References

by Tim B. Hunter, MD, MSc

Introduction

This References Section is designed to provide important, useful background information and materials specifically germane to the study of medical devices. An important aspect of this is a discussion of modern biomaterials from which all beneficial medical apparatus is made. Some medical devices are literally life-saving while the majority substantially decrease patient morbidity and significantly improve the quality of one's life. Biomaterials are specific substances brought into contact with living tissue for the treatment of medical and dental disease. Biomaterials have to be compatible with tissues chemically, mechanically, and pharmacologically. They have to have adequate strength, fatigue resistance, and chemical inertness to be used for the manufacture of medical devices. A reasonable understanding of common biomaterials and their uses provides one a better appreciation for the design, use, and complications associated with medical devices, including the orthopedic apparatus discussed in this website.

Radiography is the mainstay of modern orthopedic imaging and device evaluation. However, cross-sectional imaging with computed tomography (CT), magnetic resonance imaging (MRI), and ultrasound provides important complementary information to radiography in many cases; in some cases, it is vital and required for the correct diagnosis.

Magnetic resonance imaging (MRI) and computed tomography (CT) of bones and joints following orthopedic intervention presents both technical and diagnostic challenges due to imaging artifacts related to implanted hardware, metallic shavings, post-surgical scarring, and anatomic alteration. Orthopedic instrumentation should not be regarded as a contraindication to performing CT or MRI. A familiarity with the artifacts produced by orthopedic hardware and an appreciation for various imaging protocols to reduce these artifacts is most appropriate for an understanding of modern orthopedic apparatus. The imaging protocols section provides such an overview.

Medical device manufacturers actually produce the devices which save lives and help alleviate pain and suffering. Caring physicians, nurses, and other important healthcare providers are literally at the patient's bedside, and medical researchers constantly expand our scope of knowledge. Both groups are requisite for the advancement of modern medicine. However, the benefits of modern medicine would be of no use to any of us if pharmaceuticals and medical devices were not designed, tested, manufactured, evaluated for safety, and put on the market by medical device manufacturers and pharmaceutical companies. A listing of many of the important device manufacturers is provided as well as a detailed discussion of the legal, regulatory, and quality assurance considerations that have to be addressed for the manufacture and marketing of medical devices and pharmaceuticals.

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