It is important to distinguish among three concepts; identification, tracking, and tracing. They are different, but may have some overlap.
In the US system:
Identification tells us what the device is
Tracing provides information about critical devices and their components
Tracking provides information about the patient or user who has the device
Identification after release for distribution uses the UDI system in Part 801 and in Part 830.
For most devices the DI and PIs are on the device label and the packaging label.
In some cases the UDI is on the device itself.
Identification before release for distribution uses the system in 820.60.
Traceability applies to "critical devices" using the system in 820.65 which requires a control number. The control number applies to a critical device. There may also be a control number of a critical component. The 820.65 system is augmented by the 820.160(b) distribution records which includes "any control numbers used".
Tracking provides information about the patient or user who has the device as implemented by Part 821.
Your question is whether it is acceptable not to track surgical instruments by lot numbers once they are sent in the field. If the surgical instrument were tracked, then FDA would send you a tracking order. Then you would set up the tracking system required by Part 821. If you don't have a tracking order, then you do not need to track the device.
Because the terms are confusing, perhaps you mean traceability. I doubt the surgical instruments are critical devices and meet the control number requirements of 820.65.
I suspect the question relates to identification of the devices inside a convenience kit, the tray, Initially the UDI rule said that the tray required a UDI, but the devices inside did not. This caused confusion since the users would swap devices in convenience kits, so the kit's UDI no longer represented the devices inside. There are now FDA guidance documents that clarify the requirement.
I think the question is more specific to configuration management. I infer that when your company ships the tray (a convenience kit), the devices inside have identification. The question then becomes whether you need to keep a configuration record that includes the identification of every device in the tray. I don't know of any such requirement, but you need to check the FDA guidance documents. They make the assumption that the devices from the tray you shipped will end up in another tray.
This also raises a question about a recall at the tray level. You need to assume that the tray with the UDI no longer has the same devices inside.
------------------------------
Dan O'Leary CQA, CQE
Swanzey NH
United States
------------------------------
Original Message:
Sent: 06-May-2024 13:19
From: Anonymous Member
Subject: Traceability of surgical instruments - Requirements for lot tracking
This message was posted by a user wishing to remain anonymous
Hi,
Can anyone confirm if it is acceptable not to track surgical instruments by lot numbers once they are sent in the field? As surgical instruments are deployed in trays, we find difficult to ensure that we received back exactly what was shipped to the customer (e.g. instruments switched from one tray to another). In case of a recall, we would retrieve all of the devices regardless of the lot numbers sent to a customer not to miss anything.
Thanks in advance.