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CDRH: Minimizing Risk of TSE Agents in Medical Devices

CDRH: Minimizing Risk of TSE Agents in Medical Devices . CDR Martha O’Lone, RN, BSN CDRH TSE Working Group Chair Infection Control Devices Branch DAGID / ODE / FDA. Center for Devices and Radiological Health. * Ensure medical device safety and effectiveness

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CDRH: Minimizing Risk of TSE Agents in Medical Devices

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  1. CDRH: Minimizing Risk of TSE Agents in Medical Devices CDR Martha O’Lone, RN, BSN CDRH TSE Working Group Chair Infection Control Devices Branch DAGID / ODE / FDA

  2. Center for Devices and Radiological Health * Ensure medical device safety and effectiveness * Reduce unnecessary exposure to radiation from medical, occupational and consumer products

  3. 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

  4. 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

  5. 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

  6. Minimizing TSE Risk for Implanted Medical Devices • Premarket review Source, Manufacture, Sterilization • Guidance • Human (CBER and CDRH) • Animal (CDRH) General/Specific • Postmarket Surveillance • Inspections

  7. Minimizing TSE Risk for Neurological-General Surgical Medical Devices Examples: Neurological medical devices (cranial drill bits) General Surgical instruments (scalpels, scissors, biopsy forceps, retractors)

  8. 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

  9. 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

  10. 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

  11. 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 Mater;Guidance for Industry and FDA Staff” http://www.fda.gov/cdrh/ode/054.html CDRH Guidance Documents

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