Redefining 'Latex-Free'

New Guidance From the FDA

Laurie Scudder, DNP, NP; Geetha C. Jayan, MVSc, PhD, PMP; Michael T. Bailey, PhD


January 23, 2014

Editorial Collaboration

Medscape &

Editor's Note:Since first coming to the attention of the medical community almost 100 years ago,[1] natural rubber latex allergy is now recognized to be a common and serious concern, with the highest prevalence found in those with the most frequent exposure, including healthcare professionals.[2] In response, many manufacturers have begun to identify medical products using statements such as "latex-free" or "does not contain latex" to indicate that they were not made with natural rubber latex. Such labeling statements are scientifically inaccurate and overlook the possibility that the products could have been contaminated with natural rubber latex allergens while they were manufactured or packaged. Medscape spoke with Geetha C. Jayan, MVSc, PhD, PMP, and Michael T. Bailey, PhD, scientists with the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA) about the issue of natural rubber latex in medical products and a recently released draft guidance document [FDA issued Final Guidance Recommendations for Labeling Medical Products to Inform Users that the Product or Product Container is not Made with Natural Rubber Latex on December 2, 2014] that recommends new language.

Medscape: Can you speak to the background of latex allergy? What are the most serious potential consequences of exposure to latex in allergic individuals?

Dr. Jayan: To clarify, when we use the term "latex" in this document, we are referring to natural rubber latex. The use of products made with natural rubber latex has been documented as early as 1600 BC.[1] Its widespread use in the medical field was initially documented in 1861 for the production of dentures.[3] Subsequently, natural rubber latex was used for making other medical devices such as catheters and gloves.

Although there are sporadic reports on allergic reactions to natural rubber latex since the early 1900s, it was not until the 1970s and 1980s that reports and concerns related to natural rubber latex allergy became widespread. The exact underlying cause for the increase in reports around this time is unknown, but published reports suggest it could be due to the increased use of natural rubber latex personal protective equipment by healthcare workers.

It is challenging to pinpoint the underlying cause of natural rubber latex allergies. It is a natural plant product that contains hundreds of proteins, 11 of which have been determined to be antigenic.[3] However, we cannot say for sure that none of the others will ever cause an allergic reaction. It is also possible that some of the chemicals that are added to natural rubber latex during the manufacturing process may cause allergic reactions. In sensitive persons, mild allergic reaction to natural rubber latex products is manifested as the development of skin redness, rash, hives, or itching (ie, irritant dermatitis). More severe reactions may involve runny nose, itchy eyes, sneezing, scratchy throat, coughing, and wheezing. Rare incidences of shock and death have also been reported.

Medscape: Are there particular populations at the highest risk?

Dr. Bailey: At this point in time, I don't know that there is any good information about populations that have specific higher risk. The literature suggests that groups that have a higher risk are those that have been exposed to natural rubber latex more frequently, such as healthcare workers. Another group that is mentioned in the literature is spina bifida patients who typically undergo a number of surgeries during infancy, so therefore they might have been exposed to natural rubber latex more frequently. While increased exposure appears to be associated with greater risk, we don't yet have a clear picture about all natural rubber latex proteins or other potential allergens that lead to a reaction, nor do we yet know the significance of the route of exposure.

Medscape: Are there particular devices that present higher concern?

Dr. Bailey I do not know of any specific devices that pose a greater risk.

Medscape: Can you review the evidence that led to this recent call for new language?

Dr. Bailey: At the FDA, we have become concerned that products labeled "latex-free," "does not contain natural rubber latex," or "does not contain latex" do not convey scientifically accurate information for the consumer. "Free," from a scientific standpoint, would mean devoid of even traces of that material type or components in that product. At this time, there aren't any assays available that are able to support "free" status. Another concern is that we don't have information on what is a safe level of exposure that does not cause an allergic reaction.

In this draft guidance we are providing recommendations for accurate labeling of medical products. First, it is inaccurate to just state "latex" in product labeling -- the type of latex (ie, natural rubber latex) should be specified. Additionally, if the intent is to convey to the consumer that the product was not made with natural rubber latex, appropriate language that conveys this information should be used. Use of inaccurate language such as "latex free" can cause professionals or consumers to have a false sense of security. For example, a balloon catheter may not contain natural rubber latex components, but the manufacturer may have used equipment that had prior contact with natural rubber latex-containing products. Another example could be that manufacturers, suppliers, or packers could have been wearing natural rubber latex gloves.

Medscape: What is the bottom line for healthcare professionals? What can at-risk individuals do to protect themselves and their patients?

Dr. Bailey: Good history-taking to ensure that patients do not have a known or suspected natural rubber latex allergy is important. At the same time, the patients can be proactive. If they know or suspect an allergy to natural rubber latex, they can discuss these concerns with physicians or other clinicians in advance. That will allow the use of alternative devices not made with natural rubber latex if available. It really requires a conversation between the physician and the patient.

Dr. Jayan: Our expectation is to provide scientifically accurate information that can empower patients and consumers to make proactive, informed decisions. This is especially important for people with natural rubber latex allergy issues. Always err on the side of caution, especially if you are prone to allergic reactions. Even if the product label says that it is not made with natural rubber latex, patients who suspect that they are experiencing an allergic response should talk to their healthcare provider.

Dr. Bailey: By selecting products labeled as "not made with natural rubber latex," the hope is that the potential burden of exposure would be low to nonexistent. Currently, there is no requirement to have a "not made with natural rubber latex" statement or other information regarding the lack of use of natural rubber latex in medical product labeling. It should also be noted that medical devices made with natural rubber latex must have a statement in the labeling warning users of the presence of natural rubber latex.