A new collaborative position paper on radiation exposure during pregnancy states that pregnant women can safely work in an ionizing radiation environment if exposure to the fetus does not exceed certain dose thresholds.
The position paper aims to “avoid discouraging” women from pursuing careers in interventional cardiology/electrophysiology (IC/EP) and to “dismantle” a barrier that says, “activity under x-rays, without any weighting, is incompatible with continuation of pregnancy,” lead author Stéphane Manzo-Silberman, MD, of APHP, Sorbonne Université, told theheart.org | Medscape Cardiology.
“The main point of the statement is to show that it is possible and safe to maintain activity under radiation during pregnancy, [given] the data we have on the risk for the fetus at exposed doses, the regulations, and feedback from practice,” she said. “The data we currently have allowed us to be largely reassuring.”
The research showed that adverse effects on a fetus generally occur when radiation exposure is >100 mGy. Most countries that permit pregnant women to work in IC/EP require that the cumulative dose during the pregnancy be <1 mSv. An exception is the United States, which permits a cumulative dose of <5 mSv.
The position paper, a collaboration among the European Association of Percutaneous Cardiovascular Interventions, the European Heart Rhythm Association, the European Association of Cardiovascular Imaging, the European Society of Cardiology Regulatory Affairs Committee, and Women as One, was published online November 22 in EuroIntervention.
Current Requirements and Risks
The position paper covers regulations in various countries; fetal radiation doses that have been associated with ill effects, including abortion, malformations, and intelligence quotient reductions; the spontaneous probability of having a newborn with a congenital malformation or childhood cancer; and proposals to improve practice.
Highlights include the following:
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European, North American, Japanese, and Australian regulations permit pregnant women to work if closely monitored with an abdominal dosimeter; some countries, such as Austria, Hungary, Portugal, and Romania, do not allow women to work in IC/EP during pregnancy or breastfeeding.
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The maximum fetal dose exposure during pregnancy is 1 mSv in Europe, Australia, and Israel; 2 mSV in Japan; and 5 mSv in the United States.
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Doses associated with fetal harm are 100 times higher than those allowed during an interventional cardiologist’s entire pregnancy.
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There is a negligible risk increase in the spontaneous probability of a newborn having a congenital malformation or childhood cancer when the occupational exposure range of the mother respects a country’s limits.
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No studies have shown an increased risk of noncancerous adverse effects from prenatal radiation exposure <50 mSv.
To improve practice, the position paper suggests the following:
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Fluoroscopy operators must be guided by the “as low as reasonably achievable” principle: obtaining optimal images must be balanced with procedure safety.
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Scatter radiation emitted from the patient is the main source of radiation exposure to the operator and personnel; reducing radiation to the patient will reduce exposure for staff.
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The three fundamentals of radiation safety for an operator are (1) time, (2) distance, and (3) shielding and dosimeter monitoring. Time refers to the amount of time the operator spends using the x-ray system; distance means maximizing distance from the x-ray source; and shielding includes personal, tableside, or external protection, with each form having a degree of lead equivalence defining its radiation protective effect.
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Changes in medical school curricula and creating a friendlier workplace environment for families and pregnant interventionists are among the strategies that will promote gender equity in the profession.
“Institutional radiation protection programs should be established to increase knowledge about radiation exposure and improve specific safety requirements for everyone. This would ensure safe exposure for all physicians, [including] during pregnancy,” Manzo-Silberman concluded.
Furthermore, she said, “As has already been demonstrated in the business world, improving representation and gender equity and diversity is key to improving results and efficiency. In the field of health, this translates into better care for our patients and better working conditions for healthcare professionals.”
No commercial funding was disclosed. Manzo-Silberman has received consulting fees from Bayer, Organon, and Exeltis; lecture fees from Bayer, BMS, Exeltis, and Organon; and has served on the adjudication board for a study for Biotronik.
EuroIntervention. Published online November 22. Full text
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