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Device Manufacturer (device + manufacturer)
Selected AbstractsUnderstanding the experience of college graduates during their first year of employmentHUMAN RESOURCE DEVELOPMENT QUARTERLY, Issue 1 2004Janet L. Polach A company's college recruitment practices, as well as its socialization processes for graduates once they have joined the organization, can be improved when there is understanding of college graduates' experience during the first year of employment. This study recorded the experiences of eight college graduates who were employed by a medical device manufacturer in the Midwest. Nine themes common to all participants are identified and grouped into three categories: work environment, friendship, and performance. Related research on college graduates and first-job experiences, Generations X and Y, job expectations, and new-hire socialization is also reviewed. Recommendations are offered for consideration by the organization that employs the study's participants to improve college graduates' experience. Further research implications are also discussed. [source] Software validation for medical device manufacturingQUALITY ASSURANCE JOURNAL, Issue 4 2003Randy D. Jones Abstract The recent guidance on 21 CFR 11, the upcoming deadline for European CE Marking, and the needs of quality system regulation (QSR) have generated much discussion about approaches to software validation. In this article, a view of software validation by the design team of a QSR medical device manufacturer of precision glycohemoglobin/hemoglobin variant high performance liquid chromatography (HPLC) instrument platforms is provided. The software includes manufacturing, accounting and customer modules in one application. The unique aspect of this manufacturer's approach was to start with a risk analysis and a quality assurance audit plan to check software modules. The article also shows how a quality assurance unit should be prepared to contribute regulatory expertise for software validations that incorporate GMP, ICH, GLP, ISO and accounting standards. Copyright © 2003 John Wiley & Sons, Ltd. [source] Vestibular Effects of Cochlear Implantation,THE LARYNGOSCOPE, Issue S103 2004Craig A. Buchman MD Abstract Objectives/Hypothesis: Cochlear implantation (CI) carries with it the potential risk for vestibular system insult or stimulation with resultant dysfunction. As candidate profiles continue to evolve and with the recent development of bilateral CI, understanding the significance of this risk takes on an increasing importance. Study Design: Between 1997 to 2001, a prospective observational study was carried out in a tertiary care medical center to assess the effects of unilateral CI on the vestibular system. Methods: Assessment was performed using the dizziness handicap inventory (DHI), vestibulo-ocular reflex (VOR) testing using both alternate bithermal caloric irrigations (ENG) and rotational chair-generated sinusoidal harmonic accelerations (SHA), and computerized dynamic platform posturography (CDP) at preoperative, 1-month, 4-month, 1-year and 2-year postimplantation visits. CI was carried out without respect to the preoperative vestibular function test results. Results: Specifically, 86 patients were entered into the study after informed consent. For the group as a whole, pair wise comparisons revealed few significant differences between preoperative and postoperative values for VOR testing (ENG and SHA) at any of the follow-up intervals. Likewise, DHI testing was also unchanged except for significant reductions (improvements) in the emotional subcategory scores at both the 4-month and 1-year intervals. CDP results demonstrated substantial improvements in postural sway in the vestibular conditions (5 and 6) as well as composite scores with the device "off" and "on" at the 1-month, 4-month, 1-year, and 2-year intervals. Device activation appeared to improve postural stability in some conditions. Excluding those patients with preoperative areflexic or hyporeflexic responses in the implanted ear (total [warm + cool] caloric response , 15 deg/s), substantial reductions (,21 deg/s maximum slow phase velocity) in total caloric response were observed for 8 (29%) patients at the 4-month interval. These persisted throughout the study period. These changes were accompanied by significant low frequency phase changes on SHA testing confirming a VOR insult. Of interest, no significant changes were detected in the DHI or CDP, and there were no effects of age, sex, device manufacturer, or etiology of hearing loss (HL) for these patients. Conclusions: Unilateral CI rarely results in significant adverse effects on the vestibular system as measured by the DHI, ENG, SHA, and CDP. On the contrary, patients that underwent CI experienced significant improvements in the objective measures of postural stability as measured by CDP. Device activation in music appeared to have an additional positive effect on postural stability during CDP testing. Although VOR testing demonstrated some decreases in response, patients did not suffer from disabling vestibular effects following CI. The mechanism underlying these findings remains speculative. These findings should be considered in counseling patients about CI. [source] Donation of explanted pacemakers for reuse in underserved nationsJOURNAL OF HEALTHCARE RISK MANAGEMENT, Issue 3 2010CPHRM, FASHRM, Robert Stanyon MS Some charitable organizations and physicians are willing to assist in the compassionate donation of explanted pacemakers for reuse in medically underserved nations. However, healthcare organizations must recognize that the Food and Drug Administration (FDA), device manufacturers, professional societies and many physicians advocate return of explanted pacemakers to the manufacturer to ensure an accurate performance database promoting improved device reliability and safety for the patient. [source] | |||||||||||||