CDRH: Minimizing Risk of TSE Agents in Medical Devices

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CDRH Minimizing Risk of TSE Agents in Medical
Devices

• CDR Martha OLone, RN, BSN
• CDRH TSE Working Group Chair
• Infection Control Devices Branch
• DAGID / ODE / FDA

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Center for Devices and Radiological Health

• Ensure medical device safety and
  effectiveness
• Reduce unnecessary exposure to radiation from
  medical, occupational and consumer products

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Objective

• Overview of CDRH Measures to Minimize Risk of TSE
  Agents in Medical Devices
• Implanted Medical Devices
• Neurological Devices/General Surgical Instruments
  
• In Vitro Diagnostic Devices

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CDRH Procedures/Approach

• Premarket review 510(k), IDE, PMA
• Postmarket surveillance
• Scientific Research
• Field Inspections
• Communicate with industry, health professionals,
  consumers and foreign governments through
  letters, guidances and public meetings

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Implanted Medical Devices

• Implants devices with human/bovine tissue
• Human- cellular wound dressings, human dura
  mater, bone void fillers, human collagen
• Animal- absorbable hemostatic agents, dura
  substitutes, pericardial valves, collagen implants

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Minimizing TSE Risk for Implanted Medical Devices

• Premarket review
• Source, Manufacture, Sterilization
• Guidance
• Human (CBER and CDRH)
• Animal (CDRH) General/Specific
• Postmarket Surveillance
• Inspections

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Minimizing TSE Risk for Neurological-General
Surgical Medical Devices

• Examples
• Neurological medical devices (cranial drill bits)
• General Surgical instruments (scalpels, scissors,
  biopsy forceps, retractors)

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Approaches Used to Minimize TSE Risk for Medical
Devices

• Premarket review
• Guidance-1996 Labeling for Reuse,
• Work with CDC- to develop recommendations
• Research- Decontamination of medical devices
  exposed to TSE CBER/CDRH

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In Vitro Diagnostic Devices

• Future-Tests to aid in diagnosis of a patient
  with variant CJD or infected and at risk for
  developing CJD
• For further questions contact the CDRH Office of
  In Vitro Diagnostics
• Sally Hojvat, Director of the Division of
  Microbiology Devices 301-594-2096

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Conclusions

• CDRH has taken action to minimize risk of TSE
  transmission in medical devices in the following
  areas
• Premarket review 510(k), IDE, PMA
• Postmarket surveillance
• Scientific Research
• Field Inspections
• Communicating with industry, health
  professionals, consumers and foreign governments
  through letters, guidances and public meetings

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CDRH Guidance Documents

• 1996 FDA Guidance Labeling Reusable Medical
  Devices for Reprocessing In Health Care
  Facilities FDA Reviewer Guidance
• 1998 Guidance for Industry- Medical Devices
  Containing Materials Derived from Animal Sources
  (Except for In Vitro Diagnostic Devices)
  http//www.fda.gov/cdrh/ode/88.html
• 2000 Guidance Document for Dura Substitute
  Devices Guidance for Industry,
  http//www.fda.gov/cdrh/ode/1152.html
• 2003 Class II Special Controls Guidance Document
  Human Dura MaterGuidance for Industry and FDA
  Staff http//www.fda.gov/cdrh/ode/054.html