In my opinion, there is a disconnect between the GS1 approach and the FDA approach. GS1 has been around a long time and I don't think they anticipated some of medical device issues. For example, they could have a GTIN for a case of lettuce, but I don't think they anticipated putting a GTIN on each head.
That said, I think the only approach that works is to make the individual item, the Unit of Use item, the lowest level. In one system, with GTIN-14, the first character is the packaging level and is an integer between 1 and 9 inclusive. I would assign 1 to the Unit of Use, 2 to the box of 100, 3 to a case of boxes of 100, etc.
I learned recently that GS1 has a program to monitor GUDID. If the entries in GUDID concerning the UDI-DI are not correct, then GS1 will notify the UDI Regulatory Contact.
The good news is that you can use AccessGUDID to find a similar product from a different manufacturer. See how they did it. If the entry is old enough (at least 6 months) then GS1 probably checked it.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 15-May-2020 16:29
From: Robert Slack
Subject: Unit of Use UDI
Hi Dan,
I have a question that builds off of Summer's. My company uses GS1 as our UDI issuing agency and I have noticed that there is a slight disconnect between the packaging levels of GS1 and GUDID. In the GS1 database, the lowest level of packaging to which you can assign a GTIN is the EACH level. The EACH packaging level is defined by GS1 as "The lowest level of the item hierarchy intended or labeled for individual resale", and in this scenario would be the box of gloves, correct? But now if I need a Unit of Use DI, I cannot go any lower in the packaging hierarchy within GS1.
Would you recommend assigning the primary DI (in GUDID) as the "Inner Pack" packaging level, and assigning the Unit of Use DI the "Each" packaging level in regards to the GS1 packaging level definitions? I am confused because the lowest levels of packaging are not quite defined as the same. I would assume the best option would be to prioritize meeting the GUDID requirements and not worry as much about the GS1 definitions, but I wanted to see if I could get another opinion.
Thank you,
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Robert Slack
Regulatory Affairs Associate
Austin TX
United States
Original Message:
Sent: 15-May-2020 07:59
From: Dan O'Leary
Subject: Unit of Use UDI
The unit of use is one glove in this case.
It is the unit of measure of the contents of the box. In this case the box contains "glove, 100 each".
You will assign a UDI-DI for the box that represents one box. Because the gloves are used as an "each" you will assign a Unit of Use UDI-DI. It will not be on the individual gloves.
In GUDID
Enter the UDI-DI of the box in the Primary DI Number field
Enter 100 in the Device Count field
Because you entered a number greater than one in Device Count, GUDID will require a Unit of Use UDI-DI. Enter it into the Unit of Use DI Number field.
You don't really assign the unit of use; the hospital infers it from the box contents. Notice also that these gloves don't come in pairs (a left and a right). Each glove would fit either hand.
In your real case I infer the indicators do not a UDI-DI on each one. In this case you will assign a Unit of Use UDI-DI to each indicator. Enter the information into GUDID as above.
If each indicator does have a UDI-DI on it, then you need a different approach that does not involve a Unit of Use UDI-DI.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 14-May-2020 19:14
From: Summer Young
Subject: Unit of Use UDI
Thanks very much, Dan!
So the unit of use for gloves should be 2, that is usually how it is used, correct? In my real case, we have a box containing 100 indicators, everytime the nurse only needs to use one indicator. Do we still need the unit of use DI? Thx
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Summer Young
USA
Original Message:
Sent: 14-May-2020 16:45
From: Dan O'Leary
Subject: Unit of Use UDI
Consider this situation. A nurse uses two gloves on a patient, and needs to enter this into the patient's Electronic Health Record, EHR. The nurse scans the patient's wrist strap, the UDI on the box, and enters a quantity of two. Since there are 100 gloves in the box, the EHR shows that the nurse used 200 boxes, 200 gloves, on the patient.
To prevent this problem some devices, such as the glove, have a Unit of Use UDI-DI. It does not appear on the glove, the box of gloves, or any other physical location. It does appear in GUDID.
The hospital downloads GUDID on a regular basis. When the hospital's system knows there is a Unit of Use, from the GUDID download, it should show the quantity of gloves used as two, not two hundred.
In the stockroom, the inventory clerk scans the box and knows it is one box of 100 gloves.
For most devices the stocking unit of measure is the same as the usage unit of measure. In some cases, such as the gloves it is not.
The easiest way to understand UDI is from the point of view of the customer. The device manufacturer gets no value, in my opinion, from UDI. However, customers can receive great value such as inventory management, billing, populating the EHR, analysis of outcomes to determine the most effective device, etc.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
Original Message:
Sent: 14-May-2020 16:17
From: Summer Young
Subject: Unit of Use UDI
Regarding the unit of use DI, I am getting confused in which situation a "unit of use" DI should be applied. For example, if I have a box containing 100 gloves, do I need unit of use DI? If so, does it have to be on the box? Or only need to enter into GUDID database? Thanks!
Separate question on the UDI, I do not see there is specific requirement where you should put the UDI on the box, not sure if I missed the something. Can someone please confirm, many thanks!
Summer
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Summer Young
USA
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