Issues with UDI additions to 21 CFR 820 requirements

[Mark Meer]

I know that in previous threads I've been a bit critical of the FDA's UDI initiative, but the way they've worded the updated 21 CFR 820 requirements is yet another thing I (forgive me) can't help gripe about.

For example, complaint and service records now require:

"Any unique device identifier (UDI) or universal product code (UPC), and any other device identification(s) and control number(s) used;"
(underline added)

So, to strictly comply to the requirements as worded, is the expectation to manually record the 14+ character UDI string in addition to a batch or serial number? This, in my opinion, is unnecessarily onerous (especially for those of us using paper forms), nevermind the fact that the latter data is already embedded in the former...

To me, the important thing is that there is sufficient data recorded to identify the device. Our present practice of recording a 6-character serial number works just fine. I don't see how requiring documenting a lengthy UDI string adds any value. If anything it'll just be more prone to data-entry errors!

Am I completely misinterpreting these requirements? Should the underlined "and" be more appropriately changed to "or"? Does anyone else feel that recording UDIs on anything but the DHR is of no value?

 

[kreid]

My take on it is that the UDI could include your batch/serial number,
from 820:
Unique device identifier (UDI) means an identifier that adequately identifies a device through its distribution and use by meeting the requirements of 830.20 of this chapter. A unique device identifier is composed of:
(1) A device identifier --a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device; and
(2) A production identifier --a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device:
(i) The lot or batch within which a device was manufactured;
(ii) The serial number of a specific device;
(iii) The expiration date of a specific device;
(iv) The date a specific device was manufactured.

That way you will meet the FDA expectations and still be able to use you batch/serial numbers for internal use?

 

[Mark Meer]

My take on it is that the UDI could include your batch/serial number

Yes, it does include batch/serial number, which to me is the critical identifying element (at least when it comes to complaint and service records), and requiring all the other information is just unnecessary (as far as they may be critical information for complaint and service records).

Because of the UDI's requirement for AIDC encoding, the device identifier alone is 14 characters (at least for GS1). Is this necessary to manually document on complaint and service records? Apparently a simple model and serial number is no longer sufficient to identify a device?

I just don't see the value of mandating recording UDI's on complaint and service records (where other, simpler, means of identification would suffice).