UDI and complaints

C

cabjerk

#1
Hello,

When we receive a complaint it is traced back to the serial number of the unit.
Under 820.198 e (3) it states that "Any unique device identifier (UDI) or universal product code (UPC) AND any other device identification (s) and control number used."

Is this part only for complaints that are reportable back to FDA or is this for ALL complaints?

I know it's hard enough to get a customer to tell you the serial number let alone the full UDI number.

Just need some feedback.
 
Elsmar Forum Sponsor
M

miken99

#2
UDI is a government regulated program by the US FDA. It is a mandatory program intended to improve patient safety by monitoring and police the medical device supply chain. The FDA designed the UDI programs labeling and data components to permit them to accurately and quickly respond to foreseen issues with suppliers and products.

With that understanding, I am pretty sure they want the full UDI on any product complaint sent to the FDA. It helps a lot. I also think that they will probably evaluate any complaints. There is a FDA UDI helpdesk.

Regarding general complaints to other than the FDA, the UDI typically has the important fields of data necessary for a manufacturer to track down what happened and when it happened. However, there is no law regulating what you have to send them in a complaint.

As UDI and DSCSA get 'baked in' to our healthcare system, I think you will find that all reporting systems will come to rely on scanning the UDI or DSCSA barcodes into their systems. Accurate and easy.
 
C

cabjerk

#3
Thank you for this feedback.

Yes, we understand the importance of the UDI and find it helpful. Our serial number will link back to the UDI in our systems.

Rewording my question, Is it required for your internal complaint systems to have the UDI or is the serial number ok per the 820?

Our internal complaint system does not have the UDI listed and only serial numbers and this is what FDA wrote us up on that we don't use the UDI in our system.
 
M

miken99

#4
The UDI contains a DI (device identifier) and a PI (production identifiers such as serial, lot, mfg date) section.

The way I read 820.198 e (3) is that they essentially want both types of data either in the form of the UDI or in another form i.e. 'or universal product code (UPC) AND any other device identification (s) and control number used'. I think the serial number alone is not enough to satisfy their regulations.

You might be able to request an extension?
 

Edward Reesor

Trusted Information Resource
#5
Since the UDI is by definition a device identifier, it would serve your best interests to use it whenever possible in your complaints handling or by the information that is contained therein. For example, I would hope that your internal device tracking uses the serial number, lot number and date of manufacture which is essential information in the UDI itself.

I always ask for a picture of the label to capture all of this information as its easier for the person lodging the complaint to perform.
 

ScottK

Not out of the crisis
Leader
Super Moderator
#6
Thank you for this feedback.

Yes, we understand the importance of the UDI and find it helpful. Our serial number will link back to the UDI in our systems.

Rewording my question, Is it required for your internal complaint systems to have the UDI or is the serial number ok per the 820?

Our internal complaint system does not have the UDI listed and only serial numbers and this is what FDA wrote us up on that we don't use the UDI in our system.
(my emphasis)

So to be clear -you have UDI on your devices... you comply there. Right?
You are just not using the UDI in your complaint tracking system and an FDA inspector was not pleased with that.
Is that the gist?

Was it a 483 or just an observation?

I don't see anywhere in guidances or standards that require the UDI to used in your internal tracking. While it might be a good, easier practice if you can get to the same result with the part number and serial number you should be fine.
Is cost prohibitive to change your process to add a field to satisfy this inspector? It might be easier than the fight.
 

Edward Reesor

Trusted Information Resource
#7
Excellent point. We only have UDI on our Class II devices that are sold in the USA. On the Class I devices that currently do not require UDI, we have not created them so there is nothing to track except the Lot number.
 
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