FDA comes down hard on latex
The U.S. Food and Drug Administration (FDA) is amending its regulations regarding the labeling of medical devices containing latex. The adjusted labeling rule comes on the heels of numerous reports of severe allergic reactions to a wide range of latex-containing devices.
Mel Stratmeyer, PhD, chief of the health sciences branch of the FDA says it’s hard to say exactly when the new rule will become effective. "It’s a high priority item," says Stratmeyer, "and it will be out fairly soon. There are a lot of administrative and legal aspects that have yet to be taken care of, and they take time."
The new rule deals with two things: labeling of devices that contain latex and doing away with current inaccurate "hypoallergenic" labels. The amended rule will state that all medical devices containing latex that may directly or indirectly contact living human tissue will have to be labeled with a statement identifying the latex and stating that latex may cause allergic reactions in some individuals. Direct contact includes a device touching skin or mucous or serosal surfaces. Indirect contact includes situations in which latex proteins are suspended in liquid injections or airborne.
Devices that will require the new labeling include:
• surgical and examination gloves;
• blood pressure cuffs;
• intravascular equipment;
• electrode pads;
• hemodialysis equipment;
• wound drains;
• bandages and tape;
• cuffed barium enema tips;
• enteroclysis catheters;
• urinary catheters;
• condoms;
• diaphragms;
• oxygen cannulas;
• orthodontic appliances;
• endotracheal tubes;
• anesthetic gas masks.
The new rule also will require that misleading hypoallergenicity claims be removed from devices containing latex. Some gloves marked "hypoallergenic" have caused sensitivity problems. The Draize test, currently used to support hypoallergenicity claims, addresses only sensitivity to residual processing chemicals. The test doesn’t detect latex levels, so it is inappropriate for determining protein sensitivity.
Since 1988, the FDA has received numerous reports of sensitivity to latex proteins in medical devices. Of the several hundred incidents, 16 have reported death from anaphylactic shock.
In May 1990, nine deaths were associated with barium enema procedures. Nearly 10 million such procedures are performed each year, most without medical complications. In a period of only a few months, 150 patients had anaphylactic reactions to a natural latex cuff on the tip of new enema catheters.
The FDA foresees some problems with the new labeling requirements. Gloves, for example, are packaged in bulk, then divided and used individually. The message conveyed by the label doesn’t reach the ultimate user. The agency may develop a symbol that can be printed on each device.
The FDA is working with manufacturers to bring down the levels of latex protein content. Such gloves and devices would still contain latex, but different processing, including longer leaching time, which can reduce its intensity, allowing some sensitive people to use them safely. Statmeyer says the new process will not weaken the new gloves. "The protein that’s extractable adds no quality to the glove," he says. "A certain amount is necessary, but beyond that, removing some can be safely done. That goes a long way to solving the problem."
"We have no intention of banning latex," Stratmeyer continues. "It plays an extremely useful role. We’re just trying to make as much information as possible available to the consumer. Our function is to control the devices’ labeling."
The FDA first made recommendations about latex to health professionals in its 1991 Medical Alert: Allergic reactions to latex-containing medical devices. The alert pointed out that 6% to 7% of surgical personnel and 18% to 40% of spina bifida patients are latex-sensitive that number has worsened over time. The document advised that health professionals be prepared to identify and quickly treat latex-sensitive patients.
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