Comparing Cure Medical Catheters

Urinary catheter construction is primarily of three different materials--polyvinyl chloride (PVC), silicone, and latex. Silicone and latex are the most widely used uretic catheters. Many catheters come with a coating to provide easier insertion and to prevent infections. These coatings include hydrophilic, silicone-elastomer, polytetrafluoroethylene, silver, and PTFE-based Teflon. The coatings reduce friction and reduce the instance of inflammation and illnesses.

PVC

PVC is polyvinyl chloride plastic used in many medical products. Medical tubing, exam gloves, urine leg bags, blood collection bags, and many other items use PVC. It is a transparent material that allows observation to view the color of urine. It is pliable and soft to support insertion through the urethra. It is also a firm material that is stiff enough to push to its ultimate destination.

Advantages

• Polished or cold-punched eyelets or drainage holes facilitate less resistance during insertion
• Clear material allows observation
• Latex-free
• Color-coded funnels identify product size
• Funnels facilitate gripping and draining

Disadvantages

• Often made with DEHP or DiNP, known carcinogens that gas-off from plastic
• Damages the environment
• DEHP and DiNP adversely affects the liver, kidneys, lungs, heart, and reproductive tract

Top-Selling PVC Brands

• Cure Medical (DEHP-free)
• Rusch Tiemann
• Hollister Apogee
• Lofric
• Mentor Self-Cath
• Bard Clean-Cath

Silicone

Silicone is an inert synthetic polymer that is highly flexible and resistant to external influences. It offers both thermal and chemical stability. Silicone provides biocompatibility, it does not react to substances in your body. This material is also bio-durable and will not break-down in contact with other common chemicals found in the body.

Advantages

• Rigid flexibility for easy insertion
• Resists reactions to body fluids
• Biocompatible
• Less harmful to cells
• Less likely to form deposits
• Resistant to bacterial colonization
• Less chance of infection
• Resistant to chemical reaction
• Latex-free
• Use for up to 90 days

Disadvantages

• A weak polymer that is prone to fractures
• Some instances of catheter tips breaking off in the bladder
• May be toxic for some users
• More expensive

Top Selling Silicone Brands

• Kendall
• Rusch
• Magic3

Latex

This tubing is the most flexible and soft drainage instrument. It is a less expensive option. It is available with many different types of coatings to help reduce friction and adverse reactions. The most popular outer layers include silicone, silicone elastomer, and hydrogel.

Advantages

• Highly flexible material
• Easy to insert
• Less expensive
• Used for up to 28-days

Disadvantages

• Subject to form mineral deposits or encrustation on the outer surface
• Encrusted outer surface causes considerable friction and may rupture tissue upon removal
• Numerous people have latex allergies
• Higher risk of infections
• Higher risk of hypersensitivity reactions
• Prone to irritating the urinary tract

Top Selling Latex Catheters

• Bard
• Rusch
• Medline

Latex Allergies

Latex is a secretion from the hevea brasiliensis tree and many other plants as a protective fluid against insects. This secretion converts to natural rubber through a vulcanization process. There is also synthetic latex made of a polymer in a water-based liquid. Latex products are widely used both in homes and in hospitals. Latex allergy is an increasingly worrying problem for health professionals, not least allergy to latex urinary catheters. Medical studies demonstrate that many individuals may experience adverse reactions to the use of latex products.

Anyone with a history of frequent exposure to latex is at risk. Latex could be considered a habitual allergen. The use of latex urinary catheters should be avoided in patients who are catheterized on a daily basis.⁴

Natural rubber latex (NRL) is a ubiquitous allergen as it is a component of > 40,000 products in everyday life. Latex allergy might be attributed to skin contact or inhalation of latex particles. Latex allergy is an IgE-mediated hypersensitivity to NRL, presenting a wide range of clinical symptoms such as angioedema, swelling, cough, asthma, and anaphylactic reactions....

An immediate allergic reaction may occur within minutes of coming into contact with latex. Symptoms of a reaction include hives, wheezing, coughing, shortness of breath, sneezing, nasal congestion, runny nose, conjunctivitis, nasal, palatal, or ocular itching, urticaria, naso-rhinitis, asthma, and hypotension.

Hives can appear anywhere on the body and not necessarily at the point where direct contact with the latex occurred. Immediate reactions can be life-threatening when blood pressure drops, airways blocked, and the throat closes. This condition can eventually progress to anaphylaxis.

Avoidance of the provoking agent (latex allergen) is the most effective way to manage any allergy. Latex-free synthetic rubber such as neoprene, nitrile, styrene-butadiene rubber (SBR), butyl, and vitron are polymers that are available as alternatives to natural rubber. There are no naturally occurring proteins in them and they are not responsible for latex allergy.⁵

Catheter-associated urinary tract infections (CAUTIs) are the most common kind of nosocomial infection. Recent years have seen a significant increase in the numbers of infections caused by yeasts of the genus Candida. The adherence of a microorganism to the host surface is a decisive factor in the success of colonization and the pathogenesis of infection.

