Welcome
to the inaugural
issue of The Source
We hope you will enjoy our monthly e-newsletter.
The Source has been
designed to keep you and your patients informed
regarding updates and improvements to our donor
program. Each month you will be able to immediately
access new donor profiles, repeat donor profiles
and donors by ethnicity. We will keep you up to
date with tips and information for you and your
patients. Our inaugural issue is dedicated to
you, our valued clinicians.
If you would like to receive The
Source
monthly, please click on the "subscribe"
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Source
please check the “forward to
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Gail Anderson
The Donor Source
www.thedonorsource.com
 |
New
FDA Regulations
The new FDA regulations have given
all of us in the fertility industry a lot to consider
in relation to our own compliance. The Donor Source
has been working with Wendy Latash, PhD of Jade
Tree Solutions, a consulting firm for the fertility
field that offers FDA compliance assistance, to
help us answer the question, “How do the
new FDA regulations affect us?” The answer
depends on who you are. This article is the first
of an on going series on the new FDA regulations
and how they affect different players in the fertility
field.
Interesting
times. With all the debates and
changes going on concerning embryonic stem cell
research, embryo donation/adoption and the new
FDA regulations, nobody can say that the fertility
field is boring! Now that the new FDA regulations
have gone into effect (May 25th, 2005), we have
to determine how best to incorporate these regulations
into everyday practice. Fortunately, the day before
the ruling took effect, the FDA came out with
welcome “11th hour” FDA changes of:
| •
|
Expansion
of the window of screening and testing for
oocyte donors from 7 to 30 days;
|
| •
|
For
couples who want to consider donating their
embryos AFTER their IVF cycle and have not
undergone the 30-day window screening and
testing, they now have the opportunity to
donate with less strict provisions; and
|
| •
|
An
admission that labeling the actual vials and
straws containing reproductive tissues with
the numerous required warnings is impossible,
and directions that the required labeling
can be listed on the accompanying records. |
The new FDA regulations affecting
the fertility field are a part of the ruling that
regulates organ and tissue donor banks. The purpose
of these FDA regulations is to help prevent the
spread of infectious disease through tissue donation.
The concern over tissue safety has finally resulted
in the FDA publishing the ruling “Title
21 CFR Part 1271: Human Cells, Tissues, and Cellular
& Tissue-Based Products.” This ruling
has been added to others that went into effect
over the past 12 years as an approach to regulate
human tissue to try to ensure safety. Reproductive
tissue came into the limelight over concern about
the safety of donated semen in the early 1990s.
Now all reproductive tissue—eggs, sperm,
embryos, ovarian and testicular tissue—are
subject to a portion of the Human Cell, Tissues,
and Cellular & Tissue-Based Products
(or HCT/Ps) ruling.
To
enforce these new rulings, the FDA states that
they can visit fertility practices announced
or unannounced to inspect whether
the practice is adhering to its rulings. They
have also established the legal authority to enforce
these regulations with consequences such as:
| •
|
Imprisonment
for up to 1 year; and/or
|
| •
|
Fines
of $100,000 if a death has not occurred or
up to $250,000 if a death has resulted—per
violation. |
After
all is said and done, this ruling comes down to
four things: documentation of
policies and procedures, following
policies and procedures, reviewing
procedures on a regular basis, and taking corrective
action when problems are found.
Tune in to our next
issue for...
A Breakdown of the FDA ruling
Wendy D. Latash,
Ph.D.
Jade Tree Solutions, LLC
www.jadetreesolutions.com
 Our
best advice on
choosing a donor?
Our advice to intended parents… go with
your heart. Most intended parents have in mind
the qualities and characteristics they value most
in a donor. They often are trying to find someone
who looks just like the intended mother.
We encourage them to keep an open mind and to
look for someone they really like, not a twin,
but someone they are drawn to, who they feel they
can relate to and who will fit into their family.
We have found that most couples are happiest with
their donor when they feel a connection to her.
Gail Anderson
The Donor Source
www.thedonorsource.com
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