Quick Safety advisory on reprocessing safety for critical instruments and devices

Feb. 16, 2022

Surgical instruments and other critical devices are reprocessed and reused every day in healthcare facilities. Ensuring these instruments and devices are reusable – that they are in good condition and are cleaned and sterilized following validated manufacturer’s instructions – is critical to patient safety, according to a new report released by The Joint Commission.

The Quick Safety advisory, “Ensuring critical instruments and devices are appropriate for reuse,” highlights reprocessing guidance from the Food and Drug Administration (FDA), as well as special circumstances for single use devices (SUDs). While a SUD is intended for use on one patient during a single procedure and is not intended to be reprocessed and used on another patient, there are special circumstances under which third parties only may reprocess. The advisory details how most SUDs are not designed for reprocessing and do not allow for thorough decontamination after use, including that some are made of lower quality metals or components that will not withstand cleaning and sterilization processes and may deform, rust, pit, chip or crack if subjected to reprocessing methods.  The advisory also includes several recommended safety actions for reprocessing reusable instruments and devices, including:

  • Standardized instrument and device visualization occurring during each step of the decontamination, cleaning and sterilization processes with final inspection prior to use and removal of any instrument inappropriate for use. 
  • Integration of infection preventionist review of critical instruments and devices during the purchasing process. 
  • Readily available manufacturer’s instructions for use and intermittent review of instructions for all critical instruments and devices.
  • Education, training and competency of staff responsible for reprocessing, oversight and/or supervision of reprocessing sterile products for their role in reprocessing reusable instruments and related job duties. 
  • Effective maintenance and refurbishment processes to keep instruments in optimal condition and to determine when useful life has been met for each instrument undergoing reprocessing. 

Additional considerations related to SUDs and a list of resources are included in the full Quick Safety advisory. It may be reproduced if credited to The Joint Commission.

Joint Commission release

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