Medical Device Reporting and Tracking

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Medical Device Reporting and Tracking

• Rod Perez, M.S.E.
• Consumer Safety Officer
• Division of Small Manufacturers, International
  and Consumer Assistance
• Western Canada 2009

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Topics

• Medical Device Reporting (MDR)
• MedWatch
• Medical Device Tracking

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Medical Device Reporting(MDR) Regulations

• Regulations implementing the MDR requirements
  became effective on December 13, 1984
• May be found in 21 CFR Part 803
• The statutory authority for the MDR regulation is
  section 519(a) of the FFDC Act as amended by the
  Safe Medical Devices Act (SMDA) of 1990
• Mandatory Reporting

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History

• 1973 Voluntary Reporting
• MEDWATCH - 1993
• 1984 First Medical Device Report (MDR)
• 1996 Current MDR Regulations 21 CFR Part 803

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Medical Device ReportingPurpose

• Allows for traceability of certain devices to the
  user level
• Allows FDA to identify monitor significant
  medical device adverse events so that they can be
  detected and corrected quickly
• Provides early warning of imminent public health
  problems

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Medical Device ReportingWho Must Report?

• Device Manufacturers (U.S. and Foreign)
• U.S. Importers (including Initial Distributors
  for devices manufactured overseas)
• User Facilities (Hospitals, Nursing Homes)
• Domestic distributors only need to maintain
  complaint files

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Medical Device ReportingWhat to Report?

• Medical Device-Related
• Deaths
• Serious Injuries
• Malfunctions

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Medical Device Reporting Definition of Serious
Injury

• A reportable serious injury is an injury or
  illness that is
• Life-threatening
• Results in permanent impairment of body function
  or permanent damage to body structure

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Medical Device Reporting Definition of Serious
Injury

• Requires medical or surgical intervention to
  preclude permanent impairment of body function or
  permanent damage to body structure

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FDA Form 3500A for Mandatory Medical Device
Reporting
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Medical Device Reporting Manufacturer Reporting
Times

• 30-Day Report for Individual Events
• Deaths
• Serious Injuries
• Malfunctions
• 5-Day Report for Events that Require Remedial
  Action
• To Prevent Unreasonable Risk of Substantial Harm
  to Public Health
• As Designated by FDA

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Medical Device Reporting Importer Reporting Times

• 30-Day Report
• Death and Serious Injury to FDA and Manufacturer
• Malfunction to Manufacturer Only

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Medical Device Reporting User Facility Reporting
Times

• 10-Day Report
• Death to FDA and Manufacturer
• Serious Injury to Manufacturer Only
• Device Malfunction not required but encouraged
  to report to Manufacturer
• Annual Summary of Reported Deaths and Serious
  Injuries to FDA (Form 3419)

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Medical Device Reporting Deaths and Serious
Injuries

• CY 2005 89,000
• Voluntary 4,000
• Total Since 1984
• MDR 1,300,000
• Voluntary 78,000

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Medical Device Reporting Industry Guidance

• MDR System is audited during routine inspections
• The FDA Investigator will look for
• Written MDR procedures (803.17)
• MDR event files (803.18)
• Individual adverse event reports (803.50 and
  803.52)
• Fiveday MDR reports (803.53) and
• MDR supplemental reports (803.56)

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Medical Device ReportingAdverse Event Reporting
Data Files

• Manufacturer and User Facility Device Experience
  Database - (MAUDE Data)
• Current Database
• Voluntary reports since June 1993
• User facility reports since 1991
• Distributor reports since 1993
• Manufacturer reports since August 1996
• http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfMAUDE/search.CFM

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Medical Device ReportingAdverse Event Reporting
Data Files

• Device Experience Network Database
• Former Database
• Mandatory manufacturer reports from 1984-1996
• Voluntary reports up to June 1993
• Over 600,000 reports
• http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfMDR/Search.cfm

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Electronic Medical Device Reporting (eMDR) System

• Provides capability for electronic data entry and
  processing of medical device adverse event
  reports
• Uses FDA Gateway to receive, authenticate,
  validate and route eMDRs to CDRH
• Allows for two reporting options
• CDRH eSubmitter (CeSub) for low volume reporters
• Health Level 7 (HL7) Individual Case Safety
  Report (ICSR) for high volume reporters (Can
  accommodate individual or batch files)
• http//www.fda.gov/cdrh/emdr/index.html

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Electronic Medical Device Reporting (eMDR) System

• New proposal for Mandatory electronic reporting
  and modifications regarding the content of
  required MDRs to better track information already
  solicited on the FDA Form 3500A
• An important step towards improving the FDAs
  systems for collecting and analyzing postmarket
  MDRs
• Benefits include
• Reduction of industry's time and costs associated
  with transcribing data from internal data
  management systems to paper and mailing the paper
  reports

