The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the...

AIntroduction to the process ............................................... p. 2 BPotential themes for further reflection at the European level......... p. 6 CIssues identified ................................................................. p. 7 1. Public health challenges................................................. p. 7 2. Encompassing innovation ..........................................

management of medical devices in hospitals includes the planning of medical equipment acquisition and maintenance. The presence of critical and non-critical areas together with technological proliferation render the management of medical devices very complex. This study creates an easy and objective methodology for the analysis of medical equipment maintenance, that makes the management of medi...

The magnitude 7.0 earthquake that struck Haiti on 12 January 2010 devastated the capital city of Port-au-Prince and the surrounding area. The area's hospitals suffered major structural damage and material losses. Project HOPE sought to rebuild the medical equipment and clinical engineering capacity of the country. A team of clinical engineers from the United States of America and Haiti conducte...

This paper discusses the problems associated with the refurbishing and re-use of medical devices which are sold by manufacturers as 'single use items' by focusing in particular on the re-use of pacemakers. Re-use of single-use devices such as pacemakers does occur in Australia, and in many other parts of the world, but there has been little public awareness of this fact. The paper explains and ...

European medical device manufacturers are sometimes surprised to learn that operating ISO 13485 alone is not sufficient to meet United States (US) quality system requirements. This article discusses important considerations for meeting US and European requirements when operating under a single quality system.

The electronics of a general biomedical device consist of energy delivery, analog-to-digital conversion, signal processing, and communication subsystems. Each of these blocks must be designed for minimum energy consumption. Specific design techniques, such as aggressive voltage scaling, dynamic power-performance management, and energy-efficient signaling, must be employed to adhere to the strin...

OBJECTIVES This study investigated the benefits of and barriers to user involvement in medical device technology development and evaluation. METHODS A structured review of published literature in peer-reviewed journals was conducted. RESULTS This literature review revealed that the main benefits of user involvement were an increased access to user needs, experiences, and ideas; improvements...