Guideline for collection from High risk donors (4/17/91)

Date:     April 17, 1991

From:     Director, Center for Biologics Evaluation and
           Research

Subject:  Revision to 26 October 1989 Guideline for Collection
          of Blood or Blood Products from Donors with Positive
          Tests for Infectious Disease Markers ("High Risk"
          Donors)

To:       All Registered Blood Establishments

For approximately 10 years blood establishments have applied
certain FDA recommended precautions when collecting blood or
blood components from persons known to have positive tests for
infectious disease markers. The most recent FDA recommendation
(26 October 1989) includes a statement limiting the use of an
automated collection device to one specific program; this would
require, for example, that different equipment be used for HBsAg
reactive donors and anti-HIV-1 positive donors.

Although labeling for the equipment has never included such
limitations, this very conservative approach was initially
adopted because of the lack of information about the potential
for transmitting disease from one donor to another. This
recommendation for limiting use is now being withdrawn because
over this ten year period we have been unable to find in
reviewing the literature, consulting with the Centers for Disease
Control and other experts responsible for large apheresis
programs, any instance of disease transmission attributable to
use of these devices. Nor have we learned of operational-
problems that would support the limitation. Complaint files at
the Center for Devices and Radiological Health were also
reviewed.

Even in the past, before all portions of the fluid pathway were
completely disposable, there were no reported problems that would
indicate a potential for disease transmission. These devices are  
also used clinically in many situations where the presence of
disease markers in patients is unknown and therefore, no similar
consideration is given to patients. Likewise, this same
equipment is widely used in routine Source Plasma collection and
cytapheresis, and first-time donors may also have positive tests
for disease markers. No extra precautions in lieu of dedicated
machines have been applied for either patients or first-time
donors,

The burden created by equipment restrictions has also escalated
over time because the number of special programs has increased
from the HBsAg program in 1981 to ten or more programs currently,
as well as having a potential impact on autologous donor
programs.

Therefore, effective immediately, the "Manner of Collection"
paragraph on page 2 of the 26 October 1989 memorandum is amended
by deletion of the phrase "...if these devices are dedicated to
use only for the one specific program..." Please note that all
other precautions outlined in the 26 October 1989 memorandum,
including immediate clean-up and disinfection of any spill and
disinfection of equipment between donors should remain in place.

Licensed establishments may implement this change concurrently
with submission of notification that the less stringent procedure
will be implemented.

Questions may be addressed to the Laboratory of Blood Bank
Practices, 301-443-8483.


                             Gerald V. Quinnan, Jr., M.D.