DEHP

Summary of the 2002 Report of the Health Canada Expert Advisory Panel on DEHP in Medical Devices

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In January 2002, Health Canada released the Final Report of the Expert Advisory Panel on DEHP in Medical Devices. This fact sheet provides a summary of the Expert Panel’s findings. The Panel made recommendations based on a 2001 Health Canada review entitled “DEHP in Medical Devices: An Exposure and Toxicity Assessment,” and external studies, including the most recent findings of the US National Toxicology Program’s Center for the Evaluation of Risks to Human Reproduction (NTP-CERHR) and the US Food and Drug Administration (FDA).

Use of DEHP-Containing Medical Products and Urinary Levels of MEHP in Neonatal Intensive Care Unit Infants

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Urinary MEHP levels increased monotonically with DEHP exposure. For the low-, medium-, and high-DEHP exposure groups, median (interquartile range) MEHP levels were 4 (18), 28 (58), and 86 ng/mL (150), respectively (p = 0.004). After adjustment for institution and sex, urinary MEHP levels among infants in the high exposure group were 5.1 times those among infants in the low exposure group (p = 0.03). CONCLUSION: Intensive use of DEHP-containing medical devices in NICU infants results in higher exposure to DEHP as reflected by elevated urinary levels of MEHP.

DEHP Exposures During the Medical Care of Infants - A Cause for Concern

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  • Idioma: English

Neonates and infants who receive medical care that includes the use of plasticized PVC products may easily be exposed to DEHP at levels that are in excess of the no observed adverse effect level (NOAEL) in animal tests. For some medical therapies, these exposures also exceed the FDA-derived “tolerable intake” (TI).

Decrease in Anogenital Distance among Male Infants with Prenatal Phthalate Exposure

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Diesters of phthalic acid, commonly referred to as phthalates, are widely used in industry and commerce; they are used in personal care products (e.g. makeup, shampoo and soaps), plastics, paints and some pesticide formulations. Consistent toxicologic evidence indicates association between several of these phthalate esters and reproductive effects. Despite the growing body of literature on phthalate reproductive toxicity and data demonstrating extensive human exposure, few studies have examined the effects of these chemicals on human reproductive development.

Case Study: PVC and DEHP in Neonatal Intensive Care Units - Kaiser Permanente

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Beginning in July, 2001, after learning of the potential hazards to neonatal patients from DEHP exposure, Kaiser Permanente staff underwent a process to identify DEHP-containing medical devices used in the Neonatal Intensive Care Units and to evaluate alternatives. Upon completion of that process, the health system chose to switch to non-DEHP products for three commonly used NICU devices: umbilical vessel catheters, PICC lines, and enteral feeding products.

Case Study: Evergreen Hospital NICU Strives to Become DEHP- and PVC-free

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A nurse in the Evergreen PEDS first raised concerns regarding di-2-ethylhextlphthalate (DEHP)/polyvinyl chloride (PVC) in early 2002 and brought the concerns to the attention of Eney Gaines Wrinkle, Equipment Material Coordinator for Women's and Children’s Services. Ms. Gaines Wrinkle went to work to research the issue. She quickly learned of the patient safety issues and the environmental and human health consequences of DEHP and PVC and sought to find replacement products to use in her NICU.

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