Medical devices, the FDA, and the home healthcare clinician.

This article introduces the U.S. Food and Drug Administration's (FDA's) MedWatch adverse event reporting program that consumers and healthcare professionals can use to voluntarily report potential problems associated with medical devices.

Software-related recalls: an analysis of records.

Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software.

Stopping behavior in a VR driving simulator: a new clinical measure for the assessment of driving.

The driving privilege is a critical component of independent living for individuals who have acquired a brain injury. To date, measures of driving capacity following neurological compromise remain limited to gross performance measures, such as subjective behind the wheel evaluations. The current study demonstrates the use of a virtual reality (VR) driving simulator to provide objective and precise measures of driving behavior not previously available for clinical assessment.

Measuring finger flexion and activity trends over a 25 hour period using a low cost wireless device.

The goal of this research was to evaluate the usefulness of a wireless custom monitor in measuring real-time finger posture over an extended period of time as the wearer goes about daily life activities. One individual wore the device for 25 continuous hours in the research facility and at home. Initial data analysis methods have been presented to explore different aspects of hand activity over time.

A low cost instrumented glove for extended monitoring and functional hand assessment.

A wearable finger flexion monitor developed to measure hand function in individuals with hand dysfunction was evaluated for feasibility, measurement repeatability and reliability, fidelity of wireless transmission, and user acceptance. Configuration of the monitor allows use in situations when a traditional measurement glove cannot be worn. Five healthy individuals participated in the study of repeatability, while 10 healthy individuals and 10 individuals with acquired brain injury participated in trials to assess feasibility and user comfort.

Head-mounted displays for clinical virtual reality applications: pitfalls in understanding user behavior while using technology.

The use of virtual environments with head-mounted displays (HMDs) offers unique assets to the evaluation and therapy of clinical populations. However, research examining the effects of this technology on clinical populations is sparse. Understanding how wearers interact with the HMD is vital.

Design considerations for a wearable monitor to measure finger posture.

BACKGROUND: Objective measures of hand function as individuals participate in home and community activities are needed in order to better plan and evaluate rehabilitation treatments. Traditional measures collected in the clinical setting are often not reflective of actual functional performance. Recent advances in technology, however, enable the development of a lightweight, comfortable data collection monitor to measure hand kinematics.

Outcome assessment for spasticity management in the patient with traumatic brain injury: the state of the art.

The objective of this article was to (1) review the engineering and medical literature to structure the available information concerning the assessment of spasticity in the neurological population; (2) to discuss the strengths and weaknesses of the different methods currently in use in spasticity assessment; and (3) make recommendations for future efforts in spasticity outcome assessment. Spasticity textbooks, Web sites, and OVID, IEEE, and Medline searches from 1966 through 2003 of spasticity, quantitative measure, or outcome assessment in the rehabilitation population were used as data sources. Over 500 articles were reviewed.