[Design of a computer program for the registration of implantable medical device, field safety corrective action and advers events, as a tool for medical device surveillance]. / Diseño de un aplicativo para el registro de implantes, gestión de alertas e incidentes relacionados con productos sanitarios como herramienta para el responsable de vigilancia de productos sanitarios.

OBJECTIVE: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. METHOD: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. RESULTS: SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. CONCLUSIONS: SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.

Objetivo: Describir las funcionalidades de un programa informático de soporte a la actividad del responsable de vigilancia de productos sanitarios (PS). Analizar su utilidad tras un año de implantación. Método: Las etapas del proceso fueron: descripción de actividades básicas del responsable de vigilancia, definir las funcionalidades y datos a procesar, crear los formularios de registro y opciones de la herramienta SIVIPS, implantación en un hospital privado que gestiona PS, validación del programa y análisis de su utilidad al año. Resultados: Se desarrolló la herramienta SIVIPS en Acces® por farmacéuticos. Se describieron las variables básicas para todas las actividades del responsable de vigilancia de PS (registro implantes, registro de alertas, registro de incidentes con PS, incluidos los de diagnóstico in vitro) y las funcionalidades del programa. Al año de su implantación se encontraron registros de 564 implantes con la posibilidad de desglose por tipo de implante, 31 alertas con PS y 6 incidentes con PS, permitiendo el seguimiento de las actuaciones realizadas en estos casos. Conclusiones: SIVIPS® es la primera herramienta de soporte a la actividad del responsable de vigilancia de PS. Es una herramienta sencilla que permite de forma ágil el registro de alertas e incidentes con PS, así como el registro de los implantes realizados en el centro, consiguiendo mejorar la trazabilidad del PS.

[Safety of a multiperforated catheter implanted in the surgical wound for the continuous infusion of local anaesthetics in post-operative analgesia]. / Seguridad de un catéter multiperforado implantado en la herida quirúrgica para la infusión continua de anestésicos locales en la analgesia post-operatoria.

OBJECTIVE: To evaluate the incidence of infection at the surgical site in patients who have a multiperforated catheter implant for continuous infusion of a local anaesthetic as a local analgesic. PATIENTS AND METHOD: An observational, descriptive and prospective study, of one month duration. It included 50 patients subjected to selective laparotomy in whom a multiperforated pre-peritoneal catheter was implanted for analgesia purposes (Painfusor®. Baxter). Patients with a surgical incision of less than 15 cm and/or ASA>III, were excluded from the study. RESULTS: The catheter was removed from all patients at 48 hours. An infection at the surgical site was present in 6% of the patients who had the catheter implanted, which was similar to the incidence in clean-contaminated surgery (5.5%; 95% CI: 3.4-8.7%). Colonisation of the catheter was observed in two patients, causing only one infection of the surgical site. CONCLUSIONS: The use of an in-situ pre-peritoneal catheter for post-surgical anaesthesia does not increase the risk of surgical site infection.

[Effectiveness of peginterferon alpha-2a or -2b plus ribavirin in naïve patients with hepatitis C infection]. / Efectividad del tratamiento de la hepatitis C con peginterferón alfa (2a o 2b) más ribavirina en pacientes naïve.

INTRODUCTION: Treatment of hepatitis C is based on the combination of peginterferon alfa-2a or -2b plus ribavirin; the more effective peginterferon for this purpose has not been established. The aim of this study is to compare the effectiveness of hepatitis C treatment according to the type of peginterferon used. METHODS: A prospective cohort study was performed from November 2002 to May 2004, with up to 12 months of follow-up in all patients after completion of treatment. The study included naïve monoinfected patients, divided into two groups: Group A: peginterferon alfa-2a plus ribavirin and Group B: peginterferon alfa-2b plus ribavirin. The main variables studied were plasma glutamate pyruvate transferase levels (biochemical response), viral load (virologic response), and treatment effectiveness (biochemical and virologic response). RESULTS: A total of 202 patients were studied (Group A: 87; Group B: 115), there were no significant differences in baseline characteristics between the two groups. Sustained biochemical response: 75.8% vs. 76.2% (P = .908); Sustained virological response: 71.3% vs. 64.3% (P = .293); Effectiveness of treatment: 64.2% vs. 60.87% (P = .628). CONCLUSION: No differences in the sustained virological or biochemical response were found between groups receiving peginterferon alfa-2a or peginterferon alfa-2b plus ribavirin, suggesting that the two types of peginterferon alfa are similarly effective for treating hepatitis C in monoinfected patients.

[Toxicity of the treatment of chronic hepatitis C with peginterferon alpha (2a or 2b) plus ribavirin in patients not previously treated]. / Toxicidad del tratamiento de la hepatitis C crónica con peginterferón alpha (2a o 2b) y ribavirina en pacientes no tratados anteriormente.

BACKGROUND AND OBJECTIVE: The adverse reactions (ADR) derived from the treatment of hepatitis C with peginterferon alpha and ribavirin causes dose reductions and discontinuations of the treatment that compromise its efectiveness. The aims of this study are to determine the ADR that the patients have presented according to the type of peginterferon alpha, and the effect of these in treatment duration and accumulated dose. PATIENTS AND METHOD: Cohort, prospective and longitudinal study (from November 2002 to April 2006), with monoinfected patients not previously treated (group A: peginterferon alpha-2a plus ribavirin; group B: peginterferon alpha-2b plus ribavirin). RESULTS: Group A: 93 patients; group B: 115. Hematologyc ADR: neutropenia, 24% vs. 26.90%; anemia: 12.50% vs. 9.60%. Not hematologyc ADR: fatigue, 73.10% vs 74.80%; fever (> 38 degrees C), 81.70% vs 86.10%. Permanency in treatment < 80%: 18.3% in group A patients vs. 9.5% in group B patients. Accumulated dose of peginterferon < 80%: 13.9% in group A patients vs. 11.3% in group B patients. CONCLUSIONS: We haven't found differences in the safety profile of both peginterferons, though the patients treated with peginterferon alpha-2b shows a higher permanency in the treatment and a percentage of total received doses > 80% of the theoretical ones.