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Medical devices should comply with high standards of their safety, performance, and biocompatibility, and the kind of material to be used in the production of a device has the final word in the effectiveness of a specific device. Some of the most frequently applied elastomers in the healthcare sector include silicone and latex, which are both provided with a distinct set of characteristics that can be useful in various clinical settings.
Though these two materials are flexible, soft and can be shaped into a complex form, they are characterized by a strong contrast in their composition, safety profile, durability, and conformity to long-term or intimate medical application. The knowledge of these differences assists medical manufacturers, device designers, clinicians, and even patients to make sound decisions on the type of material to be used in a particular type of medical device.
Silicone and latex differ the most in the point of origin and chemical composition. Silicone is a synthetic polymer derived out of silicon, oxygen, carbon, and hydrogen. This synthetic composition enables silicone to have predictable performance, purity that is controllable, and the ability to resist environmental stress. Silicone used in the medical environment is of high quality and was made according to stringent regulatory requirements and lacks proteins or any other impurities that can cause immune reactions.
Due to this reason, silicone is regarded as one of the most compatible materials that can be used in medicine. It is not irritating, does not cause allergic reactions, and is not toxic to the system so it can be used in long-term contact with tissues, fluids and sensitive parts of the body.
Latex on the other hand is a natural substance that is produced by means of tapping rubber trees. Although natural latex is very elastic and sensitive to touch, it has some proteins which may cause allergic reactions on some people. Such allergies vary in the severity of skin irritation up to serious respiratory distress or anaphylaxis.
When the medical fraternity became aware of the issue of latex allergy, several hospitals and clinics shifted to use a latex-free environment as a routine. Nevertheless, latex is still useful in some regions where its ability to stretch and to be sensitive is not comparable to any other material as seen in surgical gloves and tubing that need high levels of flexibility.
Medical devices are used in environments that are drastically different and the material should be able to withstand mechanical loads, sterilization, exposure to chemicals, and change in temperature. Silicone is also superior in the aspects of durability, since its molecular structure is not affected by high temperatures and low temperatures, moisture, UV radiation, as well as a variety of chemicals.
Medical silicone materials are able to withstand repeated sterilization processes like autoclaving, gamma irradiation or ethylene oxide without losing their flexibility or structural integrity. Silicone is also suitable in reusable medical equipment, implantable devices, respiratory mask seals, pump seals and prosthetic equipment due to this long-term stability.
Although latex is a very strong and elastic material, its degradation is accelerated in the presence of heat, oils, ozone, and ultraviolet light. This is attributed to the fact that its polymer structure is natural and decomposes with time thereby making it brittle or discoloured.
Latex also is incapable of withstanding the high temperature sterilization that is a common practice in hospitals which restricts its application to disposable or short-term medical products. The difference in performance will be even greater when the devices sold have to be dimensionally stable, wearable, or able to endure sterilization conditions that are harsh.
The question of safety has come up as one of the distinguishing factors between silicone and latex in the medical field. Latex allergy has been a significant issue and the regulatory authorities in most areas have mandated the labeling and guidelines of any product that has natural rubber latex.
On the contrary, silicone is generally considered to be non irritating and hypoallergenic. Silicone is always a safer choice with patients with sensitive skin, respiratory conditions or poor immunity and softer tissue, wound care, respiratory and products positioned on infants or elderly patients. In addition to hypoallergenic properties, silicone has other advantages that include increased comfort owing to the soft non-tacky surface that is soft on the skin.
Latex, though comfortable and very elastic, can be sticky or can make one sweat, when used over a long time, on the natural surface of the latex. Latex is also not as preferred as a material in products that are in direct and prolonged contact, due to its potential of allergic reactions.
Although latex gloves and medical equipment have been developed with powder-free and low-protein materials which have minimized some of the risks, it has not eliminated them.
Cost is a factor in the way the manufacturer decides between silicone and latex. Latex is cheaper in general because it is naturally found and does not require complicated processing. Latex is economical in the case of high volume disposable products like examination gloves, tourniquets and balloon catheters.
Silicone, however, uses more complicated manufacturing processes, such as liquid injection molding, compression molding, and extrusion.
Due to the ability to shape silicone into complex geometry and highly-dimensional forms, it has been applied to high-dimensionality and precision-engineered medical devices, including valves, seals, respiratory apparatus, and implant-equipment. The thermal stability, which is exhibited by silicone when subjected to prolonged stress, is also another characteristic that qualifies silicone to be used in life-saving devices and reusable medical equipment.
Latex is still the practical option when it comes to low-cost consumables, although its shortcomings of durability, safety, and resistance to the environment limit its application in critical or long-term use.
