From bone screws to pacemakers: the changing patterns of Implants

摘要

ISO/TC 150, Implants for surgery, produces and maintains the standards for nearly all types of implants used in surgery. Its work is therefore important for industry, government regulators, purchasers, users (surgeons) and, of course, the most important end-user, the patient - who could be any of us. The benefits of advanced surgery using implants such as artificial joints or vascular prostheses is spreading to more and more of the world's population, and new surgical techniques and innovative implantable devices mean that the range of surgery grows. Increasingly the effects of ageing in causing degenerative disease can be corrected by the use of surgical implants that replace the function of the worn-out parts. Artificial hip joints are the most obvious example but the scope includes very complex devices such as heart pacemakers and implantable infusion pumps. When set up in 1972, ISO/TC 150 concentrated on producing standards that dealt with the detailed construction and dimensions of implants such as bone screws, bone plates and the intramedullary nails used to stabilize fractures while the bone healed. Big advances in outcomes for patients followed from specifying that only non-corroding and biocompatible metals should be used to make the implants. Over the years, our standards have responded to a rapidly developing industry, and moved away from the nuts-and-bolts "recipe" (construction) type of standard, towards standards that concentrate on required performance and allow that performance to be delivered in various ways that may not always be envisaged when the original standard is drawn up.