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Intravenous infusion devices - commonly known as infusion pumps - provide clinicians with mechanisms to automate the accurate dosing of potent fluid therapies to critically ill patients. In critical care applications, fluid dosing must be both accurate and safe since unwanted flow disturbance can cause physiological harm to the patient. This study consists of three discrete projects based on these vital themes of safe device design and accurate fluid delivery. The first project, commissioned by Medical Magnetics Ltd during the period 1998 onwards, proposed that the fail-safe design philosophy universally used in the design of infusion pumps, and implemented in embedded software, is lengthy and provides the manufacturer with difficulties in demonstrating the exhaustive fail-safe validation needed for an instrument to be released speedily for sale. An alternative and innovative strategy employing the design of hardware modules and using re-configurable VLSI, is proposed and shown to offer a significant reduction of the design and validation phase of development with consequent financial benefit to the manufacturer. The second project conducted as part of the Manukau Institute Research Programme for 2003 examined the manner in which dosing accuracy is assessed for infusion pumps. The International Standard used by clinicians to select apparatus suitable for treatment of 'critically-ill' patients is shown to be flawed and potentially misleading - a finding of international significance. An innovative mathematical simulation model is described that enables prediction of flow accuracy for various expected operating scenarios previously impossible to investigate using current laboratory measurement techniques. Use of this simulation model indicates that various mechanical design factors influencing system compliance and hence dosing accuracy have been previously ignored by designers and suggests that contemporary infusion pump designs are far from optimum. These findings offer an explanation for instances of dosing error previously reported in the clinical literature and are of international value. The third project of the study utilises the findings of, and is subsequent to, the second project. An innovative design is proposed for an infusion therapy device in which dosing accuracy may be maintained under operating conditions such as height change and patient venous pressure variation that cause unwanted errors in conventional equipment designs. This design is the subject of patent application, commercial exploitation and further development.

Thesis (Dr. P.H.)--University of Texas Health Science Center at Houston, School of Public Health, 1994. / Typescript. Includes bibliographical references (leaves 167-172).

To date there have been no complete reports of the nutrient intakes of persons with Type I diabetes mellitus who use continuous subcutaneous insulin infusion (CSII) pumps. The purpose of this study was to describe the sample population and to determine the nutrient intake of adult Type I diabetics from the Salt Lake City, Utah area, who use CSII. Seven male and 15 female CSII users, ages 25 to 53, completed a questionnaire and a three-day diet record as instructed. Diet records were coded and household measurements of foods were converted to gram weights for computerized nutrient analysis. Nutrient intake is reported as group mean and standard deviation for sex and age. The average duration of diabetes was 17 years. The average length of CSII use was l.6 years. Review of the medical charts revealed that weight gain since beginning CSII averaged 5.5 pounds irrespective of the duration of pump use. The dietary intake of protein, calcium, phosphorus, vitamin A, thiamin, riboflavin, niacin, vitamin B12 , and ascorbic acid met or exceeded the Recommended Dietary Allowances (RDA) for both men and women. For males, mean nutrient intakes were below the RDA for zinc (82.7%), folate (82.2%), and vitamin 86 (69.0%). For females, intakes were also below the RDA for zinc (64.0%), folate (58.3%), and vitamin 86 (69.0%), as well as for iron (58.5%) and magnesium (88.0%). The average percent of kilocalories from protein, carbohydrate and fat, (approximately 17%, 43%, and 40%) was similar for both the males and females. The day-to-day variation in carbohydrate intake for both sexes was not significantly different. Intake of added sugar in the diet was 6.6% and 5.8% of total kilocalories (14.8% and 13.9% of the carbohydrate kilocalories) for males and females, respectively. In conclusion, dietary intake for this small group of CSII users was adequate in most nutrients . Of concern is the apparent inadequate intakes of zinc, folate, vitamin s6 and iron for women, as compared to the current RDA standards. The distribution of kilocalories from protein, carbohydrate and fat approaches the 1979 recommendations by the American Diabetes Association. Weight gain may be a problem for some CSII pump users, and should be monitored.

