Hospital Plastics May Put Sick Infants At Risk
A government panel has expressed "serious concern" that chemicals used in vinyl medical products may harm the reproductive organs of critically ill male infants exposed during medical treatments.
A government panel has expressed "serious concern" that chemicals used in vinyl medical products may harm the reproductive organs of critically ill male infants exposed during medical treatments.
The panel of scientists also concluded that they have "concern" that the development of the reproductive system of healthy male infants and toddlers could have been harmed by exposure to the chemical softeners, known as phthalates, during their mother's pregnancy or from non-medical exposures during the first years of life.
Female infants may also be affected by exposure, but appear not to be as sensitive to the reproductive effects as males, the panel said.
The independent, expert panel appointed by the federal National Toxicology Program (NTP) began the phthalate review last August. This is the first time the NTP has evaluated the reproductive and developmental toxicity of a chemical rather than its cancer causing properties.
Panelists reviewed existing literature in their areas of expertise and provided other panel members with their summary evaluations. The scientists reviewed almost 1,000 reports and studies covering general toxicity of these chemicals in animals and humans, their developmental and reproductive toxicity, and information on human exposure.
The expert panel continued its work at a second meeting in December. The third meeting, held last week, concluded the panel’s literature review and summary on the effects of one particular phthalate, DEHP (di-ethylhexyl phthalate), which is used to make vinyl plastics soft and flexible.
The threat of exposure is high from some medical procedures because DEHP leaches from vinyl medical products, the panel said, as it is not chemically bonded to the plastic it softens.
The National Toxicology Program's expert panel notes that DEHP "can leach out when the medical device comes in contact with fluids such as blood, plasma and drug solutions, or it can be released and migrate when the device is heated," as in some sterilization procedures. The chemical will "readily dissolve" in blood and blood products, infant formulas, and some IV medications, the panel says.
In addition to its use in the manufacture of medical products, the chemical DEHP is used in other vinyl products, including floorings, wall coverings, furniture, luggage and children's toys.
The panel's findings confirm the report released yesterday by Health Care Without Harm, a national collaborative campaign for environmentally responsible health care made up of more than 250 citizens' organizations.
The Health Care Without Harm study found that fetuses, premature infants and newborns are exposed to large amounts of a chemical suspected to cause reproductive and developmental problems in humans.
Last October, the environmental group Greenpeace -- a member of Health Care Without Harm -- released a report on laboratory testing of 46 vinyl medical products, including intravenous bags, syringes, tubing and catheters. The products’ DEHP content ranged from 12 percent to 80 percent by weight.
Medical products manufacturers admit that DEHP can be released into intravenous solutions, blood, and even the air used in respiratory therapy. The World Health Organization believes there is a need to "reduce exposure arising from the use of plastic tubes containing DEHP in such clinical procedures as transfusion, haemodialysis, and artificial respiration."
Health Care Without Harm's report focuses on critically ill infants as the most threatened population because multiple medical interventions may require using devices that have been shown to leach DEHP. Higher exposure for sick infants comes from neonatal intensive care units filled with vinyl products.
"These babies are exposed to DEHP from multiple pieces of equipment. It is entering their bodies through their mouths, through their veins and through their lungs," said Ted Schettler, MD, science director of the Science and Environmental Health Network.
"No one knows exactly what impact these multiple exposures will have, but what we know about DEHP's effects on animals gives us cause for concern and for action."
Exposure to DEHP can cause reproductive problems, including:
The panel of scientists also concluded that they have "concern" that the development of the reproductive system of healthy male infants and toddlers could have been harmed by exposure to the chemical softeners, known as phthalates, during their mother's pregnancy or from non-medical exposures during the first years of life.
Female infants may also be affected by exposure, but appear not to be as sensitive to the reproductive effects as males, the panel said.
The independent, expert panel appointed by the federal National Toxicology Program (NTP) began the phthalate review last August. This is the first time the NTP has evaluated the reproductive and developmental toxicity of a chemical rather than its cancer causing properties.
Panelists reviewed existing literature in their areas of expertise and provided other panel members with their summary evaluations. The scientists reviewed almost 1,000 reports and studies covering general toxicity of these chemicals in animals and humans, their developmental and reproductive toxicity, and information on human exposure.
The expert panel continued its work at a second meeting in December. The third meeting, held last week, concluded the panel’s literature review and summary on the effects of one particular phthalate, DEHP (di-ethylhexyl phthalate), which is used to make vinyl plastics soft and flexible.
The threat of exposure is high from some medical procedures because DEHP leaches from vinyl medical products, the panel said, as it is not chemically bonded to the plastic it softens.
The National Toxicology Program's expert panel notes that DEHP "can leach out when the medical device comes in contact with fluids such as blood, plasma and drug solutions, or it can be released and migrate when the device is heated," as in some sterilization procedures. The chemical will "readily dissolve" in blood and blood products, infant formulas, and some IV medications, the panel says.
In addition to its use in the manufacture of medical products, the chemical DEHP is used in other vinyl products, including floorings, wall coverings, furniture, luggage and children's toys.
The panel's findings confirm the report released yesterday by Health Care Without Harm, a national collaborative campaign for environmentally responsible health care made up of more than 250 citizens' organizations.
The Health Care Without Harm study found that fetuses, premature infants and newborns are exposed to large amounts of a chemical suspected to cause reproductive and developmental problems in humans.
Last October, the environmental group Greenpeace -- a member of Health Care Without Harm -- released a report on laboratory testing of 46 vinyl medical products, including intravenous bags, syringes, tubing and catheters. The products’ DEHP content ranged from 12 percent to 80 percent by weight.
Medical products manufacturers admit that DEHP can be released into intravenous solutions, blood, and even the air used in respiratory therapy. The World Health Organization believes there is a need to "reduce exposure arising from the use of plastic tubes containing DEHP in such clinical procedures as transfusion, haemodialysis, and artificial respiration."
Health Care Without Harm's report focuses on critically ill infants as the most threatened population because multiple medical interventions may require using devices that have been shown to leach DEHP. Higher exposure for sick infants comes from neonatal intensive care units filled with vinyl products.
"These babies are exposed to DEHP from multiple pieces of equipment. It is entering their bodies through their mouths, through their veins and through their lungs," said Ted Schettler, MD, science director of the Science and Environmental Health Network.
"No one knows exactly what impact these multiple exposures will have, but what we know about DEHP's effects on animals gives us cause for concern and for action."
Exposure to DEHP can cause reproductive problems, including:
- structural changes in the testes
- reduced fertility
- changes in sperm production
- ovarian dysfunction
- decreased hormone production in females
"Laboratory animal studies of DEHP have shown it to induce both fetal malformations and adverse effects on the reproductive system," the National Toxicology Program expert panel has concluded.
Hospitals can avoid much of the exposure premature infants and newborns receive from DEHP by using products made without the chemical when available. Alternatives are now available for most products used in neonatal intensive care units, as well as for other polyvinyl chloride (PVC) products.
"Here is a government sponsored panel of eminent scientists saying that phthalate plasticizers in PVC medical products may pose a threat to the ability to bear healthy children. Now health care professionals and patients need to insist that if we can make the same products out of materials that do not threaten fertility, we should do it," said Charlotte Brody, RN, co-coordinator of Health Care Without Harm.
Health Care Without Harm’s report is available at http://www.noharm.org.
