Practicing medicine for the past 30 years, I have developed an enormous respect for those things that happen to people that are beyond our control. Sometimes, the issue of preventability is a gray one and defies definitive blame assignment. Yet, when the dust settles there remain victims who are harmed for whom we are all sympathetic. It is for this reason that we are compelled to do everything within our power to ensure that tragic errors do not occur.
Elsewhere in society there are potentially devastating outcomes to human error and, like in medicine, it may be difficult to unravel how much fault is from natural calamity and how much we could have avoided with more rigorous human controls.
Just over a week ago, the world was exposed to perhaps the worst of Mother Nature’s natural disasters: a severe earthquake with multiple aftershocks, followed by a massive Tsunami. Aside from the horrendous devastation that took place in Japan, ongoing danger persists from damage to several nuclear power plants.
These unintentional, uncontrollable catastrophes occur naturally and are arguably nobody’s fault. And although some claim that nuclear power is dangerous because of the history of accidents like at Chernobyl and Three Mile Island, nuclear power plants continue to be constructed throughout the world because many perceive that the benefits of this alternate source of energy outweigh the risks. We are assured by those responsible that these plants are safe even in the face of the worst disasters… until we learn they are not.
It is our human condition to speculate how to prevent these complications from occurring. In IVF, perhaps the greatest potential disaster we face is the mixing up of embryos.
In February, 2009, a case of a mix-up of frozen embryos in a Michigan IVF program occurred to a couple who already had a set of twins as a result of a successful IVF. Their embryos were mistakenly transferred into the wrong woman, who then carried the pregnancy and after delivery handed the baby back to his biological parents. Reports of the mix-up have triggered calls from some to make IVF illegal. This sounds like the recent calls to decommission nuclear power plants and stop production of new facilities.
Mixing up gametes and embryos is tragic and society must do everything humanly possible to prevent it… except disallow the practice of IVF. As with other societal advances, accidents are rare but have 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 strive to improve the safety of IVF, not eliminate it.
Many of the greatest advances have had tragic results, unintended accidents that could sometimes been avoided. Sometimes, like the post-earthquake nuclear disasters in Japan, they are spawned by natural causes. But other times, there is an element of human error often preventable with the institution of carefully designed safeguards with a system 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.
Cardiac bypass surgery and other surgeries save lives and relieve suffering 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 do occur rarely, usually because of a human slip. Rules are broken and mistakes result. When they do, hospitals review the procedures and protocols to better insure a sufficient system is in place to catch future errors before they effect patient care.
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 the one in Michigan.
In our 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 double-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 repeatedly throughout the IVF process from retrieval through transfer. A similar system of double checks of patient and embryo identity exists for frozen embryo transfers as well.
In over 25 years of practicing IVF, my program has not mixed up gametes or embryos.
There are approximately 3 million babies born through IVF and only a few rare mix ups reported. Perhaps we don’t hear …or know…about every mix up. I’d estimate that less than 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.
When it comes to institutions whose impact on society is of such great magnitude, it is essential that governing regulatory agencies ensure that all possible checks and balances are in place to ensure the greatest degree of safety. All involved must work hard to maintain the highest standards and then we can only pray that we have done everything possible so that such disasters never have such devastating consequences.