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Medical Device Safety Medical Device Safety

Susan Gardner, Ph.D.Susan Gardner, Ph.D.

Director, Office of Surveillance and BiometricsDirector, Office of Surveillance and Biometrics

Center for Devices and Radiological HealthCenter for Devices and Radiological Health

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AgendaAgenda

• Overview of the CDRH Postmarket Overview of the CDRH Postmarket Transformation EffortTransformation Effort

• Status of targeted postmarket Status of targeted postmarket initiativesinitiatives

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Postmarket Postmarket TransformationTransformation

44

REPORTS RECEIVED - FY 2000 - 2006

0

50,000

100,000

150,000

200,000

250,000

2000 2001 2002 2003 2004 2005 2006

Fiscal Year

Nu

mb

er

of

Rep

ort

s

Other Malfunction Injury Death

Adverse event reports are increasing…Adverse event reports are increasing…

55

Recalls remain a source of concern…Recalls remain a source of concern…

20

336

486 495

546

480

608638

571

630

2523714829

45

0

100

200

300

400

500

600

FY 98 FY 99 FY 00 FY 01 FY 02 FY 03 FY 04 FY 05 FY 06

Class 1 Recalls

Total Recalls

FY 06 as of 7-31-06

66

FDA and the medical device industry FDA and the medical device industry are under scrutiny…are under scrutiny…

F.D.A. Puts Restrictions On Guidant

Medical Devices Are Hot, Which Is Why Guidant Is

Recall of Hemodialysis Device Points to Kink in Blood Tubes

FDA To Improve Guidelines for Medical Devices

FDA Issues Alert for Abbott Glucose Meters Check the Meters' Setting, Says FDA and Abbott Diabetes Care

77

Institute of Medicine Report: Institute of Medicine Report: Save Save Medical Devices for ChildrenMedical Devices for Children

- Monitoring postmarket study commitments- Monitoring postmarket study commitments

- Public access to information about - Public access to information about postmarket studiespostmarket studies

- Adverse event reporting- Adverse event reporting

- Organizational attention to pediatric issues- Organizational attention to pediatric issues

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CDRH Post-market Safety CDRH Post-market Safety FrameworkFramework

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: CDRH Postmarket Reports: Transformation Groundwork Transformation Groundwork

• Ensuring the Safety of Medical Ensuring the Safety of Medical DevicesDevices : : inventory and assessment of inventory and assessment of our current postmarket toolsour current postmarket tools

• Strengthening FDA’s Postmarket Strengthening FDA’s Postmarket Program for Medical Devices:Program for Medical Devices: recommendations for improvementsrecommendations for improvements

1100

1. 1. Develop a Culture of CollaborationDevelop a Culture of Collaboration

• Place more emphasis on collaboration in Place more emphasis on collaboration in identifying, analyzing and solving postmarket identifying, analyzing and solving postmarket problems, both within the Center and with problems, both within the Center and with outside constituenciesoutside constituencies

•

• Create at culture of collaboration within CDRH: Create at culture of collaboration within CDRH: formalize horizontal communication …..”connect formalize horizontal communication …..”connect the dots”the dots”

1111

2. 2. Develop World Class Data Sources and Develop World Class Data Sources and SystemsSystems

• Improve data systems, enhance data quality, Improve data systems, enhance data quality, improve data analysisimprove data analysis

What we will doWhat we will do

• Champion unique device identificationChampion unique device identification

• Implement an electronic reporting systemImplement an electronic reporting system

• Evaluate MDR program to optimize Evaluate MDR program to optimize

• Optimize our surveillance program with a balance of Optimize our surveillance program with a balance of passive and active reporting, and access to external passive and active reporting, and access to external data sourcesdata sources

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3. 3. Enhance Risk/Benefit CommunicationEnhance Risk/Benefit Communication

• Maximize our ability to communicate Maximize our ability to communicate information clearly and quickly to information clearly and quickly to practitioners, patients and consumerspractitioners, patients and consumers

What we will doWhat we will do• Develop and implement a risk Develop and implement a risk

communication strategycommunication strategy

• Partner with outside professional groupsPartner with outside professional groups

• Create easier access to Center Create easier access to Center informationinformation

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4. 4. Improve Enforcement Strategies for Improve Enforcement Strategies for Postmarket IssuesPostmarket Issues

• Improve the coordination, consistency, quality and Improve the coordination, consistency, quality and timeliness of inspections, reporting and timeliness of inspections, reporting and enforcement actionsenforcement actions

What we will doWhat we will do

• Improve interactions and collaboration between Improve interactions and collaboration between ORA and CDRHORA and CDRH

