Bloom D F, Cornhill J F, Malchesky P S, Richardson D M, Bolsen K A, Haire D M, Loop F D, Cosgrove D M
Department of Biomedical Engineering, Cleveland Clinic Foundation, Cleveland 44195, USA.
J Thorac Cardiovasc Surg. 1997 Sep;114(3):448-60. doi: 10.1016/s0022-5223(97)70193-4.
OBJECTIVE(S): The reuse of disposable devices is a potential source of significant cost savings to hospitals. Venous and arterial perfusion cannulas under new and reused conditions were selected to identify the clinical, safety, technical, logistic, and economic issues that must be addressed to realize these savings.
Single- and dual-stage venous and arterial cannulas from two manufacturers were tested when new, after initial clinical use, and after a single clinical use plus up to nine simulated reuses. Reuse was simulated by end-to-end bending, coupling and uncoupling of the connectors, and by two 1-hour soaks in plasma at 4 degrees and 40 degrees C, respectively. Cannulas were decontaminated and then processed by a peracetic acid-based liquid chemical sterilization system after each use/reuse. Sterilization was validated by eliminating Bacillus subtilis spores from the cannulas on each of five consecutive cycles. Cannulas were tested for physical changes, functional integrity, biocompatibility, and in vivo performance in sheep. A cost analysis was also performed.
Sterilization was successfully achieved. Mechanical changes were less than 20% on all variables studied and were undetectable by experienced cardiac surgeons in selective evaluation. No clinically important differences were found between new and reused cannulas, even after nine simulated reuses. Reusing cannulas four times would reduce the cost per procedure from $53 to $19 (64%).
Preliminary data suggest that the perfusion cannulas tested can be safely and efficaciously used five times. Limited reuse of these disposable cannulas is technically feasible and cost-effective. Cannula reuse would result in a small incremental savings; however, with more expensive devices and higher-volume sterilization procedures, the savings could be considerably greater. This program provides a model for evaluation of other single-use medical devices for reuse.
重复使用一次性器械可能为医院节省大量成本。选择新的和重复使用后的动静脉灌注套管，以确定实现这些成本节省必须解决的临床、安全、技术、后勤和经济问题。
测试了两个制造商生产的单级和双级动静脉套管，包括新品、初次临床使用后以及单次临床使用加最多九次模拟重复使用后的情况。通过端到端弯曲、连接头的连接和拆卸以及分别在4℃和40℃的血浆中浸泡1小时来模拟重复使用。每次使用/重复使用后，对套管进行去污处理，然后通过基于过氧乙酸的液体化学消毒系统进行处理。通过在连续五个周期的每个周期中从套管中消除枯草芽孢杆菌孢子来验证消毒效果。对套管进行物理变化、功能完整性、生物相容性和在绵羊体内的性能测试。还进行了成本分析。
成功实现了消毒。在所有研究变量上，机械变化小于20%，经验丰富的心脏外科医生在选择性评估中无法检测到。即使经过九次模拟重复使用，新的和重复使用的套管之间也未发现临床上重要的差异。将套管重复使用四次可使每次手术的成本从53美元降至19美元（降低64%）。
初步数据表明，所测试的灌注套管可以安全有效地使用五次。这些一次性套管的有限重复使用在技术上是可行的且具有成本效益。套管重复使用将带来少量的额外节省；然而，对于更昂贵的器械和更高批量的消毒程序，节省可能会大得多。该方案为评估其他一次性使用的医疗器械的重复使用提供了一个模型。
