Fda Medical Alert On Latex - Philips EPIQ 7 User Manual

Biological Safety

FDA Medical Alert on Latex

March 29, 1991, Allergic Reactions to Latex-Containing Medical Devices
Because of reports of severe allergic reactions to medical devices containing latex (natural
rubber), the FDA is advising health care professionals to identify their latex sensitive patients
and be prepared to treat allergic reactions promptly. Patient reactions to latex have ranged
from contact urticaria to systemic anaphylaxis. Latex is a component of many medical devices,
including surgical and examination gloves, catheters, intubation tubes, anesthesia masks, and
dental dams.
Reports to the FDA of allergic reactions to latex-containing medical devices have increased
lately. One brand of latex cuffed enema tips was recently recalled after several patients died as
a result of anaphylactoid reactions during barium enema procedures. More reports of latex
sensitivity have also been found in the medical literature. Repeated exposure to latex both in
medical devices and in other consumer products may be part of the reason that the prevalence
of latex sensitivity appears to be increasing. For example, it has been reported that 6% to 7% of
surgical personnel and 18% to 40% of spina bifida patients are latex sensitive.
Proteins in the latex itself appear to be the primary source of the allergic reactions. Although it
is not now known how much protein is likely to cause severe reactions, the FDA is working with
manufacturers of latex-containing medical devices to make protein levels in their products as
low as possible.
FDA's recommendations to health professionals in regard to this problem are as follows:
• When taking general histories of patients, include questions about latex sensitivity. For
surgical and radiology patients, spina bifida patients and health care workers, this
recommendation is especially important. Questions about itching, rash or wheezing after
wearing latex gloves or inflating a toy balloon may be useful. Patients with positive histories
should have their charts flagged.
• If latex sensitivity is suspected, consider using devices made with alternative materials, such
as plastic. For example, a health professional could wear a non-latex glove over the latex
glove if the patient is sensitive. If both the health professional and the patient are sensitive,
a latex middle glove could be used. (Latex gloves labeled "Hypoallergenic" may not always
prevent adverse reactions.)
• Whenever latex-containing medical devices are used, especially when the latex comes in
contact with mucous membranes, be alert to the possibility of an allergic reaction.
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