Hello,
I need to reply to the comment on UDI direct marking for reprocessed devices. FDA put out a clarification on this guidance last year that direct marking of reusable devices was only applicable for those devices sterilized or cleaned with a high-level or intermediate disinfectant...(I.e., a critical or semi-critical device). This would NOT apply to something considered a non-critical device (per CDC guidance) not sterilized and disinfected by a means such as wiping down with isopropyl alcohol.
So I would suggest you review the CDC guidance and classify your device (critical, semi-critical, or non-critical) then build this into your risk assessment and do a note or letter to file or something in your design requirements that direct part marking is or is not required, with the rationale.
As always, you still have to prove and document the suitability of the reprocessing process, whatever it is, and provide instruction on it to the user.
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Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com------------------------------
Original Message:
Sent: 09-Oct-2018 08:13
From: Michael Winter
Subject: UDI direct part marking
To add to this discussion, make sure that DM is required. It focuses on the definition of reprocessing.
UDI Direct Marking Requirement
"Sec. 801.45 Devices that must be directly marked with a unique device identifier.
(a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use."
FDA UDI Guidance Document
"For purposes of UDI direct marking requirements, we consider a device that is intended to be cleaned and either sterilized or disinfected before each use to be intended to be reprocessed. If a device is intended only to be cleaned between uses by different patients, this would not be considered reprocessing for the purposes of the UDI direct marking requirements. If the device is intended to be used more than once on or by the same patient, and not on or by different patients, the device does not need to be directly marked with a UDI."
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Michael Winter RAC
Curbell Medical
Sr. Director, Quality and Regulatory Affairs
Alden NY
United States
Original Message:
Sent: 25-Sep-2018 23:49
From: Anonymous Member
Subject: UDI direct part marking
This message was posted by a user wishing to remain anonymous
Hi,
Can you confirm if we need to have all the Production identifiers in the barcode , or can we have only have the serial number ( our devices are non-sterile and do not have an expiry date) .Is it mandatory to have a manufacturing date?
Also can you confirm if it is permissible to have only the AIDC ( barcode only) without the Human readable text for small reusable devices (direct marking) ?