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Curate implanted-device / UDI details for safety surveillance

This recipe is part of Advanced Data Curation: capturing facts that do not exist in OMOP.

User goal
Structure implanted-device details such as pacemakers, ICDs, stents, orthopedic implants, make, model, and lot number.

When to use this
Use for device-safety surveillance, recall response, post-market studies, or any analysis that needs make/model/lot details.

Required inputs/data

  • Dataset built from a cohort or ingestion results (see the "Build a dataset" recipe reference in Scenario: S3 to cohort to dataset to Data Curation) for patients with procedures or notes referencing implants
  • Note types such as operative notes, procedure notes, implant logs, cardiology reports, orthopedic reports, or discharge summaries
  • A custom registry defining the device fields

Custom registry fields (illustrative)

  • device_type
  • manufacturer
  • model
  • serial_or_lot
  • implant_date
  • implant_site
  • explant_date

Patient Journey Intelligence features involved

  • Dataset Builder / Explorer
  • Data Curation Studio
  • Custom Registries
  • Curation Results and evidence review
  • Result export

Step-by-step workflow

  1. Build a dataset of patients with implant-related procedures or documents.
  2. Define a custom registry with the device fields.
  3. Run the curation job.
  4. Review extracted make/model/lot values against their evidence spans.
  5. Correct and validate values; flag partial captures such as model without lot.
  6. Export the device table for cross-matching against a recall or advisory list.

Expected output

  • Structured per-patient implanted-device record
  • Evidence-linked, reviewed values
  • Exportable table that supports recall and advisory matching

Edge cases / limitations

  • Serial or lot numbers are often missing from notes even when the device is named.
  • The same device may be referenced inconsistently across notes; deduplicate per implant episode.
  • Distinguish implant from explant or revision events.
  • Device identifiers can carry residual privacy risk; apply governance before sharing.

User value

  • Turns scattered operative narrative into a device registry that can answer which patients may be affected by a device recall.

Next step​

See related recipes: Recipe 13: Curate reason for medication discontinuation or switch, Recipe 15: Curate cancer recurrence events, Recipe 16: Curate family history with pedigree detail.