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As a result of recent “superbug” (carbapenemresistant Enterobacteriaceae) outbreaks traced to contaminated surgical instruments, awareness of the issues surrounding reprocessing has increased among health officials and the general public. In its final guidance for manufacturers, the Food and Drug Administration (FDA) recommended that manufacturer instructions for use (IFU) be readily available and followed each time a surgical instrument is reprocessed.1 The FDA also recommended that healthcare facilities use supplemental measures to prevent future outbreaks.2 Much of the focus on improving reprocessing adds responsibilities to central sterile and supply departments (CSSDs) by increasing reliance on the manufacturer’s IFU and by requiring additional timeand resource-consuming methods for reprocessing. The following two unpublished case studies, taken from a validation study and an ethnography study, demonstrate the reality of the CSSD. These studies demonstrate how the recommendation to follow along with the IFU is impractical and how the limited involvement of CSSDs in the design and purchasing of surgical instruments increases mental and financial burdens on an already strained system.

Barriers to Adopting FDA Guidance in Central Sterile Departments