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1993.07.01 :  Safety of Blood Supply

Contact:  Monica Revelle (301) 443-4177; 
          Anne Verano (202) 690-6145
July 1, 1993

       The Food and Drug Administration today issued Proposals to
  enhance the safety of the blood supply by significantly
  strengthening the standards  under which blood products are
  manufactured.
       "These proposals are designed to strengthen our efforts to
  protect the nation blood supply and to minimize any risk to
  patients who need this life-saving gift," said HHS Secretary
  Donna E. Shalala.
       FDA proposed a guideline for U.S. blood centers that places
  the emphasis on preventing problems rather than on detecting them
  after the fact.  The guideline calls on manufacturers of blood
  and blood components to develop well-planned, written and managed
  quality assurance programs.   These programs include employee
  training and competency evaluations, equipment validation and
  laboratory testing procedures as well as self-policing audits. 
  These programs are designed to prevent accidents and errors that
  can result in the release of blood products that pose a risk for
  the transmission of infectious diseases.
       "FDA is committed to holding all blood centers to the
  highest standards," said FDA Commissioner David A. Kessler, M.D.
  "When it comes to these vital products, our standards can never
  be too high."
        Through its intensified oversight of blood centers in 
recent years, FDA has identified deficiencies related to blood
centers, quality control procedures and practices.  Based on these
findings, FDA's proposed guideline would help blood centers develop
effective quality assurance programs.
     These quality assurance programs are intended to recognize and
prevent recurrent problems in a blood center's performance by
eliminating causes of errors, ensuring the integrity of test
results, implementing affective controls for manufacturing
processes and record-keeping systems, and ensuring the adequacy of
employee training.
     In addition, FDA is proposing to make consistent and uniform
the "look back" policy now being followed by blood centers.  Blood
centers are required to retrieve and a reactive units from prior
collections whenever a repeat donor has a reactive screening test
for HIV.  Blood centers are then required to perform additional,
more specific tests on the donor's blood.  Based on the results of
the additional tests, blood centers are required to eliminate those
previously donated units of blood from use in transfusions,
     Under FDA's proposed rule and a companion rule from the Health
Care Financing AdMinistration, blood centers would also provide
donor test results to hospitals to ensure that a patient who had
received units from prior donations could be notified if the same
donor should later test positive for the antibody to HIV.
      "The regulation we are proposing provides an extra measure 
of protection for the public and demonstrates our commitment to a
safe blood supply," said HCFA Administrator Bruce C. Vladeck.
     Written comments on FDA's proposals should be sent, within 60
days, to the Dockets Management Branch (HFA-205), Food and Drug
Administration, Room 1-23, 12420 Parklawn Drive, Rockville, Md.
20857.  Comments on HCFA's proposal may be submitted, also within
60 days, to the Health Care Financing Administration, Attn. BPD--
633-P, P.O. Box 26688, Baltimore, Md. 21207.
     FDA is one of the eight Public Health service agencies in HHS. 
HCFA, also an HHS agency, directs that Medicare and Medicaid
programs which help pay the medical bills of 67 million Americans.