Department of Pharmaceutical and Pharmacological Sciences, University of Padova, Padova, Italy.
SDS srl, Treviso, Italy.
Cell Tissue Bank. 2024 Jun;25(2):521-528. doi: 10.1007/s10561-023-10107-y. Epub 2023 Sep 20.
Musculoskeletal allografts represent an important practice in orthopedic surgeries and the demand for them has been growing. For this reason, in order to reduce clinical risk and to more efficiently manage the increase of allograft usage and also to optimize timing of the surgeries, the thawing and washing processes with aseptic technique were centralized in the department of Hospital Pharmacy. This study describe the design and execution of an adapted Media Fill Test (MFT) to demonstrate aseptic thawing and washing of allografts. For this specific and innovative setting, to better simulate the actual processing steps, a surrogate system was developed to simulate the tendon allograft. The aseptic technique of four operators was assessed and an initial performance validation and the first revalidation were described. All MFT were completed successfully, with no observation of turbidity. The readapted MFT shown in this study can provide insight into this innovative and growing field to other health professionals who want to implement this service.
同种异体移植物在矫形外科手术中是一种重要的实践，其需求一直在增长。出于这个原因，为了降低临床风险，更有效地管理同种异体移植物使用的增加，并优化手术时间，我们将无菌技术的解冻和清洗过程集中在医院药房部门进行。本研究描述了适应的介质填充测试（MFT）的设计和执行，以证明同种异体移植物的无菌解冻和清洗。对于这种特殊和创新的设置，为了更好地模拟实际的处理步骤，开发了一个替代系统来模拟肌腱同种异体移植物。评估了四名操作人员的无菌技术，并描述了初步的性能验证和首次重新验证。所有的 MFT 都成功完成，没有观察到浊度。本研究中重新调整的 MFT 可以为其他希望实施这项服务的卫生专业人员提供对这个创新和不断发展的领域的深入了解。
