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 MEDWATCH - 1993 1973 – Voluntary Reporting 1984 – First Medical Device Report (MDR) 1996 – Current MDR Regulations 21 CFR Part 803 “We will begin this presentation by looking at a brief history of how adverse event reporting came about...” “The Medical Device & Laboratory Product Problem Reporting Program was known as PRP. It was modeled after the Drug Problem Reporting program and was the primary means of post market product surveillance for medical device products from 1973 to 1984. In addition to health care professionals, voluntary reports were also received through consumer complaints, literature sources, Department of Defense facilities, state health departments and foreign health ministry complaints.” “Under the MDR regulation 21 CFR 803 that became effective on 12/13/84, Manufacturers were required to submit to FDA/CDRH reports of incidents involving their devices where a death or serious injury occurred or a malfunction occurred that could cause or contribute to a death or serious injury.”

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: Deaths Serious Injuries Malfunctions

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 Your must use FDA Form 3500 or a FDA approved facsimile when submitting MDR reports to FDA. **Briefly recap the information on this overhead. In addition: “Manufacturers are responsible for completing Sections G & H and obtaining and providing FDA with information that is incomplete or missing from reports submitted by User Facilities, distributors and other initial reporters. If a manufacturer receives the initial report in some form other than on a 3500A form, the manufactuer is responsible for completing sections A, B, D, & E, as well as Sections G & H and will identify the report with its manufacturer reporting number only--such may be the case with malfunction reports since a user facility is not required to submit malfunction reports to the manufacturer.” “Some general guidelines for completing a 3500A include: 1) Complete all fields of each section required to be completed. 2) When information is not readily available, use: - NA (for Not Applicable) - NI (for No Information at this time) - Unknown 3) Dates should be entered as month/day/4-digit calendar year (e.g., 3/10/1996)”

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 Report Death and Serious Injury to FDA and Manufacturer Malfunction 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) Five­day 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 reports http://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 Alerts Monthly Safety Summaries E-list Notification Partners 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 Information MDR 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 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: DSMICA: - e-mail: dsmica@fda.hhs.gov 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