Reviews (2)

Summarizes FDA rules, but does not discuss them
I bought the book based on only one review, but was a bit disappointed. It did indeed list all relevant code, and referenced it for further study, but the codes themselves are hardly self-explanatory. Except for some introductory comments, there was very little in the way of further explanation on the topics in this book.

I was looking for some interpretation, examples, what is typically done in the real world to meet requirements, etc.

It's a good reference book, but just a starting point in understanding what is necessary to satisfy the FDA in medical device manufacturing. Buy it used if possible, you won't be using it much except for reference.

Good at laying out the rules
Mfg. Engr. manager for a large medical device company.

After spending 2.5 days with an FDA auditor, I realized that I did not know what was expected by the regulatory body in terms of process validations, equipment installation and maintenance and all of the record-keeping and documentation that is required for them.

To learn all of that quickly, I purchased and studied this book. For each subject (process validations, equipment, calibration and all other areas), it lists the FDA regulation, the corresponding ISO regulation and then has an "FDA guidance" section that breaks down both into plainer English. It was helpful to have all of the information in one place.

The frustrating part with the FDA is that they won't tell you exactly how to do things, they'll just lay out the rules and you have to figure out how to get there from here. This book is good at laying out all of the rules.

I would recommend this book to any level person who may have to answer to an auditor. There are sections on Design Control, Nonconforming Production, Labeling and Packaging, Statistical Techniques and more that apply to each area of the business. ... Read more

Amazon.com

For most of human history, our bodies have been inscrutable, accessible only to exterior or postmortem examination.But over the past hundred years, we've found tricky ways of viewing our bones, brains, and unborn children and thus greatly enriched our health. Medical physicist Anthony Brinton Wolbarst celebrates this revolution in Looking Within, an intriguing survey of medical imaging from the early days of Roentgen to the latest developments in thermography and functional magnetic resonance imaging.Writing for a general, if well-educated, audience, he guides us through the century by explaining the theories underlying each imaging technique as applied to real cases: broken bones, tumors, and heart disease all make their presence known through increasingly sophisticated technology.

The images, both reproductions and explanatory diagrams, are top-notch, lending a visual balance to the text that carries the reader through even when Wolbarst (rarely) gets a bit too technical.His experience with the National Cancer Institute and the Environmental Protection Agency broadens his range of understanding of the effects of radiological imaging on our lives, making his explanations more cogent and practical.Whether you want to gain insight into that ultrasound you have coming up or you simply want to marvel at the miracles of modern medicine, Looking Within will help you see what's really going on--just like a shoe store fluoroscope. --Rob Lightner ... Read more

Book Description

This highly illustrated, comprehensive yet practical guide provides a complete, highly visual, step-by-step guide to using the Laryngeal Mask Airway. Containing over 250 top quality photographs accompanied by over 100 line diagrams, anatomy and technique are clarified for the reader in a uniquely visual way. In addition, the images are supplemented with comprehensive background information made highly accessible with textual summaries and key points. The text will also highlight common pitfalls and give guidance on how to avoid them. Boxed "case histories" will be integrated throughout the book to demonstrate the clinical scenarios and applications of the LMA.The second edition contains essential information and guidelines on basic and advanced uses of the LMA in anesthesiology, with emphasis on its role in management of the difficult airway and resuscitation. Laryngeal Mask Anesthesia: Principles and Practice, second edition, will continue to be an invaluable resource for all those who need to understand, implement and expand their use of this valuable and innovative airway management device. ... Read more

Book Description

This sourcebook offers all the information you need to understand and design biomedical instruments. Biomedical Instruments contains extensive analysis of signal processing electronic design for medical instruments, in-depth descriptions of design methods for medical transducers, and an introduction to medical imaging and tomographic algorithms. Transducers covered include variable R, L, and C, piezoelectric, electrodynamic and magnetostrictive, force balance, and fiber optic. Operational amplifiers, analog filters, biotelemetry, discriminators, phase-locked loops, and microprocessors are covered in a comprehensive section on circuitry. Exercises and problems accompany each chapter of the text.
This is the first paragraph of the preface...either the paragraph above, or this paragraph can be used for the blurb_
From the Preface:
The book aims at (a) presenting a physical explanation for the behavior of various transducer, (b) developing the mathematical theory applicable to these transducers, and (c) discussing the practical design of biomedical instruments. Our hope is that the book will serve as a text for biomedical engineering students who will be engaged in the design of instruments, as a reference book for medical instrument designers, and as a source of ideas for the large numbers of biomedical research workers who, at one time or another, must build a gadget to implement their research. Numerous examples of medical instrument design are presented in order to clarify the mathematical analyses.

