OCD FY2004 Part 5. Protecting the Homeland - Counter Terrorism - CDRH Strategic Goal: Public Health Impact
Detection of a Biothreat Pathogen with First Anthrax Quick Elisa Test
In June 2004, CDRH cleared the first Anthrax Quick Elisa test. The test, manufactured by Immunetics Inc. of Boston, detects antibodies produced by a Bacillus anthracis infection in less than one hour and is an important new diagnostic tool in the ability of U.S. laboratories to address a serious potential biothreat pathogen. Before CDRH approval, very few laboratories other than the Centers for Disease Control and Prevention and the U.S. Army had the ability to test blood for antibodies to anthrax. The new test is available for use in state and private laboratories. This clearance was the result of a collaborative interaction between CDRH, Centers for Disease Control and Prevention and a commercial partner, showing how such cooperative work can lead to approval of diagnostic tests for biothreat agents and emerging infectious diseases.
Process to Identify Shortages
CDRH developed a new, more responsive process of identifying potential device shortages and the responsibilities for managing the shortages during public health emergencies/terrorist events.
Emergency Shortages Data Collection System
CDRH developed an improved Emergency Shortages Data Collection System that allows quick identification of device manufacturers and available inventories. This is intended to facilitate identifying potential shortages in medical and in vitro diagnostic devices that may be needed by emergency healthcare personnel in the acute phase of an emergency/disaster. This data is handled as non-releasable, confidential commercial information.
Emergency Preparedness SOPs
CDRH developed standard operating procedures to sustain standardization of activities relevant to successful emergency preparedness, such as SOPs for handling and storing Top Secret and Secret documents.
Emergency Response Coordinating Workgroup
CDRH formed the Emergency Response Coordinating Workgroup (ERCW), which includes the core emergency personnel involved in initial response to a call for action in an emergency. ERCW responsibilities cover revising and updating the Emergency and Disaster Operations Procedures, writing new SOPs to update and improve response times, trouble-shooting on issues related to emergency exercises, and developing after action reports (AAR) to clarify issues after an exercise.
CDRH updated the Continuation of Operations Plans (COOP) and conducted quarterly exercises to improve readiness of all COOP and communication systems in CDRH.
Response Plans for Radiological Emergencies
CDRH participated in interagency working groups focused on developing protective action guides following Radiological Dispersal Devices and Improvised Nuclear Devices events. In FY 04, we finalized the Emergency Preparedness and Radiological Health Response plan, identified essential emergency personnel, and established a Corporate Communications Center to conduct emergency operations related to medical devices and radiological health products.