User's Manual

21
2 enin
Operator Safety
InnoSight Ultrasound System
P6992-4, EN, 16/12/6
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  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  of surgical personnel and 1 to 4 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 199 FDA Drug Bulletin) To report an incident, contact the FDA
Problem Reporting Program, MedWatch, at 1--332-1, or on the Internet:
wwwfdagov/Safety/MedWatch/
For a single copy of a reference list on latex sensitivity, write to: LATE, FDA, HFZ-22, Rockville, MD 2
Operator Safety
The following issues and situations can affect operator safety when you are using an ultrasound system