"From Machon Puah"

Preventing Mistakes

Last week we discussed a case that made worldwide headlines last month. An American non-Jewish couple, John and Carolyn Savage had learned that the baby Carolyn was carrying was not her genetic baby. A human error in the lab led to her being impregnated with another couple’s embryo.
Although it is impossible to totally remove human error from IVF or any fertility treatment, there are procedures and systems that can reduce the risk to levels near zero. In fact, these systems have been in place for over a decade and have saved dozens of families from dilemmas such as that of the Savages.
In Jerusalem in the early 1990s, religious Jewish couples seeking to undergo the relatively new process of IVF were turning to their Rabbis for advice on the permissibility of these procedures in halacha. Issues such as allowing surrogacy and identifying parentage in such cases became major concerns without precedent upon which to base their rulings.
At the time, precisely because of concern over potential errors similar to the one that happened to the Savages, most Rabbinic authorities forbade any fertility treatment that required processing of genetic materials outside the body. Without a process to verify the veracity of the labs, the risk of error was deemed excessive. As we can see, that reasoning is clearly justified by the fact that in 2009, with all of our modern technologies, mistakes are still being made.
Additionally, halacha requires clear verification of lineage to determine things such as inheritance or issues regarding yibum, etc. The advent of IVF and other fertility technologies required some form of certification of the identity of each child born as a result of these treatments. According to halacha, anyone who has a potential conflict of interest (such as the embryologist) in these cases is ineligible to provide such certification. As such, there was a need for some system that would, in a manner consistent with halacha, provide independent certification.
Rabbi Mordechai Eliyahu, the Chief Rabbi of Israel at the time, assigned Rabbi Menachem Burstein, one of his students, to study the technology behind IVF and fertility treatments and reconcile any issues regarding halacha. In 1991, Rabbi Burstein founded the PUAH Institute in Jerusalem, named after one of the Jewish midwives in galut Mitzrayim. PUAH Institute was to serve as a center for study of fertility and halacha as well as the counseling of couples with fertility issues.
Seeking to provide a means for religiously acceptable certification, Rabbi Burstein devised a method of independent supervision of all fertility processes, expanding upon the existing practices being used in the certification of Kosher food. The process requires constant and direct monitoring of the processing of the genetic materials by an independent third party, from the time the materials are taken from the body until the time they are reintroduced to the womb.
The introduction of an independent observer serves a vital purpose. Although embryologists are clearly professional and careful in their approach, when we consider the fact that they each perform hundreds and thousands of these procedures each year, human error is unavoidable. The independent observer provides an additional pair of eyes whose sole focus is maintaining the integrity of the process and as a result, the avoidance of human error. The supervisor is not concerned with the processing of the materials, monitoring their growth or any other factor involved with the laboratory work.
PUAH Institute has documented dozens of cases in which their independent supervisor avoided a lab error. Put another way, PUAH Institute has been instrumental in preventing dozens of families from facing a crisis such as the one the Savage family has had to endure. Regardless of the checks and balances that currently exist, there is a clear need for PUAH style certification.
Although PUAH’s efforts focus primarily on the Jewish market worldwide (with 100+ supervisors based out of Jerusalem, New York, Los Angeles and Paris), our methods and system are based on a practical approach to the verification of the identity of all genetic materials. PUAH methods, designed to provide active certification for religious purposes should be the model which is adapted for more universal use.
This case has been a wake up call for the fertility community. Without a universal standard for verification, one that involves independent monitoring of some form at each step, human error will still creep into the equation. Any parent whose child was born in a modern hospital within the last 15 years will vouch for the fact that there are multiple layers of checking and double checking that each couple leaves with their own baby. Fertility professionals need to hold themselves to the same standard.
With an efficient network in place, the additional labor costs of having a human being operating the monitoring system should only be dollars per procedure. The peace of mind provided to the couples involved is priceless.
Next week - If they had been Jewish, what is the Halachic view?

• Other "From Machon Puah"
• Medication on Pesach
• Sometimes, Miracles DO Happen
• OCD and the Halacha