Economic analysis of reprocessing single-use medical devices: a systematic literature review.
OBJECTIVES This study was designed to determine the effectiveness, safety and costs associated with reuse of angioplasty catheters and to compare these results with those of a contemporary center that employed a single-use strategy. BACKGROUND Coronary angioplasty is an important but expensive procedure. To overcome the financial constraints of the Canadian health care system, reuse of angioplasty catheters is routinely practiced in some institutions. METHODS In a prospective observational study, data forms were completed after each angioplasty procedure and before patient discharge over a 10-month period. RESULTS A total of 693 patients underwent coronary angioplasty in the two centers. Clinical and lesion characteristics were similar except for a higher incidence of unstable angina at the reuse center (p < 0.005). The angiographic success rate was identical (88%) at both centers. The reuse center utilized more balloon catheters/lesion (mean +/- SD 2.4 +/- 1.5 vs. 1.2 +/- 0.5, p < 0.00001) and had a higher incidence of initial balloon failure (10.2% vs. 3.3%, p < 0.0001). Significant prolongation of the procedure time (81 +/- 41 vs. 68 +/- 32 min, p < 0.0001) and increased volume of contrast medium (201 +/- 86 vs. 165 +/- 61 ml, p < 0.0001) were seen in the reuse center. A higher rate of adverse clinical events (7.8% vs. 3.8%, p < 0.025) was observed in the reuse center, especially in patients with unstable angina. CONCLUSIONS The reuse strategy was associated with a higher rate of adverse events, prolonged procedure time and increased use of contrast medium, especially in lesions that were not crossed by the initial balloon and in patients with unstable angina. Whether these differences are related to the reuse strategy or to differences in patient groups cannot be ascertained by this observational study. A multicenter randomized trial is required to further assess the safety and the cost/benefit ratio of this strategy.