• Assess the effectiveness of current enforcement Assess the effectiveness of current enforcement strategies and revise accordinglystrategies and revise accordingly

• Update data systems; use metrics to monitor and Update data systems; use metrics to monitor and improve performanceimprove performance

• Integrate postmarket information in CDRH to Integrate postmarket information in CDRH to improve signal detection and decision making improve signal detection and decision making

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Medical Device Reporting (MDR)Medical Device Reporting (MDR)Basic FactsBasic Facts

• 200,000 reports per year200,000 reports per year

• Database: over 1.25 millionDatabase: over 1.25 million

• Individual reports: redacted for WebIndividual reports: redacted for Web

• Over half the reports are SummaryOver half the reports are Summary

• Over 90% are from industry (mandatory)Over 90% are from industry (mandatory)

• 3% are voluntary (MedWatch)3% are voluntary (MedWatch)

• 2% user facilities2% user facilities

• > 1% international> 1% international

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Value of MDRValue of MDR

• Detection of rare, unexpected eventsDetection of rare, unexpected events

• Following high profile devicesFollowing high profile devices

• Signals for emerging issuesSignals for emerging issues

• Trends for familiar, mature products Trends for familiar, mature products (summary)(summary)

• Adjunct analysis for investigationsAdjunct analysis for investigations

• Available for public useAvailable for public use

• High value of voluntary reports (MedWatch)High value of voluntary reports (MedWatch)

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Challenges of MDRChallenges of MDR

• Passive reporting system – depends on Passive reporting system – depends on recognition of a problem - no validationrecognition of a problem - no validation

• Poor reporting; not timely; not completePoor reporting; not timely; not complete

• Lack of context for incidentLack of context for incident

• Inadequate analysis of eventInadequate analysis of event

• More quantity than qualityMore quantity than quality

1177

Medical Product Safety Network: MedSunMedical Product Safety Network: MedSun

• Network of 350 health care facilitiesNetwork of 350 health care facilities

• Specifically trained to report device related Specifically trained to report device related adverse eventsadverse events

• Barriers to reporting reduced through education, Barriers to reporting reduced through education, extensive feedback of safety informationextensive feedback of safety information

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How MedSun Enhances How MedSun Enhances Surveillance:Surveillance:

Direct Access to Device UsersDirect Access to Device Users

• Better reports: real-time contact with Better reports: real-time contact with reporterreporter

• Emphasis on use errorEmphasis on use error

• Emphasis is on prevention: close callsEmphasis is on prevention: close calls

• Laboratory for research ( rapid Laboratory for research ( rapid response/evaluation surveys)response/evaluation surveys)

• Targeted surveillance: LabNet, HeartNet, Targeted surveillance: LabNet, HeartNet, KidNetKidNet

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Post- approval StudiesPost- approval Studies

• Condition of Approval Postmarket StudiesCondition of Approval Postmarket Studies

– Automated tracking system for all PASAutomated tracking system for all PAS

– Involvement of epidemiologists for study Involvement of epidemiologists for study designdesign

– Guidance documentGuidance document

– Website for status of studiesWebsite for status of studies

– Feedback to Advisory PanelsFeedback to Advisory Panels

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Section 522 StudiesSection 522 Studies

• Discretionary postmarket studies for Class ll Discretionary postmarket studies for Class ll and Class ll productsand Class ll products

• - Intended to be implanted for more than - Intended to be implanted for more than one year,orone year,or

• - Life sustaining/life supporting and use - Life sustaining/life supporting and use outside user facility ,oroutside user facility ,or

• - Failure would likely cause serious health - Failure would likely cause serious health consequencesconsequences

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Improve and Expand Data sourcesImprove and Expand Data sources

• Increase use of registries for Increase use of registries for postmarket surveillance and postmarket surveillance and postmarket studiespostmarket studies

• Support applied epi programSupport applied epi program

• Collaborations with other agenciesCollaborations with other agencies

• Increase collaborations with Increase collaborations with professional organizations (HRS)professional organizations (HRS)

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Unique Device Identifiers Unique Device Identifiers

• Federal Register notice for comment in August Federal Register notice for comment in August 20062006

• Public meeting in October 2006Public meeting in October 2006

• Standardized ID would facilitate tracking for Standardized ID would facilitate tracking for recallsrecalls

• Increase ability to identify products associated Increase ability to identify products associated with AEwith AE

• Assist hospitals in tracking and managing devicesAssist hospitals in tracking and managing devices

• Enhance value of electronic health records – allow Enhance value of electronic health records – allow improved surveillanceimproved surveillance

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Also coming…..Also coming…..

• eMDReMDR

• New device coding systemNew device coding system

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