Latex Product Alert
Philips ultrasound systems and transducers do not contain natural rubber latex that contacts humans. Natural rubber latex is not used on any ultrasound transducer, including transthoracic, intraoperative, and transesophageal echocardiography (TEE) transducers. It also is not used on Philips ECG cables for the products in this manual.
WARNINGS
- Transducer covers can contain natural rubber latex, which may cause allergic reactions in some individuals.
- The M2203A bite guard strap contains natural rubber latex, which may cause allergic reactions.
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.
- If an allergic reaction does occur and latex is suspected, advise the patient of a possible latex sensitivity and consider an immunologic evaluation.
- Advise the patient to tell health professionals and emergency personnel about any known latex sensitivity before undergoing medical procedures. Consider advising patients with severe latex sensitivity to wear a medical identification bracelet.
The FDA is asking health professionals to report incidents of adverse reactions to latex or other materials used in medical devices. (See the October 1990 FDA Drug Bulletin.) To report an incident, contact the FDA Problem Reporting Program, MedWatch, at 1-800-332-1088, or on the Internet: www.fda.gov/Safety/MedWatch/
For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220, Rockville, MD 20857.
