Safety

All About Phthalates

Phthalates, pronounced THAL-ates, are plasticizers used to make products more flexible and harder to break. They’re utilized only in flexible forms of polyvinyl chloride (PVC, or vinyl for short).

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Although exposure to phthalates is not limited to a single source, some exposures occur from the use of medical devices made with flexible vinyl. However, phthalates have been used safely in vinyl materials in medical device applications for decades.

These flexible vinyl materials benefit society every day by offering effective products that have important medical benefits, some of which save lives.

Phthalates allow manufacturers to create products that possess all the important characteristics of vinyl (durability, resistance to chemicals and oxygen, etc.) while being flexible and resistant to breakage. Some of the most common applications of flexible vinyl that contains phthalates are:

Some concerns have arisen about the safety of exposure to phthalates because of adverse effects in experimental animals. No studies have been conducted that show effects in humans. Although the use of flexible vinyl in medical products may result in exposure to phthalates, this exposure has been shown to be very low.

At these very low levels of exposure, the risk of any adverse effects of phthalates to human health is very small and does not give rise to a health or safety concern. The small risk is clearly offset by the benefits of the use of flexible vinyl in medical applications.

One such benefit is that flexible vinyl tubing does not react with most medications and allows for the administration of these life saving drugs. Flexible vinyl bags prevent contamination of stored blood and has a beneficial effect on the shelf-life of this blood.

There continues to be no more effective material than flexible vinyl for medical applications and data indicates that phthalates can be safely used in these applications.

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