Number

187-EN

Section

General Section

Use

Abstract

This case study is a comparison between different materials used for manufacturing catheters. The comparative assessment that is the basis for this case study was done by the Dow Corning Corporation and aimed at evaluating PVC, latex and silicone for use as catheter material. While all materials have their respective strengths and drawbacks, the conclusion of the study was that silicone was the best available option.

Substituted substances

Alternative Substances

Reliability of information

Internet information: data are from an internet document and only a basic and partial evaluation could be performed

Reason substitution

CMR
vPvB
skin/respiratory sensitizing

Hazard Assessment

The material PVC have no official hazard classification while several of the possible associated phthalates are classified as toxic to reproduction. PVC may also cause release of hazardous chemicals during production (mercury) and during combustion (dioxins). The main problem with PVC is the plasticizers and the problems concerning its fate after use. Latex and product additives are sensitizers and latex allergy is a major concern in healthcare.

Description of Substitution

Catheters are medical devices, typically in the form of a tube, that is inserted into the body to drain fluid, create an opening, or deliver a drug. Some of the most common materials used for making catheters are polyvinylchloride (PVC), latex and silicone. Each of these compounds come with their own strengths and drawbacks and there is therefore no such thing as an ideal catheter material. The basis for this case study is a report which aimed at evaluating the different materials used based on their biocompatibility. PVC which has been used extensively as a catheter material is associated with several problems, perhaps the most well-known is the problems with plasticizers. The raw polymer PVC is hard and stiff so in order to make the polymer soft and flexible certain chemical compounds called plasticizers have to be added. One group of commonly used plasticizers in PVC are phthalates, a large family of compounds where many have been linked to severe human health effects. Since the plasticizers are not chemically bound to the polymer, they tend to leach out of the product which can cause both damage to human health and actual damage to the polymer. Another drawback with PVC is the problem with disposing used products containing PVC. Combustion of PVC can produce dioxins which are extremely toxic chemicals and also environmentally persistent and bioaccumulating. Latex, which is also frequently used as a catheter material contain no toxic materials and is biodegradable. It is however also allergenic and to people who are allergic to latex, a catheter made of latex can be hazardous, especially considering the way a catheter is used. Silicone contains no toxic compounds, nor is it allergenic or difficult to dispose of. Studies also show that catheters made of silicone are equally good or in some cases even better than PVC or latex catheters concerning incidence of phlebitis, frequency of sepsis and the likeliness of mineral encrustations. Silicone is ,however, a more expensive alternative, even though this may be offset by decreased costs concerning allergies and other health problems associated with PVC or latex.

Case/substitution evaluation

PVC is a polymer associated with many negative aspects, both concerning human health and the environment and should therefore be phased out. Latex is in some ways a poor substitute since there are indications of potential hazards to human health because of allergies and increased risk of infections. Silicone seems to be a suitable alternative since there are no known drawbacks to its used except its slightly higher cost.

State of implementation

In use

Availability ofAlternative

On the market.

Type of information supplier

Producer / distributor

Contact

www.dowcorning.com

Type of publication and availability

Freely available

Publication source: author, company, institute, year

Author: Jim Curtis & Paul Klykken Company: Dow Corning Corporation Year: 2008

Publication source

Type of publication and availability

http://citeseerx.ist.psu.edu/viewdoc/summary?doi=10.1.1.521.7260&rank=1

Date, reviewed

November 26, 2021