Outside Instrument and Material Tracking (Regulatory Requirements)

Outside Instrument and Material Tracking (Regulatory Requirements)

Guidlines:

• Consider loaned instruments contaminated on arrival. They should be delivered directly to decontamination for reprocessing
  • The facility should establish policies and procedures for managing outside instruments and materials
  • Request loaned instruments when surgery is scheduled, delivery in sufficient time to allow in-house sterilization
  • Obtain manufacturers IFU for processing and accessories needed to process loaned instruments
  • Inspect instruments for defects and correct function upon receipt
  • Document the type and quality of loaned instruments and confirm receipt with the lender upon delivery
  • Clean, decontaminate, inspect, and sterilize loaned instruments before use
  • Disassemble, clean, decontaminate, and inspect loaned instruments before returning them to the vendor or lending facility

 

Considerations:

• It is not possible to verify how loaned instruments and devices have been handled, cleaned, inspected, or processed before receipt
• Failure to clean, inspect, disinfect, or sterilize an item may lead to transmission of pathogenic microorganisms from a contaminated device
• Creates a risk for patient injury, including surgical site infection

 

Nurse’s role:

• Ensure loaned instruments are requested at the time surgery is scheduled
• Ensure requested loaned instruments are delivered in sufficient time for in-house inventory, inspection, disassembly, cleaning, packaging, and terminal sterilization
• Ensure aseptic technique is followed in regard to loaner instrumentation
• Document any missing or damaged items from loaner instrument sets
• Follow facility policies and procedures
• Follow manufacturers’ IFU

 

Pitfalls:

• Flash sterilization (IUSS)  should not be used as a substitute for sufficient instrument inventory, including when loaner instruments or implants are delivered late
  • Emergency situations allowing premature release and flash sterilization should be defined in the facility’s policies
  • Documentation per facility’s policies

 

Examples:

• N/A

 

Linchpins (Key Points):

• Follow facility policies and procedures for managing loaned items
• Follow manufacturer’s IFU for processing loaned instruments
• Consider loaned instruments contaminated and have them delivered directly to decontamination for reprocessing
• Promote patient safety by ensuring aseptic technique is followed