Safety Biological Safety
36 Lumify Ultrasound System
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
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.
To Next Page
Loading...