OCD FY2005: Preparing and Responding to Emergencies, Obtaining Information, Annual Reports, CDRH Websites
Preparing and Responding to Emergencies
CDRH made significant progress in this area. The Center routinely consulted with other government agencies on diagnostic and monitoring devices, radiological counter measures and radiation-emitting devices with potential to be used as weapons (e.g., visible lasers) and on radiation safety issues, including preventing unnecessary radiological exposure from security screening products.
CDRH formed a technical work group to address the use and rapid approval of diagnostics issues related to influenza and assisted CDC in making available to the laboratory response network CDC’s rapid diagnostic test.
Responding to Hurricane Katrina
In September 2005, as a response to the Hurricane Katrina emergency, CDRH began posting hurricane and emergency-related information in its web site, available at http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/default.htm. CDRH’s web site includes information about:
- Disposal of Contaminated Devices
- FDA Offers Advice About Reopening Dialysis Centers After Restoration of Power and Water
- Natural Disasters - Effects on Mammography Facilities
- FDA Offers Tips about Medical Devices and Hurricane Disasters
- FDA Advice for Medical Devices that Require Refrigeration
- FDA Advice About Medical Devices that Have Been Exposed to High Heat and Humidity
- FDA Health and Safety Tips After Hurricanes for Food, Drugs, Biologic Products, and Animal Health
Continuation of Operational Planning (COOP)
The Center conducted COOP activities, participated in emergency preparedness exercises, and maintained the database of medical and in vitro diagnostic devices. The database allows quick identification of device manufacturers and available inventories to facilitate identifying potential shortages in medical and in vitro diagnostic devices that may be needed by emergency health care personnel in the acute phase of an emergency or disaster.
CDRH posted information on cleared and approved devices for personal protection on its emergency information web site, http://www.fda.gov/MedicalDevices/Safety/EmergencySituations/ucm161496.htm. These devices are integral to minimizing the spread of infectious agents, including those used in bioterrorism.
CDRH Offices and its Ombudsman publish annual reports. These documents are available on the CDRH web site. A comprehensive list of available annual reports can be found at http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHReports/default.htm.
CDRH Web Sites
Internet addresses are listed in many sections of this report. CDRH encourages readers to visit these web sites and take advantage of the vast amount of information available in them.