WHAT DOES LATEX FREE MEAN

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

Disclosures

January 23, 2014


Editorial Collaboration

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Editor"s Note:Since initially coming to the attention of the clinical community virtually 100 years earlier,<1> herbal rubber latex allergy is currently known to be a widespread and also severe concern, with the highest prevalence uncovered in those with the the majority of regular expocertain, consisting of healthtreatment professionals.

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<2> In response, many type of manufacturers have actually started to identify medical assets utilizing statements such as "latex-free" or "does not contain latex" to indicate that they were not made through natural rubber latex. Such labeling statements are scientifically inexact and also overlook the possibility that the commodities can have been contaminated with herbal rubber latex allergens while they were made or packaged. sibbap.org spoke via Geetha C. Jayan, MVSc, PhD, PMP, and Michael T. Bailey, PhD, researchers via the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA) around the worry of organic rubber latex in medical products and a freshly released draft guidance record that recommends brand-new language.

sibbap.org: Can you sheight to the background of latex allergy? What are the a lot of serious potential after-effects of expocertain to latex in allergic individuals?

Dr. Jayan: To clarify, once we use the term "latex" in this record, we are referring to natural rubber latex. The usage of commodities made via natural rubber latex has actually been recorded as early on as 1600 BC.<1> Its widespreview use in the medical field was initially documented in 1861 for the production of dentures.<3> Subsequently, organic rubber latex was offered for making other medical tools such as catheters and gloves.

Although there are sporadic reports on allergic reactions to natural rubber latex given that the early on 1900s, it was not till the 1970s and 1980s that reports and also concerns related to organic rubber latex allergy came to be widespreview. The exact underlying cause for the boost in reports about this time is unknown, but publimelted reports suggest it could be as a result of the boosted usage of organic rubber latex personal protective equipment by healthtreatment employees.

It is challenging to pinallude the underlying cause of organic rubber latex allergies. It is a natural plant product that contains hundreds of proteins, 11 of which have actually been determined to be antigenic.<3> However, we cannot say for certain that namong the others will certainly ever cause an allergic reaction. It is also feasible that some of the chemicals that are included to herbal rubber latex during the manufacturing procedure may cause allergic reactions. In sensitive persons, mild allergic reaction to natural rubber latex products is shown up as the advancement of skin redness, rash, hives, or itching (ie, irritant dermatitis). More serious reactions might involve runny nose, itchy eyes, sneezing, scratchy throat, coughing, and also wheezing. Rare incidences of shock and death have additionally been reported.

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sibbap.org: Are tbelow particular populaces at the highest risk?

Dr. Bailey: At this allude in time, I don"t recognize that there is any kind of great indevelopment about populaces that have actually particular greater danger. The literature suggests that groups that have a higher risk are those that have been exposed to natural rubber latex even more frequently, such as healthcare employees. Anvarious other group that is mentioned in the literary works is spina bifida patients who frequently undergo a variety of surgeries during inelaborate, so therefore they can have been exposed to herbal rubber latex even more commonly. While boosted exposure shows up to be connected through better threat, we don"t yet have a clear image around all natural rubber latex proteins or other potential allergens that lead to a reaction, nor carry out we yet know the significance of the route of expocertain.

sibbap.org: Are tbelow certain devices that current greater concern?

Dr. Bailey I carry out not understand of any type of particular tools that pose a higher risk.

sibbap.org: Can you evaluation the proof that led to this recent call for brand-new language?

Dr. Bailey: At the FDA, we have become pertained to that commodities labeled "latex-free," "does not contain organic rubber latex," or "does not contain latex" execute not convey scientifically precise information for the consumer. "Free," from a scientific standsuggest, would mean devoid of even traces of that material type or components in that product. Right now, there aren"t any assays available that are able to assistance "free" condition. Anvarious other worry is that we don"t have indevelopment on what is a safe level of exposure that does not cause an allergic reaction.

In this draft guidance we are providing references for precise labeling of medical products. First, it is inspecific to simply state "latex" in product labeling -- the form of latex (ie, organic rubber latex) should be specified. Additionally, if the intent is to convey to the customer that the product was not made via organic rubber latex, appropriate language that conveys this indevelopment must be supplied. Use of inexact language such as "latex free" deserve to reason specialists or consumers to have actually a false sense of protection. For example, a balloon catheter might not contain natural rubber latex components, yet the manufacturer might have provided devices that had prior call with herbal rubber latex-containing assets. Another instance could be that manufacturers, service providers, or packers can have been wearing natural rubber latex gloves.

sibbap.org: What is the bottom line for healthtreatment professionals? What have the right to at-threat individuals perform to defend themselves and their patients?

Dr. Bailey: Good history-taking to encertain that patients perform not have actually a recognized or suspected organic rubber latex allergy is crucial. At the very same time, the patients have the right to be proenergetic. If they recognize or suspect an allergy to organic rubber latex, they can comment on these pertains to with doctors or other clinicians in development. That will allow the usage of alternative tools not made via herbal rubber latex if accessible. It really requires a conversation in between the doctor and the patient.

Dr. Jayan: Our expectation is to administer scientifically specific indevelopment that have the right to empower patients and also consumers to make proactive, increated decisions. This is particularly necessary for world through organic rubber latex allergy worries. Almeans err on the side of caution, especially if you are susceptible to allergic reactions. Even if the product label says that it is not made through herbal rubber latex, patients that suspect that they are experiencing an allergic response must talk to their healthtreatment provider.

Dr. Bailey: By choosing commodities labeled as "not made via herbal rubber latex," the hope is that the potential burden of expocertain would certainly be low to nonexistent. Currently, tbelow is no necessity to have actually a "not made via herbal rubber latex" statement or other information concerning the absence of use of organic rubber latex in clinical product labeling. It need to also be noted that medical devices made via organic rubber latex should have actually a statement in the labeling warning users of the existence of herbal rubber latex.