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):


     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?



     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