Implantable Devices Details in Client Profile

As part of the ONC Certification process, Healthie now enables delivering information to all providers so that they can know what devices their clients have, and use that information to deliver safer and more effective care. 

A Unique Device Identifier (UDI) is a unique numeric or alphanumeric code that consists of two parts:

  1. A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
  2. A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device: the lot or batch number within which a device was manufactured; the serial number of a specific device; the expiration date of a specific device; the date a specific device was manufactured; the distinct identification code required by 21 CFR 1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

To help providers appropriately document a comprehensive list of implantable devices for their clients, we've added an option within the Client Profile > Actions > Implantable Devices > Add Implantable Device

Implantable Devices

Healthie wants to ensure that the device list remains accurate and up to date as devices are added, edited, or removed for clients. Within the Implantable Devices field, you'll see an "Add Implantable Device" button. When "Add Implantable Device" is selected, a new window for "Add Implantable Device" will appear.

Neither the Device Name nor UDI field can be left blank if you are looking to add a device. Fill in both fields and click on "Add Device" to save your Implantable Device entry.

Unique Device Identification (UDI)

UDI stands for Unique Device Identification, and this can be found on the client's device label or on the device itself. Healthie will automatically validate the entered UDI to prevent duplicates or incorrect formats via this API provided by the National Library of Medicine (NLM).

UDIs are created based on international standards for unique identification. Private organizations, called "Issuing Agencies", are accredited by the FDA to operate a system for the issuance of UDIs based on these standards.

A unique device identifier (UDI) on a device label appears in both plain text and in machine-readable format. Below is an example of a unique device identifier (UDI) from GS1, one of the FDA-accredited issuing agencies. It uses a 1D barcode for its machine-readable format.

Note: In the event that the UDI you have provided does not match any device in the NLM database, you will see an error message saying "UDI not found."

Editing and Removing Implantable Devices

As a provider, in order to be able to edit and remove Implantable Device items, clicking the three dots in the right hand of the section will present you with two options: Edit and Remove Device.

In order to edit your Implantable Device, make the appropriate edits within the right hand panel that pops up, and click on Save Changes. 

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