PH+Reporting+User+Story+-+Medical+Device+Reporting+(FDA-CDRH)

include component="page" wikiName="siframework" page="PHRI Header" =User Story: Medical Device Reporting (FDA/CDRH)=

Contact Info:
Leslie M. Tompkins (Leslie.Tompkins@fda.hhs.gov, phone: 301.796.7593) -- FDA/CDRH/OSB Informatics Staff Indira Konduri (Indira.Konduri@fda.hhs.gov, phone: 301.796.6658) -- FDA/CDRH/OSB Informatic Staff Terrie Reed (Terrie.Reed@fda.hhs.gov, phone: 301.796.6130) -- Associate Director, FDA/CDRH/OSB Informatics

Date Received:
11/18/2011


 * 1.1. ****Introduction **

__Background: __ Research indicates that clinicians do not routinely complete adverse event reports and that the number of reported events can increase when the process of reporting events is integrated into the clinical workflow. In addition, the accuracy and timeliness of reporting can be significantly increased when information automatically derived from clinical information systems (or EHR) can be used to populate the adverse event report form. ASTER-D can be designed to assist not only in identifying adverse event reports on a specified type of device, but to compare reported events to all devices across multiple facilities. In the EHR space (if designed differently) – it could be used to identify EHR AEs.

__Primary Objective __ Determine the risks and benefits that result when the reporting requirements change from a reliance on manual data entry after an event to real-time, automated data capture, storage, and transmission using standard vocabularies and open data transmission methods.


 * 1.2. ****User Story Narrative **
 * User Story – FDA, Medical Device Reporting **

__The Event : __  On April 29, 2010, baby A. B. Smith was born premature @ 32 weeks. All appropriate interventions were initiated to support life, including ventilator support. Staff started a new EHR entry for Baby Smith documenting all procedures, drugs and devices. After 12hrs, the ventilator alarm alerted staff and the ventilator was switched out for another. Airway support was continued successfully for another 72hrs.

__The Trigger : __  Upon entering the change of ventilator into the EHR, a dialogue box pops up and asks “Why are you changing the device?” The options are: 1) there’s a problem with the device; 2) the device is needed by another patient; 3) patient no longer needs the device. If the answer is 1) there’s a problem with the device, the system triggers the retrieval of FDA Medwatch 3500A/3500 data set via a CDISC Request For Data (RFD) capture and pre-populates with the patient and device information, including the Unique Device Identifier (UDI) and associated attributes. The device information is linked to the patient record after scanning the patient armband and the device barcode. The UDI from the device links to the internal hospital asset management system. This system has downloaded UDI and associated attributes from the public FDA UDI database. The hospital asset management system also tracks similar events with this device that may have occurred at the hospital and saves important safety information, recalls, alerts etc. from the FDA. This is made available at the point of care to the health practitioner. .

__The Initial Report : __  Data collection for the FDA Medwatch 3500A/3500 data set about the event occurs at the point of failure, but data elements shared between the 3500A/3500 data set and EHR system are pre-populated with the patient information collected at point of care. A completed data set of all required elements is then sent through the workflow system:
 * 1) Report may be sent to Biomedical Engineering, where they may input additional data
 * 2) <span style="font-family: 'Arial','sans-serif';">Report moves to Risk Manager, who investigates and decided if this is a reportable event
 * 3) <span style="font-family: 'Arial','sans-serif';">If it is determined to be a reportable event, the report is formatted into a well-formed ICSR by the system and sent electronically via the gateway to FDA/CDRH; a copy of the ICSR is sent to Manufacturer

__<span style="font-family: 'Arial','sans-serif';">Response to Report : __ <span style="font-family: 'Arial','sans-serif';"> After receiving the report,
 * 1) <span style="font-family: 'Arial','sans-serif';">The FDA Electronic Submissions Gateway will send a receipt of submission to the data submitter.
 * 2) <span style="font-family: 'Arial','sans-serif';">If there are adverse events associated with the device type, FDA will send safety information to the reporter. Information sent may include recalls, safety alerts along with a link to appropriate FDA databases. Appropriate information is reviewed and saved into the Hospital Asset Management system for future use and action.
 * 3) <span style="font-family: 'Arial','sans-serif';">FDA may request additional information regarding the adverse event from the hospital/manufacturer
 * 4) <span style="font-family: 'Arial','sans-serif';">Manufacturer may need to submit an adverse event report to the FDA as stipulated in the MDR Regulation.

