Effects of Different Sterilization Methods on Materials Used for Single Use Devices (SUDs)
S. A. Brown1, K. Merritt2, T. O. Woods1 and V. M. Hitchins2, 1Division of Mechanics and Materials Science, 2Division of Life Sciences, CDRH/ FDA, Rockville, MD 20852
Driven by economic and time constraints, some medical centers and third parties are resterilizing SUDs for reuse. The steam autoclave is quick, but most plastics used in SUDs can not survive the temperature. Thus, a number of new methods are being introduced on the market. To date, this program has studied the effects of five: EtO, peracetic acid + peroxide (Steris), high temp formaldehyde, (Chemiclave), low temp peroxide gas plasma - (Sterrad), and low temp peracetic acid gas plasma (Abtox). Tensile strength testing has shown that silicone elastomer is unaffected, whereas the strength of nylon, polyethyelene and latex was reduced by some of the methods. Depending on the formulation the strength of polyurethane either increased or decreased. The results demonstrate that the effect of sterilization depends on the method and the materials used in the device.