Observe the following warnings and cautions when using disinfectants and gels. More specific warnings and cautions are included within the various procedures and on the labels of the cleaning or disinfection solutions.
General Warnings
- Disinfectants listed in Disinfectants Search Results are recommended because of their chemical compatibility with product materials, not their biological effectiveness. For the biological effectiveness of a disinfectant, see the guidelines and recommendations of the disinfectant manufacturer, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
- The level of disinfection required for a device is dictated by the type of tissue it will contact during use. Ensure the disinfectant type is appropriate for the type of transducer and the transducer application. For information on the levels of disinfection requirements, see Choosing a Disinfectant. Also, see the disinfectant label instructions and the recommendations of the Association for Professionals in Infection Control, the U.S. Food and Drug Administration, and the U.S. Centers for Disease Control.
- Some transducers cannot be sterilized. For intraoperative procedures, high-level disinfections and the use of a sterile transducer cover and gel (as described in the instructions provided with the transducer cover) is an accepted method of infection control. See the FDA Guidance document "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers," updated September 9, 2008, at the following Web site: www.fda.gov/downloads/.
- The use of protective transducer covers and coupling gel is recommended for clinical applications of all endocavity transducers (including transesophageal). Use a sterile protective transducer cover with sterile ultrasound transmission gel during intraoperative and biopsy examinations.
- Do not apply the transducer cover and gel until you are ready to perform the procedure. Transducers should not be left soaking in gel.
- In neurosurgical applications, sterilized transducers should be used with sterile gel and a sterile pyrogen-free transducer cover.
- Transducer covers can contain natural rubber latex, which may cause allergic reactions in some individuals. See Latex Product Alert.
For information on ordering transducer covers, contact CIVCO (See Transducer Supplies and Accessories).
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Latex Product Alert
Philips Ultrasound Systems and transducers do not contain natural rubber latex on any patient- or operator-contact surfaces. Natural rubber latex is not used on any ultrasound transducer, including transthoracic, intraoperative, and transesophageal echocardiographic (TEE) transducers. It also is not used on Philips ECG cables.
The following section provides information from the FDA regarding allergic reactions to latex-containing medical devices:
FDA Medical Alert, 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, call the FDA Problem Reporting Program, operated through the U.S. Pharmacopeia toll-free number: 800-638-6725. (In Maryland, call collect 301-881-0256.)
For a single copy of a reference list on latex sensitivity, write to: LATEX, FDA, HFZ-220, Rockville, MD 20857.
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Transmissible Spongiform Encephalopathy
WARNING: If a sterile transducer cover becomes compromised during an intraoperative application involving a patient with transmissible spongiform encephalopathy, such as Creutzfeldt-Jakob disease, follow the guidelines of the U.S. Center for Disease Control and this document from the World Heath Organization: WHO/CDS/CSR/APH/2000.3, WHO Infection Control Guidelines for Transmissible Spongiform Encephalopathies. The transducers for your system cannot be decontaminated using a heat process.
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Acoustic Coupling Medium
For proper transmission of the acoustic beam, use the ultrasound transmission gel supplied by or recommended by Philips, or another glycol-, glycerol-, or water-based acoustic coupling medium.
Caution: Do not use mineral oil, oil-based couplants, gels with lotions or emollients of any kind, or other unapproved materials because they might damage the transducer.
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