Transcript Slide 1

Medical Device Safety
Susan Gardner, Ph.D.
Director, Office of Surveillance and Biometrics
Center for Devices and Radiological Health
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Agenda
• Overview of the CDRH Postmarket Transformation
Effort
• Status of targeted postmarket initiatives
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Postmarket Transformation
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Adverse event reports are increasing…
REPORTS RECEIVED - FY 2000 - 2006
Other
Malfunction
Injury
Death
Number of Reports
250,000
200,000
150,000
100,000
50,000
0
2000
2001
2002
2003
Fiscal Year
2004
2005
2006
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Recalls remain a source of concern…
638
Class 1 Recalls
600
571
Total Recalls
546
495
486
500
630
608
480
400
336
300
200
100
29
5
4
FY 98
FY 99
8
14
7
23
25
FY 03
FY 04
FY 05
20
0
FY 00
FY 01
FY 02
FY 06
FY 06 as of 7-31-06
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FDA and the medical device industry are under
scrutiny…
FDA To Improve Guidelines for
Medical Devices
Recall of Hemodialysis Device
Points to Kink in Blood Tubes
F.D.A. Puts Restrictions On
Guidant
Medical Devices Are Hot, Which
Is Why Guidant Is
FDA Issues Alert for Abbott
Glucose Meters
Check the Meters' Setting, Says
FDA and Abbott Diabetes Care
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Institute of Medicine Report: Save Medical
Devices for Children
- Monitoring postmarket study commitments
- Public access to information about postmarket studies
- Adverse event reporting
- Organizational attention to pediatric issues
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CDRH Post-market Safety Framework
Premarket Approval Process
Adverse Event
Reporting
Inspections
Problem
Assessment
Groups
Postmarket
Problem
Assessment
Postmarket
Problem
Identification Tools
Additional
Signals
Internal Data
Analysis
Information
Education
Post
Approval
Studies
Laboratory
Research &
Analysis
Information
Dissemination
Postmarket
Tools Public Health
Response
External Data
Analysis
Enforcement
Public Health Partners
A network programs and tools focused towards minimizing harm
and maximizing benefit associated with the use of marketed
medical devices.
It is linked to CDRH pre-market programs and supported by
CDRH’s external public health partners.
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CDRH Postmarket Reports: Transformation
Groundwork
• Ensuring the Safety of Medical Devices : inventory
and assessment of our current postmarket tools
• Strengthening FDA’s Postmarket Program for
Medical Devices: recommendations for
improvements
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1. Develop a Culture of Collaboration
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Place more emphasis on collaboration in identifying, analyzing and
solving postmarket problems, both within the Center and with
outside constituencies
•
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Create at culture of collaboration within CDRH: formalize
horizontal communication …..”connect the dots”
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2. Develop World Class Data Sources and Systems
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Improve data systems, enhance data quality, improve data analysis
What we will do
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Champion unique device identification
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Implement an electronic reporting system
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Evaluate MDR program to optimize
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Optimize our surveillance program with a balance of passive and active
reporting, and access to external data sources
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3. Enhance Risk/Benefit Communication
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Maximize our ability to communicate information
clearly and quickly to practitioners, patients and
consumers
What we will do
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Develop and implement a risk communication
strategy
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Partner with outside professional groups
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Create easier access to Center information
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4. Improve Enforcement Strategies for Postmarket
Issues
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Improve the coordination, consistency, quality and timeliness of
inspections, reporting and enforcement actions
What we will do
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Improve interactions and collaboration between ORA and CDRH
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Assess the effectiveness of current enforcement strategies and
revise accordingly
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Update data systems; use metrics to monitor and improve
performance
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Integrate postmarket information in CDRH to improve signal
detection and decision making
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Medical Device Reporting (MDR)
Basic Facts
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200,000 reports per year
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Database: over 1.25 million
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Individual reports: redacted for Web
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Over half the reports are Summary
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Over 90% are from industry (mandatory)
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3% are voluntary (MedWatch)
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2% user facilities
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> 1% international
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Value of MDR
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Detection of rare, unexpected events
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Following high profile devices
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Signals for emerging issues
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Trends for familiar, mature products (summary)
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Adjunct analysis for investigations
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Available for public use
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High value of voluntary reports (MedWatch)
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Challenges of MDR
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Passive reporting system – depends on recognition of a
problem - no validation
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Poor reporting; not timely; not complete
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Lack of context for incident
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Inadequate analysis of event
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More quantity than quality
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Medical Product Safety Network: MedSun
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Network of 350 health care facilities
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Specifically trained to report device related adverse events
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Barriers to reporting reduced through education, extensive
feedback of safety information
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How MedSun Enhances Surveillance:
Direct Access to Device Users
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Better reports: real-time contact with reporter
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Emphasis on use error
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Emphasis is on prevention: close calls
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Laboratory for research ( rapid response/evaluation surveys)
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Targeted surveillance: LabNet, HeartNet, KidNet
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Post- approval Studies
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Condition of Approval Postmarket Studies
– Automated tracking system for all PAS
– Involvement of epidemiologists for study design
– Guidance document
– Website for status of studies
– Feedback to Advisory Panels
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Section 522 Studies
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Discretionary postmarket studies for Class ll and Class ll
products
- Intended to be implanted for more than one year,or
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- Life sustaining/life supporting and use outside user facility
,or
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- Failure would likely cause serious health consequences
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Improve and Expand Data sources
• Increase use of registries for postmarket
surveillance and postmarket studies
• Support applied epi program
• Collaborations with other agencies
• Increase collaborations with professional
organizations (HRS)
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Unique Device Identifiers
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Federal Register notice for comment in August 2006
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Public meeting in October 2006
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Standardized ID would facilitate tracking for recalls
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Increase ability to identify products associated with AE
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Assist hospitals in tracking and managing devices
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Enhance value of electronic health records – allow improved
surveillance
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Also coming…..
• eMDR
• New device coding system
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