Posted 22/02/08 | Permalink | No comments! |
As always, the Medical Device Link (whose owner Canon Communications LLC is the publisher of great magazines such as Medical Device & Diagnostic Industry and IVD Technology )has some interesting articles in recent issues of their magazines.
The february issue of MDDI has an article on designing medical devices for home care use which cites some points to take into consideration in the design process, such as ease of use and mobility. In fact, this is another trend int the medical device sector which is tied, for example, to the usability trend in medical device design (which is a cosntante feature of MDDI - this same issue has an article with tips for integrating usabiliy, also know as human factors, in the design development process). Oh, and as all trends, there´s a standard on the horizon about the subject, collateral standard IEC 60601-1-11, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment.
One interesting note in this issue is about the struggle of the FDA against the makers of some bogus devices. I mean, electrophysiological feedback to treat cancer and AIDS? Come on!
The notes also have some points on the recently finished case Riegel vs Medtronic in which the US Supreme Court ruled that consumers cannot sue FDA approved medical devices companies under state law because this would impose requirements different from the federal law (the FDA approves the safety and effectiveness of devices under the federal law). This case has been making a buzz for some time and the decision will continue this trend, as can be seen by the some comments from politicians
Also in this issue, an article comments on the changes on the new version of the medical devices directive - MDD, which took place on september 2007 and will go into effect in march 2010.
The january / february issue of European Medical Device Manufacturer has a paper on the recently published IEC 60601-1-9 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design. The standard requires that manufactuers take into account envinronmental aspects, such as use of environmetal friendly materials, on the design of medical equipment. What i found interesting about the article is the link to www.medical-ecodesign.com, a web-based service which helps manufacturers design equipment in conformance with the standard. As a admirer of web-based solutions, i found this one really interesting and a possible starting point for more general ones.
Finally, the january/february issue of Medical Device Technology has two articles that i liked, one on recent developments of funcional electrical stimulation systems, and another discusses the scope of the european medical devices directives, focusing on the legal implications of products that are excluded from the scope of the directives.
Tttthat´s all, folks!
