Although offering several benefits, the universal serial bus (USB) port has not been rapidly adopted for connecting medical equipment. This is because it could affect safety procedures, with equipment not operating isolated from the mains. To overcome this, a single package isolation device has been developed that can be inserted directly into the USB signal path.
The requirements for conducting medical device clinical studies in Europe are not identical in all Member States. That is, variations exist in the way that the requirements in the European Directives are interpreted and enforced. This article provides an overview of the requirements that currently apply in Italy.
Choosing the correct polymer for a medical device requires a comprehensive look at many aspects of performance and economy. This decision-making process is illustrated here with approaches to choosing materials for an injection moulded steam sterilisation tray for surgical instruments and goods.
Developments in electrospinning are set to provide novel nanofibre-based structures including intelligent coatings that promote the growth of bone tissue into an implant.
Intra-arterial injection of drugs intended for intravenous delivery is a frequent and potentially devastating consequence of placing an arterial line in a patient. A system is described here that prevents this complication from occurring and its use is advocated in intensive care and operating theatre settings.
Biomaterials have evolved over the past decade in response to the need for more sophisticated technologies for therapeutic and diagnostic purposes. We consider here the ways in which biomaterials are changing and the consequences of this for medical technology.
As human exposure to heavy metals increases, the impact these metals are having on morbidity is a growing concern. Methods of evaluating potential toxicity in medical device materials are discussed.
The successful launch ofa combination product in the United States (US) will depend on how well a company understands applicable US regulations and policies, which differ in important ways from requirements in Europe. This article provides an overview of useful information on the US regulation of these products that can be found on the newly redesigned Food and Drug Administration website.
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