Implant Records and Tracking for Certified Perioperative Nurse (CNOR)
Included In This Lesson
Outline
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
Transcript
References
- Rothrock, J. (2019). Alexander’s Care of the Patient in Surgery (16th ed.). Elsevier Health Sciences.
- Association of perioperative Registered Nurses (AORN): Guideline Essentials (website), 2022, https://www.aorn.org/guidelines-resources/guidelines-for-perioperative-practice/guideline-essentials
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