Implementing a Complaint Management and Reporting System using TrackWise

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Implementing a Complaint Management and

Gambro Use Case

Reporting System using TrackWise

Kai Kiefer Manager, IT Center‐of‐Excellence ECM & Quality Solutions Gambro Dialysatoren GmbH y Yohay Yafe Director, Professional Services, Sparta Systems

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Agenda



Why eMDR? (a Business View)

Agenda



What is eMDR? (a Technical View)



How did we implement eMDR at GAMBRO?

− Who is GAMBRO?

− Project essentials (when, how, why)

− Solution overview (building blocks)

− TrackWise workflow & record design

TrackWise workflow & record design

− Conversion from TrackWise record to ICSR

− Submission workflow to FDA (ESG)

− eMDR in the context of Gambro complaint handling and why we

choose TrackWise

− Testing & validation approach



Lessons learned during implementation

Q&A



Q&A

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Why eMDR? (an FDA View)

 Adverse events and product problems for medical devices are sent to

Why eMDR? (an FDA View)

FDA Center of Devices and Radiological Health (CDRH) using MedWatch 3500A. ‐> each MedWatch Report is getting manually transferred into the a central database “MAUDE”  CDRH implemented 2009 the support of an electronic transfer with a 4 year voluntary period − After that Paper submissions are still possible but requires a handling cost  Motivation for FDA

 Assumption is today there is a “underreporting” in medical devicesAssumption is today there is a underreporting in medical devices compared to drugs

‐> Push to industry to report more and more frequent

 Reduce costs and increase transparency

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Why eMDR? Motivation for Industry

Compliance / Traceability

Why eMDR? Motivation for Industry

Costs Costs  Material, Shipping ~10€ (standard)  Resources prepare Shipment/Archiving 30min ~40‐60€

 Total costs per MedWatch ~ 50 70€

 Total costs per MedWatch ~ 50‐70€

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What is eMDR? (a Technical View)

 eMDR = electronic Medical Device Reporting

What is eMDR? (a Technical View)

− XML File, describes the data captured in MedWatch Report − conform with HL7 ISCR, like Adverse Events used for Pharma  Use of FDA electronic Submission Gateway (ESG) which routes XML file to FDA Center of Devices and Radiological Health (CDRH)  Data than will be imported into FDA CDRH MAUDE database  Additional Features  Additional Features − Support single reporting and batch reporting − Support initial and follow‐up reporting − Support of attachmentspp − Sends acknowledgements  2 Ways for Manufactures to submit − “manually” using FDA eSubmitter − Automated using a central database

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eMDR High‐level Steps

eMDR High level Steps

Convert into eMDR Convert into eMDR

Sent to FDA FDA FDA _CDRH “MAUDE” DB FDA Gateway

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eMDR ‐ Example

eMDR Example

Two Challenges Two Challenges 1. Generate an XML message compliant to HL7 ICSR 2. Use NCI / MAUDE coding values

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Two Solutions

Free FDA Tools Enterprise Solution

Convert into eMDR FDA eSubmitter TrackWise eMDR

AS2 Gateway solutions

Sent to FDA ESG _{FDA WebTrader} AS2 Gateway solutions

Axway, SAP PI, /nSoftware

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FDA eSubmitter

http://www fda gov/ForIndustry/FDAeSubmitter/

http://www.fda.gov/ForIndustry/FDAeSubmitter/

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FDA WebTrader

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How did we implement eMDR at

GAMBRO?

Gambro is a global medical technology company with products and therapies for Kidney and Liver dialysis, Myeloma Kidney h d h l h i

GAMBRO?

_{therapy, and other extracorporeal therapies} for Chronic and Acute patients. Founded in 1964, Gambro today has 7 600 employees, production facilities in 9 countries and sales in more than 100 countries. Revenues of SEK 12 billion, with majority of business and infrastructure in Europep

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Gambro’s Portfolio

Chronic Care Acute Care _Ventures

Gambro s Portfolio

2. 1.

