medical device reporting and tracking rod perez, m.s.e. consumer safety officer division of small...
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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 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: [email protected] fax: 301-847-8149- phone: 1-800-638-2041 or 301-796-7100