Medical Device Warning Letters: Trend analysis from 2011 to 2016
The medical device industry is one of the most dynamic fields of medical progress with thousands of new products marketed every year among other revolutionized technologies. The USFDA’s Center for Devices and Radiological Health (USFDA/CDRH) governs the Regulatory oversight of the medical devices. This article presents a summary of the Warning Letters issued for medical devices by USFDA from 2011 to 2016 and a trend analysis and statistics were made, which demonstrates a clear picture of the number of Warning Letters issued for 10 categories of Medical Devices. This was done to highlight the special issues that were observed. By comparing this data to that of the recent fiscal years, Pharmaceutical and Medical Devices manufacturing firms can gain a fair picture of the FDA enforcement trends and their probable impact on both Business and industry. The study found that the implementation of quality improvement strategies such as Six sigma, Quality by Design (QbD), Total Quality Management (TQM) can minimize the number of deviations and defects which leads to reduction in 483 observations and FDA Warning Letters.: It was found that739 Warning Letters for medical devices were issued by USFDA for FYs 2011 to 2016, wherein the FY 2012 (171) issuance was more and least in 2016 (43). Adulteration and failure to implement CAPA were the major deficiencies for which the Warning Letters were issued and the number has declined by 2016.
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Proximate and PAH compositions of raw and smoked samples of Scomber scombrus and Trachurus trachurus
Proximate and polycyclic aromatic hydrocarbon (PAH) compositions were analyzed in raw and smoked samples of two exotic fish species; mackerel (Scomber scombrus) and horse mackerel (Trachurus trachurus) obtained from a local market in Umuahia, Nigeria. The fish were procured in triplicate and split into two equal parts. One part was analyzed raw while the other was smoked with firewood before analysis. Moisture content was higher in the raw samples compared to their corresponding smoked samples. Crude protein was higher in horse mackerel samples for both raw and smoked categories while other parameters were generally higher in mackerel. Horse mackerel had the higher value of 44.784 mg/kg for total mean PAH (?mPAH) but PAH4 (sum of the four indicators of PAH contamination; benzo[a]pyrene, benz[a]anthracene, benzo[b]fluoranthene and chrysene) was similar in raw mackerel and horse mackerel. Mean BaP concentrations were higher than the EU limits (2 µg/kg) while PAH4 values were within the EU limit (12 µg/kg) in raw samples of both species. For the smoked samples, Mean BaP concentrations and mean PAH4 exceeded the EU maximum limits in the muscle of smoked fish and public health authorities are urged to take appropriate action.
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Level subset of bipolar valued fuzzy subsemirings of a semiring
In this paper, we study some of the properties of (?, ?)-level subsets of bipolar valued fuzzy subsemiring and prove some results on these.
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Horizontal dispersion of solute in semi-infinite porous medium with periodic input source and velocity
Analytical solution of advection-dispersion equation (ADE) is obtained for one-dimensional semi-infinite porous medium with periodic input boundary and periodic flow velocity. The dispersion coefficient is directly proportional to flow velocity. Laplace Transformation Technique is employing to get the analytical solution with exponentially increasing function of space variable initial condition and periodic input boundary condition. Analytical solution is illustrated graphically.
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Field Relation and lithology of South-Eastern Madurai Block, Tamil Nadu, India
Madurai Block belt is the largest high among the crustal fragments of the Southern Granulite Terrane. Our study focuses on the southeastern part of the Madurai Block which falls in the Thoothukudi District of Tamil Nadu. The geomorphology of the area is represented by high and mid-land regions with prominent hillocks and associated valleys. This region chiefly comprises of crystalline basement rocks that experienced granulite facies metamorphism. The southeastern region has been mapped, and the major rock types observed were identified as charnockite, hornblende-biotite gneiss, pyroxene granulite, quartzite, granite, pink granite and pegmatite. Massive garnet bearing charnockite exists as hills and which are intermixed with banded and migmatised hornblende-biotite gneiss. Diorite occurs as boudins and small enclaves within the charnockite. The charnockite occurs as both massive and foliated rocks in outcrops. A 5 km long intrusive body of pyroxene granulite is identified during the field study which trends NW-SE. Due to intense weathering they are found as boulders of varying size and shape.
