Volume Limits - Automated Collection of Source Plasma (11/4/92)
 
Date:	  4 November 1992
 
From:	  Director, Center for Biologics Evaluation and
 
Research
 
Subject:	  Volume Limits for Automated Collection of Source
 
Plasma
 
To:	  All Registered Blood Establishments
 
The increased number of automated plasma collection devices with
 
varying capacities for tailoring each collection to the specific
 
donor has resulted in the existence of multiple Food and Drug
 
Administration (FDA) approved nomograms which specify, for each
 
piece of equipment, the maximum volume of plasma to be harvested
 
from each donor category.  Current considerations in determining
 
the volume of plasma to be collected include gender, height,
 
weight, hematocrit, and in some centers, the length of time in
 
process or the number of cycles.  Because multiple equipment
 
types commonly coexist in a location, the potential for error 

due to application of an inappropriate nomogram is significantly
 
increased.  The use of various anticoagulant solutions, differing
 
concentrations of the anticoagulant, and a range of anticoagulant
 
to plasma ratios, additionally complicates some schema and
 
creates additional opportunity for error.
 
The experience to date with all of the approved equipment
 
indicates that there is no discernible impact on donor safety or
 
product quality with the use of any of the current limits in
 
preference to any other.  Some Source Plasma manufacturers have
 
requested and received approval for simplified nomograms.  The
 
FDA supports this type of process change which potentially
 
improves the consistency of procedures for manufacturing and
 
minimizes the opportunity for staff error.
 
To promote rapid implementation of such simplified schema, the
 
Center for Biologics Evaluation and Research is informing all
 
manufacturers that the following limits may be adopted without
 
further notice.  The anticoagulant volume is included in the
 
third column below.  This volume is based on a 1:16 (0.06) ratio
 
of anticoagulant to anticoagulated-blood. 

Donor Weight       Plasma Volume or Weight      Collection Volume

 10-149 lbs            625 mL (640 g)            690 mL (705 g)

 150-174 lbs           750 mL (770 g)            825 mL (845 g) 

175 lbs & up          800 mL (820 g)            880 mL (900 g)
  It has been determined that the use of this simplified nomogram
 
does not constitute a significant change in manufacturing and,
 
therefore, does not require advance approval of amendments to
 
licenses.  However, it should be noted that the nomogram is
 
intended to be adopted as a complete set of limits.  The
 
simplified nomogram and the equipment manufacturer's nomogram
 
should not be used simultaneously in the same center. Portions of
 
the table should not be selectively applied in combination with
 
some other system of limits.  Variations will require advance
 
approval of license amendments based on supporting documentation
 
including evidence that the chance of error is not increased.
 
To monitor potential adverse reactions and ensure that no
 
increased frequency of reactions is observed with this change in
 
the volume of plasma collected, it is requested that any
 
reactions observed for the first 1,000 procedures done under your
 
license be reported to the FDA.  If plasma from 1,000 donors has
 
not been collected during the first three months after
 
implementation of the new nomogram, please provide an interim
 
report of any reactions occurring during the first three months. 

For your convenience we have provided a format for reporting of
 
the desired information on adverse reactions. 

Kathryn C. Zoon, Ph.D.

 _____________________________________________________
 
Addendum to FDA Memorandum
 
Suggested Format for
 
Experience Report On Plasma Collection Adverse Events
 
Automated device used for collection:
 
Anticoagulant used:
 
Anticoagulant to anticoagulated-whole blood ratio used during
 
this collection procedure:
 
Weight of donor:
 
Height of donor:
 
Donor number and gender of donor:
 
Hematocrit prior to collection:
 
Total protein prior to collection:
 
Amount of plasma collected when reaction occurred:
 
Amount of anticoagulant used before reaction occurred:
  Amount of saline administered before reaction (if any):
 
Type of reaction and severity (mild, moderate, severe, life-

threatening):
 
Signs/symptoms of reaction:
 
Blood pressure at time of reaction:
 
Was physician notified?:
 
Treatment of donor:
 
Any operator error detected?
 
If yes, please provide additional details in accordance with FDA
 
memorandum, March 20, 1991:  Responsibilities of Blood
 
Establishments Related to Errors & Accidents in the Manufacture
 
of Blood and Blood Components.
 
Other comments:
 
Submit to: Dr. Kathryn C. Zoon, Director

 Center for Biologics Evaluation and Research

 8800 Rockville Pike HFB-940

 Bethesda, MD 20892