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a blog by David Kreiner, M.D., F.A.C.O.G.
Father Thomas Berg, Executive Director of the Westchester Institute for Ethics and the Human Person, said the recent case of a woman implanted with an embryo from another couple was the sort of "tragic mistake” that can happen” in "the unregulated world of IVF." I agree that mixing up gametes and embryos is tragic and society must do everything humanly possible to prevent such a mix up except disallow the practice of IVF. As with other societal advances, accidents have rarely and unfortunately happened in the field of IVF but, weighed against the benefit of all the babies who otherwise would never have been born, we should improve the safety of IVF, not eliminate it.
Many of the greatest advances have had tragic results, ones that are unintended accidents that should have been avoided. Usually, they are the result of lapses in the most carefully designed safeguards of checks and balances.
Significant risk, including that of injury or death, is part of nearly everything we do in life today. The construction industry has always been plagued with accidental deaths. Not a bridge or a great high rise has been completed without misfortune. Do we stop construction? No, we ensure that all possible regulations that could protect those involved are in place and followed as strictly as possible to prevent further accidents.
In the Finance industry, society has recently suffered from scams, the worst being the Madoff ponzi scheme. Charities are facing potential ruin with significant direct financial and emotional impact on thousands of lives. Rules and regulations have been reviewed since and policies are currently changing to avoid such disasters from recurring.
Nuclear power is controversial because of the fear of accidents. Despite past accidents at Chernobyl and Three Mile Island, nuclear power plants continue to be constructed throughout the world because it is perceived that the possible benefits of this alternate source of energy outweighs the concerns for the risks.
People are electrocuted by power lines several times a year. Yet we do not consider living without electricity. We search for ways to make it safer to live without causing an accident.
Fast food leads to obesity and increased risks of developing heart disease. Yet we offer it in stores and restaurants because it’s a convenience many people are willing to accept, despite the obvious danger to their health.
Cardiac bypass surgery and other surgeries saves lives but, occasionally, patients intended to benefit are hurt or even killed accidentally. Rules and regulations are instituted to avoid problems such as performing the wrong operation on the wrong patient, using the wrong medication, operating on the wrong limb. Yet situations occur, usually because of a human slip. Rules are broken and mistakes result.
Just as we have safeguards in the operating room, we have them in place for identifying gametes and embryos with checks and balances that should prevent a mix up such as this one case in the news recently.
In the operating room, patients are identified while they are awake by the embryologist, nurse, physician and anesthesiologist by full name and birth date. As soon as the ovaries are aspirated, the eggs are identified and put in dishes with the patient’s full name and birth date on them. When the dishes are changed to replace the media, again matching names are put on the new dishes with a unique case number. A partner’s sperm specimen is labeled by him and processed in tubes labeled to match the partner’s name and the corresponding patient’s name and the case number. This is doubly checked with the patient’s record which will also reflect the unique case number. It is reviewed by two embryologists for accuracy prior to fertilization. Finally, when the embryo is loaded in a catheter for transfer, the identity of the dish from the embryo is checked by the physician, embryologist, nurse and the patient herself prior to the transfer being performed.
Every attempt is made to confirm the identity of the gametes and embryos throughout the IVF process prior to transfer. In 24 years of practicing IVF, my program has not mixed up gametes or embryos.
There are approximately 1 million babies born through IVF and only a few rare mix ups reported.
Perhaps we don’t hear about every mix ups? I’d estimate that between 1/50,000 and 1/100,000 pregnancies from IVF have occurred with some mix up in the embryo or gamete. When it occurs, it is tragic and requires the attention of our field and a refocus on those checks and balances we have in place to prevent such mishaps.
I work hard and I pray that we do everything possible so that this never happens again. The FDA regulates gamete donation. The New York State Department of Health regulates our labs and our operating rooms. These checks and balances are in place and are included in the monitoring performed by these agencies.
Perhaps, if the other states required as strict a monitoring to ensure their clinics and doctors are adhering to the necessary safeguards as well then the mix ups would not occur?
Dr. David Kreiner is the Director of East Coast Fertility, a multi-office practice on Long Island, New York. You can learn more about Dr. Kreiner and his practice here.