Introdução. Apesar das evidências dos efeitos imunomodulatórios da morfina, não há na literatura estudos que tenham comparado a interação entre citocinas, imunidade celular (linfócitos T, B e NK) e a administração prolongada de morfina administrada pelas vias oral ou intratecal em doentes com dor crônica neuropática não relacionada ao câncer. Foram avaliados de forma transversal e comparativa 50 doentes com diagnóstico de dor lombar crônica e com presença de radiculopatia (dor neuropática) previamente operados para tratar hérnia discal lombar (Síndrome Dolorosa Pós- Laminectomia), sendo 18 doentes tratados prolongadamente com infusão de morfina pela via intratecal com uso de sistema implantável no compartimento subaracnóideo (grupo intratecal); 17 doentes tratados prolongadamente com morfina pela via oral (n=17) e 15 doentes tratados com fármacos mas sem opióides (grupo sem opioide). Foram analisadas as concentração das citocinas IL-2, IL-4, IL-8, TNFalfa, IFNy, IL-5, GM-CSF, IL-6, IL-10 e IL-1beta no plasma e no líquido cefalorraquidiano; imunofenotipagem de linfócitos T, B e células NK e avaliados os Índice de Escalonamento de Opióide (em percentagem de opióide utilizada e em mg), dose cumulativa de morfina (mg), duração do tratamento em meses, dose final de morfina utilizada (em mg), e equivalente de morfina por via oral (em mg). Resultados. Não houve diferença estatisticamente significativa entre o número de linfócitos T, B e NK nos doentes com morfina administrada pelas vias IT, VO e os não usuários de morfina. Houve correlação positiva entre as concentrações de linfócitos T CD4 e o Índice de Escalonamento de Opióide (em % e mg) nos doentes tratados com morfina por via intratecal. Houve correlação negativa entre as concentrações de células NK (CD56+) e o Índice de Escalonamento de Opióide (em % e mg) nos doentes tratados com morfina por via intratecal. Houve correlação positiva entre o número de células NK (CD56+) e a dose cumulativa de morfina (em mg) administrada pelas vias intratecal e oral. Houve correlação positiva entre as concentrações de linfócitos T CD8 e a duração do tratamento em meses nos doentes tratados com morfina pela via oral. As concentrações de IL-8 e IL-1beta foram maiores no LCR do que no plasma em todos os doentes da amostra analisada. As concentrações de IFNy no LCR foram maiores nos doentes que utilizavam morfina pela via oral e nos não usuários de morfina do que nos que a utilizavam pela via intratecal. As concentrações de plasmáticas de IL-5 foram maiores nos doentes utilizavam morfina pela via oral ou intratecal do que nos que não a utilizavam. A concentração de IL-5 no LCR correlacionou-se negativamente com a magnitude da dor de acordo com a EVA nos doentes tratados com morfina pelas via oral ou intratecal. Nos doentes tratados com morfina pelas via oral ou intratecal, a concentração de IL-2 no LCR correlacionou-se positivamente com a magnitude da dor de acordo com a EVA e negativamente com o Índice de Escalonamento de Opióide (em % e mg) e a dose cumulativa de morfina (em mg). As concentrações plasmáticas de GMCSF foram maiores nos doentes utilizavam morfina pela via oral ou intratecal do que nos não a utilizavam. A concentração de TNFalfa no LCR nos doentes tratados com morfina pela via intratecal correlacionou-se negativamente com o Índice de Escalonamento de Opióide (em % e mg), a dose cumulativa de morfina (em mg) e dose equivalente por via oral (em mg) de morfina. A concentração plasmática das citocinas IL-6 e IL-10 correlacionou-se negativamente com a duração do tratamento (em meses) nos doentes tratados com morfina administrada pela via oral. O Índice de Escalonamento de Opióide (em mg e %) correlacionou-se negativamente com as concentrações no LCR de IL-2 e TNFalfa nos doentes tratados com morfina administrada pela via intratecal. O Índice de Escalonamento de Opióide (em mg e %) correlacionou-se negativamente com as concentrações no LCR de IL-2 e IL-5 nos doentes tratados com morfina administrada pela via oral. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações de IL-5 e IL-2 no LCR nos doentes tratados com morfina administrada pelas vias oral e intratecal. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações plasmáticas de IL-4 nos doentes tratados com morfina administrada pela via intratecal. