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The manual user-operated Arise Standing Wheelchair (SWC) is the end-result of multiple design iterations based on comments from user trials. The Arise SWC provides standing functionality, outdoor mobility, affordability, and customizability. This paper describes a user experience study of the Arise SWC's pre-commercial version. Thirty participants (N = 30, 25 Male, 5 Female) were recruited for the study. All the participants were people with spinal cord injury. The study was conducted over a period of six weeks (five participants per week) within the hospital premises under the supervision of clinical personnel. A 30 min interactive training session involved thirteen activities. During the trial period, the participants were trained to perform twenty-two activities to familiarize themselves with the SWC. The participants were also trained to perform four functional usage activities with the SWC. At the end of the study, participant responses to ten outcome measures were captured using a smiley-based Likert-scale questionnaire. A majority of the participants (93.3%) felt happy when they stood in the SWC. The majority participants (83.3%) preferred the Arise SWC over their current wheelchair. Also, 80% participants anticipated that they could get more work done at home using the standing function of the wheelchair. A one-time fitting and training ensured optimal effort for the SWC operation, correct posture, and comfortable user experience. With proper dissemination and awareness, it is believed that the Arise SWC will benefit eligible users and improve their quality of life. The Arise wheelchair provides standing functionality, outdoor mobility, affordability, and customizability. Study confirms that incorporating standing functionality can improve the quality of life for wheelchair users. The majority of users were happy, felt safe and expected to do more with the standing functionality. Study results support further testing in real world conditions beyond the hospital setting. [ABSTRACT FROM AUTHOR]

With advances in technology, there are an increasing number of direct-reading instruments available to occupational health and safety professionals to evaluate occupational aerosol exposures. Despite the wide array of direct-reading instruments available to professionals, the adoption of direct-reading technology to monitor workplace exposures has been limited, partly due to a lack of knowledge on how the instruments operate, how to select an appropriate instrument, and challenges in data analysis techniques. This paper presents a review of direct-reading aerosol instruments available to occupational health and safety professionals, describes the principles of operation, guides instrument selection based on the workplace and exposure, and discusses data analysis techniques to overcome these barriers to adoption. This paper does not cover all direct-reading instruments for aerosols but only those that an occupational health and safety professional could use in a workplace to evaluate exposures. Therefore, this paper focuses on instruments that have the most potential for workplace use due to their robustness, past workplace use, and price with regard to return on investment. The instruments covered in this paper include those that measure aerosol number concentration, mass concentration, and aerosol size distributions. [ABSTRACT FROM AUTHOR]

This paper reports the design of a powered stapler for gastrointestinal anastomosis and evaluates its performance. The proposed stapling instrument is intended to simplify and optimize the current procedure of mechanical stapling, while providing controllable operation for the powered stapling procedure, such as conditioning the tissue to the right stage before firing of the stapler. The feasibility and efficacy of the prototype were assessed by ex vivo experiments with porcine small intestine segments, where the tissue conditioning operation, burst pressure of the stapled intestine samples, and staple malformation rate were examined. The functionality of the developed powered stapler was validated, where the theoretical, numerical, and experimental results agree well with each other. The preliminary results indicated that the proposed tissue conditioning operation could lower the clamping pressure with a maximum level of 1.35 g/mm2. The average burst pressure of the stapled segments (16 samples) is 6.37 kPa, and the maximum malformation rate of the tested groups (five groups, each group with 90 staplers) was 5.56%. The developed novel tissue conditioning procedure could reduce the pressure response of the intestine tissue samples. The proposed powered stapler proves effective for performing gastrointestinal anastomosis procedures. [ABSTRACT FROM AUTHOR]

This paper addresses a fundamentally important issue in health care, namely how to make informed decisions on product selection when two products, from different manufacturers, appear to be similar and have medical claims that sound comparable. In such cases, manufacturers of competing products often use each other's evidence. They argue that the published evidence is generally applicable even if the original bioengineering tests and clinical trials were performed on a specific product, and no equivalence was obtained for their product that has similar medical claims. In this work, we use prophylactic dressings for pressure injury prevention as a good demonstrative example on how patient safety may be compromised if study conclusions are generally projected to such unstudied products. The medical device industry is regulated differently than the pharmaceutical industry, and consequently, voids in current medical device regulation are sometimes used to promote commercial interests. This paper analyzes gaps and potential pitfalls that occur where guiding documentations (e.g. guidelines, standards) do not cope well with medical technology. We explain how that can eventually lead to potential compromises to the well-being of patients, primarily if nurses are unaware of the aforementioned pitfalls. We conclude that currently, there is no alternative to rigorousness: Clinicians and decision-makers need to scrutinize up-to-date literature, decide which products have the best portfolio of bioengineering and clinical research to support the claims made, and which products have the best cost–benefit models. This is fundamentally different from simply buying the least expensive product because of appealing sale arguments. [ABSTRACT FROM AUTHOR]