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Electronic Medical Device Reporting (eMDR) System

• Elimination of FDA transcription errors, time,
  and costs associated with receiving paper reports
  and transcribing data to electronic format for
  review and analysis
• Expediting of FDAs access to safety information
  in a format that would support more efficient and
  comprehensive data analysis and reviews
• Enhancing the Agencys ability to rapidly
  communicate information about suspected

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Electronic Medical Device Reporting (eMDR) System

• problems to the medical device industry, health
  care providers, consumers, and other government
  agencies
• New draft guidance document provides
  recommendations on how to prepare and submit
  electronic MDRs to FDA in a manner that satisfies
  the requirements of the proposed MDR regulation
• http//www.fda.gov/MedicalDevices/DeviceRegulation
  andGuidance/GuidanceDocuments/ucm175805.htm

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GHTF Study Group 2Vigilance

• SG2-N6R3 Comparison of the Device Adverse
  Reporting Systems in USA, Europe, Canada,
  Australia and Japan
• Low of 10 Day Reporting
• High of 30 Day Reporting
• www.ghtf.org

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MedWatch Overview

• Voluntary Reporting
• Regulations implementing MedWatch became
  effective in 1973
• Mechanism for reporting serious adverse events
  for human medical products (drugs, biologics,
  devices, special nutritionals, and cosmetics)
• For consumers and health professionals

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MedWatch Overview

• What to Report for Medical Devices
• Serious Adverse Events
• Product Quality Problems
• Device Use Errors
• May report
• Online
• By mail/fax/phone

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MedWatch Overview

• Safety Information Resources
• Individual Safety Alerts
• Monthly Safety Summaries
• E-list Notification
• Partners Program
• Website www.fda.gov/medwatch

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Medical Device ReportingWebsites

• Regulation
• http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfcfr/CFRSearch.cfm?CFRPart821
• Guidances
• http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfTopic/topicindex/guidance.cfm?topic224

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FDA Contact InformationMDR Regulations and
Policies

• Office of Surveillance Biometrics
• Division of Surveillance Systems
• Reporting Systems and Monitoring Branch
• 10903 New Hampshire Avenue
• WO Bldg. 66, Rm. 3217
• Silver Spring, MD 20993-0002
• Phone [phone]
• Fax [phone]

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Medical Device TrackingRegulations

• Regulations implementing the tracking
  requirements became effective on August 29, 1993
• May be found in 21 CFR Part 821
• Part of the Postmarket Surveillance Process

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Medical Device TrackingPurpose

• To ensure that manufacturers of certain devices
  are able to promptly locate devices in commercial
  distribution 
• To ensure that manufacturers can expeditiously
  remove potentially dangerous or defective devices
  from the market and/or notify patients of
  significant device problems

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Medical Device TrackingPurpose

• To facilitate public health notifications and
  mandatory recalls ordered by FDA regarding
  unreasonable risk of substantial harm associated
  with a medical device

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Medical Device TrackingImplementation

• FDA has discretion to order manufacturers of
  certain types of Class II or Class III devices to
  initiate a program to track their medical devices
  down to the patient level
• Implementation of the Medical Device Tracking
  Regulation can be found in the "Guidance on
  Medical Device Tracking"

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Medical Device TrackingWho and When?

• Manufacturers, Importers, Distributors
• If FDA issues an order to do so
• Required for the useful life of the device, or
  until device is returned, destroyed, explanted,
  or the patient dies

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Medical Device Tracking Devices Subject to
Tracking

• May include any Class II or Class III device
• Devices likely to have serious adverse health
  consequences if they failed
• Life-sustaining or life-supporting devices used
  outside of a device user facility (hospital,
  nursing home)
• Devices intended to be implanted in the human
  body for more than one year
• Current list of tracked devices is to be found in
  the "Guidance on Medical Device Tracking"

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Medical Device Tracking Responsibilities

• Manufacturers must establish written SOPs which
  includes
• a method for tracking the device throughout
  distribution
• a quality assurance program including audit
  procedures
• at 6-month intervals for the first 3 years a
  device is tracked, and then annually after 3
  years
• Final distributors will be required to provide
  manufacturers with patient information

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Medical Device TrackingResponsibilities

• Manufacturers will have 3 days to provide
  critical information about devices that have not
  yet been distributed to a patient and 10 working
  days for devices that have been distributed to
  patients

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Medical Device TrackingWebsites

• Regulation
• http//www.accessdata.fda.gov/scripts/cdrh/cfdocs/
  cfcfr/CFRSearch.cfm?CFRPart821
• Guidance
• http//www.fda.gov/cdrh/comp/guidance/169.html

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Questions?

• FDAs CDRH webpage
• http//www.fda.gov/cdrh
• DSMICA
• - e-mail dsmica_at_fda.hhs.gov
• - fax [phone]
• - phone [phone] or 301-796-7100