Biocompatibility of urinary catheters--present status. 1991

M L Ruutu, and M T Talja, and L C Andersson, and O S Alfthan
Fourth Department of Surgery and Clinical Urology, Helsinki University Central Hospital, Finland.

Biocompatibility aspects of urinary catheters have been recognized by clinicians during the 1980's. After multiple reports of severe urethral damage caused by latex catheters, a series of investigations revealed that toxic substances added to the catheters during the manufacturing process can leak from the devices in situ and cause urethritis developing severe urethral strictures. Consequently, most manufacturers have improved their catheters, but there are still some catheters of inferior quality on the market. Quality is dependent on the biocompatibility testing methods. Cell culture tests are recommended, but there are no common standards regarding these. British Standards Institution has been the first in Europe to adopt toxicity limits for a cell culture test, but those are not acceptable. It is a task for the standardization committees working for the European Community to create adequate biocompatibility testing standards with clinically relevant toxicity limits. If this is not done, the use of latex catheters should be abandoned as potentially harmful devices.

UI MeSH Term Description Entries
D007840 Latex A milky, product excreted from the latex canals of a variety of plant species that contain cauotchouc. Latex is composed of 25-35% caoutchouc, 60-75% water, 2% protein, 2% resin, 1.5% sugar & 1% ash. RUBBER is made by the removal of water from latex.(From Concise Encyclopedia Biochemistry and Molecular Biology, 3rd ed). Hevein proteins are responsible for LATEX HYPERSENSITIVITY. Latexes are used as inert vehicles to carry antibodies or antigens in LATEX FIXATION TESTS. Latices,Latice
D008422 Materials Testing The testing of materials and devices, especially those used for PROSTHESES AND IMPLANTS; SUTURES; TISSUE ADHESIVES; etc., for hardness, strength, durability, safety, efficacy, and biocompatibility. Biocompatibility Testing,Biocompatible Materials Testing,Hemocompatibility Testing,Testing, Biocompatible Materials,Testing, Hemocompatible Materials,Hemocompatibility Testings,Hemocompatible Materials Testing,Materials Testing, Biocompatible,Materials Testing, Hemocompatible,Testing, Biocompatibility,Testing, Hemocompatibility,Testing, Materials,Testings, Biocompatibility
D011092 Polyethylene Glycols Polymers of ETHYLENE OXIDE and water, and their ethers. They vary in consistency from liquid to solid depending on the molecular weight indicated by a number following the name. They are used as SURFACTANTS, dispersing agents, solvents, ointment and suppository bases, vehicles, and tablet excipients. Some specific groups are NONOXYNOLS, OCTOXYNOLS, and POLOXAMERS. Macrogols,Polyoxyethylenes,Carbowax,Macrogol,Polyethylene Glycol,Polyethylene Oxide,Polyethyleneoxide,Polyglycol,Glycol, Polyethylene,Glycols, Polyethylene,Oxide, Polyethylene,Oxides, Polyethylene,Polyethylene Oxides,Polyethyleneoxides,Polyglycols,Polyoxyethylene
D011143 Polyvinyl Chloride A polyvinyl resin used extensively in the manufacture of plastics, including medical devices, tubing, and other packaging. It is also used as a rubber substitute. Chloroethylene Polymer,Polychloroethylene,Vinyl Chloride Polymer,Chloroethylene Homopolymer,Geon,PVC,Ultron,Viaflex,Vinylite,Chloride, Polyvinyl,Homopolymer, Chloroethylene,Polymer, Chloroethylene,Polymer, Vinyl Chloride
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001672 Biocompatible Materials Synthetic or natural materials, other than DRUGS, that are used to replace or repair any body TISSUES or bodily function. Biomaterials,Bioartificial Materials,Hemocompatible Materials,Bioartificial Material,Biocompatible Material,Biomaterial,Hemocompatible Material,Material, Bioartificial,Material, Biocompatible,Material, Hemocompatible
D012828 Silicones A broad family of synthetic organosiloxane polymers containing a repeating silicon-oxygen backbone with organic side groups attached via carbon-silicon bonds. Depending on their structure, they are classified as liquids, gels, and elastomers. (From Merck Index, 12th ed) Silicone
D012834 Silver An element with the atomic symbol Ag, atomic number 47, and atomic weight 107.87. It is a soft metal that is used medically in surgical instruments, dental prostheses, and alloys. Long-continued use of silver salts can lead to a form of poisoning known as ARGYRIA.
D014546 Urinary Catheterization Passage of a CATHETER into the URINARY BLADDER or kidney. Catheterization, Ureteral,Catheterization, Urethral,Catheterization, Urinary,Foley Catheterization,Ureteral Catheterization,Urethral Catheterization,Catheterization, Foley,Catheterizations, Ureteral,Catheterizations, Urethral,Catheterizations, Urinary,Ureteral Catheterizations,Urethral Catheterizations,Urinary Catheterizations

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