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Hospital UDI requirements

K

katastic2908

#1
Hello,

I know the requirements for medical device manufacturers but what requirements are there for hospitals? Are they required to scan the UDI? If a UDI doesn't scan but the human readable is correct, can you rationalize not relabeling the devices?
 
Elsmar Forum Sponsor
#2
My understanding is that FDA requires manufacturers to provide UDI (both human readable and AIDC format) to the point of care. Whether and how hospitals use it doesn't have any bearing on the regulatory requirements of the manufacturer.
 
K

katastic2908

#3
My understanding is that FDA requires manufacturers to provide UDI (both human readable and AIDC format) to the point of care. Whether and how hospitals use it doesn't have any bearing on the regulatory requirements of the manufacturer.
I realize that and thank you. What I wanted to determine is if the hospitals had a requirement to scan the UDI.

We have some labels in inventory where the AIDC format isn't in an acceptable format for the FDA, maybe. They used to include special characters in their lot codes, the +sign and -hyphen. All of the human readable is correct.

So we have to decide to relabel or use as is with a justification that the human readable is correct and therefore ........ I first wanted to make sure the hospitals don't have a requirement to scan or at least if they did the option to enter the human readable manually. The internet was of little help.

Do you think we could justify not relabeling?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
I realize that and thank you. What I wanted to determine is if the hospitals had a requirement to scan the UDI.

We have some labels in inventory where the AIDC format isn't in an acceptable format for the FDA, maybe. They used to include special characters in their lot codes, the +sign and -hyphen. All of the human readable is correct.

So we have to decide to relabel or use as is with a justification that the human readable is correct and therefore ........ I first wanted to make sure the hospitals don't have a requirement to scan or at least if they did the option to enter the human readable manually. The internet was of little help.

Do you think we could justify not relabeling?
Are you asking WRT hospitals outside the USA? I think that WRT supply inside the USA the FDA is pretty clear about the do's and don't's - regardless of what hospitals actually require or practice.
 

Al Rosen

Staff member
Super Moderator
#5
Misbranding (see Labeling requirements regarding misbranding)
Section 502 of the Federal Food, Drug and Cosmetic Act (FFDCA) contains provisions on misbranding including some that relate to false or misleading labeling. A device’s labeling misbrands the product if:
  • Its labeling is false or misleading in any particular;
If the UDI is incorrect, I believe that would be considered misbranding whether a health facility scans it or not.
 
K

katastic2908

#6
The UDI is correct just the barcode isn't compliant with the FDA and not in an obvious way. It took a great deal of research and process of elimination to figure out it was because he used a +sign and -hyphen in our lot codes. They are allowed by GS1 standards, but the FDA can't read it. Here is a quote from the creator of the app "
Alas, it is not the app but the FDA. As you’ll have noticed the app is telling you that the FDA is rejecting the code format - this means the app has read the code, sent it to the FDA, who break it apart and return details on the (01) part of the identifier as well as returning its expiration (17) ...Lot number (10) ...and serial number (21)…
In this case the + is telling the FDA that you have more information to follow (in a second barcode)"

So for my purposes the point is now moot because we are going to relabel.
 

pziemlewicz

Involved In Discussions
#7
From a liability standpoint, you might consider having the manufacturer relabel as opposed to doing it yourselves. While the change seems simple enough, should there be a product issue later, you will have violated T&Cs by modifying the label.
 
K

katastic2908

#8
From a liability standpoint, you might consider having the manufacturer relabel as opposed to doing it yourselves. While the change seems simple enough, should there be a product issue later, you will have violated T&Cs by modifying the label.
We are the manufacturer.
 
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