Regulatory Open Forum

Hello Looking for guidance on how to execute a mock recall for a invitro diagnostic device. Can someone please provide step by step guidance on how to do it? Thank you ------------------------------------------- Srividya Kalyanasundaram Concord CA United States -------------------------------------------

Hi there, below is what we do for mock recall.

First, obtain a list of customers who have purchased the product of interest.

A spreadsheet should show the following for each customer:
1) Product Code,
2) Quantity sold,
3) Customer Contact name
4) Customer account name
5) customer's phone #, fax#, email, etc

Now, you need to create a notice of Medical Device Recall.

Include the following information:
1) Date, Attention (make reference to the above spreadsheet - hyperlink is good)
2) Issuer of Recall, Risk Class, Means of Communications
3) Description of Product: Name, Catalogue #, Lot #, Exp Date, and Test format.
4) Reason for Recall
5) Instruction to Customers and Consignees
6) Contact info for issuer of recall.

Hope that helps.

-------------------------------------------
Kyung Tae Song
BTNX
North York ON
Canada
-------------------------------------------






Original Message:
Sent: 11-26-2013 19:31
From: Srividya Kalyanasundaram
Subject: mock recalls - in vitro diagnostic devices


Hello
Looking for guidance on how to execute a mock recall for a invitro diagnostic device. Can someone please provide step by step guidance on how to do it?
Thank you
-------------------------------------------
Srividya Kalyanasundaram
Concord CA
United States
-------------------------------------------

I'd like to add a bit more detail to the listing below:

The software used to generate the information below should allow for sorting by date, lot/serial number and, most important, print out each recipient's name/address/contact just once.   Sometimes this last item is more difficult because the "contact person" may, in fact, be more than one person at the same facility since the product could go to several departments.   With this type of software program, you can also print out mailing labels if you intend to send the notice by mail.   Having a program like this will save a lot of time when the action is needed.   

If a facility doesn't have such software in place, the budget can also be justified by calling it a "product distribution program."   The software described can then also be better used for targeted mailings because of the sorting capability.

If you desire a post card response with the quantity on hand quarantined, quantity being destroyed and/or quantity returned to document they followed the instructions, then then print out two sets of mailing labels:  One for the notice and one for the return card.   It is critical to have an itemization of the material affected, which is implied below in the instructions to the customer.   

If you want to get really fancy, you could set up a web site where the customer number can fill out a form and do the whole response electronically, but in some cases, hospital server firewalls inhibit such internet access.

-------------------------------------------
Glen Freiberg
President, RCQ Consulting
Rancho Santa Fe CA
United States
-------------------------------------------






Original Message:
Sent: 11-27-2013 13:48
From: Kyung Tae Song
Subject: mock recalls - in vitro diagnostic devices

Hi there, below is what we do for mock recall.

First, obtain a list of customers who have purchased the product of interest.

A spreadsheet should show the following for each customer:
1) Product Code,
2) Quantity sold,
3) Customer Contact name
4) Customer account name
5) customer's phone #, fax#, email, etc

Now, you need to create a notice of Medical Device Recall.

Include the following information:
1) Date, Attention (make reference to the above spreadsheet - hyperlink is good)
2) Issuer of Recall, Risk Class, Means of Communications
3) Description of Product: Name, Catalogue #, Lot #, Exp Date, and Test format.
4) Reason for Recall
5) Instruction to Customers and Consignees
6) Contact info for issuer of recall.

Hope that helps.

-------------------------------------------
Kyung Tae Song
BTNX
North York ON
Canada
-------------------------------------------






Original Message:
Sent: 11-26-2013 19:31
From: Srividya Kalyanasundaram
Subject: mock recalls - in vitro diagnostic devices


Hello
Looking for guidance on how to execute a mock recall for a invitro diagnostic device. Can someone please provide step by step guidance on how to do it?
Thank you
-------------------------------------------
Srividya Kalyanasundaram
Concord CA
United States
-------------------------------------------

One new element to include in a mock recall is the UDI. If the IVD is packaged as a kit, the individual devices in the kit do not a UDI, but there must be a UDI on the kit label. See 801.30(a)(11).

 

Simulate the data you would put on the label, especially the AIDC data, since this is how the customer is expected to identify a recalled device. Pay particular attention to the Device Identifier, since it is the key to the GUDID.

 

As part of a mock recall simulate the data in the GUDID (see Appendix B of the draft guidance) to learn the information your customer's would learn.

 

Once the compliance date arrives, you would have real data.

 

One of the stated purposes of the UDI rule is "Provide for More Rapid, More Efficient Resolution of Device Recalls. Delays in identifying recalled devices can result in the continued use of those devices on patients and involves an increased risk for patient harm. A device labeled with a UDI can be identified rapidly and with great precision. The more rapidly a recall is implemented and completed, the more rapidly the risks presented are reduced or eliminated."

 

Regards,

Dan

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






Original Message:
Sent: 11-27-2013 14:30
From: Glen Freiberg
Subject: mock recalls - in vitro diagnostic devices

I'd like to add a bit more detail to the listing below:

The software used to generate the information below should allow for sorting by date, lot/serial number and, most important, print out each recipient's name/address/contact just once.   Sometimes this last item is more difficult because the "contact person" may, in fact, be more than one person at the same facility since the product could go to several departments.   With this type of software program, you can also print out mailing labels if you intend to send the notice by mail.   Having a program like this will save a lot of time when the action is needed.   

If a facility doesn't have such software in place, the budget can also be justified by calling it a "product distribution program."   The software described can then also be better used for targeted mailings because of the sorting capability.

If you desire a post card response with the quantity on hand quarantined, quantity being destroyed and/or quantity returned to document they followed the instructions, then then print out two sets of mailing labels:  One for the notice and one for the return card.   It is critical to have an itemization of the material affected, which is implied below in the instructions to the customer.   

If you want to get really fancy, you could set up a web site where the customer number can fill out a form and do the whole response electronically, but in some cases, hospital server firewalls inhibit such internet access.

-------------------------------------------
Glen Freiberg
President, RCQ Consulting
Rancho Santa Fe CA
United States
-------------------------------------------






Original Message:
Sent: 11-27-2013 13:48
From: Kyung Tae Song
Subject: mock recalls - in vitro diagnostic devices

Hi there, below is what we do for mock recall.

First, obtain a list of customers who have purchased the product of interest.

A spreadsheet should show the following for each customer:
1) Product Code,
2) Quantity sold,
3) Customer Contact name
4) Customer account name
5) customer's phone #, fax#, email, etc

Now, you need to create a notice of Medical Device Recall.

Include the following information:
1) Date, Attention (make reference to the above spreadsheet - hyperlink is good)
2) Issuer of Recall, Risk Class, Means of Communications
3) Description of Product: Name, Catalogue #, Lot #, Exp Date, and Test format.
4) Reason for Recall
5) Instruction to Customers and Consignees
6) Contact info for issuer of recall.

Hope that helps.

-------------------------------------------
Kyung Tae Song
BTNX
North York ON
Canada
-------------------------------------------






Original Message:
Sent: 11-26-2013 19:31
From: Srividya Kalyanasundaram
Subject: mock recalls - in vitro diagnostic devices


Hello
Looking for guidance on how to execute a mock recall for a invitro diagnostic device. Can someone please provide step by step guidance on how to do it?
Thank you
-------------------------------------------
Srividya Kalyanasundaram
Concord CA
United States
-------------------------------------------