ABSTRACT
The Association for the Advancement of Medical Instrumentation has published a Technical Information Report on Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Manufacturers. The manufacturer has an important ethical and regulatory responsibility to support product label claims. Comprehensive instructions should be provided on handling, cleaning, disinfection, packaging, sterilization and aeration, if applicable. The risk of improper use and handling of a device is high if the manufacturer’s instructions are nonexistent, incomplete or incompatible with routine user operations. The manufacturer provides the reusable device and instructions for its use and reprocessing. Management and control of the proper reuse of devices is complicated and is the shared responsibility of the device manufacturer, equipment vendors and chemical disinfectant/sterilant suppliers as well as the user or healthcare facility. Many manufacturers have improved device designs and label information, but they must also augment their team efforts with healthcare providers.
