Regulatory Open Forum

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------

The final rule requires a UDI on the kit itself. The label of a kit as well as device packages of the kit
must have their own UDI, and as long as the kit has a UDI, then any devices within the kit are exempt from UDI.

This exemption is for all single use device except implants.


-------------------------------------------
Marc Sanchez
Attorney and Regulatory Consultant
Adjunct Professor Northeastern University 
-------------------------------------------






Original Message:
Sent: 09-25-2013 16:15
From: Justin Baker
Subject: UDI: 801.45 and Convenience Kits

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------

Implants are exempt from marking on the implant but must still be labeled with a UDI.  I read this as replenishment implants in separate packaging must be labeled with a UDI, but if they are in an instrument and implant set to be sterilized by the customer they do not need to have a label for that implant, only the set.

Does anyone interpret it differently?

-------------------------------------------
John Minier
Small Bone Innovations, Inc
Morrisville PA
United States
-------------------------------------------






Original Message:
Sent: 09-26-2013 07:41
From: Marc Sanchez
Subject: UDI: 801.45 and Convenience Kits


The final rule requires a UDI on the kit itself. The label of a kit as well as device packages of the kit
must have their own UDI, and as long as the kit has a UDI, then any devices within the kit are exempt from UDI.

This exemption is for all single use device except implants.


-------------------------------------------
Marc Sanchez
Attorney and Regulatory Consultant
Adjunct Professor Northeastern University 
-------------------------------------------






Original Message:
Sent: 09-25-2013 16:15
From: Justin Baker
Subject: UDI: 801.45 and Convenience Kits

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------

I distinguish among permanent marking UDI, label UDI, and package UDI. Implants are not required to have permanent marking UDI.

 

In general, all devices must have a label UDI under 801.20(a), but 801.30(b) offers some exceptions.

 

A relevant exception in this case seems to be in 801.30(a)(3) which exempts, "Individual single-use devices, all of a single version or model, that are distributed together in a single device package, intended to be stored in that device package until removed for use, and which are not intended for individual commercial distribution." Unfortunately, "This exception is not available for any implantable device."

 

From this I conclude that each implant in a single device package must have a label UDI. I also believe the package would require a package UDI showing the number of individual single device packages inside.

 

Another exception seems to be in 801.30(a)(3), which applies to convenience kits. There the individual devices in the kit do not need a label UDI, but the whole kit does require a label UDI.

 

For an instrument and implant set, if it is a convenience kit, than the kit requires a label UDI, but the individual devices inside do not require a label UDI. The place that sterilizes the kit is not relevant to the label UDI, but would change the corresponding entry in the GUDID.

-------------------------------------------
Dan O'Leary
Swanzey NH
United States
-------------------------------------------






Original Message:
Sent: 09-27-2013 09:44
From: John Minier
Subject: UDI: 801.45 and Convenience Kits

Implants are exempt from marking on the implant but must still be labeled with a UDI.  I read this as replenishment implants in separate packaging must be labeled with a UDI, but if they are in an instrument and implant set to be sterilized by the customer they do not need to have a label for that implant, only the set.

Does anyone interpret it differently?

-------------------------------------------
John Minier
Small Bone Innovations, Inc
Morrisville PA
United States
-------------------------------------------






Original Message:
Sent: 09-26-2013 07:41
From: Marc Sanchez
Subject: UDI: 801.45 and Convenience Kits


The final rule requires a UDI on the kit itself. The label of a kit as well as device packages of the kit
must have their own UDI, and as long as the kit has a UDI, then any devices within the kit are exempt from UDI.

This exemption is for all single use device except implants.


-------------------------------------------
Marc Sanchez
Attorney and Regulatory Consultant
Adjunct Professor Northeastern University 
-------------------------------------------






Original Message:
Sent: 09-25-2013 16:15
From: Justin Baker
Subject: UDI: 801.45 and Convenience Kits

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------

Marc-

Yes, but what if the convenience kit is holding devices that are not single use and are intended to be reused and resterilized? Is it still just the convenience kit that must bear the UDI or also the devices within the kit?

Justin

-------------------------------------------
Justin Baker PHD
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------






Original Message:
Sent: 09-26-2013 07:41
From: Marc Sanchez
Subject: UDI: 801.45 and Convenience Kits


The final rule requires a UDI on the kit itself. The label of a kit as well as device packages of the kit
must have their own UDI, and as long as the kit has a UDI, then any devices within the kit are exempt from UDI.

This exemption is for all single use device except implants.


-------------------------------------------
Marc Sanchez
Attorney and Regulatory Consultant
Adjunct Professor Northeastern University 
-------------------------------------------






Original Message:
Sent: 09-25-2013 16:15
From: Justin Baker
Subject: UDI: 801.45 and Convenience Kits

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------

I don't read the regulation the way you suggest.

 

I distinguish between the label UDI and the permanent marking UDI as part of my analysis.

 

The intent of 801.30(a)(11) is to exempt the contents of a convenience kit from the label UDI when the kit itself has a label UDI.. In the draft regulations all the devices in the kit would have also required a label UDI. They may still have a label UDI for other reasons. For example, if you were to purchase a device and include it in the convenience, it would have a UDI from that device's labeler. You are not forbidden from having a label UDI on any of the kit's content.

 

You ask if "only the sterilization case/tray need contain a UDI". I believe the answer is no because of the word "only". The sterilization case/tray requires a label UDI, so that is the level to which 801.45(a) applies. Then, look at the rest of the requirement. Rewriting it to clarify the if-then structure it says, "IF the device is intended to be used more than once and intended to be reprocessed before each use, THEN the device must also bear a permanent marking."

 

You say, "This convenience kit and the included devices will be intended to be re-used and resterilized." Resteralization is a form of reprocessing, so the IF part is true. As a result, you must apply the THEN part. You say, that the individual device components within the kit are intended to be reused and resterilized. I believe that, as a result, the individual device components require permanent marking UDI.

-------------------------------------------
Dan O'Leary
Swanzey NH
United States
-------------------------------------------






Original Message:
Sent: 09-25-2013 16:15
From: Justin Baker
Subject: UDI: 801.45 and Convenience Kits

I just read the UDI Final Rule and am left with a question that I am hoping someone else is able to clear up. Within the UDI rule, Sec. 801.45 states that a device that is intended for more than one use and must be sterilized before each use bear a permanent marking providing the UDI. It also states (Sec. 801.30(a)(11) that a device that is packaged in a convenience kit (e.g., an orthopedic case/tray kit) is an exception as long as the label of the convenience kit bears a UDI. 

My question is which one of these rules trumps the other? I have a device that will go in a sterilization case/tray that could be considered a convenience kit. This convenience kit and the included devices will be intended to be re-used and resterilized. Am I understanding correctly that only the sterilization case/tray need contain a UDI? And that the individual device components within it need not contain the UDI regardless of Sec. 801.45 and that they are intended to be reused and resterilized? My initial thought is that Sec. 801.30(a)(11) would also create an exception to 801.45 but I wanted to see if others understood this the same as I did.

Thanks!

-------------------------------------------
Justin Baker PHD
Regulatory & Quality Manager
Custom Orthopaedic Solutions
Cleveland OH
United States
-------------------------------------------