Use Case 6: Consolidated reporting of medical device recalls

From Demand-Driven Open Data for HHS
(Redirected from Use Case 6)
Jump to: navigation, search


Requirements

Use case summary

Description

  • Need "single source of truth" for medical device recalls, rather than trying to reconcile between the two data sources.
  • Solution alternative #1: Provide single, consolidated source
  • Solution alternative #2: Enable exact linking:
    • Provide unique recall ID to link data from these two sources.
    • Provide standardized, consistent product name or registered device key (such as PMA # or 510(k) #)

Value

  • Value to customer: Helps hospitals catch devices in their inventory that have been recalled and prevent them from buying potentially unsafe ones. Also, suggests equivalent or substitute products as replacements.
  • Value to industry/public: Improve outcomes and patient safety by lowering probability of hospitals being unaware of devices have been recalled.

Customer

  • Procured Health: Provides outcomes-driven device acquisition and management to hospitals

Current data and limitation

Data source #1

  • Data source: Enforcement Reports (weekly, incremental, XML feed)
  • Fields provided: Product Type, Event ID, Status, Recalling Firm, City, State, Country, Voluntary/Mandated, Initial Firm Notification of Consignee or Public, Distribution Pattern, Recall Number, Classification, Product Description, Code Info, Code Info (Continued), Product Quantity, Reason for Recall, Recall Initiation Date, Report Date
  • Challenges:
  • Available via OpenFDA API, but the "Beta" disclaimer makes it risky to commercially rely on
  • OpenFDA provides the same fields as the Enforcement Report (downloadable CSV), but lacks links to the Recall database

Data source #2

  • Data source: Medical Device Recalls database (search & scrape via HTML)
    • (Caution: To avoid confusion, refer to the "Medical Device Recalls" system as the Recall database. Don't use "MDR", which references Medical Device Reporting for adverse events.)
  • Challenges:
    • Medical Device Recalls can be downloaded as XLS or CSV files, but only 500 records can be downloaded per file.
    • The alternative is scraping paginated HTML on the website, but that's a fragile and inefficient process.
    • The recall history only goes back to November 2002. Earlier history is valuable.

Overall Problem

  • Data is inconsistent and difficult to reconcile between the 2 sources. Need "single source of truth".
  • Solution:
    • Provide unique recall ID to link data from these two sources.
    • Provide standardized, consistent product name or registered device key (such as PMA # or 510(k) #)
    • Though both datasets use a "z-number" as an identifier, the URL for the recall page has a different ID number which is not the z-number. There's no unique key that maps the two.

Specifications

  • Fields: (schema)
    • Unique recall ID to link data between these 2 data sources
    • Provide standardized, consistent product name or registered device key (such as PMA # or 510k #)
    • "Recall Number", "Recall Event ID"
    • z-number
  • Update frequency: Weekly, same as existing Enforcement Reports
  • Joins between datasets: N/A
  • Procedural: Remove "Beta" disclaimer from OpenFDA API. Or at least specify a target data for this to happen.
  • Lag time:
    • Specify how long it takes a recall that has been reported to the FDA to be shared via the enforcement report.
    • Or eliminate the lag by posting the recall immediately once it has been reported to the FDA
  • Time frame / history: Make all history available, if possible. Now only back to June 2012.

Solution

Understanding the data sources described in use case

  • RES (Recall Enterprise System) is the internal system of record for the ORA (Office of Regulatory Affairs) organization
  • Relation to Enforcement Reports
  • Enforcement Reports are currently being manually generated from RES on a weekly basis
  • Eventually, Enforcement Reports will be auto-generated from RES on a more frequent basis

Long term solution

Solution: API via openFDA.gov


Example API calls:

Call from Recall API: https://api.fda.gov/device/recall.json?search=res_event_number:%2269910%22

 {
  "meta": {
    "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, 
you should assume all results are unvalidated.",
    "license": "http://open.fda.gov/license",
    "last_updated": "2015-08-31",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "other_submission_description": "",
      "res_event_number": "69910",
      "firm_fei_number": "",
      "k_numbers": [
        "K131254"
      ],
      "openfda": {
        "device_name": "Tube, Tracheal (W/Wo Connector)",
        "medical_specialty_description": "Anesthesiology",
        "device_class": "2",
        "regulation_number": "868.5730"
      },
      "product_code": "BTR",
      "root_cause_description": "Nonconforming Material/Component",
      "pma_numbers": [],
      "event_date_terminated": "2015-08-18",
      "product_res_number": "Z-0868-2015"
    }
  ]
}


Call from Enforcement API: https://api.fda.gov/device/enforcement.json?search=event_id:%2269910%22

