FDA Guidelines for Reprocessing Surgical Supply

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    Decontamination

    • FDA guidelines require used surgical supplies to be decontaminated before reuse. The directives mandate that surgical supplies be broken down and thoroughly cleaned with a disinfectant. FDA guidelines suggest additional sterilization for surgical supplies that might have been contaminated with a virus.

    Label Specifications

    • FDA guidelines require the label to indicate that the product must be thoroughly cleaned before reuse. In addition, the labeling instructions must be written in a clear and concise manner that is easily understood.

    Relabeling Requirements

    • The manufacturer must provide adequate instructions for reprocessing surgical supplies. The guidelines require the manufacturer to test the efficacy of the instructions. The health care facility is responsible for implementing the reprocessing instructions, though.

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