Explant Preparation (Final Disposition)

Guidelines:

• Explanted medical devices are FDA-regulated
• Healthcare organizations are required to handle them safely and consistently in accordance with federal, state, and local regulations, and the device manufacturer’s instructions for use (IFU)
• Healthcare facilities should have policies and procedures in place pertaining to the handling and disposition of explants

Considerations:

• If an implant must be returned to the manufacturer, return in accordance with the manufacturer’s instructions and the facilities policies and procedures.
• The unique device identifier from explanted medical devices should be documented in the patient’s medical record or recorded in a facility tracking log, when available

Nurse’s role:

• Follow healthcare organization policies and procedures for handling and disposition of explants
• Team communication: Pre-procedural briefing, time-out, debriefing
• Use sterile technique and standard precautions
• Document per healthcare organization policy

Pitfalls:

• If device is returned to patient, or a patient requests their device be returned to them:
• Follow healthcare organization policies and procedures for items that can be returned, process for returning including decontamination, and liability release

Examples:

• Infusaport removal

Linchpins (Key Points):

• Follow healthcare organization’s policies and procedures for explant handling and disposition
• Include explant handling and disposition in team communication
• Document per policy