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações plasmáticas de IL-1beta nos doentes tratados com morfina administrada pela via intratecal. Conclusões: Os resultados sugerem associações entre citocinas e imunidade celular (células T , B e NK) e o tratamento prolongado com morfina administrada pela via oral ou intratecal. Estes resultados podem contribuir para a compreensão da imunomodulação da morfina administrada por diferentes vias em doentes com dor neuropática crônica não oncológica . São necessários mais estudos sobre os efeitos da morfina sobre o sistema imunológico / Objective: To analyze plasma and cerebrospinal fluid (CSF) cytokine levels and cell-mediated immunity (T, B and NK cells) of chronic neuropathic pain patients under long-term morphine treatment administered through the oral or spinal routes. Design: Cross- sectional clinical and laboratory analysis. Subjects:Fifty ambulatory patients with diagnosis of chronic low back pain and presence of radiculopathy (neuropathic pain) previously operated to treat lumbar disc hernia (failed back surgery syndrome) receiving long term morphine treatment (minimum 180 days); 18 patients receiving long term morphine into the intrathecal space through a implanted pump (\"spinal group\"); 17 patients treated with long-term oral morphine (\"oral group\") and 15 patients treated with non-opioid analgesics (\"without opioid group\"). Methods: Were analyzed plasma and cerebrospinal fluid concentrations of 10 cytokines using a multiplex system (Luminex®) for the following cytokines: IL- 2, IL-4, IL-8, TNFalfa, IFNy, IL-5, GM-CSF, IL-6, IL-10 and IL-1beta; immunophenotyping of lymphocytes T, B and NK cells. Results: There were no significant group demographic differences. No significant T, B and NK cells differences were observed between the 3 groups. CD4 levels and Opioid Escalation Index (OEI) were positively correlated in spninal group. NK cells levels and OEI were negatively correlated in spinal group. NK cells levels and cumulative morphine dose were positively correlated in spninal and oral groups. CSF concentrations of IL-8 and IL-1beta were higher than plasma concentrations in all groups. CSF concentration of FNg were higher in oral and without opioid group. Plasma IL-5 concentrations were higher in the oral and spinal groups compared to without opioid group. CSF concentration of IL-5 was negatively correlated with pain intensity in the oral and spinal groups. CSF concentrations of IL-2 was positively correlated with pain intensity and negatively correlated with OEI and cumulative morphine dose in the oral and spinal groups. GM-CSF plasma concentrations were higher in oral and spinal group compared to without opioid group. TNFa CSF concentrations was negatively correlated with OEI, cumulative morphine dose and equivalent oral morphine dose in the spinal group. IL-6 and IL-10 plasma concentrations were negatively correlated with treatment duration in the oral group. OEI The significant inverse correlations observed between pain intensity and the plasma IL-6 and IL-10 concentrations in patients receiving longterm i.t. opioids for chronic pain management, suggests that these cytokines are worthy of further investigation as possible biomarkers of persistent pain. CSF concentrations of IL-2 and TNFa were negatively correlated with OEI in spinal group. CSF concentrations of IL-2 and IL-5 were negatively correlated with OEI in oral group and with pain intensity in the oral and spinal group. Plasma concentrations of IL-4 was negatively correlated with pain intensity in spinal group. Plasma concentrations of IL-1beta were negatively correlated with pain intensity in spinal group. Conclusions: The results suggest associations between long term morphine treatment administered by oral or spinal routes and cytokines concentrations and cellmediated immunity (T, B and NK cells). These results can contribute to the understanding of immunomodulation by morphine administered through diferent routes in patients with chronic neuropathic non-cancer pain. Further studies on the effects of morphine on the immune system are needed

The purpose of this research study was to improve the nursing care of intravenous catheters by providing evidence on the effects of prolonged duration of intravenous administration set use. Intravenous therapy is a vital part of modern health care. However, its invasive nature can result in infection, with high associated morbidity and mortality. The highest infection rates are displayed in intensive care patients with central venous catheters. The duration of intravenous administration set use may have an impact on infection rates,however the current practice usage and the optimum duration of use is unknown. Previous studies of central venous catheters have reported equal infection rates with 1 to 4 days of administration set use; however few patients have been evaluated with administration sets