<span style="font-family: 'Arial','sans-serif';">The goal of this reporting system is to generate a thorough and accurate report (containing all required FDA data elements) with minimal effort from the healthcare practitioner. This ensures that important public health safety information is submitted at the point of care. This may provide for higher rate of quality reporting, compared to reports submitted as an administrative function, much later after the event occurs, where the actors may be different and submitted information may not be as accurate.
 * <span style="font-family: 'Arial','sans-serif';">1.2.1. ****<span style="font-family: 'Arial','sans-serif';">Goal **

__<span style="font-family: 'Arial','sans-serif';">Reporting events: __
 * <span style="font-family: 'Arial','sans-serif';">1.2.2. ****<span style="font-family: 'Arial','sans-serif';">Description of Data Reporting Events, Actors and Triggers **
 * <span style="font-family: 'Arial','sans-serif';">Device malfunction resulting in serious harm or death – required
 * <span style="font-family: 'Arial','sans-serif';">Device malfunction resulting in minor or no harm – voluntary

__<span style="font-family: 'Arial','sans-serif';">Triggers: __
 * <span style="font-family: 'Arial','sans-serif';">Change of device
 * <span style="font-family: 'Arial','sans-serif';">Patient injury requiring a change of device

__<span style="font-family: 'Arial','sans-serif';">Actors: __
 * <span style="font-family: 'Arial','sans-serif';">Patient
 * <span style="font-family: 'Arial','sans-serif';">Healthcare Practitioner/Hospital Administrative Staff
 * <span style="font-family: 'Arial','sans-serif';">Biomedical Engineering Department
 * <span style="font-family: 'Arial','sans-serif';">Asset Manager
 * <span style="font-family: 'Arial','sans-serif';">Risk/Safety Officer
 * <span style="font-family: 'Arial','sans-serif';">FDA
 * <span style="font-family: 'Arial','sans-serif';">Manufacturer

<span style="font-family: 'Arial','sans-serif';">The proposed data set below is derived from the FDA 3500A\3500 reporting form.
 * <span style="font-family: 'Arial','sans-serif';">1.2.3. ****<span style="font-family: 'Arial','sans-serif';">Data **
 * **<span style="font-family: 'Arial','sans-serif';">Data Elements ** || **<span style="font-family: 'Arial','sans-serif';">Source ** || **<span style="font-family: 'Arial','sans-serif';">When Collected ** || **<span style="font-family: 'Arial','sans-serif';">Actor (Who) ** || **<span style="font-family: 'Arial','sans-serif';">Reason for Collection ** ||
 * **<span style="font-family: 'Arial','sans-serif';">Patient Identifier ** ||
 * <span style="font-family: 'Arial','sans-serif';">Patient ID || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When admitted || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hosptial Admin Staff || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care ||
 * <span style="font-family: 'Arial','sans-serif';">Sex || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When admitted || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hosptial Admin Staff || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care ||
 * <span style="font-family: 'Arial','sans-serif';">Weight || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When admitted || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hosptial Admin Staff || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care ||
 * **<span style="font-family: 'Arial','sans-serif';">Adverse Event Information ** ||
 * <span style="font-family: 'Arial','sans-serif';">Adverse Event? Yes/No || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Product Problem? (Yes/No) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Date of Event || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Date of the Report || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When report is submitted || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk Manager or Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Relevant Tests, Laboratory Data || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care ||
 * <span style="font-family: 'Arial','sans-serif';">Other relevant history, including preexisting medical conditions || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care ||
 * <span style="font-family: 'Arial','sans-serif';">Location where event Occurred || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Outcomes Attributed to Adverse Event (Death, Disability etc.) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Event Problem Codes (from CDRH Device Problem code list) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitoner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||
 * **<span style="font-family: 'Arial','sans-serif';">Device Information ** ||
 * <span style="font-family: 'Arial','sans-serif';">Unique Device Identifier (UDI) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Brand/Trade/Propietary Name || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Model Number || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Catalog Number || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Serial Number || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Manufacturer Information (Name, Address, Contact) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Implant Date || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitioner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Explant Date || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital EHR || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Point of care || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Health Practitioner || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Reprocessed? || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Reused? || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Reprocessor Information || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Device Manufacture Date || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Device Age || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Asset Management System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">When device is received by hospital || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Asset Manager || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * **<span style="font-family: 'Arial','sans-serif';">Initial Reporter ** ||
 * <span style="font-family: 'Arial','sans-serif';">Initial Reporter Information || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk manager/ Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Health Professional? (Yes/No) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk manager/ Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Occupation || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk manager/ Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Report Sent to FDA? (Yes/No) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk manager/ Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * <span style="font-family: 'Arial','sans-serif';">Report Sent to Manufacturer? (Yes/No) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk manager/ Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting, Inventory Management ||
 * **<span style="font-family: 'Arial','sans-serif';">Hospital Information ** ||
 * <span style="font-family: 'Arial','sans-serif';">Hospital Information (ID number, address) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk Manager/Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Contact Person Information || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk Manager/Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Hospital Information (ID number, address) || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk Manager/Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||
 * <span style="font-family: 'Arial','sans-serif';">Contact Person Information || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Hospital Incident Reporting System || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">During report submission to FDA || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Risk Manager/Biomedical Department || <span style="display: block; font-family: 'Arial','sans-serif'; text-align: center;">Patient care, Public Health Reporting ||


