1. 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. 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. 3 ObjectiveObjective l 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. 4 CDRH Procedures/Approach l Premarket review: 510(k), IDE, PMA l Postmarket surveillance l Scientific Research l Field Inspections l Communicate with industry, health professionals, consumers and foreign governments through letters, guidances and public meetings

5. 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. 6 Minimizing TSE Risk for Implanted Medical Devices l Premarket review Source, Manufacture, Sterilization l Guidance Human (CBER and CDRH) Animal (CDRH) General/Specific l Postmarket Surveillance l Inspections

7. 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. 8 Approaches Used to Minimize TSE Risk for Medical Devices l Premarket review l Guidance-1996 Labeling for Reuse, l Work with CDC- to develop recommendations l Research- Decontamination of medical devices exposed to TSE CBER/CDRH

9. 9 In Vitro Diagnostic Devices l Future-Tests to aid in diagnosis of a patient with variant CJD or infected and at risk for developing CJD l For further questions contact the CDRH Office of In Vitro Diagnostics: Sally Hojvat, Director of the Division of Microbiology Devices: 301-594-2096

10. 10 ConclusionsConclusions l CDRH has taken action to minimize risk of TSE transmission in medical devices in the following areas: l Premarket review: 510(k), IDE, PMA l Postmarket surveillance l Scientific Research l Field Inspections l Communicating with industry, health professionals, consumers and foreign governments through letters, guidances and public meetings

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12. 12 CDRH Guidance Documents l 1996 FDA Guidance: Labeling Reusable Medical Devices for Reprocessing In Health Care Facilities: FDA Reviewer Guidance l 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 l 2000 Guidance Document for Dura Substitute Devices;” Guidance for Industry”, http://www.fda.gov/cdrh/ode/1152.html l 2003 Class II Special Controls Guidance Document: Human Dura Mater;Guidance for Industry and FDA Staff” http://www.fda.gov/cdrh/ode/054.html