Objectives: This paper presents the design and construction of a viable pupillometer system and demonstrates its merits with extensive validation tests. Materials and Methods: A web camera was modified by removing its infrared filter and mounted on a chin rest. Light emitting diodes (LEDs) operating at infrared and visible spectra were integrated to provide background and light stimulus, respectively. The LEDs were controlled by a microprocessor board. Stimulation was presented using a periodic paradigm with variable period and duty cycle. Videos of both pupils were recorded at 30 frames/second and processed offline using software developed in-house. The overall system was validated with data gathered from individuals with healthy vision under different stimulation paradigms. T emporal variations in pupil size were determined and analyzed statistically. Results: The analysis revealed that the pupil sizes were accurately measured from the video frames provided that reflections from both infrared and visible lights remain outside the pupil. The system achieved moderate to excellent repeatability scores (87.8 and 86.8% for short 1 second and long 2 second pulses, respectively), which demonstrated its effectiveness and confirmed that it can be used reliably as a pupillometer. Conclusion: The proposed pupillometer system produces useful, quantitative data characterizing pupillary light response. However, further development and implementation are needed to potentially turn it into a low-cost alternative for other studies involving the autonomic nervous system, cognitive function, drug metabolism, pain response, psychology, fatigue, and sleep disorders. [ABSTRACT FROM AUTHOR]

Background Peripheral venous catheterisation is the most frequent invasive procedure performed in hospitalised patients; yet over 30% of peripheral venous catheters fail before treatment ends. Objectives To assess the effects of peripheral venous catheter dressings and securement devices on the incidence of peripheral venous catheter failure. Data sources We searched the Cochrane Wounds Group Register, The Cochrane Central Register of Controlled Trials, MEDLINE; EMBASE and CINAHL for any randomised controlled trials comparing different dressings or securement devices used to stabilise peripheral venous catheters. The reference lists of included studies were also searched for any previously unidentified studies. Results We included six randomised controlled trials (1539 participants) that compared various dressings and securement devices (transparent dressings versus gauze; bordered transparent dressings versus a securement device; bordered transparent dressings versus tape; and transparent dressing versus sticking plaster). Trial sizes ranged from 50 to 703 participants. The quality of evidence ranged from low to very low. Catheter dislodgements or accidental removals were lower with transparent dressings compared with gauze (two studies, 278 participants, risk ratio (RR) 0.40; 95% confidence interval (CI) 0.17–0.92, P = 0.03%). However, the relative effects of transparent dressings and gauze on phlebitis (RR 0.89; 95% CI 0.47–1.68) and infiltration (RR 0.80; 95% CI 0.48–1.33) are unclear. A single study identified less frequent dislodgement or accidental catheter removal with bordered transparent dressings compared to a securement device (RR 0.14, 95% CI 0.03–0.63) but more phlebitis with bordered dressings (RR 8.11, 95% CI 1.03–64.02). A comparison of a bordered transparent dressing and tape found more peripheral venous catheter failure with the bordered dressing (RR 1.84, 95% CI 1.08–3.11) but the relative effect on dislodgement was unclear. Conclusions There is no strong evidence to suggest that any one dressing or securement product for preventing peripheral venous catheter failure is more effective than any other product. All of the included trials were small, had high or unclear risk of bias for one or more of the quality elements we assessed, and wide confidence intervals, indicating that further randomised controlled trials are necessary. There is a need for suitably powered, high quality trials to evaluate the newer, high use products and novel – but expensive – securement methods, such as surgical grade glue. [ABSTRACT FROM AUTHOR]

