover, not all devices integrate with such mannequins. Even more problematic is that not all functions of medical devices involve direct patient response (e.g., setting alarms, recording outputs, communicating with other devices, setting preferences, and the like).
One unique approach was taken in U.S. Pat. No. 5,853,292 to Eggert, et al., which discloses using sensor-equipped “virtual” instruments interfaced with a patient simulator through a computer interface module (CIM). The CIM confirms correct placement of the various instruments onto the patient. The system is used in conjunction with a training program on a computer. For example, a user can select the CPR training session. The screen displays include sequential actions which integrate the basic concepts of CPR. The session may be recorded and the results displayed. This system, however, carries over the same disadvantage of the above-noted patient simulators in that it still requires a large capital outlay for the equipment and uses only virtual (rather than real) medical devices.
Accordingly, there is a need in the art for a method, system and apparatus that provides medical device training in a user friendly, cost effective way.
BRIEF SUMMARY OF THE INVENTION
The present invention solves the needs in the art by providing a method, system, and apparatus for training users in the understanding and use of numerous medical devices, including providing for documentation of competency during the training exercise. The invention can also be used to train the lay public on consumer medical devices. The apparatus of the invention serves as a training interface module to provide a common hardware platform that can be connected to various medical devices regardless of manufacturer and enables users to learn at their own pace, receive remediation when necessary, and provide documentation of proficiency with the device.
In a preferred embodiment, the invention comprises a training interface apparatus for teaching proper use of a variety of medical devices, which includes a processor; a computer program under control of the processor that provides interactive training sessions to the user for each of the medical devices; a user interface under control of the processor for receiving input from a user; a display unit operable to display an output corresponding to the interactive training sessions; and communications means for interfacing with the medical devices.
The interactive training session may be loaded onto a storage device of the training apparatus from an external communications network, from at least one of the plurality of devices, from a removable storage media, or it may reside on a storage device of the training apparatus. The interactive training session may be launched upon selection by the user or may be automatically launched when a device is connected to the training interface apparatus. The display unit may include a simulated image that resembles the device such that the simulated image shows graphical representations of the controls which are actuated by the user interface. The simulated image may also include representations of the output of the device. The user interface may include an external input device interfaced with the training interface apparatus or an integrated input device of the training interface apparatus. In another embodiment, the user interface is a communications interface operatively connected between the device and the training interface apparatus for detecting inputs directly from the controls of the device. It may further include a communications port for standard input/output functions.
The interactive training session includes, for example, a lesson on applicable physiology related to the device, a lesson on instrument physics related to the device, a lesson on operation of the device, including inputs and outputs, a lesson on pathophysiology that describes the use of the device with patients in different disease states, and a lesson on patient management exercises which manages aspects of a simulated patient. The training session also includes educational content (e.g., user interactions, testing, and educational materials). The interactive training session tracks progress of a user and adjusts the lessons based on the progress.
As a method for teaching prope
Melker Richard J.
Van Oostrom Johannes H.
Saliwanchik Lloyd & Saliwanchik
University of Florida
Vo Hieu T.
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