Medical
 PVC Medical Products Are Proven
Life-Savers
The most essential, life-saving devices in modern medicine have
come under attack from environmental and healthcare groups in the
United States. They claim that the plasticisers used in the
manufacture of the devices are a risk to human health. European
manufacturers of the plasticisers explain why they are wrong:
Vinyl medical products, including flexible tubing, intravenous
bags, catheters and protective gloves, have been used for more than
40 years in healthcare establishments around the world and there is
not one known case of a patient having suffered as a result. To the
contrary, there are millions of healthy people today who have
benefited from having been treated with life-saving PVC medical
products.
Like many components of both man-made and natural products,
phthalate plasticisers – used to make PVC soft and supple
– may be absorbed in small quantities by the fluids they come
into contact with. This is a known occurrence and therefore the
safety of such products is regularly reviewed and stringently
monitored by both industry and regulatory authorities. Medical
devices in Europe are strictly regulated by the EU’s Medical
Device Directive (93/42/EEC).
No indication that DEHP is unsafe
During the past 20 years, hundreds of studies have been
conducted by independent researchers and reviews by numerous
government agencies have provided no indication that the
plasticiser used, di(2-ethylhexyl) phthalate (DEHP), is unsafe for
use in vinyl medical products, even among those people who use the
products most frequently. In Europe, DEHP is the plasticiser
recommended in the European Pharmacopoeia for medical devices.
Claims by environmental and healthcare groups that medical
patients may be exposed to a cancer risk as a result of being
treated using medical products containing the plasticiser are
unfounded. The World Health Organisation and the European
Commission have both conducted extensive reviews of DEHP but
neither has classified the phthalate as a human carcinogen. Health
Canada classifies it as ‘unlikely to be carcinogenic to
humans’.
In the United States, DEHP is listed as a probable human
carcinogen by the Environmental Protection Agency (EPA) but this is
based on rodent studies and there is disagreement even within the
EPA as to whether the classification is correct.
In rodent studies, during which DEHP was administered at very
high doses, there has been evidence of liver cancer. However, the
significant species differences that exist between the ways in
which a human liver and a rodent liver respond to DEHP means that
carcinogenicity in humans from DEHP exposure is extremely
unlikely.
Phthalates among most widely studied compounds
Phthalates are among the most widely studied and best understood
of all compounds. They also combine superior performance and cost
effectiveness to create vinyl medical products that have led to
improved and affordable patient care. In particular, the use of
flexible PVC has been critical in establishing disposable medical
products that have dramatically reduced infection rates and the
spread of disease.
Due to DEHP’s unique properties, many different PVC
formulations can be developed, ranging from glassy compositions to
soft, highly flexible materials. It also enables the construction
of transparent PVC products, a factor important in many medical
applications. Its advantages in medical tubing include a high
resistance to kinking to ensure that critical fluids reach a
patient in prescribed doses.
In the United States, the Food and Drug Administration says
alarm is unnecessary. “Every product has trace contamination
of some chemical,” said Dr David Feigal, a blood safety
specialist from the FDA’s Centre for Biologics. “We
need to make sure we don’t rush to an alternative that is not
as safe as this. Using glass to store blood is riskier because
dangerous bacteria seep into glass containers far more easily than
into sealed plastic.”
Further Reading
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