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B.
Braun Medical Inc. Applauds FDA Public Health Notification on
Devices Containing DEHP
Safety
Healthcare Products Leader Adds its Voice to Growing Concern Over
Impact of DEHP Leaching on Neonates and other High Risk Patients
Bethlehem,
PA (August 6, 2002) – B. Braun Medical Inc., today applauded
the U.S. Food and Drug Administration (FDA) for its recent Public
Health Notification: PVC Devices Containing the Plasticizer DEHP,
and encouraged healthcare providers worldwide to aggressively
implement DEHP-free solutions throughout the healthcare continuum
– especially in perinatal care.
In its recent
Public Health Notification about DEHP, the FDA suggests using
non-PVC, non-DEHP alternative medical devices during a number
of medical procedures for neonates, peripubertal males, pregnant
or lactating women, and adults undergoing certain procedures.
According to the notification, "exposure to DEHP has produced
a range of adverse effects in laboratory animals, but of greatest
concern are effects on the development of the male reproductive
system and production of normal sperm in young animals."
In published
reports following the release of the FDA Notification, FDA biologist
Laura Alonge stated that health workers should consider using
alternative medical equipment, such as devices coated with heparin,
silicon, or other substances to prevent DEHP from leaching.
Di(2-ethylhexyl)phthalate
(DEHP) is a chemical compound used to make polyvinyl chloride
products like intravenous bags and tubing soft and pliable. DEHP
has been classified as a Group B2, probable human carcinogen by
the U.S. Environmental Protection Agency (EPA).
"We
are pleased that the FDA has brought this very serious healthcare
concern to the forefront," said Caroll Neubauer, Chairman
and Chief Executive Officer of B. Braun Medical Inc. "As
a company focused on patient and provider safety for more than
160 years, we have pioneered the development of DEHP-free alternatives
for healthcare providers. While more studies to determine the
exact impact that leached-DEHP has on neonates and other high-risk
patients may be warranted, why expose any patient to DEHP when
DEHP-free alternatives are readily available?"
Over ten
years ago, B. Braun invested more than $40 million into the development
of a line of IV solutions in non-PVC/non-DEHP containers. Today,
its EXCEL® and PAB® containers are used at major healthcare
providers across the United States. "As a hospital that has been
nationally recognized for making patient safety a priority, we
have been concerned about this issue for years and have been using
PVC/DEHP-free products since 1994," said Fred Pane, R.Ph., Lehigh
Valley Hospital and Health Network's administrator of pharmacy
services. "We hope the FDA's notification prompts other healthcare
organizations to remove the potential hazards of DEHP where possible."
B. Braun
is currently the only company in the United States to generally
offer this alternative for all basic IV solutions. B. Braun’s
EXCEL and PAB IV containers are manufactured with non-PVC/non-DEHP
plastics and are biologically inert. In addition, B. Braun provides
non-DEHP IV tubing, as well as packaging amino acids and other
special formulations in non-PVC containers.
About
B. Braun
With more than 28,000 employees worldwide, B. Braun is a full
line supplier of innovative healthcare products & programs
designed to improve both patient and clinician safety. Through
its People, Products, and Programs - "Working Together for
Excellence in Safety™" initiative, B. Braun promotes
best practices and products for continuous improvement of safety.
B. Braun
is proud of its longstanding tradition and commitment to delivering
innovative healthcare products and programs with unmatched quality,
superior technology, and cost-effectiveness, while maintaining
environmental responsibility. For more information about B. Braun
or its safety healthcare products, call 800-854-6851, or visit
B. Braun at www.bbraunusa.com.
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