used beyond this time. Previous research has been limited by the inadequacy of available definitions for Catheter-Related Infection. A prospective, randomised, controlled clinical trial was performed to assess the infection risk of using administration sets for prolonged periods. In the developmental phase prior to the clinical trial; definitions of Catheter-Related Bloodstream Infection (CRBSI) were developed; a nursing practice survey was undertaken to establish the current duration of administration set use; and laboratory experiments were executed to assess the impact of prolonged use on administration set physical integrity and performance. Central venous catheters were randomised to have their administration sets used for 4 days (n = 203) or 7 days (n = 201). Percutaneous central venous catheters were enrolled into the study from two adult intensive care units at a metropolitan, tertiary-referral, teaching hospital. Catheters were multiple-lumen, chlorhexidine-gluconate and silver-sulphadiazine coated lines, both inserted and removed in the intensive care unit. Catheters were cultured for microbial colonisation on removal using the Maki roll-plate technique. Patients were assessed for CRBSI using the developed definitions consisting of categories: definite, probable (type I and II), possible and absent. Prior to the clinical trial, a practice survey questionnaire was administered, and laboratory experimentation was performed. Normality of distribution for continuous variables was assessed using the Kolmogorov- Smirnov statistic. The distribution between groups of variables considered risk factors for Catheter-Related Infection were tested to assess for bias using Chi-square and T-test. Logistic regression modelling was performed to analyse the influence of potentially confounding variables. The incidence of catheter colonisation and CRBSI was tested between groups using Kaplan-Meier survival curve with Log-rank test. Paired T-tests were performed to test for difference in programmed and delivered volumes of administration sets. A general linear model (ANOVA)± a Scheffe post hoc test to isolate difference was fitted to the standardised values of delivered volumes to determine the effects of day of measurement and volume delivery rate on the accuracy of volume delivery. There were 10 colonised tips in the intervention group and 19 in the control group. This difference was not statistically significant (Kaplan Meier survival analysis, Log Rank = 0.87, df = 1, p = 0.35). There were 3 cases of CRBSI per group and the difference in survival from CRBSI was not statistically significant (Kaplan Meier with Log Rank test, p = 0.86). The pre-clinical trial phases of the research programme established that current clinical practice was 3 to 7-day use of administration sets; that administration sets were physically intact and delivered clinically accurate volumes after 7 days of use; and developed useful definitions of CRBSI. Prolonged intravenous administration set use of 7 days was found to have no significant impact on patient infection indicators or physical performance of the sets. This finding is congruent with previous research and trends in current clinical practice. In conclusion, the research findings support the use of intravenous administration sets for 7 days.

Submitted by Johnny Rodrigues (johnnyrodrigues@ufcg.edu.br) on 2018-04-21T13:58:34Z No. of bitstreams: 1 SIDNEY ACIOLE RODRIGUES - DISSERTAÇÃO PPGEE 2014..pdf: 10747994 bytes, checksum: a201eceb35c011516f93accef0c024f9 (MD5) / Made available in DSpace on 2018-04-21T13:58:34Z (GMT). No. of bitstreams: 1 SIDNEY ACIOLE RODRIGUES - DISSERTAÇÃO PPGEE 2014..pdf: 10747994 bytes, checksum: a201eceb35c011516f93accef0c024f9 (MD5) Previous issue date: 2014-09 / De acordo com a Administração Federal de Alimentos e Medicamentos estadunidense (Food and Drug Administration – FDA), bombas de infusão são consideradas atualmente os dispositivos médicos cuja segurança é a mais crítica, devido à natureza de suas operações e os riscos a elas associados. O projeto destes dispositivos ainda é uma questão em aberto e várias iniciativas de melhoria estão sob investigação. No entanto, as especificações de tais sistemas ainda não estão adaptadas ao estado-da-arte do desenvolvimento de sistemas arquiteturais. Por exemplo, nesta pesquisa não foi possível identificar qualquer projeto que atenda aos padrões, considerando as especificação e documentação de arquiteturas de sistemas e de software durante o processo de engenharia. Em face desta situação, nesta dissertação é apresentada a especificação funcional de uma arquitetura