{
  "meta": {
    "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate, 
you should assume all results are unvalidated.",
    "license": "http://open.fda.gov/license",
    "last_updated": "2015-08-17",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 5
    }
  },
  "results": [
    {
      "country": "US",
      "city": "Roswell",
      "reason_for_recall": "The cuff inflation line may detach from the endotracheal tube during use.",
      "classification": "Class I",
      "openfda": {},
      "recall_number": "Z-0867-2015",
      "recalling_firm": "Halyard Health",
      "initial_firm_notification": "Letter",
      "code_info": "Product Code: 13222, Lot numbers: AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, 
AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, 
AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, 
AA4134V01, AA4146V01, AA4146V04, AA4155V03, AA4167V01, AA4170V01, AA4174V01, AA4217V01 & AA4226V01.",
      "product_quantity": "400 cases (10 tubes per case)",
      "event_id": "69910",
      "product_type": "Devices",
      "@checksum": "7229cab10882d171fff037a5173c3c96f08a40c3",
      "recall_initiation_date": "20141117",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, 
OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, 
Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.",
      "state": "GA",
      "@id": "16b5d2f28f147ebcb525b7b837477f6927c5ad300262dbec257328b8c9231f4a",
      "product_description": "KimVent* Microcuff* Subglottic Suctioning, Endotracheal Tube, 8.0 mm, Distributed by Kimberly Clark Global Sales, 
LLC.KimVent Microcuff Subglottic Suctioning Endotracheal Tubes are indicated for airway management by oral intubation of the trachea and for 
removal of secretions that accumulate in the subglottic space.",
      "voluntary_mandated": "Voluntary: Firm Initiated",
      "report_date": "20141231",
      "status": "Ongoing"
    }
  ]
}


Call from 510(k) API (as check that the product referenced in the Recall and Enforcement API are the same; k_number obtained from Recall API result): https://api.fda.gov/device/510k.json?search=k_number:%22K131254%22

{
  "meta": {
    "disclaimer": "openFDA is a beta research project and not for clinical use. While we make every effort to ensure that data is accurate,
 you should assume all results are unvalidated.",
    "license": "http://open.fda.gov/license",
    "last_updated": "2015-08-31",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "third_party_flag": "N",
      "city": "ROSWELL",
      "advisory_committee_description": "Anesthesiology",
      "address_1": "1400 HOLCOMB BRIDGE RD.",
      "address_2": "",
      "statement_or_summary": "Summary",
      "product_code": "BTR",
      "openfda": {
        "device_name": "Tube, Tracheal (W/Wo Connector)",
        "registration_number": [
          "3009746061",
          "3003924186",
          "8020785",
          "3005949151",
          "9611710",
          "1219795",
          "3006061749",
          "1048735",
          "3006082230",
          "1319447",
          "3011581942",
          "9681384",
          ...
        ],
        "fei_number": [
          "3009746061",
          "2518040",
          "3003924186",
          "3005949151",
          "1219795",
          "1000138054",
          "3006061749",
          "1048735",
          ...
        ],
        "device_class": "2",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5730"
      },
      "zip_code": "30076",
      "applicant": "KIMBERLY-CLARK CORP.",
      "decision_code": "SESE",
      "decision_date": "2013-08-20",
      "country_code": "US",
      "device_name": "KIMVENT MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE",
      "advisory_committee": "AN",
      "expedited_review_flag": "",
      "contact": "MARCIA  JOHNSON",
      "state": "GA",
      "review_advisory_committee": "AN",
      "k_number": "K131254",
      "date_received": "2013-05-02",
      "postal_code": "30076",
      "clearance_type": "Traditional",
      "decision_description": "Substantially Equivalent"
    }
  ]
}

Short-term Workaround #1

  • Until auto-publication interface is available, use the following steps
  • Start with Enforcement Reports and pull list of recalls
  • Download the CSV version which contains 18 fields. Be sure to capture the Recall #.
  • If more RES fields are needed (such as Product Classification, Product Code, FDA Determined Cause, Action), go to the Medical Device Recalls (Recalls) application site and query it by the Recall # obtained from Enforcement Reports
  • You will have to scrape the HTML, rather than download, because the download:
    • Is limited to 500 records
    • Has only 6 fields (Recall Number, Trade Name/Product, Recall Class, Date Posted, Recalling Manufacturer, Reason for Recall) -- Compared to approx 22 total via the web interface

Short-term Workaround #2

Short-term Workaround #3

  • In relation to the long term solution outlined below... (Details still need to be worked out with the data owners)
  • Consider getting involved with pre-release validation
  • Consider requesting information about future data model and other specifications
  • Consider requesting to be updated if release schedules or delivery status change