FDA COMMENTS ON EMERGENCY SHORTAGES SYSTEM

The FDA has released a submission for the Office of Management and Budget Review on the Emergency Shortages Data Collection System, formerly known as the Emergency Medical Device Shortage Program Survey.

The agency said that subsequent to the Sept. 11, 2001 attacks, its Center for Devices and Radiological Health began planning for medical device shortage issues associated with counterterrorism strategies. The CDRH had planned to establish a data collection system as a supplemental source for available products. As a result of Sept. 11, however, local and state governments have obtained stockpiles of backup supplies to cover an emergency for the first 12 hours following a terrorist attack. The second 12 hours will have additional devices supplied by the Centers for Disease Control's Strategic National Stockpile and the National Acquisition Center.

If additional supplies are needed in the first 12 hours, HHS will request that the FDA provide the number of devices readily available to meet demands. HHS has an established transportation and delivery plan in place to provide these needs to the authorities.

The data collection system will only be comprised of those devices that are expected to be in demand and in short supply in an emergency. The collection system will include life saving and life-sustaining products as well products that would require frequent changes resulting in rapidly depleted supplies such as face masks and gloves. The new system will be updated every four months to keep information current and because manufacturers have a high turnover rate, the FDA said.

The Emergency Medical Device Shortage Survey was established in 1992 to collect data to assist the FDA in implementing an emergency device shortage program. In 2004, FDA changed the process for the data collection and the name was subsequently changed.