Objective: Laryngeal paralysis of central or peripheral origin can potentially be treated using functional electrical stimulation (FES) of laryngeal muscles. Experiments in canines (dogs) were performed using implant prototypes capable of closed-loop FES to refine engineering designs and specifications, test surgical approaches for implantation, and better understand the in vivo effects of laryngeal muscle stimulation on short- and long-term glottic function. Study Design: Prospective, laboratory. Methods: We designed and tested a series of microprocessor-based implantable devices that can stimulate glottic opening or closing based on input from physiological control signals (real-time processing of electromyographic [EMG] signals). After acute device testing experiments, 2 dogs were implanted for 8 and 24 months, with periodic testing of closed-loop laryngeal muscle stimulation triggered from EMG signals. In total, 5 dogs were tested for the effects of laryngeal muscle stimulation on vocal fold (VF) posturing in larynges with nerve supplies that were intact (7 VFs), synkinetically reinnervated (2 VFs), or chronically denervated (1 VF). In 3 cases, the stimulation was combined with airflow-driven phonation to study the consequent modulation of phonatory parameters. Results: Initial device prototypes used inductive coupling for power and communication, while later iterations used battery power and infrared light communication (detailed descriptions are provided in the Part 1 companion paper). Two animals were successfully implanted with the inductively powered units, which operated until removed at 8 months in 1 animal or for more than 16 months in the second animal. Surgically, the encapsulated implants were well tolerated, and procedures for placing, attaching, and connecting the devices were developed. To simulate EMG control signals in anesthetized animals, we created 2 types of nerve/muscle signal sources. In one approach, a neck muscle had a cuff electrode placed on its motor nerve that was connected to transdermal electrical connection ports for periodic testing. In the second approach, the recurrent laryngeal nerve on one side of the larynx was stimulated to generate a VF EMG signal, which was then used to trigger FES of the paralyzed contralateral side (eg, restoring VF movement symmetry). Implant testing identified effective stimulation parameters and closed-loop stimulation artifact rejection techniques for FES of both healthy and paralyzed VFs. Stimulation levels effective for VF adduction did not cause signs of discomfort during awake testing. Conclusion: Our inductive and battery-powered prototypes performed effectively during in vivo testing, and the 2 units that were implanted for long-term evaluation held up well. As a proof of concept, we demonstrated that elicited neck strap muscle or laryngeal EMG potentials could be used as a control signal for closed-loop stimulation of laryngeal adduction and vocal pitch modulation, depending on electrode positioning, and that VFs were stimulable in the presence of synkinetic reinnervation or chronic denervation. [ABSTRACT FROM AUTHOR]

Background: This study was conducted to evaluate the therapeutic efficacy of a device designed to deliver high-frequency vibratory stimulation through direct intravaginal tampon application (VIPON) compared with a low-dose over-the-counter pharmacologic treatment of dysmenorrhea. Methods: A randomized, open-label, prospective study comparing the investigational device to an oral self-administration of the over-the-counter dose of 200-400 mg of ibuprofen with the onset of menstrual discomfort was conducted at two academic medical centers in the Midwest region of the United States. Women age 18 and older with self-reported dysmenorrhea were treated with either VIPON or a single dose of 200-400 mg of ibuprofen, randomized for each of the next four menstrual cycles, and pain reduction from baseline was measured according to the Melzack-McGill pain scale. Results: Overall, both ibuprofen and VIPON have significant effects on pain reduction according to the Melzack-McGill pain scale. However, the VIPON group achieved statistically significant greater, and more rapid, pain relief at every time point when compared with the ibuprofen. Conclusion: VIPON tampon is a viable, nonpharmacologic option to traditional low-dose over-the-counter pharmacologic therapies for menstrual pain management with more rapid onset of action. [ABSTRACT FROM AUTHOR]

With the rise in wearable technology and “health culture”, we are seeing an increasing interest and affordances in studying how to not only prolong life expectancy but also in how to improve individuals’ quality of life. On the one hand, this attempts to give meaning to the increasing life expectancy, as living above a certain threshold of pain and lack of autonomy or mobility is both degrading and unfair. On the other hand, it lowers the cost of continuous care, as individuals with high quality of life indexes tend to have lower hospital readmissions or secondary complications, not to mention higher physical and mental health. In this paper, we evaluate the current state of the art in physiological therapy (biofeedback) along with the existing medical grade and consumer grade hardware for physiological research. We provide a quick primer on the most commonly monitored physiologic metrics, as well as a brief discussion on the current state of the art in biofeedback-assisted medical applications. We then go on to present a comparative analysis between medical and consumer grade biofeedback devices and discuss the hardware specifications and potential practical applications of each consumer grade device in terms of functionality and adaptability for controlled (laboratory) and uncontrolled (field) studies. We end this article with some empirical observations based on our study so that readers might use take them into consideration when arranging a laboratory or real-world experience, thus avoiding costly time delays and material expenditures. [ABSTRACT FROM AUTHOR]