Implant Records and Tracking

Guidelines:

• United States Food and Drug Association (FDA) requires strict guidelines in properly documenting and tracking implants
• Documentation should included in, but not limited to:
  • Patient’s permanent record
  • Patient’s operative record
  • Implant registry maintained by the OR
• Implant registry includes:
  • Lot #
  • Serial #
  • Manufacturer
  • Size
  • Type
  • Anatomic position of implant

Considerations:

• Implants may be medical devices, tissue, or tissue products
  • Allografts
  • Xenografts

Nurse’s role:

• Perioperative nurses are responsible for:
  • Complying with tracking regulations for implantable materials and devices
  • Follow institutional policy for implant tracking and documentation requirements
  • Document complete implant information in the OR documentation
  • Promote patient safety and privacy

Pitfalls:

• Incomplete documentation of implants can endanger the patient
• Policies and procedures for required implant documentation and logging may not be the same at other healthcare organizations

Examples:

• N/A

Linchpins (Key Points):

• FDA: requires implants to be documented and tracked
• Healthcare organization: creates policies and procedures for documentation and tracking
• Manufacturer: provides and tracks implants
• Perioperative RN: complies with tracking regulations and documentation policies for implantable material and devices