Time is Money! Influence on Operating Theater and Sterilization Times of Patient-specific Cutting Guides and Single-use Instrumentation for Total Knee Arthroplasty: A Full Factorial Design of 136 Patients.

Background: Patient-specific cutting guides (PSGs) and single-use disposable instrumentation (SUI) have emerged as potential beneficial innovations for total knee arthroplasty. The aim of this study was to evaluate the impact of PSG and SUI for total knee arthroplasty on operating room (OR) and sterilization times. Methods: A monocentric, prospective, interventional, full factorial design study, including 136 patients, compared patient-specific (PSG, n = 68) to conventional cutting guides (n = 68) and SUI (n = 68) to conventional instrumentation (CVI, n = 68). In the OR, we recorded the number of instrument trays, operating time, and room occupancy time. In the central sterile services department, the total sterilization duration was assessed. The primary outcome was operating time and sterilization duration. Secondary outcomes were difference in the number of trays, Oxford Knee Score, and postoperative mechanical axis. Results: The median operating time was 80 minutes (Q1-Q3: 73-90) and was significantly increased for SUI compared to that for CVI (+5 minutes, P = .0072). The median sterilization duration was 1261 minutes (Q1-Q3: 934-1603). It was significantly in favor of SUI (936 minutes) over CVI (1565 minutes) (+629 minutes, P < .0001). The total number of instrument trays was 404 for 136 patients: 252 for CVI and 152 for SUI (P < .0001) and 189 for PSG and 215 for conventional cutting guides (P = .0006). There was no significant difference in OKS (P = .86) nor in the postoperative alignment which was between 177° and 183° (75% patients, P = .24). Conclusions: SUI lowers the number of instrument trays and sterilization duration. PSG is not associated with significant OR or sterilization time reduction. The use of SUI could reduce the risk of noncompliance of instrument trays.

Interest of the preliminary risk analysis method in a central sterile supply department.

OBJECTIVES: In order to improve its quality-assurance programme based on ISO 9001, the Central Sterile Supply Department of a public university hospital has performed a prospective risk analysis using the Preliminary Risk Analysis method (PRA). The objectives were the achievement of a global risk mapping related to the whole process of sterilising medical devices, and second, the implementation of corrective measures to reduce identified risks. METHODS: A multidisciplinary team, formed in January 2008, validated results at each step of the study. During the analysis, 416 hazardous situations were identified, among which 81 were quoted first in priority and led to the description of 141 risk scenarios. The PRA team assessed 42 scenarios with risk ranking assessed as 'acceptable under control' or 'unacceptable.' They adopted 23 follow-up actions measures and 13 safety parameters. RESULTS AND DISCUSSION: The PRA constitutes an appropriate tool for assessing quality-improvement policy and safety in healthcare facilities that can be easily integrated into standard quality-management systems.