May 1, 1991 TO ALL MANUFACTURERS OF LATEX DEVICES: The Food and Drug Administration (FDA) has become aware of an increase in the number of reported adverse reactions and deaths associated with the use of one brand of enema devices with cuffs made of latex. During its investigation of enema devices, the FDA also reviewed the medical literature, data in FDA files, and other sources. Information about reactions to latex devices were found in these various sources. As a result of this review, the FDA is concerned that deficiencies in the manufacturing process for latex devices could be a contributing factor for some of these adverse events. That is, insufficient leaching or insufficient surface treatment by some manufacturers will not remove leachable proteins that are associated with these reactions. The concern by the FDA is not meant to be an implication of the latex device industry. The FDA is, however, aware that the latex industry is always interested in meeting emerging health care needs. Consequently, the following advice has been developed by FDA in an effort to minimize the possibility that latex contaminants are either a source or a contributing factor in the adverse reactions attributed to various type of latex devices. FDA's advice is as follows: 1. LEACHING 2. POST CURE PROCESSING 3. LATEX SPECIFICATIONS If such components are not available, then all constituents in the components or in compounding materials which could present a hazard to health must be removed from the devices or limited to an amount that will not present such a hazard. The content of water soluble proteins in raw latex can be reduced by centrifugation and other techniques. Thus, a finished latex device manufacturer may deem it appropriate to specify the water soluble protein content of the raw latex to be purchased. Then, there should be adequate assurance that each lot of latex received meets the protein content specification. However, unless the raw latex is completely deproteinized, further processing of the resulting devices may be needed to remove or reduce the residual water soluble proteins. 4. MANUFACTURING AND QA PROCESS VALIDATION If you have any questions about these procedures, please contact: |