Hemodialyisis Kidney, Liver, Fluid overload, Sepsis

Water, Vascular access, New therapies Gambro’s incubator business to build a leading membrane technology business for adjacent extracorporeal therapies & life

i li ti science applications

System integration for improved outcome

Complete system for

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Project Scope

 Gambro has been using TrackWise since 2006 as a global database for complaint

Project Scope

handling, in 2009 the process had been optimized and streamlined − ~ 1.000 Complaints & 5.000 Repairs/ month handled − ‐> today more 700.000 records − Requires coordination of MDRs from 13 different manufacturing sites a cross the worldq g  Implement full end‐to‐end eMDR solution integrated with the current CEM Process − MDR Creation in TrackWise − MDR Review in TrackWise

MDR Approval for submission in TrackWise − MDR Approval for submission in TrackWise − Creation and validation of technical eMDR file − Tracking of FDA responses in TrackWise  Support of − Sending Attachments − Sending Updates  Out of Scope

− Submission of ADRs / ADERs (effort will be reviewed after eMDR implementation) − Submission of ADRs / ADERs (effort will be reviewed after eMDR implementation) − Submission to other Authorities than FDA

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Envisioned Solution

TrackWise

Envisioned Solution

TrackWise

Co

mm

plain

t

Reportable Review Write AS2 Connector /nSoftware

P

XI

t Proc

e

MDR

eMDR

FDA

GATEWAY

Approve eMDR Sent

SA

P

e

ss

Event Reported Ack(s)

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Project Approach for TrackWise

Implementation

Oct Dec May June

2010 2010 2011 2011 Jan 2010 2010 2010 2010 2011 2011 Prepare Change & Documentation Update and Qualify G Li Request FDA Access Susp e TrackWise Configuration Setup / Qualify Gateway Perform PQ / incl FDA Go‐Live ension Pe ri User Training iodiod

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Gambro TrackWise Records

Customer Event Investigation Vigilance Report eMDR Report eMDR Supplemental Report

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eMDR Roles / Records

Sales Complaint Handler

t

Site Complaint Handler

er

Ev

en

t

ce Re p o rt m en ta l

Manager Clinical Investigator

Americas

_Cus

tom

Vigilan

c eMDR t / Supple m

VP Global Regulatory Compliance

Re p o rt

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TrackWise Workflow & Record Design

QA M f t QA Manufacturer US Regulatory Office Automail TrackWise US Regulatory Office Server QA Manufacturer

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Section B:

Adverse Event or Product Problem

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Section D:

Suspected Medical Device

By selecting the Brand Name related y g

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Auto Creation of Report Numbers

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Print‐outs

Print outs

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Conversion from TrackWise Record to

ICSR

Use TrackWise Export Utility

ICSR

p

y



Features

− Runs as a service and connects to the TrackWise Database (like

Coordinator)

− Triggers exports and Imports into records and can be linked into

coordinator by posting activities

− Maps TrackWise fields and values into ICSR XML File

− Future will provide file handling to EDI/Web Services interfaces

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Conversion from TrackWise Record to

ICSR

Use MAUDE Values than it will be mapped will be mapped automatically

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Conversion from TrackWise Record to

ICSR

Export Utility p y Posts Activities Coordinator Fetches Posted Activities

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Submission Workflow to FDA (ESG)



We have chosen to establish a dedicated AS2 Gateway

Submission Workflow to FDA (ESG)

− To isolate validation/qualification and change control efforts − To reduce costs − /nSoftware AS2 Connector (http://www.freeas2.com/) < 1k€ R i fi i ff (f i l ) − Requires some configuration effort (for routing messages correctly) A2 AS2 Message Fir e _FDA TWS A2

Gateway _{AS2 Message}

ewa ll FDA ESG (Gateway) TWS Server Gambro Test AS2 Gateway -WIN2k3 Server

- IIS & AS2 Connector - Certificate

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And now the cool thing ….

… all Transactions are imported back into TrackWise and … all Transactions are imported back into TrackWise and readable by the user into the AuditTrail

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FDA ESG Interesting Notes

Obtaining FDA Production Account

1 Register Test Account (letter & certificate)

FDA ESG Interesting Notes

1. Register Test Account (letter & certificate) 2. Perform Testing 3. Setup Production and Approval Tests to perform Tests to perform  A complete Initial 3500A  A complete Initial 3500A with an attachment  A complete Initial 3500A followed by a supplemental 3500A by a supplemental 3500A (be submitted after initial is loaded successfully)  A complete Initial 3500A with section F filled out  A complete Initial 3500A and source report(s) Must read documentation  FDA ESG Guide & FAQ http://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/  eMDR FAQ http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107914.htm

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Why we choose TrackWise

eMDR in the context of Gambro Complaint Handling

Why we choose TrackWise

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Lessons Learned During Implementation

 TrackWise Implementation − Implement eMDR as MedWatch Form

Lessons Learned During Implementation

p • Use MAUDE values ‐> lower training and documentation effort (as well as configuration and testing effort  ) • _{Use of Auto numbering a is great value, reduces need of manual coordination work} • _{User Facility Report Numbers issue unresolved today} • _{Use of 510K list makes creation of eMDR a wash} • _{Consider to make a Crystal MDR report (if you do not have one yet)} − TrackWise Export Utility • Great value in getting a configuration done quickly and safely, reduces test efforts ‐> Wish to have a more pre‐packaged solution by including the some good prep‐material  Gateway Setup − Get people involved familiar with AS2 handling and certificates

