FDA 483 - Wesley Medical Center - December 10, 2024

An FDA inspection conducted at Wesley Medical Center's Transfusion Service in Wichita, KS, from December 5-10, 2024, revealed significant compliance issues. The hospital blood bank was cited for failing to maintain adequate records concerning the validation of its electronic equipment. Specifically, an electronic system implemented in 2019 lacked documented protocols and acceptance criteria for critical elements such as hardware, software, and user performance, which were deemed inadequate during review.

Furthermore, the inspection identified a critical failure to notify transfusion recipients, their physicians, or legal representatives regarding the potential risk of Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) transmission from previously transfused blood components. Multiple instances were cited where necessary notifications were not processed following information about donors testing positive for HIV or HCV, or related product withdrawals and tracebacks. These observations highlight deficiencies in the facility's adherence to federal regulatory requirements for blood product safety and recipient notification procedures. Wesley Medical Center is expected to implement prompt and comprehensive corrective actions to address these serious issues and ensure full compliance with regulations governing blood banking operations.