Functional properties and performance of new and reprocessed coronary angioplasty balloon catheters

The need of health costs control has prompted the reuse of devices originally manufactured for single use only. To assess reprocessing feasibility of disposable medical devices, hygienic, technical, and functional aspects must be taken into account in addition to economical, ethical, and legal implications. This study aims to characterize coronary angioplasty catheters and to evaluate performance changes induced by reprocessing. Multiple analysis including crossing profile, slipperiness, compliance, mechanical, and burst pressure tests were performed at different steps of the protocol on 25 catheters reprocessed up to two times. The results highlighted that both use and reprocessing can affect the features of angioplasty catheters. Mechanical stress caused by clinical inflation and thermal-chemical stress undergone by polymers during cleaning and sterilization procedures caused partial modifications of material properties, inducing an overall shrinking effect on balloons. Compliance tests reported a maximum variation of 6.2% from nominal values, showing the conformity of reprocessed devices with manufacturers' original specifications (+/-10%). The burst pressure of reprocessed devices was 80% higher than the rated burst pressure certified by manufacturers, thus reducing concerns of breakage during reuse. A strict dependence on device model in the behavior of catheters was found, especially for balloons crossing profile and slipperiness. Main changes occurred after the first reprocessing cycle, while a second cleaning and sterilization did not introduce further significant alterations. On the whole, the magnitude of modifications introduced up to two reprocessing cycles did not compromise catheters performance.