para bombas de infusão que pode ser realizada mediante o emprego de várias tendências tecnológicas para esses produtos, a fim de melhorar a segurança. A especificação arquitetural apresentada foi validada pelo desenvolvimento de um protótipo multicanal de uma bomba de infusão que pode ser programada utilizando dados obtidos a partir de um serviço web, usando um aplicativo de celular, como controle remoto, que permita mudar os parâmetros de infusão de acordo com dados da prescrição médica. Assim, a principal contribuição deste trabalho pode ser apresentada como uma arquitetura distribuída para esse tipo de dispositivo, permitindo a integração com registros eletrônicos de saúde para o domínio de sistemas embarcados que implicam em redução de erros durante a atividade de programação. / According to the Food and Drug Administration - FDA, infusion pumps are currently considered the most safety-critical medical device due to the nature of their operations and associated risks. Design of these devices is still an open question and several improvement initiatives are under research. However, the released specifications of such systems are not yet adapted to the current state-of-art systems architectural developments. For example, in this work, we could not identify any project meeting the patterns of views and viewpoints for specification and documentation of system and software architectures during the engineering process. Due to this, this dissertation proposes a functional specification of an architecture for infusion pumps that can be realized through several technological trends for these products in order to improve safety. The presented architectural specification was validated by the development of a multichannel prototype of an infusion pump that can be programmed through data retrieved from a web service using a mobile application as a remote control and changing the infusion parameters according to medical prescription. Thus, the main contribution of this paper can be presented as a distributed architecture for this sort of device, allowing early integration with Electronic Health Records for the embedded systems domain implying in risk reductions during the programming activity.

Introdução. Apesar das evidências dos efeitos imunomodulatórios da morfina, não há na literatura estudos que tenham comparado a interação entre citocinas, imunidade celular (linfócitos T, B e NK) e a administração prolongada de morfina administrada pelas vias oral ou intratecal em doentes com dor crônica neuropática não relacionada ao câncer. Foram avaliados de forma transversal e comparativa 50 doentes com diagnóstico de dor lombar crônica e com presença de radiculopatia (dor neuropática) previamente operados para tratar hérnia discal lombar (Síndrome Dolorosa Pós- Laminectomia), sendo 18 doentes tratados prolongadamente com infusão de morfina pela via intratecal com uso de sistema implantável no compartimento subaracnóideo (grupo intratecal); 17 doentes tratados prolongadamente com morfina pela via oral (n=17) e 15 doentes tratados com fármacos mas sem opióides (grupo sem opioide). Foram analisadas as concentração das citocinas IL-2, IL-4, IL-8, TNFalfa, IFNy, IL-5, GM-CSF, IL-6, IL-10 e IL-1beta no plasma e no líquido cefalorraquidiano; imunofenotipagem de linfócitos T, B e células NK e avaliados os Índice de Escalonamento de Opióide (em percentagem de opióide utilizada e em mg), dose cumulativa de morfina (mg), duração do tratamento em meses, dose final de morfina utilizada (em mg), e equivalente de morfina por via oral (em mg). Resultados. Não houve diferença estatisticamente significativa entre o número de linfócitos T, B e NK nos doentes com morfina administrada pelas vias IT, VO e os não usuários de morfina. Houve correlação positiva entre as concentrações de linfócitos T CD4 e o Índice de Escalonamento de Opióide (em % e mg) nos doentes tratados com morfina por via intratecal. Houve correlação negativa entre as concentrações de células NK (CD56+) e o Índice de Escalonamento de Opióide (em % e mg) nos doentes tratados com morfina por via intratecal. Houve correlação positiva entre o número de células NK (CD56+) e a dose cumulativa de morfina (em mg) administrada pelas vias intratecal e oral. Houve correlação positiva entre as concentrações de linfócitos T CD8 e a duração do tratamento em meses nos doentes tratados com morfina pela via oral. As concentrações de IL-8 e IL-1beta foram maiores no LCR do que no plasma em todos os doentes da amostra analisada. As concentrações de IFNy no LCR foram maiores nos doentes que utilizavam morfina pela via oral e nos não usuários