PURPOSE: To ensure that instruments obtained from other facilities or from a vendor are cleaned and processed according to the manufacturer’s instructions

POLICY: All loaner instruments will be cleaned and sterilized according to the manufacturer’s instructions and the facility's protocols for sterilization; the instruments will be cleaned and sterilized prior to returning the instruments to the vendor or other facility

PROCEDURE:

  1. Notify individuals responsible for sterile processing that loaner instruments will be used for a procedure(s)
  2. Obtain the instruments from a reputable vendor or facility, allowing for time to clean and sterilize the instruments prior to use (48 hours is recommended for existing sets, 72 hours for new sets); record the date and time received, the name of the facility/vendor, the name of the instrument tray, and the date and time of the scheduled case on the “Loaner Instrument Documentation Form” .
  3. An inventory sheet from the vendor should be provided, which includes the catalog number of the instruments, description (preferably with pictures) of the instruments, and quantity of each instrument.
  4. Obtain a copy of the manufacturer's FDA approved written instructions for the cleaning, packaging and sterilization of the instruments and document its availability on the documentation form
  5. Visually inspect the instruments to be certain nothing is broken, that they meet quality standards such as not having rust or pitting, and perform an inventory to be certain nothing is missing
  6. If the tray comes in a container, check the condition of the container, ensuring there are no cracks, dents, rust, tape, or residue
  7. Label the trays in a manner that will identify them as belonging to another entity and record the information on the documentation form accordingly; consider using a numbering system and placing the patient’s name and the surgeon’s name on the tray
  8. If the instruments are new to the facility, be certain the scrub techs. and circulators have familiarized themselves with the tray contents and the instrument functionality
  9. Ensure that the weight of each instrument tray does not exceed 25 pounds
  10. Process the instruments using the procedures of cleaning, disinfection and sterilization according to manufacturer’s instructions and the facility's processes; record the date and time the processing was completed on the documentation form
  11. Use the instruments as required and document the date and time the procedure was completed
  1. Clean and reprocess the instruments according to manufacturer’s instructions and document the date and time of completion on the documentation form
  2. Perform an inventory and quality check of the instruments before returning to the owner; document the date and time the tray was returned on the documentation form.
  3. Monitoring, assessment, and periodic reviews of the loaner program to make sure patient safety is not jeopardized will occur.

REFERENCES

International Association of Central Service Materiel Management. IAHCSMM Position Paper on the Management of Loaner Instrumentation. Chicago, Illinois.

DISCLAIMER: All data and information provided by the Oregon Patient Safety Commission is for informational purposes only. The Oregon Patient Safety Commission makes no representations that the patient safety recommendations will protect you from litigation or regulatory action if the recommendations are followed. The Oregon Patient Safety Commission is not liable for any errors, omissions, losses, injuries, or damages arising from the use of these recommendations.

3.10 LOANER INSTRUMENT POLICY & PROCEDURE 1