Abstract
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.
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OA and RT contributed to the study concepts, study design; GG, GM, SAF, RF and RT contributed to the experimental studies and data acquisition; GC and SM contributed to the data analysis; OA, GC, RT contributed to the manuscript preparation and RN and TZ contributed to the manuscript editing and review; All authors read and approved the final manuscript.
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Ossato, A., Gasperoni, C., Stella, M. et al. Validation of orthopedic allograft preparation process: a new application of media fill test. Cell Tissue Bank (2023). https://doi.org/10.1007/s10561-023-10107-y
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DOI: https://doi.org/10.1007/s10561-023-10107-y