ABSTRACT
A significant shift is occurring in the delivery of medical devices to the end user. In the 1980s, the reuse of hemodialyzers began, with 63 percent of dialysis centers reusing devices by 1986. A survey conducted by Infection Control and Sterilization Technology indicated that 35 percent of hospitals responding to the survey reuse devices, primarily catheters, blades and knives; 43 percent reprocess items, with catheters again being the device mentioned most frequently. All label claims of reuse provided in instructions for the handling, cleaning, disinfection, packaging and sterilization of products in the healthcare facility must be tested and validated. Manufacturers have had long-standing concerns the reuse of single-use devices including product quality, safety and liability. The Health Industry Manufacturers Association (HIMA) has adopted a set of guiding principles pertaining to the reuse of single-use devices. These principles are presented in a position paper published by HIMA.
