DEPARTMENT OF HEALTH&. HUMAN SERVICES  Public Health Service 
Food and Drug Administration 
1401 Rockville Pike 
Rockville  MD 20852-1448 
Date:  December  4,  1995 
From:  Director,  Center  for  Biologics  Evaluation  and  Research 
Subject:  Donor  Deferral  Due  to Red  Blood  Cell  Loss  During  Collection 
of  Source  Plasma  by Automated  Plasmapheresis 
To:  All  Registered Blood  and  Source  Plasma  Establishments 
INTRODUCTION 
This  memorandum  addresses  the  temporary deferral  of  Source  Plasma 
donors  who  have  lost  red blood  cells due  to  technical  difficulties 
during  an  automated plasmapheresis  procedure.  Any  person who  has 
donated  one  unit  or more  of whole  blood  (450  mL)  or who  has  lost  the 
equivalent  amount  of  red blood cells  should not  serve  as  a  donor  of 
Source  Plasma  for  eight  weeks  [21  CFR  640.63(e)].  The  issue  of  red 
blood  cell  loss  during  automated  plasmapheresis  was  presented by  the 
Food  and  Drug  Administration  (FDA)  to  the  Blood  Products  Advisory 
Committee  in a  public  meeting  on  June  21,  1994.  The  majority of  the 
Committee  members  agreed  that  the  volume,  as  stated below,  of  red 
blood  cell  loss  during  automated  plasmapheresis  procedures  for  the 
collection of  Source  Plasma  would  not  compromise  donor  safety. 
POLICY 
FDA  provides  the  following  guidance  on  deferral  of  donors  who  have 
lost  red blood  cells during  automated  plasmapheresis  for  the 
collection of  Source  Plasma  and  believes  that  safeguards  to protect 
Source  Plasma  donors  will  not  be  compromised  by  this guidance. 
Prior  to  the  collection of  Source  Plasma  from  each  donor,  records 
should  be  reviewed  to determine  if any  red  cell  loss  has  occurred 
during  the  past  eight  weeks. 
1.  If  a  red blood  cell  loss  occurred during  an  automated 
plasmapheresis  procedure,  the  volume  of  loss  recorded  should 
be  the  total  extracorporeal  red blood  cell volume  calculated 
as  described by  the  manufacturer  of  the  apheresis  equipment. 
No  attempt  should be  made  to open  the  system  in order  to 
measure  the  red blood  cell  loss,  because  to do  so  would  lead 
to  an  unnecessary exposure  to biohazardous  agents.  2.  If a  donor  loses  more  than  200  mL  of  red blood  cells  during 
a  plasmapheresis  procedure,  as  calculated above,  the  donor 
should be  deferred  for  eight  weeks.  However,  it would  not  be 
necessary to defer a  donor  for  any  single  incident  as  long 
as  the  red blood  cell  loss  does  not  exceed  200  mL. 
3.  During  the  eight  week  period  following  the  first  observable 
red blood  cell  loss  of  less  than  200  mL,  a  second  observable 
red blood  cell  loss  (exceeding  any  residual  red blood  cells 
remaining  in the  tubing)  should  result  in  an  eight  week 
deferral  from  the  date  of  the  most  recent  red blood  cell 
loss. 
The  recommendations  in this memorandum  may  be  implemented  immediately 
without  prior approval  from  FDA.  Licensed  Source  Plasma  establishments 
should  submit  by  official  correspondence  a  statement  to  their product 
license  file  indicating  the  date  that  the  revised standard operating 
procedures  (SOPs)  consistent  with  these  recommendations  have  been 
established and  implemented.  Receipt  of  this  statement  will  be 
acknowledged.  It  is not  necessary to  submit  revised  SOPs  to  CBER  for 
review  and  approval.  If an  establishment  believes  that  an  alternative 
approach would  provide  equivalent  protection,  the  establishment  is 
invited to discuss  the  approach with  FDA  for  FDA's  evaluation. 
Please  refer technical  questions  to the  Division of  Blood 
Applications,  Office  of  Blood  Research  and  Review,  Center  for 
Biologics  Evaluation  and  Research,  FDA,  HFM-375,  1401  Rockville  Pike, 
Rockville,  MD  20852-1448,  301-594-6487  or F  301-594-6431. 
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