A medical device manufacturer who exports products to the United States (US) may risk success in this activity by not being aware of US importer and distributor requirements. This article discusses the requirements and actions that nonUS manufacturers should take to ensure these requirements are met.

The third in a series of guides intended to help medical device engineers in specific problem areas.

A newly-released international standard for medical equipment alarms, IEC 60601-1-8, incorporates a long-standing suggestion that alarms should indicate their source through distinctive melodies. In this paper we examine this suggestion. We describe the proposed alarms, outline the history of the idea, and review recent research on the effectiveness of the alarms, some of it performed in our la...

Melodic alarms proposed in the IEC 60601-1-8 standard for medical electrical equipment were tested for learnability and discriminability. Thirty-three non-anaesthetist participants learned the alarms over two sessions of practice, with or without mnemonics suggested in the standard. Fewer than 30% of participants could identify the alarms with 100% accuracy at the end of practice. Confusions pe...

Smart shape-memory polymers can memorize and recover their permanent shape in response to an external stimulus (for example, heat). They have been extensively exploited for a wide spectrum of applications ranging from biomedical devices to aerospace morphing structures. However, most of the existing shape-memory polymers are thermoresponsive and their performance is hindered by heat-demanding p...

The use of durable medical equipment in the home, while not a recent development, was formally recognized by the Congress with the passage of the original Medicare legislation. Since that time the statute has been amended to provide for a more workable, economical, and desirable interface among the administrative, supplier, and user communities. To assist in achieving this end, a research proje...

In this article, the authors explore why medical device innovation has traditionally been geared so thoroughly toward improving performance, with little regard to cost. They argue that the changing incentives in the health care sector and the move to value-based payment models, accelerated by the implementation of the Affordable Care Act, will force device manufacturers to redirect investments ...

Introduction Materials property characterization is central to nearly all facets of medical device design, production, and pre or post-use testing. Material properties are routinely evaluated to meet needs in R&D & quality assurance, and to obtain regulatory approval for sale. Devices that have been used clinically or experimentally are also routinely analyzed to better understand mechanisms of...

As 2005 came to a close, the European Commission issued its formal proposal for a Directive amending the medical devices Directives. This article discusses certain aspects of the proposed amendments and encourages readers to review them in their entirety.

Healthcare providers worldwide are facing an increasingly competitive environment and, in response, are downsizing to reduce costs and improve efficiency. Providers that are unable or unwilling to become more efficient will close. To stay in business, healthcare institutions must consider the cost of medical equipment and plan accordingly. Policies based on sound principles and experience preve...