0
Postmarket
Surveillance:
Medical Devices
Susan Gardner, PhD
Director, Office of Surveillance and
Biometrics, CDRH
FDLI Ann...
Office of Surveillance and
Biometrics: Basic Functions
 Premarket review
   Statisticians
   Epidemiologists
 Signal detec...
Boston Scientific Expands Recall
 Boston Scientific Stent                   of Troubled Stent
Recall Grows to 96K Units
  ...
Pre-Postmarket Balance

 Use premarket data to make initial
 decisions about safety and
 effectiveness and gain understand...
Need for Postmarket Studies
and Surveillance
 Limited size of premarket studies cannot detect or
 characterize events that...
Condition of Approval Studies
Immediate Postapproval Concerns


  Postapproval requirements can
  include
“continuing eval...
Indications for CoA Studies

 Need to refine risk estimates or better
 characterize safety issues, particularly
 uncommon ...
CoA Quality Study: 2002-3

 1998 through 2000: 127 PMAs
 approved with 45 CoA orders.
 CDRH had limited procedures for
 tr...
Strategy for Change

 Transfer CoA tracking and follow-up
 to OSB
   Develop and institute automated
   tracking system
  ...
Strategy for Change

 Add epidemiologist to PMA review
 team
   Tasked with the development of a
   postmarket monitoring ...
Strategy for Change

 Develop guidance for industry and
 FDA to provide clear guidelines for
 content, format and due date...
Least burdensome
Approach
 Least burdensome principles apply
 Acknowledged in FDA guidance
 “integrated in premarket…, as ...
Elements of Protocols for
Analytic Studies
 Study objective – reason for doing the
 study
 Define study group
 Outcomes of...
Elements of Protocols for
Analytic Studies
 Our goal is to have these elements of
 the study protocol agreed upon before
 ...
Adverse Event Reporting
 Medical Device Reporting (MDR)
   Approximate 130k reports/year
   Half are Summary Reports
   Af...
MDR Reports: 1998-2004
180000
160000
140000
120000
100000                               Individual
 80000                 ...
Medical Device Safety Network
(MedSun)
 300 hospitals and other facilities trained to
 recognize and report device related...
Postmarket Surveillance:
Section 522
 Allows CDRH to order postmarket
 surveillance studies for:
   Class ll or Class lll ...
Postmarket Surveillance:
Section 522
 CDRH poses public health question to
 industry
 Industry develops plan to address
 q...
Other Surveillance Tools

 Observational Studies – de novo or
 existing cohorts
 Medical care claims data
 Registries – re...
Future Directions

Goal: To improve our postmarket
 toolkit to allow us to make
 reasonable science-based
 decisions in ev...
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Postmarket Surveillance Medical Devices

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Author:Susan Gardner, PhD
Director, Office of Surveillance and Biometrics, CDRH
FDLI Annual Meeting 4/08/05

Published in: Business, Health & Medicine
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Transcript of "Postmarket Surveillance Medical Devices"