Key Features
* Brings the volume up-to-date with new material on microprocessor applications, fiber optic instruments, and modern imaging systems
* Explains behavior of transducers
* Develops mathematical theory for transducers
* Discusses the design of biomedical instruments
* Serves as a text for biomedical engineers or a reference for medical instrument designers
* Provides suitable homework problems at the end of each chapter ... Read more

Book Description

Thoroughly covers the management of medical instrumentation systems with a strong emphasis placed on safety. Coverage includes data communications within hospitals and mobile emergency units, including ambulances and other medical squads. Contains a wealth of practical, how-to advice including and selecting the best desktop computer for biomedical systems, repair methods for water damaged medical equipment, determining what test equipment tools are needed, choosing the right solid-state replacement components, and many others. Provides a vitally important section on preventative maintenance and proper program design. This handy reference isideal for the clinical technician. ... Read more

Book Description

According to the FDA Quality System Regulations, manufacturers must ensure that "device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution." As specific as this statement is, the FDA does not provide instructions on how to achieve their standards. Validating Medical Packaging demystifies the validation procedure for medical device packaging by providing specific examples and templates for creating and maintaining a validation file.About the author: Ronald Pilchik has over 30 years of experience in the healthcare manufacturing industry. As principal of the Techmark Group, he provided consulting services to diverse multinational manufacturers on selecting, developing, and validating medical packaging compatible with their sterilization requirements. He has been chairman of the healthcare packaging section of TAPPI, the packaging committee of HIMA, and a member of AAMI's ISO198 working group on packaging. Mr. Pilchik is program chairman of the HealthPack Conference Series on medical device packaging. ... Read more

Book Description

A full-color photographic manual, INSTRUMENTATION FOR THE OPERATING ROOM familiarizes perioperative and operating room personnel with today's surgical instruments for all major surgical procedures.Reflecting the advances of modern technology, this text features the most current instrumentation and equipment available, including new instruments for endoscopic surgery, neurosurgery, ophthalmic surgery, orthopedic surgery, and oral, maxilla, and facial surgery.All images are new and photographed digitally to illustrate the necessary detail of instruments and improve image clarity. Operating room personnel as well as students in perioperative nursing and surgical technology programs benefit from this valuable reference. ... Read more

Reviews (4)

Great for initial learning of instruments...
As a student of Surgical Technology, I need to know all the instruments to hand to the surgeon and assistant. The book is good, but has one shortfall; the pictures are somewhat vague. I mean, that many instruments look alike. The photographs could've been taken to show the curve of many instruments or a macro lens could've been utilized. Still, it's the best book out that I know of to help you learn the instruments.

Not very helpul in recognizing instruments.
Instrumentation for the Operating Room Photographic Instrumentation manual. Although this manual is very well organized in instrument sets and procedures, the photographs are are unclear in instrument detail. These images should be on a white background and in sharper detail as this is crucial in identifying instruments.

Comprehensive and detailed
This manual is excellent for beginners, due to its thoroughness and wonderful, close-up detailed photos of the tips of the instruments, where most of the differentiation occurs. Also features photos of similar instruments side-by-side, so size differences are more obvious. The only detraction was that some of the names used to identify the instruments were not familiar to me (I only know a Kocher by that name, which is not even given as an alternate name in this book). However, this is a minor, infrequently occurring problem. Overall, the most helpful manual I've found.

Surgery instrumentations
This is a very comprehensive book and is put in perfert catagories for the beginniner to expert. ... Read more

Book Description

The fourth edition of Equipment Theory for Respiratory Care employs a comprehensive, competency-based approach to describe the equipment and latest technology used in the respiratory care setting. With an approachable style, the book covers the practice of respiratory theory, including: the administration of oxygen and oxygen mixtures by various devices and appliances; the application of mechanical ventilators to assist or control breathing; the maintenance of clear airways by humidification; the education of patients in the rehabilitation clinic; and many other topics. Additionally, more universal algorithms, an expanded art program, and enhanced Clinical Corner problems round out this new edition.New to this Edition:More universal algorithms, versus brand-specific, help learners troubleshoot various problems and situations they may face when using different types of equipment Learning objectives and self-assessment quizzes at the NBRC level ensure thorough understanding of the material presented New instructor materials, including a PowerPoint presentation, Computerized Test Bank, and Image Library, provide more support in the classroom AARC Clinical Practice Guidelines printed near relevant text discussion present real-world application of topics ... Read more

Book Description

Choosing equipment to suit an individual with a disability can be a complex task. Much research exists regarding the needs of people with disabilities on the one hand and about the equipment available for them on the other. The authors of this much-needed book uniquely bring together these two strands of research, showing how choices about equipment can be matched to an assessment of need. ... Read more

Book Description

The design of medical electronics is unique because of the background needed by the engineers and scientists involved. Often the designer is a medical or life science professional without any training in electronics or design. Likewise, few engineers are specifically trained in biomedical engineering and have little or no exposure to the specific medical requirements of these devices. Design of Medical Electronic Devices presents all essential topics necessary for basic and advanced design. All aspects of the electronics of medical devices are also covered. This is an essential book for graduate students as well as professionals involved in the design of medical equipment.

