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Recording Implantable Devices

Capturing a Patient's implanted devices is a core function of an Electronic Health Record system. Requirements for EHR Implantable Device list are described in the ONC (a)(14) criteria.

Implantable device list can be input via multiple methods, for example via application user interface (UI), synchronized via integration or written via API.

The USCDI V2 data standard outlines specific technical requirements, you can see the profile on HL7.org.

caution

Medplum ONC (a)(14) certification is under development. Contact us at info@medplum.com for more details.

Device Specific Identifiers​

The recording of implantable devices needs to support several use cases. Here's a few examples:

  • When giving a treatment or test, implantable devices must be considered for safe and effective care
  • In case of a recall, it should be possible to query for affected patients.
  • If a patient experiences an adverse event, the clinician should have the details needed to report it.

At minimum, the presence of the device and the coded-representation of the device type must be stored in the EHR.

The EHR also must have the option to collect the following data:

  • The Device Identifier (UDI-DI)
  • A Unique Device Identifier (UDI) numeric or alphanumeric code either as the Human Readable Form (HRF) string representation of the barcode or the Automatic Identification and Data Capture (AIDC) representation.
  • The following parsed Production Identifiers (UDI-PI) from the UDI
  • the manufacture date
  • the expiration date
  • the lot number
  • the serial number
  • the distinct identifier (i.e., the distinct identification code)
  • device safety, specifically MRI safety and the presence of latex in device

User Interface​

Medplum provides React components for implantable devices that fulfill data collection requirements and can be embedded in your application.

To obtain a list of embedded devices for a given patient in your application, embed a search control for Device resources with for that patient. Documentation for constructing a search by reference is described in the search documentation.

The FHIR Resource that represents the implanted device is a FHIR Device resource. A sample FHIR Bundle is available for download.

Querying the FDA API​

Medplum supports querying the FDA Device Lookup API to pull in identifiers, name, manufacturer details and safety information from the FDA API. Entering the correct device specific identifier can trigger a request to the API to fill in specific data to the ONC (a)(14) standard.