What is the proper handling protocol for explants after a defect is observed?

• A. Autoclave them immediately.
• B. Document the serial number in the medical record.
• C. Store them at room temperature.
• D. Return them to the manufacturer.

Answer: (B)

The proper handling protocol for explants after observing a defect includes documenting the serial number in the medical record. This step is crucial for tracking and accountability. It ensures that detailed information regarding the defective device can be linked to the patient's medical history, facilitating proper investigation, reporting, and potential recalls. Keeping accurate records also supports compliance with regulatory requirements and helps to improve patient safety by allowing healthcare facilities to monitor the performance of devices over time.

This documentation is essential because it provides a reference point for the manufacturer and any regulatory bodies involved in evaluating the safety and efficacy of the device. Moreover, it aids in effective communication among the healthcare team, ensuring everyone is informed about the specific device issues encountered during the procedure.

Other options, such as autoclaving immediately or storing at room temperature, do not follow the proper protocol because they may not preserve the integrity of the explants for investigation or proper handling. Returning them to the manufacturer is a logical step, but this typically comes after appropriate documentation has been completed.