Using Custom Content for Provider-specific Product Details

Why Use Customized Content?

Does the recall include specific product information such as unique device identifiers (UDI), serial numbers, or lot numbers? Do you want to notify each location of their affected products with this specific information? Do you want to collect responses for each specific UDI?

By using Custom Content, Suppliers can add UDIs specific to a recall and notify the provider locations that purchased those products. Affected Providers will receive those product details in addition to general product information. Moreover, the supplier can request that a Provider answer certain actions for each unique product rather than give a general response to the affected products.

If you are not already familiar with the Supplier's basic recall creation process, please review this article.

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Enabling Custom Content

As a default, Custom Content is not enabled.  In order to enable Custom Content, the Supplier's designated NotiSphere Administrator can go to Organizational Settings-> General to turn on Custom Content. This setting should be turned on if your organization plans to send notifications with the specific product information for provider locations.  If you do not always need to send detailed product information, the Recall Coordinator can de-select Custom Content as needed.

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Add a Recall Event

To add a new event with Custom Content, click “Add” in the top-right corner of the screen.

Step 1: Add Recall Details

Enter all required fields:

• Recall Name
• Recall Type
• Recall Date
• Recall ID
• FDA Classification
• Description
• Risk to Health
• Attach any relevant documents for your providers

NotiSphere strongly recommends that you include any documents in the “Supporting Documents” section that you would have sent via mail if you did not use the NotiSphere platform. You may include PDFs, images, spreadsheets, and other types of files. Providers will be able to view and download these files.

Enable the Custom Content Flag if the recall contains product information specific to the Provider.

Once finished, click Next at the bottom of the screen to continue or Save and Close to save a draft of your recall.  You can reopen the recall to edit information when the recall has a Draft status.

Step 2: Create Affected Product File

From the Product tab of the recall you just created, click Import Products.

Then, click Download Template from the pop-up window.  You will use this template to load the product information and affected locations.  Review it to determine which product fields are relevant for your recall. Keep in mind that a few fields are mandatory.

Mandatory Fields

For each affected product, include the following information:

• ‍Location ID - This is the unique location identifier for the affected provider location loaded as part of your Master Location File during implementation. In the case of a Custom Content recall, each location will be associated with specific product identifiers such as serial number and lot number.  There may be duplicate location IDs in the file if the location is affected by more than one item.
• ‍Description  - This a brief explanation of the affected product and recall.
• ‍Catalog Number - This number identifies the product in your company's catalog. There may be duplicates.
• ‍Customized Field - You can enter Serial number, UDI, Lot number or other information identifying the specific product on which you wish to collect specific information from the Provider. You may identify one or more fields that contain specific product information associated with a particular location. Custom fields are available if you do not see the particular field you need.

Step 3: Load Affected Product File

From the Product tab, load file you just created by clicking Choose File or Drag the file.  Note the file must be closed before you can upload it.

From the pop-up window, choose the column(s) from your file that includes the Customized Field(s) as described in the previous section. Once you have chosen the appropriate field, click Process File.

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• Review the Product List and click Save to save the results and continue. Note that your Customized field will include a drop down displaying specific values listed in your file for that product for every field marked as Custom.

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Review Affected Locations by clicking on Affected Location tab.  Location IDs listed in your file will be separated by the Status listed below:

• Locations Covered – indicates these locations are verified by the Provider for receipt of electronic notifications via NotiSphere
• Not Covered – indicates that the location has not been verified by the Provider and you should continue to mail paper notifications to these locations
• Location Unrecognized – indicates that this location does not yet exist in the master location file for your organization

To Download, use the download icon on the right of each list to download the information if needed.

Step 4 - Add Required Actions

Click on the Actions tab at the top to access the actions list. There you will see a list of standard Template Actions. You will also see a place to add any new action you wish to include on the recall. Use the pencil icon to edit any of the existing actions.

Actions marked as Custom Action will require a separate response for each product from the Provider responding to the recall.

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