FDA Policy Statement on Urgent Collection, Shipment, and Use of Whole Blood and Blood Components Intended for Transfusion to Address Blood Supply Needs in the Current Disaster Situation

September 11, 2001

The extent of casualties from today's disasters including attacks on the New York World Trade Center and the Pentagon is still being assessed. In anticipation of a large and urgent demand for blood, FDA has been in contact with key national blood suppliers and local collectors in the New York metropolitan area to facilitate the availability of adequate blood supplies to address medical needs in this emergency.

Due to the recognized need for rapid and high volume blood collections under non-routine circumstances, FDA has developed the following guidance that should be applied to ensure the safest possible blood products.

Training and certification of emergency staff members

To provide sufficient personnel to manage donor screening, blood collection and processing, emergency healthcare workers may need to be trained. The following guidelines should be followed:

  1. The emergency staff members are trained in their tasks by the blood center's routine trainers. The relevant trainer determines adequacy of the training.
  2. The emergency staff members are trained according to established standard operating procedures (SOP).
  3. The collection procedures are performed according to established SOP.
  4. The training is documented. At a minimum, the documentation should include: emergency staff members's name, emergency staff members's contact information (e.g., telephone number), trainer's name, date of training, task(s) the emergency staff members was trained to perform. Signatures should be documented from both the trainee and the trainer.

Release and use of units that are not fully tested

CBER is aware that the blood products may be needed for emergency use before all infectious disease testing has been completed. The following procedures should be followed:

  1. If the products are released for transfusion before FDA required or recommended testing has been completed, the product must be labeled "For Emergency Use Only," (21 CFR 606.121(h)) and the label should list the tests that have not yet been completed. This applies to tests for the following markers: anti-HIV-1 and 2, HIV-1 p24 antigen, anti-HCV, anti-HTLV-I and II, HBsAg, anti-HBc and syphilis serology.
  2. If the products are released for transfusion before non-required or non-recommended testing that is normally performed has been completed, the product should be labeled with a list of the tests that are not completed. This applies to nucleic acid tests (NAT) and ALT.
  3. The tests should be completed as soon as possible and appropriate actions taken in the event of a reactive screening test result. (See, e.g., 21 CFR 606.121(h)).

Shipping unlicensed blood components in interstate commerce

  1. FDA is aware that some blood centers may seek to transport unlicensed blood products across state lines to support the emergency blood need. In this case, FDA intends to exercise its enforcement discretion provided the blood products are labeled "Unlicensed, For Emergency Use Only," and otherwise follow the procedures set forth in this guidance.

Product Identification and Recordkeeping

  1. The blood collection facility should establish a mechanism for identification of the blood products that are collected under emergency conditions.
  2. Hospital transfusion services should maintain a record of issuance of units that were labeled "For Emergency Use Only" including the fact of any donor screening tests that were not fully completed at the time of issuance.

Blood centers may call the Office of Blood Research and Review, FDA at (301) 526-4809 or (301) 233-1716 to discuss emergency procedures related to blood products, or FDA Emergency Operations at (301) 443-1240 to discuss additional concerns.

 
Updated: September 11, 2001