were received. The total average review time for 510(k)s also decreased slightlyâfrom 100 in FY 2002 to 96 days in FY 2003. The report is loaded with these ...
Regulatory Issues (continued)
were received. The total average review time for 510(k)s also decreased slightly—from 100 in FY 2002 to 96 days in FY 2003. The report is loaded with these and many more operational statistics, which may be useful in establishing a guideline for how long a review at the FDA might take. The report also lists all the products that were approved with an original
PMA, and also what they considered to be significant medical device approvals (there are too many in a year to list all clearances in the report— they provide a Web link instead). One interesting section is called “Advances in Patient Care,” where they highlight with a picture and paragraph a few of the significant new medical devices that were approved this year. The
devices highlighted by ODE in this section are shown in Table 1.
Grace Bartoo is a biomedical engineer who now is a regulatory and clinical consultant at Decus Biomedical (www. decusbiomedical.com). She can be reached at grace@decusbiomedical. com.
Book Reviews (continued from page 98) delivery/development-based preventative medicine and immunology. It is, however, probably a little too specialized for medical students, undergraduates, and graduates in microbiology or bioengineering, as a certain level of understanding of immunology would be required to make use of this volume. After reading this volume, Kauffman makes us realize that we do survive in a world that is multifold populated by micro-organisms. But the material in this book really does demonstrate how novel vaccination methods have truly blossomed in the postgenomic “war against infection” era. —Guruprasad Madhavan State University of New York, Binghamton Risk Assessment: Basics and Benchmarks
Bruce Main (Editor), www.designsafe. com, 2004. ISBN: 0-9741248-0-8, xxvi + 485 pages, US$95. I have used the software (designsafe), written by Bruce Main and sold through his company, for a number of years in my biomedical engineering senior design lectures and homework exercises. I require the use of the software in student projects to ensure that students have considered safety in their design process. I was pleased to see that he has written a text covering his and others’ practices in risk assessment. 100 IEEE ENGINEERING IN MEDICINE AND BIOLOGY MAGAZINE
This text is a well-written, comprehensive coverage of the field of risk assessment, consisting of 44 chapters and five appendices. The preface suggests that the text was written for engineers, safety practitioners, and managers who face responsibility for assessing the risks of equipment, product, facility, or system designs. I would add design instructors (in any engineering area) to this list because the book covers a large number of applications. In the following review, I will pay special attention, to its use in biomedical engineering. The text begins with an executive summary of the contents, followed by an introductory chapter on the field of risk assessment. The remainder of the book is broken into four major sections with multiple chapters covering different aspects of the material. The first section covers, in four chapters, the basic concepts involved in the field of risk assessment. It gives a nice overview of the basic terminology used and cost savings realized when safety is considered throughout the design process, the acceptable risks, and the process necessary for design reviews. The second section is titled “Practical Guidance.” It primarly covers taskbased team reviews and justifies the use of true teams of designers, management, maintenance, and users in design reviews (and the occasional use of lawyers too!). One chapter details seven examples (from bagel slicer to medical
device) of design reviews, another discusses implementation processes, and a final chapter details several scoring systems used. The third section, titled “Risk Assessment Benchmarks,” has 28 chapters, covering industry-specific guidelines and benchmarks. Specific to biomedical engineering design are chapters on the environment, ergonomics, maintenance, consumer product safety, food safety, medical-device safety, process safety, education, robotics, and liability. Each of these chapters could easily be a lecture in a design sequence. The final section is titled “Improving the Risk Analysis Process” and covers other techniques used in risk analysis, harmonization possibilities, and a brief discussion of the future of risk analysis. Each chapter begins with a bullet list of key points included in the chapter. Each chapter is also well referenced. The appendices assist in reconciling the different terminologies and methods used in risk analysis. Also appended is a CD with a demonstration version of the designsafe software. The text is comprehensive in coverage, and examples and references are international in nature. For medical device manufacturers, risk analysis is mandated for sales involving the CE mark. This text is highly recommended for designers and design instructors in biomedical engineering. —Paul King Vanderbilt University JANUARY/FEBRUARY 2005
