A patient undergoing cochlear implant surgery refuses to allow tracking of the device. What is the appropriate action?

• A. Cancel the procedure and reschedule at a different facility
• B. Notify the surgeon and let them decide what to do
• C. Proceed with the surgery and document in the perioperative notes that the patient has refused to allow tracking of the medical device
• D. Report the incident to the U.S. Food and Drug Administration

Answer: (C)

Respecting the patient’s right to refuse is the guiding principle here. Some implanted devices require post‑implant tracking for safety and regulatory reasons, but a patient can opt out of that tracking. The perioperative nurse’s job is to ensure that this refusal is clearly documented in the surgical record and that the rest of the team is aware of the patient’s decision. If the surgeon agrees that proceeding with the implantation is appropriate despite the tracking refusal, the operation can continue and the note should reflect that tracking was declined. This approach maintains patient autonomy, avoids unnecessary delays, and keeps the record accurate for post‑operative surveillance.

Reporting to the FDA isn’t warranted based solely on a patient’s refusal to allow tracking, since there’s no adverse event or regulatory threshold being met by the refusal itself. Canceling the procedure solely for refusal would undermine patient choice and disrupt care.