# Presentation: 135708

## 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**
*** Reduce unnecessary exposure to radiation from medical, occupational and consumer products**
**	****	**

## 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**

## 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**

## 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**

## Minimizing TSE Risk for Implanted Medical Devices

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

## Minimizing TSE Risk for Neurological-General Surgical Medical Devices  

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

## 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**

## 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**

## 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**

## Slide 11

## 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 Mater;Guidance for Industry and FDA Staff” **_**http://www.fda.gov/cdrh/ode/054.html**_** **