de morfina do que nos que a utilizavam pela via intratecal. As concentrações de plasmáticas de IL-5 foram maiores nos doentes utilizavam morfina pela via oral ou intratecal do que nos que não a utilizavam. A concentração de IL-5 no LCR correlacionou-se negativamente com a magnitude da dor de acordo com a EVA nos doentes tratados com morfina pelas via oral ou intratecal. Nos doentes tratados com morfina pelas via oral ou intratecal, a concentração de IL-2 no LCR correlacionou-se positivamente com a magnitude da dor de acordo com a EVA e negativamente com o Índice de Escalonamento de Opióide (em % e mg) e a dose cumulativa de morfina (em mg). As concentrações plasmáticas de GMCSF foram maiores nos doentes utilizavam morfina pela via oral ou intratecal do que nos não a utilizavam. A concentração de TNFalfa no LCR nos doentes tratados com morfina pela via intratecal correlacionou-se negativamente com o Índice de Escalonamento de Opióide (em % e mg), a dose cumulativa de morfina (em mg) e dose equivalente por via oral (em mg) de morfina. A concentração plasmática das citocinas IL-6 e IL-10 correlacionou-se negativamente com a duração do tratamento (em meses) nos doentes tratados com morfina administrada pela via oral. O Índice de Escalonamento de Opióide (em mg e %) correlacionou-se negativamente com as concentrações no LCR de IL-2 e TNFalfa nos doentes tratados com morfina administrada pela via intratecal. O Índice de Escalonamento de Opióide (em mg e %) correlacionou-se negativamente com as concentrações no LCR de IL-2 e IL-5 nos doentes tratados com morfina administrada pela via oral. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações de IL-5 e IL-2 no LCR nos doentes tratados com morfina administrada pelas vias oral e intratecal. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações plasmáticas de IL-4 nos doentes tratados com morfina administrada pela via intratecal. Houve correlação negativa entre a intensidade da dor de acordo com a EVA e as concentrações plasmáticas de IL-1beta nos doentes tratados com morfina administrada pela via intratecal. Conclusões: Os resultados sugerem associações entre citocinas e imunidade celular (células T , B e NK) e o tratamento prolongado com morfina administrada pela via oral ou intratecal. Estes resultados podem contribuir para a compreensão da imunomodulação da morfina administrada por diferentes vias em doentes com dor neuropática crônica não oncológica . São necessários mais estudos sobre os efeitos da morfina sobre o sistema imunológico / Objective: To analyze plasma and cerebrospinal fluid (CSF) cytokine levels and cell-mediated immunity (T, B and NK cells) of chronic neuropathic pain patients under long-term morphine treatment administered through the oral or spinal routes. Design: Cross- sectional clinical and laboratory analysis. Subjects:Fifty ambulatory patients with diagnosis of chronic low back pain and presence of radiculopathy (neuropathic pain) previously operated to treat lumbar disc hernia (failed back surgery syndrome) receiving long term morphine treatment (minimum 180 days); 18 patients receiving long term morphine into the intrathecal space through a implanted pump (\"spinal group\"); 17 patients treated with long-term oral morphine (\"oral group\") and 15 patients treated with non-opioid analgesics (\"without opioid group\"). Methods: Were analyzed plasma and cerebrospinal fluid concentrations of 10 cytokines using a multiplex system (Luminex®) for the following cytokines: IL- 2, IL-4, IL-8, TNFalfa, IFNy, IL-5, GM-CSF, IL-6, IL-10 and IL-1beta; immunophenotyping of lymphocytes T, B and NK cells. Results: There were no significant group demographic differences. No significant T, B and NK cells differences were observed between the 3 groups. CD4 levels and Opioid Escalation Index (OEI) were positively correlated in spninal group. NK cells levels and OEI were negatively correlated in spinal group. NK cells levels and cumulative morphine dose were positively correlated in spninal and oral groups. CSF concentrations of IL-8 and IL-1beta were higher than plasma concentrations in all groups. CSF concentration of FNg were higher in oral and without opioid group. Plasma IL-5 concentrations were higher in the oral and spinal groups compared to without opioid group. CSF concentration of IL-5 was negatively correlated with pain intensity in the oral and spinal groups. CSF concentrations of IL-2 was positively correlated with pain intensity and negatively correlated with OEI and cumulative morphine dose in the oral and spinal groups. GM-CSF plasma concentrations were higher in oral and spinal group