Replies to LegCo questions
LCQ16: Medical devices containing plasticisers
Following is a question by the Dr Hon Joseph Lee and a written reply by the
Acting Secretary for Food and Health, Professor Gabriel Leung, in the
Legislative Council today (July 13):
Question:
It has been reported that some Taiwanese academics found, in testing auxiliary
medical devices (e.g. blood bags and infusion bags) earlier, that
Polyvinylchloride (PVC) materials could easily release plasticisers, and the
concentration was at an exceedingly high level. As PVC materials are widely used
in medical supplies, Hong Kong is equally exposed to the risk of contamination
by plasticisers. It has also been reported that when fatty solutions (e.g.
chemotherapy drugs and blood, etc.) come into contact with auxiliary medical
devices containing PVC materials, more plasticisers will be released, which may
be transmitted into the body through these medical devices and may cause more
serious harm than consuming food contaminated by plasticisers, in particular to
premature babies, chronic patients and patients with severe illness. In this
connection, will the Government inform this Council:
(a) whether the authorities know if, at present, there are auxiliary medical
devices in Hong Kong which contain PVC materials; if there are, set out such
devices by type;
(b) whether the authorities have tested the level of plasticisers contained in
auxiliary medical devices commonly used in Hong Kong, to ensure that the devices
are not contaminated by plasticisers; if they have, of the standards and
criteria adopted by the authorities for testing such devices; if not, whether
they will conduct such tests to address the concerns of the public; and
(c) whether the authorities have explored using alternatives to auxiliary
medical devices containing PVC materials, which may have the risk of being
contaminated by plasticisers; if they have, of the details; if not, whether they
will consider conducting studies?
Reply:
President,
Di (2-ethylhexyl) phthalate (DEHP) is widely used as a plasticiser for polyvinyl
chloride (PVC) products. PVC is used in various consumer products such as
imitation leather, rainwear, footwear, upholstery, flooring, wire and cable,
tablecloths, shower curtains, food packaging materials, medical equipment and
children's toys. Besides, DEHP is also one of the common environmental
contaminants in air, water, soil and food.
Although animal studies showed possible health effects after long-term exposure
to high dose DEHP, the United States (US) survey results showed that finding a
detectable amount of DEHP metabolites in urine did not indicate an adverse
health effect on human. According to scientific literature, plasticisers have
been detected in blood or urine samples of most people in various parts of the
world (e.g. US, Germany).
My reply to the various parts of the question is as follows:
(a) Plasticisers are purposely added to PVC-made medical devices to make them
softer, more flexible and easier to use. Otherwise, medical devices may cause
discomfort to patients and even damage to their bodies. PVC-made medical devices
that may contain DEHP as plasticisers include:
- Intravenous (IV) bags and tubing
- Blood bags and infusion bags
- Enteral nutrition feeding bags
- Nasogastric tubes
- Peritoneal dialysis bags and tubing
(b)&(c) International medical device control authorities have indicated that
there is no scientific evidence so far to suggest that medical devices
plasticised with DEHP present an unacceptable health risk to humans. In
addition, given the important clinical benefits of these medical devices,
critical medical procedures should not be avoided simply because of the possible
health risks associated with DEHP.
While alternatives to DEHP have been used for some medical devices in the
market, studies on the health risks of such alternatives are very limited.
Before using devices containing alternatives to DEHP in specific medical
procedures, there should be adequate data on their safety and efficacy.
To conclude, regulatory authorities all over the world consider that the
benefits of medical devices plasticised with DEHP outweigh the risks for
patients according to the information available so far. Hence, they are still
the popular choice in the market. We will continue to keep abreast of the
situation and the relevant studies in other places and take actions as
appropriate to safeguard public health.
Ends/Wednesday, July 13, 2011
Issued at HKT 16:46
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