Covers every stage of the process, from design to manufacturing to implementation
Topics covered include analogue/digital conversions, data acquisition, signal processing, optics, and reliability and failure ... Read more

Reviews (1)

good book for an earlier start in this field
for the students of medical instrumentation at graduate level the contents are not sufficient.current developments in technology should also be included ... Read more

Book Description

The stethoscope has come to represent the physician perhaps more than any other symbol save the shaft of Aesculapius. It has had a profound influence on the practice of medicine. Called a "fascinating book" by the New York Times, An Ear to the Chest: An Illustrated History of the Evolution of the Stethoscope explores the debate over the value of the stethoscope, its design, and its acceptance by the public and the professionals who used it. The book contains fascinating details about the stethoscope from its beginnings as a simple wooden tube to the complex binaural devices used today. The variety of stethoscopes that have been designed number in the hundreds or more. Providing information about the instrument and insights into its inventors, the author has included truly evolutionary examples of the stethoscope and those that illustrate the wide variety of approaches taken in its development.Written by Dr. M. Donald Blaufox, noted medical historian and co-author with N.H. Naqvi of Blood Pressure Measurement: An Illustrated History, this book presents a visual history of the evolution of the instrument that is now universally recognized as a symbol for medicine and healing. It provides diagrams, early photographs and drawings, as well as excerpts from contemporary writings and patents. Informative and entertaining An Ear to the Chest: An Illustrated History of the Evolution of the Stethoscope explores the practices used prior to the development of the stethoscope, the early days of its use, and current practice. ... Read more

Reviews (2)

Stethoscope History
This book is the very informative result of extensive research. It has a lengthy appendix full of photographs of antique stethoscopes, over ten pages of references, and what I thought of as some pretty tedious text. Of course, that comment is coming from someone whose symbolic and sort of romantic fascination with the music of the human heart drove her to purchase anything concerning stethoscopes, and this book is certainly not directed at people who just love listening to hearts. I'm sure it's better suited to the medical professional or collector, and I'm neither one of those. I wound up with more information than I necessarily needed, but there's no harm in that, especially considering the price of the book.

The book discusses immediate and mediate auscultation and percussion, and the numerous changes the stethoscope has undergone since the first one was invented by Rene Laennec in 1816. It also touches on the controversies that surrounded the stethoscope when it was first invented and how many medical professionals doubted its value. Much of the same skepticism was present when the monaural stethoscope went out of style and the binaural stethoscope (the kind we see today) was ushered in. It also discusses specialized stethoscopes like the obstetrical stethoscope, differential stethoscope, and the teaching stethoscope. I can't imagine another resource that would contain more information on stethoscope history.

The writing is very uninvolved and strictly factual until the final chapter, which concerns modern medicine. Blaufox discusses the current electronic stethoscopes that are widely used today and successfully amplify sound to allow for more effective diagnoses and benefit the hearing-impaired. He then goes on to briefly discuss the various more advanced techniques that have come to replace traditional auscultation recently, such as echocardiography, tomography, and electrocardiography. He is very articulate in his assertion that medicine has become more unproductive and impersonal as a result of these technological advances. Sadly, fewer and fewer students have sufficient auscultation skills but are competent with other equipment. I liked the fact that Blaufox expressed his opinion in his last chapter that the decline in reliance upon the stethoscope is an unfortunate development.

Unique reference
This is an excellent reference and makes a wonderful addition to the library of the medical historian or antique collector. Although I imagine the target audience for this book is small, it is virtually indispensable to the collector of antique stethoscopes. There is some informative prose about the inception and development of the stethoscope and its integration to medical practice, but the uniquely valuable part of this book is the 45-page appendix where various stethoscope designs are pictured and described. This is the best single reference for identifying model types of antique stethoscopes that I have encountered. There is also an exhaustive bibliography for those who wish to pursue further research. The book is well worth the investment for the interested reader. ... Read more

Book Description

A wide variety of technological devices are used in the course of treating patients in clinical settings. This variety is increasing and individual devices are becoming more complex. A Guide to Patient Care Technology: A Review of Medical Equipment examines the range of patient care technology commonly encountered in hospitals and clinics, gives a clear and concise description of the principle of operation of each device, and outlines its use.The book is divided into sections corresponding to various areas of a hospital. Each section contains descriptions of equipment found primarily in that area. A special section covers those devices found throughout the hospital. After the description of each device, there are three short lists: other names by which the device might be known; equipment used with or related to the device; and the locations where the device is most likely to be found. Photographs illustrate the devices in the field giving you a feel for their appearance while in use. Knowing how a particular medical device works allows you to get the most effective use out of your equipment, understand the applications, and helps avoid costly and unnecessary problems from increasingly sophisticated and complex electronic equipment. Often, the user manual is unavailable or has gone missing. A Guide to Patient Care Technology: A Review of Medical Equipment provides easy-to-understand descriptions of the extensive range of devices in current medical use in a portable, easy-to-use format. ... Read more

Reviews (1)

A superficial reference work
A comprehensive review of this book appears in the May-June 2003 issue of "Biomedical Instrumentation and Technology", Vol. 37, No. 3, page 223. The book is of such a brief and limited work as to make it virtually useless. ... Read more