Decubitus ulcers occur in an estimated 2.5 million Americans each year at an annual cost of $11 billion to the U.S. health system. Current screening and prevention techniques for assessing risk for decubitus ulcer formation and repositioning patients every 1–2 hours are labor-intensive and can be subjective. We propose use of a Bluetooth-enabled fabric-based pressure sensor array as a simple tool to objectively assess and continuously monitor decubitus ulcer risk.
Biologically inert elastomers such as silicone are favorable materials for medical device fabrication, but forming and curing these elastomers using traditional liquid injection molding processes can be an expensive process due to tooling and equipment costs. As a result, it has traditionally been impractical to use liquid injection molding for low-cost, rapid prototyping applications. We have devised a method for rapid and low-cost production of liquid elastomer injection molded devices that utilizes fused deposition modeling 3D printers for mold design and a modified desiccator as an injection system. Low costs and rapid turnaround time in this technique lower the barrier to iteratively designing and prototyping complex elastomer devices. Furthermore, CAD models developed in this process can be later adapted for metal mold tooling design, enabling an easy transition to a traditional injection molding process. We have used this technique to manufacture intravaginal probes involving complex geometries, as well as overmolding over metal parts, using tools commonly available within an academic research laboratory. However, this technique can be easily adapted to create liquid injection molded devices for many other applications.
Human errors in medical device use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical device use is critical for developing interventions to reduce such errors either by redesigning the devices or, if redesign is not an option, by training the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices with integral information technology, then applied and tested them on several infusion pumps. The first method is a modified discount-usability method called heuristic evaluation. The method was used to evaluate and compare the safety of two 1-channel volumetric infusion pumps. The results show that heuristic evaluation, when modified for medical devices, is a useful, efficient, and low-cost method for evaluating patient safety features of medical devices through the identification of usability problems and their severities. The second method is an extended hierarchical task analysis (EHTA), devised to predict medical errors in medical device use. EHTA divides the task space between the external world of the device interface and the internal cognitive world of the user, allowing for descriptive predictions of potential user errors at the human device level. Its use is demonstrated in the analysis of two infusion pumps. The estimates of the likelihood of user errors with the two pumps are consistent with the corresponding reported use errors in the Federal Drug Administration (FDA)'s Manufacturer and User Device Experience (MAUDE) database, thus demonstrating the usefulness of this tool for predicting medical device use errors.
Preterm birth causes 1 million infant deaths worldwide every year, making it the leading cause of infant mortality. Existing diagnostic tests such as transvaginal ultrasound or fetal fibronectin either cannot determine if preterm birth will occur in the future or can only predict the occurrence once cervical shortening has begun, at which point it is too late to reverse the accelerated parturition process. Using iterative and rapid prototyping techniques, we have developed an intravaginal proof-of-concept device that measures both cervical bioimpedance and cervical fluorescence to characterize microstructural changes in a pregnant woman's cervix in hopes of detecting preterm birth before macroscopic changes manifest in the tissue. If successful, such an early alert during this “silent phase” of the preterm birth syndrome may open a new window of opportunity for interventions that may reverse and avoid preterm birth altogether.
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