Allergic Reactions To Latex in Medical Devices

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Contact: MDB Enquiries

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No. 99 JULY 17, 1991

To: Hospital Administrators Nursing Home Administrators

Attention: All Staff

Subject: Allergic Reactions To Latex in Medical Devices

There has recently been an increase in the number of reported allergic reactions to medical devices containing latex (natural rubber) (1). Reactions to latex range from mild itching of the skin to systemic anaphylaxis. one brand of barium enema tip with an inflatable latex cuff was recalled in North America in October 1990 after several patients experienced severe allergic reactions, resulting in the death of some patients during barium enema procedures (2-4).

Latex is a component of many medical devices including surgical and examination gloves, catheters, condoms, dental dams, intubation tubes, anaesthesia masks, enema tips, drug administration devices and haemodialysis equipment. The primary source of allergic reaction appears to be proteins in the latex itself.

Health care professionals and patients as well as persons involved in the manufacture of these devices are all at risk (2). Published reports indicate that 6% to 7% of surgical personnel and 18% to 40% of spinal bifida patients are sensitive to latex (5).

Patients at higher risk include those who are frequently exposed to latex products. They include haemodialysis patients or children with spina bifida who may undergo numerous treatments or surgical procedures and may require frequent urinary catheterization and intravenous infusion, as well as those who are sensitized to common airborne allergens or those with an impairment of the skin barrier such as eczema. Surgical, examination or dental procedures may permit the allergen(s) to cross rectal, vaginal or buccal mucosa.

The Branch advises that health care professionals identify latex sensitive patients and be prepared to treat allergic reactions by following the recommendations listed below to reduce the potential for, or consequences of, an adverse reaction to latex:

• Acquire information about latex sensitivity when taking a patient history (potential symptoms include itching, rash, breathing difficulties, etc. when wearing rubber gloves to perform household chores or when inflating a balloon).
• Use alternative materials such as plastic where possible whenever latex sensitivity is suspected or has been confirmed.
• Alert hospital personnel to the potential for latex reactions and establish procedures to follow for the various types of potential reactions.
• Encourage latex sensitive patients to advise all health care professionals of their latex sensitivity.

The Branch would appreciate receiving user experience reports concerning allergic reaction to latex. Correspondence should be addressed to the Director, Bureau of Radiation and Medical Devices, 775 Brookfield Road, Ottawa, Ontario, KIA lCl. Reporters may also use the Bureau's Medical Devices HotnLine at 1-800-267-9675.

A.J. Liston, Ph.D.
Assistant Deputy Minister

References

• Leynadier F, Pecquet C, Dry J. Anaphylaxis to latex during surgery. Anaethesia 1989;44;547-550.
• Gelfand DW. Barium enemas, latex balloons, and anaphylactic reactions. AJR January 1991;156;1-2.
• Emergency Care Research Institute. Allergic reactions associated with barium enemas. Technology for Materials Management 1991;11;8.
• Center for Devices and Radiological Health, U.S. Food and Drug Administration. Center seeks information on reactions associated with barium enema procedures. Medical Devices Bulletin July 1990;VIII,7;1-2.
• U.S. Food and Drug Administration. Allergic reactions to latexcontaining medical devices. Medical Alert MDA91-1, March 29, 1991.

^© Minister of Supply and Services, 1991