Donor Deferral Due to Red Blood Cell Loss During Collection of Source Plasma by Automated Plasmapheresis

Administrative guidance, not enacted legislation. This captured publisher edition preserves the listed document and attachments; later developments are not independently consolidated.

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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