Caused us a 3 4 weeks delay due to misunderstandings • _{Caused us a 3‐4 weeks delay due to misunderstandings}

− Setup a outside AS2 test facility, costs are low <10k€ but value

− If you do not have an validated AS2 gateway today consider building a dedicated one

 Validation & Testing

− Qualification/Testing effort like normal TrackWise process using Test GatewayQualification/Testing effort like normal TrackWise process using Test Gateway

− Perform FDA Testing as part of your PQ, consider using your Production Environment (so you test records are maintained)

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Q&A

CDRH Electronic Medical Device Reporting (eMDR) Webinar Announcement

Q&A

 Find out all you need to know to take the mystery out of electronic reporting at one of our upcoming free interactive webinars (no registration required) and meet CDRH’s eMDR Team: Friday, June 03, 2011, 1:30 PM – 5:00 PM EDT Friday, August 05, 2011, 1:30 PM – 5:00 PM EDT Friday, September 30, 2011, 1:30 PM – 5:00 PM EDT Friday November 18 2011 1:30 PM – 5:00 PM EDT Friday, November 18, 2011, 1:30 PM – 5:00 PM EDT http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm arketRequirements/ReportingAdverseEvents/eMDR–q / p g / ElectronicMedicalDeviceReporting/ucm252958.htm Or Google  Or Google 

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Implementation Approaches



Evolution of paper 3500A to eMDR

Implementation Approaches

p p

− Modify workflow to support ACKs, data validation errors − Retain 3500A report template in case of FDA Gateway downtime



Incremental addition of eMDR to complaint handling (without



Incremental addition of eMDR to complaint handling (without

electronic 3500A)

− Add MedWatch elements to complaint/regulatory reporting process − Workflow, group permissions to support eMDR process



New complaint handling solution with eMDR

− Complaint/investigation/assessment/regulatory report processesComplaint/investigation/assessment/regulatory report processes − Security, responsibilities at different levels

− Streamlined, complete solution



B2B gateway solution

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Implementation Approaches

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Implementation points to consider:

Implementation Approaches

p

− Storage of eMDR file and ACKs

− All functional and non‐functional failure points

MDR fil d

t

t d

•

_{eMDR file does not get generated}

•

_{What to do when gateway is down – Look for the root}

cause/ Alternative gateway.

− What to do when ACK3 comes back negative

‐ Look for the

root cause and take decision (Workflow wise)

− FDA audit – what to show?

− READ, READ, READ!

•

_{eMDR website – Keep updated with 3500A updates}

•

Notice of regulation

•

Notice of regulation

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Transition



Harmonize complaint and MedWatch processes

Transition

p



Set up EDI (Electronic Data Interchange) tool to submit

eMDR file to FDA



Set up EDI tool to process Acknowledgements (3)



E‐Mail notifications, Dashboard set up to alert user based

d t il

f A k

l d

t

on details of Acknowledgements



Automatically progress MedWatch if submission is valid,

and “passed”

and passed



Workflow activity, e‐mail notifications in case of “failure”

message from FDA

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eMDR Project Team Roles and

Responsibilities

Role Responsibilities

Project Sponsors ∙ Provides overall strategic direction

Project Sponsors Provides overall strategic direction ∙ approve scope changes ∙ resolve project issues escalated to this level ∙ promote project throughout organization ∙ support project leaders Business Lead ∙ communicate with FDA ∙ build consensus with MDR users ∙ assist in requirements gathering, user acceptance testing ∙ eMDR requirements knowledge leader IS Lead ∙ manager overall IS solution and delivery ∙ escalate issues as needed ∙ main conduit to business lead Vendor representativep ∙ Support internal resourcespp ∙ Escalate software issues ∙ Provide domain expertise Project Manager ∙ Manager project timelines and schedules ∙ Escalate IS/Business issues ∙ Validate overall testing Complaint/MDR team ∙ Provide business requirements for eMDR ∙ participate in user acceptance testing, generating eMDR files ∙ evaluate eMDR prototypes Vendor software Lead ∙ Manage software solution delivery and implementation ∙ Support software issues ∙ Ensure software complies with FDA requirements B2B Gateway Lead ∙ Manage Gateway solution delivery and implementation ∙ Support gateway issue resolution ∙ Ensure Gateway complies with FDA's Gateway requirements Quality Assurance _∙ _{Advice Project Managers on Quality needs} ∙ Approve all quality documents

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