Effects of Use and Reprocessing on Single Use Coronary Catheters
S. A. Brown1, K. Merritt2, V. M. Hitchins2 and T. O. Woods1, 1Division of Mechanics and Materials Science, 2Division of Life Sciences, CDRH/ FDA, Rockville, MD 20852
Although sold for single use only, some medical devices, such as coronary catheters, are being processed for reuse. Over 400 PTCA and 300 EP catheters have been retrieved after single patient use at Walter Reed Army Hospital. After disinfection and cleaning, a variety of performance characteristics were determined, and then some were subjected to ETO sterilization and simulated reuse. The results demonstrated that cleaning was not a trivial problem. The balloon compliance data demonstrated model specific changes. Some catheters became more sticky making insertion more difficult. Some models of EP's were non-lumen, whereas others had hollow cores sometimes contaminated with blood. Damage to electrode seals exposed the lumens as well as copper wires connected to the electrodes. Unbeknownst to the user, subtle changes in device appearance may be associated with major changes in the performance of a used or reused device.