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Medical devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the FDA 510(k) process. In recent years, individuals and organizations have expressed concern that the 510(k) process is neither making safe and effective devices available to patients nor promoting innovation in the medical-device industry. Several high-profile mass-media reports and consumer-protection groups have profiled recognized or potential problems with medical devices cleared through the 510(k) clearance process. The medical-device industry and some patients have asserted that the process has become too burdensome and is delaying or stalling the entry of important new medical devices to the market. At the request of the FDA, the Institute of Medicine (IOM) examined the 510(k) process. Medical Devices and the Public's Health examines the current 510(k) clearance process and whether it optimally protects patients and promotes innovation in support of public health. It also identifies legislative, regulatory, or administrative changes that will achieve the goals of the 510(k) clearance process. Medical Devices and the Public's Health recommends that the U.S. Food and Drug Administration gather the information needed to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices. According to the report, the FDA's finite resources are best invested in developing an integrated premarket and postmarket regulatory framework.
While joint replacements at the lower extremity, particularly at the hip and knee, are performed on a daily basis in most departments of Orthopaedics, with great clinical success and long longetivity of the implant, the indications are much less frequent at the upper limb. Basic research follows the same tendency: while there are numerous basic or clinical research projects devoted to the hip or knee, very scarce reports are published on upper extremity joint replacements.The aims of publishing this volume are to promote the exchange of ideas, and to forster collaborative investigations among clinicians, manufacturers, engineers and other basic scientists involved with the problems of replacement arthroplasty in upper extremity joints, from the finger to the shoulder. The specific aims are: (1) to summarize scientific knowledge in the area of upper extremity joint replacement; (2) to discuss currently unsolved clinical problems and potential solutions based on current scientific knowledge; (3) to review new prosthetic designs; and (4) to explore future directions of investigation.In the first section, general concepts of arthroplasty and of upper extremity reconstruction are presented. Ronald Linscheid presents a short history of finger joint replacement. Alain Potaznik and Franz Burny discuss the problems of friction, wear and biological responses after the implantation of artificial joint replacement. Laurie Faro presents the European legislation for medical devices, such as arthroplasties. Finally, Frédéric Schuind and Franz Burny review the indications and contraindications to upper extremity arthroplasty.The following sections discuss for each upper extremity joint the indications of joint replacement, including the most frequent diseases, the prostheses designed for that particular joint, the biomechanical evaluation after prosthetic implantation, and the early or long-term clinical results. We made a special effort to include at the end of each section some alternative procedures of reconstruction.We are convinced that this unique book fills an important gap in the medical literature.