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Santana H.T.,National Health Surveillance Agency ANVISA | de Freitas M.R.,Federal University of Rio Grande do Norte | Ferraz E.M.,Federal University of Pernambuco | Evangelista M.D.S.N.,University of Brasilia
Journal of Infection and Public Health

The World Health Organization (WHO) created the WHO Surgical Safety Checklist to prevent adverse events in operating rooms. The aim of this study was to analyze WHO checklist implementation in three operating rooms of public hospitals in the Brazilian Federal District. A prospective cross-sectional study was performed with pre- (Period I) and post (Period II)-checklist intervention evaluations. A total of 1141 patients and 1052 patients were studied in Periods I and II for a total of 2193 patients. Period I took place from December 2012 to March 2013, and Period II took place from April 2013 to August 2014. Regarding the pre-operatory items, most surgeries were classified as clean-contaminated in both phases, and team attire improved from 19.2% to 71.0% in Period II. Regarding checklist adherence in Period II, "Patient identification" significantly improved in the stage "Before induction of anesthesia". "Allergy verification", "Airway obstruction verification", and "Risk of blood loss assessment" had low adherence in all three hospitals. The items in the stage "Before surgical incision" showed greater than 90.0% adherence with the exception of "Anticipated critical events: Anesthesia team review" (86.7%) and "Essential imaging display" (80.0%). Low adherence was noted in "Instrument counts" and "Equipment problems" in the stage "Before patient leaves operating room". Complications and deaths were low in both periods. Despite the variability in checklist item compliance in the surveyed hospitals, WHO checklist implementation as an intervention tool showed good adherence to the majority of the items on the list. Nevertheless, motivation to use the instrument by the surgical team with the intent of improving surgical patient safety continues to be crucial. © 2016. Source

Castanheira L.G.,National Health Surveillance Agency ANVISA

Non clinical studies are one of the requirements for the Brazilian National Regulatory Authority, ANVISA, for licensing a similar biotherapeutic product. During the WHO/KFDA workshop on implementing WHO guidelines on evaluating similar biotherapeutic products (SBP) in Seoul, Republic of Korea, the Brazilian experience with the non clinical studies of a Granulocyte Colony Stimulatory Factor (G-CSF), filgrastim, was presented. The applicant presented a reduced non clinical data package, but the key studies with relevant species were conducted and the non-clinical studies were considered sufficient for approval. Using the comparability exercise, these studies were taken together with the appropriate quality and clinical packages presented. © 2011. Source

De Souza J.H.C.,National Health Surveillance Agency ANVISA | Ferreira J.L.,University of Brasilia
IEEE Transactions on Plasma Science

In this paper, we present some results of a plasma source developed at the Plasma Laboratory of the University of Brasilia for sterilization studies at atmospheric pressure. This source was primarily conceived to produce a corona-type discharge to be used on pollutant control experiments. We used ordinary air as the precursor gas. Our apparatus consists of two coaxial cylindrical tubes with different radii connected to a high-voltage power source. We used G. stearothermophilus spores as the biological indicators. We counted the viable spores after the exposure to the plasma with the pour plate technique. Finally, we studied the biocide mechanisms of the plasma and related the inactivation of the microorganisms to plasma-induced chemical and physical processes. © 2012 IEEE. Source

Guerra C.M.,Federal University of Sao Paulo | Ramos M.P.,Federal University of Sao Paulo | Penna V.Z.,Federal University of Sao Paulo | Goto J.M.,Federal University of Sao Paulo | And 4 more authors.
American Journal of Infection Control

Background: Several countries have conducted studies to assess the status of their infection control programs (ICP) with the objective of improving quality of infection control practices. Methods: To assess the perceptions and attitudes of the health care workers (HCW) concerning ICP in Brazilian hospitals, we conducted a cross-sectional survey using a self-administered online questionnaire during a Web-based course (WBC) on infection control (IC) and antimicrobial resistance (AR). Results: Of 6256 Brazilian HCW registered for the WBC, 1998 were members of infection control committees (ICC) and answered the survey. Eight hundred six (40.4%) respondents said that an ICP was established for more than 10 years in their institutions. Most professionals reported that their hospitals perform microbiologic surveillance targeted at epidemiologically important multidrug-resistant organisms, but the majority underestimated the prevalence of AR. Conclusion: Our survey highlights important information about the perceptions and attitudes of ICC members that may be used to tailor key interventions for implementing effective ICP. It suggests, additionally, that, to achieve countrywide standardized IC mechanisms in a developing country, authorities should consider the social, cultural, and economical disparities between regions and identify specific regional needs to make available the resources required to minimize such disparities. © 2010 Association for Professionals in Infection Control and Epidemiology, Inc. Source

Peres B.S.,National Health Surveillance Agency ANVISA | Padilha G.,Oswaldo Cruz Foundation | Quental C.,Oswaldo Cruz Foundation
Revista Brasileira de Epidemiologia

When the patent of a drug expires, low cost generics may be introduced in market. Trial results that demonstrate the safety and efficacy of the reference product can be extrapolated to the generic, simplifying the approval process. This paradigm cannot be applied to biopharmaceutical products, large molecules difficult to be characterized. Minor changes in the production process can influence the biological and clinical properties of the product and result in differences in efficacy and safety profiles. It is not possible to demonstrate the identical nature of biopharmaceuticals arising from different manufacturing sources, so they cannot be approved as simple generics and need specific regulation. A bibliographical survey of the main issues involved in the approval of similar versions of biopharmaceuticals was performed as well as a comparative analysis of the regulatory situation in the largests pharmaceutical markets - U.S. and European Union - based on legislation, draft laws, guidelines and technical references issued by their regulatory agencies - FDA (Food and Drug Administration) and EMEA (European Medicines Agency), respectively, in order enlight the discussion now taking place in Brazil. Based on the laws and guidelines studied, it is concluded that, although Brazil, Europe and the United States are at different stages of setting their regulatory framework for biossimilars, it is possible to identify some similarities in approach, such as the need for different treatment for each product class (or a case by case focus) and a step by step comparison exercise, the results of which will define the amount of data and non-clinical and clinical studies required. However, issues such as interchangeability and automatic substitution of biossimilars for reference products are not yet clearly defined. From the sanitary point of view, Europe has a more conservative posture, while the U.S. and Brazil seem to be building a more flexible framework. Besides the health issues, however, we highlight the economic issues, of great importance in Europe and U.S. legislation, and not addressed in the Brazilian regulation - which can bring insecurity to producers interested in this market. Source

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