Publications by authors named "Eliana Auxiliadora Magalhaes Costa"

Background: Pacemakers (PMs) and implantable cardioverter-defibrillators (ICDs) have reduced mortality and improved the quality of life of cardiac patients. However, the high cost of these devices prevents their large-scale incorporation, particularly in low-income countries, where reusing explanted PMs/ICDs has become an alternative.

Methods: A systematic review and meta-analysis were conducted of studies that compare infection rates, device-related deaths, malfunction and premature battery depletion in patients with reused PM and ICD implants and those with new devices.

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Objective: To analyze the technical conditions for medical product reprocessing in hospitals.

Methods: This was a descriptive study on multiple cases in materials and sterilization centers at four hospitals in the city of Salvador, Southeastern Brazil, in 2010. Semi-structured interviews were conducted and direct observations were made, based on a regulatory model for medical product reprocessing that was drawn up with the technique of consensus verification as the reference standard.

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Medical device reprocessing is extremely important and complex, thus requiring both the operational skills for its implementation and the technical qualification of the professionals involved in the activity. The typical issues of medical device reprocessing involve technical, economical and regulatory aspects when involving either the so-called reusable articles or those considered as for a single use. The objective of the present study is to propose a new regulatory model for medical device reprocessing in Brazil that would, on the one hand, satisfy the requirements for quality and safety, as recommended in the literature and, on the other hand, prove to be operational under the conditions prevailing in Brazilian hospitals.

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The number of technological resources used in health care interventions is growing and continually expanding with the introduction of new products and articles. Problems associated with the reutilization of medical products, both reusable and of single use, affect policies and related technical-operational, economic, political, ethical, legal, and environmental matters. This study aims to contextualize the regulatory systems of medical products, and analyze the subsequent operational implications for Brazilian hospital practices.

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