Newborn babies are exceptionally delicate — especially if they are preterm. Yet they are regularly exposed to toxic chemicals in the neonatal units of hospitals.
Di (2-ethylhexl) phthalate (DEHP) is a phthalate plasticizer added to polyvinyl chloride (PVC) plastic medical devices to make them soft and flexible –– it is also a developmental and reproductive toxin.
Recent reports from the National Toxicology Program (NTP) and the U.S. Food and Drug Administration (FDA) affirm that babies undergoing certain types of treatments, such as Extracorporeal Membrane Oxygenation therapy, exchange transfusions, enteral and total parenteral nutrition feeding, are placed at risk of developing additional health complications due to exposure to the chemical.
PSR-LA is taking the lead in addressing this ubiquitous toxic chemical. In conjunction with the Perinatal Program, PSR-LA is distributing information on DEHP, and its alternatives, to physicians and nurses in neonatal intensive care units throughout the state. PSR-LA has also won the support of the California Association of Neonatologists to advocate for a DEHP phase out and is working with health care facilities to evaluate alternatives to DEHP-added PVC tubing.
Manufacturers were only required to conduct limited safety testing after the mid-1970’s when the FDA began to regulate medical devices, but the recent reports by the FDA and NTP are clear in their findings.
Donald Marlowe, Director of the FDA’s Office of Science and Technology, acknowledges, “We are being specific here, suggesting to clinicians and the users of these devices that they consider devices that are made of alternate materials.”
The evidence compiled by the FDA and NTP prompted the California Medical Association to pass a resolution last year urging health care facilities to look at alternatives to DEHP-added PVC. In December 2001, the American Medical Association identified DEHP as a threat to infant health by approving a resolution that offers assistance to the FDA in informing health care facilities of the identified threats associated with the chemical’s use.
Feeding bags, blood bags, respiratory therapy products including tubing, masks and oxygen reservoir bags, IV products, ECMO tubing, and sometimes mattress covers and examination gloves are made of DEHP added PVC plastic. In applications where flexibility of PVC plastic is critical, DEHP can comprise up to 80% of the weight of the medical device.
Even more disturbing, DEHP does not bind to the PVC polymer, and readily leaches from medical bags and tubing into feeding solutions, blood, or directly into the patients’ system. If the solution is high in fat, leaching rates increase dramatically, as DEHP has an affinity to fat.
When an infant undergoes multiple treatments, exposure is increased substantially to levels 5 – 20 times higher than the tolerable dose.
Organs that may be the most adversely affected by DEHP exposure are the lungs, liver, kidneys and the male reproductive tract.
DEHP is currently the only phthalate approved by the FDA for medical use, and its production volume is tremendous —approximately 2 million tons are manufactured each year. Yet alternatives to DEHP products are readily available. Polyurethane, polypropylene, silicone, and ethylene vinyl acetate are a few of the medical-grade polymers that can replace DEHP-added PVC.
For more information on DEHP contact Johanna Congleton, Public Health Organizer, [email protected], (213) 386- 4901 x111.