Are Intraaortic Balloons Suitable for Reuse? A Survey Study of 112 Used Intraaortic Balloons

• Published in: Artificial organs 1997-02, Vol.21 (2), p.121-130
• Main Authors: Yang, Mingjing, Deng, Xiaoyan, Zhang, Ze, Mien, Maryse, Pelletier, Fabrice, Desaulniers, Denis, Cossette, Robert, Teijeira, Francisco-Javier, Laroche, Gaetan, Guidoin, Robert
• Format: Article
• Language: English
• Subjects: Calibration; Calorimetry, Differential Scanning; Catheterization; Data Collection; Equipment Reuse - standards; Humans; Intra-Aortic Balloon Pumping - standards; Intra-Aortic Balloon Pumping - trends; Longitudinal Studies; Microscopy, Electron, Scanning; Polyurethanes - chemistry; Quebec; Spectrophotometry, Infrared; Surface Properties; Tensile Strength
• ISSN: 0160-564X; 1525-1594
• DOI: 10.1111/j.1525-1594.1997.tb00348.x

To assess the safety of reusing single-use intraaortic balloon devices (IABs), 112 used devices were investigated in terms of physical integrity, gas leakage inspection, mechanical performance, surface chemistry and morphology, and physical stability. These IABs were all used clinically only once, and the duration of the IABs in vivo ranged from 6 to 312 h. Macroscopic examination of the balloons and the outer catheters revealed no obvious change in either shape or color. No discernible abrasions or cracks were observed on the balloons. However, 61% of the balloons were creased, and 40% of the central lumens and 21% of the sheaths showed visible bending flaws. Moreover, 65% of the balloons and 38% of the central lumens were contaminated by visible residual organic debris. The physical integrity of each device was verified in a specially designed leakage-fatigue tester for 72 h. Ninety-seven percent of the devices passed the leakage inspection. Stress-strain testing, differential scanning calorimetry, attenuated total reflection-Fourier transform infrared, and scanning electron microscopy analyses clearly indicated that there were no significant differences in the mechanical properties, bulk material morphology, surface chemistry, and external surface morphology between the used balloons and virgin controls. Although some surface modifications occurred on the internal side of the balloons, the external surfaces of most balloons suffered no trauma. Most of the used IABs examined in this study maintained physical and mechanical properties similar to those of the virgin devices. The chemistry of the balloon material was stable after short-term in vivo use. However, it does not seem possible to establish a rigorous protocol of cleaning, sterilization, and inspection to guarantee a safer reuse of these devices. The presence of residual organic debris that cannot be eliminated results in an imperative preclusion not to reuse the IABs.