  1. 1. Postmarket Surveillance: Medical Devices Susan Gardner, PhD Director, Office of Surveillance and Biometrics, CDRH FDLI Annual Meeting 4/08/05
  2. 2. Office of Surveillance and Biometrics: Basic Functions Premarket review Statisticians Epidemiologists Signal detection via monitoring tools including MDR, MedSun Risk characterization (analysis) Coordination of nonregulatory response Interpretation of MDR regulation
  3. 3. Boston Scientific Expands Recall Boston Scientific Stent of Troubled Stent Recall Grows to 96K Units FDA won't expand recall of stents Drug-coated stents may face additional FDA scrutiny FDA Is Reviewing Reports of Trouble With Taxus Stent Boston Scientific's Older Stents Draw FDA Temperature Scrutiny of FDA up over Cordis FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents
  4. 4. Pre-Postmarket Balance Use premarket data to make initial decisions about safety and effectiveness and gain understanding of device benefits and risks Use postmarket data to improve our understanding of the risk benefit profile; disseminate timely safety information or take regulatory action as appropriate
  5. 5. Need for Postmarket Studies and Surveillance Limited size of premarket studies cannot detect or characterize events that occur at a low rate Need for long term follow-up (issues of durability/biocompatibility etc.) Use error Use of device in community practice or home care Concerns for selected patient groups Device/device or device/drug interactions Device failure Off label use
  6. 6. Condition of Approval Studies Immediate Postapproval Concerns Postapproval requirements can include “continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use.” 21 CFR 814.82 (a) (2).
  7. 7. Indications for CoA Studies Need to refine risk estimates or better characterize safety issues, particularly uncommon and serious Need to study specific population subgroups Need to study long term effects Need to study use of device under conditions of general use
  8. 8. CoA Quality Study: 2002-3 1998 through 2000: 127 PMAs approved with 45 CoA orders. CDRH had limited procedures for tracking progress or results Turnover of lead reviewers resulted in lack of follow-up No results received for 22% Two studies had not been started at all
  9. 9. Strategy for Change Transfer CoA tracking and follow-up to OSB Develop and institute automated tracking system Acknowledge the receipt of study reports Follow-up when reports are not received
  10. 10. Strategy for Change Add epidemiologist to PMA review team Tasked with the development of a postmarket monitoring plan Lead design of postmarket study development Lead the development of well formulated postmarket questions Lead in evaluation of study progress and results Will continue to work with PMA team
  11. 11. Strategy for Change Develop guidance for industry and FDA to provide clear guidelines for content, format and due dates Periodically report the results of CoA to Advisory Panels CDRH may post periodic status reports of CoA on Agency website
  12. 12. Least burdensome Approach Least burdensome principles apply Acknowledged in FDA guidance “integrated in premarket…, as well as postmarket…as they relate to premarket… The “way” to Least burdensome is to discuss pre/postmarket balance as early as possible in the approval process.
  13. 13. Elements of Protocols for Analytic Studies Study objective – reason for doing the study Define study group Outcomes of interest – safety issues Study design and procedures Study size Analysis plan Reporting requirements
  14. 14. Elements of Protocols for Analytic Studies Our goal is to have these elements of the study protocol agreed upon before product approval.
  15. 15. Adverse Event Reporting Medical Device Reporting (MDR) Approximate 130k reports/year Half are Summary Reports After initial triage, individual reports are monitored by analysts Look for rare, unexpected events, increase in events, seriousness of event, population affected, preventability Summary reports are monitored for change in trends Primarily manufacturer reports (90%)
  16. 16. MDR Reports: 1998-2004 180000 160000 140000 120000 100000 Individual 80000 Summary 60000 Total 40000 20000 0 1998 2000 2002 2004
  17. 17. Medical Device Safety Network (MedSun) 300 hospitals and other facilities trained to recognize and report device related adverse events; goal to reduce barriers to reporting Reports include “close calls”; emphasis on prevention Provides CDRH with connection to device users Reports and actions tend to focus on user issues, “everyday safety issues” Provides laboratory for quick surveys and other research projects
  18. 18. Postmarket Surveillance: Section 522 Allows CDRH to order postmarket surveillance studies for: Class ll or Class lll products Intended to be implanted for more than one year, or Life sustaining/life supporting and used outside user facility, or Failure would likely cause serious health consequences
  19. 19. Postmarket Surveillance: Section 522 CDRH poses public health question to industry Industry develops plan to address question Wide variety of study methods acceptable Generally limited to three year studies
  20. 20. Other Surveillance Tools Observational Studies – de novo or existing cohorts Medical care claims data Registries – real world use International vigilance Rapid Response surveys
  21. 21. Future Directions Goal: To improve our postmarket toolkit to allow us to make reasonable science-based decisions in evaluating the benefits and risks of medical devices
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