With respect to the FDA-regulated jurisdiction, power cords that have their own part number and label, and are used over and over and are only wiped down when needed, would not need to be direct marked for UDI. Rationale/background provided below:
As you allude to, FDA's UDI regulations require that devices intended to be reused and reprocessed before each use must be directly marked with the UDI. Also of note is that FDA's final general guidance on reprocessing includes basic cleaning in the scope of "reprocessing" and shows FDA's general expectation that, at a minimum, reusable devices, even those deemed "non-critical" are to receive basic cleaning between each use. But in FDA's draft UDI direct marking guidance, FDA proposed to exempt basic cleaning from the definition of "reprocessing" for the purposes of UDI direct marking, and then FDA solicited corresponding public opinion, thereby leaving the topic ambiguous for a time.
Well, a few days ago on 17 November, FDA finalized its guidance on UDI Direct Marking. Therein, FDA clarified its position on basic cleaning. Specifically, FDA says, "…For purposes of UDI direct marking requirements, we consider a device intended to be reprocessed if it is intended to undergo high-level disinfection and/or sterilization before each use or between uses. This means that devices that are only intended to be cleaned and/or to undergo lower levels of disinfection without subsequent high-level disinfection4 or sterilization before each use or between uses are not required to be directly marked with a UDI under 21 CFR 801.45…For purposes of this guidance document, high-level disinfection is a lethal process utilizing a sterilant under less than sterilizing conditions. The process kills all forms of microbial life except for large numbers of bacterial spores…"
Hope this helps,
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Kevin Randall, ASQ CQA, RAC (U.S., Canada, Europe)
Principal Consultant
ComplianceAcuity, Inc.
Golden CO
United States
www.complianceacuity.com------------------------------
Original Message:
Sent: 21-Nov-2017 10:42
From: Anonymous Member
Subject: UDI Direct Part Marking For Power Cords
This message was posted by a user wishing to remain anonymous
For power cords that have their own part number and label, and are used over and over and are only wiped down when needed, do they need to be direct marked for UDI?