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Study of alexithymia in relation to general health, somatic health and social support among institutionalized and non institutionalized adolescents
Adolescence, as the last developmental stepping stone to adulthood, is a period of pronounced growth and change. Alexithymia is primarily seen as a personality constructs a trait. It means difficulty to express feelings. It affects ones mental health and somatic health positively or negatively. Social support helps the person to maintain mental health. The aim of the present investigation is to study the alexithymia in relation to general health, somatic health and social support among institutionalized and non institutionalized adolescents. The sample for the study consists of 100 institutionalized and 100 non institutionalized adolescents ranging in the age of 16 to 19 years selected randomly from Punjab, Haryana and Chandigarh. TAS-20 Hindi version used to measure alexithymia (Bagby, Parker, & Taylor, 1994), General Health Questionnaire (GHQ- 28) by Goldberg, 1978, Somatic Health Complaints by Urmila Rani Srivastava ( ) and Social Support Questionnaire by Sarason et al., 1983. Descriptive statistics, correlation and 2X2 ANOVA (for main and interaction effect) were used. RESULTS- The calculated values show the significant association of general health with the somatic health as the values comes out to be .311 and between general health and satisfaction with social support the value found to be -.183. It was found that there was no interaction effect between alexithymia and type of stay on general health. There was significant main effect of alexithymia on GH total and SHC as the values comes out to be 0.00. The values disclosed that there was significant interaction effect of both the independent variables i.e. alexithymia and type of stay on perceived social support. The calculated F-value found to be 3.931 which is significant at 0.05 level.
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The Impact of Posing (Lead in) Pre-reading Questions on Reading Engagement of Iranian EFL Learners: Focusing on Extensive Reading
The significance and effectiveness of pre-reading activities in the contexts of both ESL and EFL has been acknowledged by many researchers. If students lack the required background knowledge, a teacher must activate students’ background knowledge or offer background information prior to reading a text. The present study aimed at investigating the role of pre-reading questions plus extensive reading in affecting the reading engagement of Iranian EFL learners. Participants of the study included two groups of 30 EFL learners with similar language proficiency. Reading engagement was measured using Reading Engagement Index developed by Wigfield and Guthrie (2004). Language learners were pretested on reading engagement and it was found that the two groups of the study were not significantly different in terms of reading engagement. Afterwards, one group received extensive reading plus pre-reading questions and another group received just extensive reading. The two groups’ reading engagement was measured after treatment to explore the effect of treatment on reading engagement of language learners. The results of paired samples and independent samples t-test indicated that pre-reading plus extensive reading was more successful in enhancing reading engagement of language learners compared to extensive reading.
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Home Perception in Iranian Housing Architecture
Perceiving an environment is the first step linking people to a place. The emergence of this perception which is achieved through a mental and sensory process depends on several factors. In this study, different theories regarding the perception of the environment are investigated as the research objectives. The aim of this study is to measure the individuals’ perception paradigm of traditional housing style in Iran compared to modern housing style. Thus, it compares the perception of citizens of the two housing styles. The traditional style consists of a group of traditional houses from Zand and Qajar era in Shiraz while the modern style consists of modern houses in the same city. Accordingly, after a review of literature, the theoretical framework of the research was developed and a questionnaire and interviews were prepared during a month period. Finally, the quantitative data was analyzed with the help of SPSS Software and the qualitative data was analyzed based on the interviews. The results showed that there is a significant difference among different dimensions of home perception, including cognitive, emotional, interpretive and evaluative perception in both traditional and modern Iranian houses. In this relation, essential items such as stimulating the sense of smell in the yard, injecting the smell of humidity and soil, making physical and emotional bonds with residents show the conceptual differences between the traditional and modern houses in Iran.
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Effect of strategic partnership on organizational performance of the health sector in Kenya
Strategic supply chain partnership is a collaborative coalition of two or more firms in a market to facilitate joint efforts collaborations in one or more core values. Many different stakeholders are involved in health care supply chain practices. Therefore, the application of supply chain management practices in a health care setting is almost by definition related to organizational aspects like building relationships, allocating authorities and responsibilities, and organizing interface processes. The performance of most public health facilities in supply chain management has been wanting. The study therefore sought to establish effect of strategic partnership on organizational performance. The study adopted descriptive survey design. The target population was 3500 employees in Moi Teaching and Referral Hospital. Purposive sampling was used to select employees in the procurement department that gave a sample size of 133 respondents. Questionnaires was used to collect data. The data collected was analyzed using descriptive statistics with the aid of Statistical Package for Social Sciences (SPSS v 21.0). The study established that the organization maintains good relationship with suppliers and distributors, collaborates with suppliers in coming up with specification, involves major suppliers in their planning and collaborates with major suppliers in implementing business activities. Strategic partnership has significant effect on organizational performance. The study recommended that the organizations should explore other avenues that they can benefit on strategic partnership with the suppliers.
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The effects of globalization on library practices- A case study of ekiti state university
Effectiveness of library services in the present digital age depends largely upon the application of information and communication technology, with integration into global information initiatives. This paper attempts to explore the impact of globalization on library and information services with emphasis on information environment globally. It is worthy to note that libraries in Africa seems unaffected by globalization and its information driven. It was further observed that African Libraries journeyed to the 21st century is a long and tortuous venture that encompassed with bumps and hiccups. It also analyzed the Nigerian libraries in the era of globalization and concluded by recommending that bold step towards launching Nigerian information environment in the global system becomes not only imperative but a necessity
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