ABSTRACT
Cost-effective health care depends in part on the availability of devices for reuse in healthcare facilities. Device manufacturers are responsible for device design and product labeling, including validation of label claims for reuse. Once manufacturers have developed and qualified instructions for the reuse of their devices, healthcare practitioners are then responsible for reviewing and evaluating the reuse requirements and instructions to ensure that they can be consistently repeated by their personnel. Manufacturers of reusable devices and those responsible for defining the regulatory requirements for such devices deal with many issues, ranging from the design of the devices to the development and validation of safe and effective processes for decontamination, cleaning and resterilization between uses. Beginning in the late 1980s, many issues involving the reprocessing of reusable devices were addressed in part through the development of standards by the Sterilization Standards Committee of the Association for the Advancement of Medical Instrumentation.
