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 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

1973 – Voluntary Reporting MEDWATCH - 1993

1984 – First Medical Device Report (MDR)

1996 – Current MDR Regulations 21 CFR Part 803

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?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-Related:DeathsSerious InjuriesMalfunctions

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 Injury

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

FDA Form 3500A for Mandatory Medical Device Reporting

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

30-Day ReportDeath and Serious Injury to

FDA and ManufacturerMalfunction to Manufacturer

Only

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

CY 2005 = 89,000 Voluntary = 4,000

Total Since 1984 MDR = 1,300,000 Voluntary = 78,000

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) Five day MDR reports (§803.53) and MDR supplemental reports (§803.56)

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 Files

Device Experience Network Database Former Database Mandatory manufacturer reports from

1984-1996 Voluntary reports up to June 1993 Over 600,000 reportshttp://www.accessdata.fda.gov/scripts/

cdrh/cfdocs/cfMDR/Search.cfm

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) 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) 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) 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”

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

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: Overview

What to Report for Medical Devices: Serious Adverse Events Product Quality Problems Device Use Errors

May report: Online By mail/fax/phone

MedWatch: Overview

Safety Information Resources: Individual Safety AlertsMonthly Safety SummariesE-list NotificationPartners Program

Website: www.fda.gov/medwatch

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 InformationMDR Regulations and Policies

Office of Surveillance & BiometricsDivision of Surveillance SystemsReporting Systems and Monitoring Branch10903 New Hampshire AvenueWO Bldg. 66, Rm. 3217 Silver Spring, MD 20993-0002Phone: 301-796-6670

Fax: 301-827-3333

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

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: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

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?

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 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 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: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 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?

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