compared to without opioid group. TNFa CSF concentrations was negatively correlated with OEI, cumulative morphine dose and equivalent oral morphine dose in the spinal group. IL-6 and IL-10 plasma concentrations were negatively correlated with treatment duration in the oral group. OEI The significant inverse correlations observed between pain intensity and the plasma IL-6 and IL-10 concentrations in patients receiving longterm i.t. opioids for chronic pain management, suggests that these cytokines are worthy of further investigation as possible biomarkers of persistent pain. CSF concentrations of IL-2 and TNFa were negatively correlated with OEI in spinal group. CSF concentrations of IL-2 and IL-5 were negatively correlated with OEI in oral group and with pain intensity in the oral and spinal group. Plasma concentrations of IL-4 was negatively correlated with pain intensity in spinal group. Plasma concentrations of IL-1beta were negatively correlated with pain intensity in spinal group. Conclusions: The results suggest associations between long term morphine treatment administered by oral or spinal routes and cytokines concentrations and cellmediated immunity (T, B and NK cells). These results can contribute to the understanding of immunomodulation by morphine administered through diferent routes in patients with chronic neuropathic non-cancer pain. Further studies on the effects of morphine on the immune system are needed

The aim of this thesis was to introduce the intrathecal baclofen delivery method and assessment of its efficacy on patients with severe spasticity. It is an invasive spasticity affecting method which uses an abdominally implanted programmable infusion pump connected with a catheter inserted in the spinal canal. The pump delivers baclofen to the cerebrospinal fluid (baclofen is the central myorelaxans). This method reduces adverse effects of the drug, however it is an invasive method, that can bring various complications. In the practical part, I evaluated one patient with spinal spasticity before and after the treatment initiation. The spasm frequency was decreased by 2 points. The muscular tone measured by the Ashworth scale was decreased by 0,5 point, by 0,7 according to the modified Ashworth scale. Powered by TCPDF (www.tcpdf.org)

Medical devices are used to diagnose, treat, or prevent a disease or abnormal physical condition without any chemical action in the body. They can also result in unintended incidents and other errors. This thesis was divided into three chapters: i) a systematic review on the recognition, reporting and resolution of incidents related to medical devices and other health technologies; ii) telephone interviews with physicians and registered nurses (RNs) to solicit information on the resolution, reporting and resolution of medical device-related incidents based on their professional experience; and iii) a case study to review the continuous quality improvement (CQI) data retrieved from the wireless smart infusion pump system at The Ottawa Hospital (TOH) and to propose a CQI data analysis process. The systematic review included 30 studies on factors that influence the recognition, reporting and resolution of incidents in hospitals and interventions to improve patient safety. Central themes that emerged for incident reporting were personal attitudes, awareness and perception of incident reporting systems, organizational culture, and feedback to healthcare professionals. In our telephone interviews, physicians and RNs attributed incident recognition to devices not operating based on the manufacturer’s instructions, and to the hospital staff’s knowledge of and professional experience with the use of the medical device, and clinical manifestations of patients. Suggestions to improve medical device safety surveillance centered on education and training to ensure that the staff is able to use the medical device properly and know what would be considered an error, and how to report these errors. The results of the systematic review and interviews helped to inform the design of a medical device surveillance framework in a hospital setting. Our case study assessed the Dose Error Reduction Software compliance and frequency of soft and hard limit alerts with wireless smart infusion pump systems over a one year period. A CQI data analysis process to monitor the performance of wireless smart infusion pumps is proposed. The findings of this doctoral thesis can contribute to the development of a medical device surveillance system that would help to improve health care delivery and patient safety in a health care institution.