The results demonstrated that the latex catheter facilitated adherence more than the silicon catheter. The adherence of the C. albicans was significantly greater than C. parapsilosis on latex, but it was similar on silicon.⁶

A nursing study observed that latex allergies are an increasingly worrying problem for health professionals, not [the] least urinary catheters. The pathophysiology of latex allergies, the toxicity leading to urethritis, stricture formation, and crustation emergence requires screening patients for latex catheter risk factors.⁷

The Foley catheter, introduced in the mid-1930s and originally manufactured from latex, is still the most commonly used device for the management of urinary incontinence (UI). Despite the passage of time, there are still problems associated with the use of these devices. It is currently estimated that the management and treatment of UI cost the UK National Health Service (NHS) in the order of £500 million per annum. Faced with the known demographic changes in the adult population these costs will continue to rise for the foreseeable future.⁸

Di-Ethylhexyl Phthalate (DEHP)

DEHP is a plasticizer used in the manufacturing of plastic. It softens plastics like Polyvinyl Chloride (PVC) to make medical devices more flexible. Studies with animals demonstrated damage to the liver, kidneys, and reproductive organs. DEPH is a carcinogen, according to the Centers for Disease Control.

Polyvinyl chloride (PVC) plasticizers are widely present in the environment. These compounds are mainly used to soften PVC and to improve the flexibility of a broad range of objects including food packaging, toys, flooring, shower curtains, and cables. In particular, they enter into the composition of medical devices (MD) made with PVC such as tubing and medical gloves

Until 2010, the most commonly used plasticizer in MDs was di-(2-ethylhexyl) phthalate (DEHP), which can account for 30 to 40% of the weight of plastics for medical use. As they have no chemical bond with plastic materials, phthalates are easily released into the environment and DEHP can be released from MDs

Diisononyl Phthalate (DiNP)

DiNP is a phthalate in plastic catalyst to make items flexible. It is one of the most widely used plasticizers in manufacturing. Several animal studies have demonstrated that DiNP exposure increased the incidence of liver, spleen, and kidney tumors. DiNP induces antiandrogenic effects in animals and, therefore, can contribute to the cumulative risk from exposure to other antiandrogenic phthalates.¹³

In 2008, the US passed a new law, the Consumer Products Safety Improvement Act, which banned the use of six phthalates in children’s toys: DiNP, DEHP, DBP, BzBP, DiDP, and DnOP.^14,15

Bisphenol A (BPA)

Bisphenol A (BPA) is used to manufacture polycarbonate plastics. Testing for BPA shows widespread exposure to the U.S. population. There is extensive evidence that bisphenol A (BPA) is related to a wide range of adverse health effects based on both human and experimental animal studies.¹⁶

BPA is an additive for the elimination of surfeit of hydrochloric acid during the polyvinyl chloride (PVC) production.... BPA is metabolized in the liver to form bisphenol A glucuronide and mostly in this form is excreted with urine. Due to its phenolic structure BPA has been shown to interact with estrogen receptors and to act as agonist or antagonist via estrogen receptor (ER) dependent signalling pathways. Therefore, BPA has been shown to play a role in the pathogenesis of several endocrine disorders including female and male infertility, precocious puberty, hormone dependent tumours such as breast and prostate cancer and several metabolic disorders including polycystic ovary syndrome (PCOS). Because of the constant, daily exposure and its tendency [towards] bio-accumulation this substance is harmful to catheter patients.^{17, 18,},¹⁹

There is an inhibitory effect of BPA on nuclear estrogen (E2) production in granulosa cells of developing follicles that disrupt normal development to the antral follicles via suppression of E2 in granulosa cells of developing follicles during the menstrual cycle followed by a reduction in the number of oocytes retrieved in in-vitro fertilization (IVF) patients. Several studies corroborate an inverse association between serum and/or urinary BPA concentration and the IVF outcome.²⁰

Coatings

Urinary catheters are commonly used in chronic care facilities and senior facilities throughout the world. Many of the problems associated with catheters include infection, encrustation, tissue trauma, and inflammation. These issues can be correlated to the catheter surface. Many of the shortcomings with catheter surfaces can be alleviated by simply adding a friction-reducing coating. Several coatings are now in use, including hydrogel, Teflon,® and silicone. Hydrophilic coatings appear to be the best option. Hydrogel provides a smooth, soft surface with lubricating properties.²¹

Hydrophilic

A hydrophilic surface coating is a polymer layer that readily absorbs liquid. When immersed in water, it swells to a smooth, slick film. The film provides for easier insertion into the body. A hydrogel-coated latex urinary catheter has a smooth surface with fissures, ripples, and furrows filled with a slick cover. The topography of the hydrophilic coated latex surface compares with a 100% silicone catheter.²²

Silicone

A silicone coating provides a smooth surface. A silicone outer layer on a latex catheter provides a smooth covering to help reduce patient discomfort and irritation during insertion.

Silicone-Elastomer

A silicone-elastomer coating is a hydrophobic material that repels moisture. This layer helps to protect the urethral from irritation. It offers a glassy surface for a less painful insertion.

Polytetrafluoroethylene

Polytetrafluoroethylene (PTFE) or Teflon is a fluorocarbon-based polymer that lines the catheter to reduce friction by providing a smooth surface. PTFE coatings increase torque control, flexion, and stiffness to provides easier insertion.

Antimicrobial Agents

Silver is an antibacterial agent. Adding silver or another antimicrobial such as chlorhexidine, Triclosan, enzymes, nitric oxide, or liposomes to the coating reduces the risk of infection and inflammation. Antimicrobial coatings help protect from urinary tract infections (UTI) that often plaque long-term catheterization patients.

More than 75% of hospital-acquired or nosocomial urinary tract infections began by urinary catheters. These devices treated 15 to 25% of hospitalized patients. Among other purposes, urinary catheters are primarily used for draining urine after surgeries and for urinary incontinence. During catheter-associated urinary tract infections, bacteria travel up to the bladder and cause infection.²³