Change of the mechanical properties of two different balloon catheters with increasing numbers of cycles of resterilization.

An increasing number of centers are reusing PTCA catheters even though manufacturers warrant single use only. This prospective bench laboratory trial addresses the quality of PTCA balloon catheters after up to three resterilization cycles in order to determine whether a larger trial is warranted to discern whether catheters should be reused. Forty PTCA catheters from two different manufacturers (nominal diameters 1.5 and 3.0 mm) were taken from the shelf. An independent institute tested mechanical properties such as burst pressure, nominal diameter, crossing profile, and balloon surface. The crossing profile increased by 22.5%-39.2% with no additional deterioration after repeated sterilizations. The nominal diameter either increased or decreased by a maximum of 47%. In all 1.5 mm balloons, the burst pressure remained above the manufacturers' values, whereas in the 3.0 mm balloons, the value dropped below the rated burst pressure in 40%-50% of the trials. In conclusion, in both catheter types analyzed, reuse was associated with a considerably worse quality, which puts in question their routine clinical use.
(Copyright 2003 Wiley-Liss, Inc.)