 * <span style="font-family: 'Arial','sans-serif';">1.2.4. ****<span style="font-family: 'Arial','sans-serif';">Other information **

__<span style="font-family: 'Arial','sans-serif';">Primary Objective __ <span style="font-family: 'Arial','sans-serif';">Determine the risks and benefits that result when the reporting requirements change from a reliance on manual data entry after an event to real-time, automated data capture, storage, and transmission using standard vocabularies and open data transmission methods.

__<span style="font-family: 'Arial','sans-serif';">Detailed Objectives __
 * <span style="font-family: 'Arial','sans-serif';">Evaluate the effectiveness of identifying and using triggers and/or user prompts to initiate the capture and integration of adverse event data from the patient’s electronic health record, tie it with entries in the healthcare facility’s incident reporting system(s) and automatically generate and report that information to regulatory authorities including FDA CDRH.
 * <span style="font-family: 'Arial','sans-serif';">Demonstrate the benefits of using standard vocabularies and standard methods of data exchange to improve FDA’s ability to identify safety signals.
 * <span style="font-family: 'Arial','sans-serif';">Use products that have a UDI (unique device identifier) and Identify risks and benefits when UDI and GMDN information is linked to an adverse event report by including products that have a UDI (unique device identifier) and GMDN as part of the study.
 * <span style="font-family: 'Arial','sans-serif';">Explore the use of auto-generated forms, data storage and methods of linking AE reporting information to Patient Safety Organizations (PSOs) using functionality that is independent of the source application (EHR, incident system etc).
 * <span style="font-family: 'Arial','sans-serif';">Leverage relationships with stakeholders who share a common interest in the use of electronic triggers, automated data capture, use of standard terminologies, and methods of data exchange including HL7 and the National Health Information Network.

__<span style="font-family: 'Arial','sans-serif';">ASTER-D Proof of Concept: Example with EHR __

<span style="font-family: 'Arial','sans-serif';">

<span style="font-family: 'Arial','sans-serif';">FDA\CDRH has received strong user commitment from the healthcare community with respect to the ASTER-D proposal. Two hospitals have agreed to pilot the project and collaborate with CDRH.
 * <span style="font-family: 'Arial','sans-serif';">1.3. ****<span style="font-family: 'Arial','sans-serif';">Stakeholder Commitment **

<span style="font-family: 'Arial','sans-serif';">Leslie M. Tompkins <span style="font-family: 'Arial','sans-serif';">FDA/CDRH/OSB Informatics Staff <span style="font-family: 'Arial','sans-serif';">301-796-7593 <span style="font-family: 'Arial','sans-serif';">Leslie.Tompkins@fda.hhs.gov
 * <span style="font-family: 'Arial','sans-serif';">1.4. ****<span style="font-family: 'Arial','sans-serif';">Contact Information **

<span style="font-family: 'Arial','sans-serif';">Indira Konduri <span style="font-family: 'Arial','sans-serif';">FDA/CDRH/OSB Informatic Staff <span style="font-family: 'Arial','sans-serif';">301-796-6658 <span style="font-family: 'Arial','sans-serif';">Indira.Konduri@fda.hhs.gov

<span style="font-family: 'Arial','sans-serif';">Terrie Reed <span style="font-family: 'Arial','sans-serif';">Associate Director <span style="font-family: 'Arial','sans-serif';">FDA/CDRH/OSB Informatics <span style="font-family: 'Arial','sans-serif';">301-796-6130 <span style="font-family: 'Arial','sans-serif';">Terrie.Reed@fda.hhs.gov

Supporting Files:

 * **Description** || **File** ||
 * This document contains the initial draft user story submission. || [[file:Initial Draft Submission - Medical Device Reporting - November 18 2011.docx]] ||  ||

Comments:
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