Reduction of latex-allergen content in Swedish medical catheter balloons--a survey of 3 years' production.
Anaphylactic reactions after intravascular exposure to natural rubber latex (NRL) have been reported. Thus, there is an urgent need to produce medical devices with the lowest possible latex-allergen content. The latex-allergen concentration in extracts prepared from 92 lots of medical catheter (MC) balloons, manufactured by Nolato Polymer AB, Torekov, Sweden, from April 1993 to March 1996, was measured with an EAI (IgE antibody inhibition) assay. Inhibitory capacity was expressed in arbitrary units/ml (U/ml) in relation to reference NRL sap, given an arbitrary value of 1000 U. Extracts from randomly selected lots were measured for protein by the modified Lowry method. Water leaching, chlorination, and treatment with savinase were used experimentally to study reduction of the latex-allergen content. The latex-allergen content in extract from the regular MC balloons varied from 0.1 to 2.9 U/ml. All the methods used to reduce the allergen content were effective, and increased leaching stabilized the allergen content at a low level. The protein concentration of the extracts varied between 9 and 100 mg/l. No correlation was found between protein and allergen content. As a result of this study, the manufacturer has extended the stage of water leaching in the production process. This study shows that cooperation between immunologists and manufacturers may result in product development and improvement.
Lundberg
M
M
Department of Clinical Immunology, Karolinska Hospital, Stockholm, Sweden.
Wrangsjö
K
K
Eriksson-Widblom
K
K
Johansson
S G
SG
D000328:Adult; D000485:Allergens / Q000032:analysis*; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D004342:Drug Hypersensitivity / Q000209:etiology / Q000276:immunology; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology; D007073:Immunoglobulin E / Q000097:blood; D007840:Latex / Q000009:adverse effects / Q000032:analysis* / Q000276:immunology*; D008420:Manufactured Materials / Q000009:adverse effects / Q000032:analysis; D011506:Proteins / Q000032:analysis; D013548:Sweden
D000485:Allergens; D007840:Latex; D011506:Proteins; D007073:Immunoglobulin E