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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. Topics. Medical Device Reporting (MDR) MedWatch Medical Device Tracking. Medical Device Reporting (MDR): Regulations.

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medical device reporting and tracking
Medical Device Reporting and Tracking

Rod Perez, M.S.E.

Consumer Safety Officer

Division of Small Manufacturers, International and Consumer Assistance

Western Canada 2009

topics
Topics

Medical Device Reporting (MDR)

MedWatch

Medical Device Tracking

medical device reporting mdr regulations
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 FFD&C Act as amended by the Safe Medical Devices Act (SMDA) of 1990

Mandatory Reporting

history
History
  • 1973 – Voluntary Reporting
    • MEDWATCH - 1993
  • 1984 – First Medical Device Report (MDR)
  • 1996 – Current MDR Regulations 21 CFR Part 803
medical device reporting purpose
Medical Device Reporting:Purpose

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

medical device reporting who must report
Medical Device Reporting:Who 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

medical device reporting what to report
Medical Device Reporting:What to Report?

Medical Device-Related:

Deaths

Serious Injuries

Malfunctions

medical device reporting definition of serious injury
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
medical device reporting definition of serious injury1
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
medical device reporting manufacturer reporting times
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

medical device reporting importer reporting times
Medical Device Reporting: Importer Reporting Times

30-Day Report

Death and Serious Injury to FDA and Manufacturer

Malfunction to Manufacturer Only

medical device reporting user facility reporting times
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)

medical device reporting deaths and serious injuries
Medical Device Reporting: Deaths and Serious Injuries

CY 2005 = 89,000

Voluntary = 4,000

Total Since 1984

MDR = 1,300,000

Voluntary = 78,000

medical device reporting industry guidance
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)
medical device reporting adverse event reporting data files
Medical Device Reporting:Adverse 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

medical device reporting adverse event reporting data files1
Medical Device Reporting:Adverse 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

electronic medical device reporting emdr system
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

electronic medical device reporting emdr system1
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 FDA’s 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
electronic medical device reporting emdr system2
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 FDA’s access to safety information in a format that would support more efficient and comprehensive data analysis and reviews
  • Enhancing the Agency’s ability to rapidly communicate information about suspected
electronic medical device reporting emdr system3
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/DeviceRegulationandGuidance/GuidanceDocuments/ucm175805.htm
ghtf study group 2 vigilance
GHTF Study Group 2“Vigilance”
  • 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
medwatch overview
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

medwatch overview1
MedWatch: Overview
  • What to Report for Medical Devices:
    • Serious Adverse Events
    • Product Quality Problems
    • Device Use Errors
  • May report:
    • Online
    • By mail/fax/phone
medwatch overview2
MedWatch: Overview

Safety Information Resources:

  • Individual Safety Alerts
  • Monthly Safety Summaries
  • E-list Notification
  • Partners Program

Website:www.fda.gov/medwatch

medical device reporting websites
Medical Device Reporting:Websites

Regulation:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821

Guidances:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/topicindex/guidance.cfm?topic=224

fda contact information mdr regulations and policies
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: 301-796-6670

Fax: 301-827-3333

medical device tracking regulations
Medical Device Tracking:Regulations

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

medical device tracking purpose
Medical Device Tracking:Purpose
  • 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
medical device tracking purpose1
Medical Device Tracking:Purpose

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

medical device tracking implementation
Medical Device Tracking:Implementation

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"

medical device tracking who and when
Medical Device Tracking:Who 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

medical device tracking devices subject to tracking
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"

medical device tracking responsibilities
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

medical device tracking responsibilities1
Medical Device Tracking:Responsibilities

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

medical device tracking websites
Medical Device Tracking:Websites

Regulation:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=821

Guidance:

http://www.fda.gov/cdrh/comp/guidance/169.html

questions
Questions?

FDA’s CDRH webpage:

http://www.fda.gov/cdrh

DSMICA:

- e-mail: dsmica@fda.hhs.gov

- fax: 301-847-8149

- phone: 1-800-638-2041 or 301-796-7100