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HD11 XE Getting Started
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Safety
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 sys-
temic 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 reac-
tions. 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 sensi-
tivity. For surgical and radiology patients, spina bifida patients and health care
workers, this recommendation is especially important. Questions about itch-
ing, 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.)