Latex allergies are common in the healthcare industry. So are latex-free claims on many products in close contact with clinicians’ skin. While we want to protect our providers, avoiding latex products is hard. Even the Food and Drug Administration (FDA) has said there is not a conclusive way to verify a product is completely 100 percent free of the latex proteins that cause allergic reactions.
To avoid the false assurance and guarantee about this potential hazard, the FDA is recommending manufacturers stop using the terms “latex free,” “does not contain latex” or “does not contain natural rubber latex” on labels. These terms and phrases are inaccurate and misleading to the buyer and end users.
Related: Latex Allergies | Causes, Symptoms, & Prevention
Consequently, the final guidance document issued by FDA states the acceptable terminology on labels is not made with natural rubber latex. This indicates FDA-regulated products were not manufactured with natural rubber latex.
Who is at Risk?
Although anyone can develop a latex allergy, it usually occurs in people with repeated exposure to natural rubber latex proteins. Sometimes the allergies and sensitivities build up over time and manifest as skin-site reactions. Healthcare workers are at a higher risk because natural rubber latex is found in many medical devices. This includes latex gloves, vial stoppers and bandages. The Occupational Safety and Health Administration estimates eight to 12 percent of health care workers are sensitive to latex.
This ultimately turns into a critical concern for purchasing departments. Buyers are looking for products that will not cause harm to their co-workers and workforce. However, if someone is allergic to natural rubber latex, the products labeled “latex-free” can still cause allergic reactions, include anaphylaxis. Thus, knowing what to look for on labels and sales sheets is the key to buying the right products for your staff.
What Can You do to Minimize Latex Risks?
Sadly, there is no cure for latex allergy. Avoiding latex is crucial to minimize risks for you and your staff. To help with this critical concern, some manufacturers have moved to using latex alternatives. This is especially important for items that come into close contact with your skin, like nitrile gloves. Some companies now make these products with nitrile and polyvinyl chloride. These materials are made from synthetic latex and do not contain the allergy-provoking latex proteins. These alternatives should live up to latex free claims. They will not cause latex allergies or sensitivities to those individuals at risk.
Therefore, you should look for labels and sales sheets that state “not made from natural rubber latex”, or “non-latex.” Manufacturers make these products with latex alternatives in facilities with dedicated machinery to avoid contamination. When manufacturers make both latex and non-latex products, there is never a guarantee contamination won’t occur during processing or packaging. To go a step further, you might even look for facilities that only manufacture “non-latex” varieties to reduce risk.
How can we help?
At Caresfield we are concerned about your staff’s needs. We are doing the research for you. We’re sourcing non-latex varieties of some of our common items,including tourniquets, gloves (nitrile), patient ID wristbands, cohesive bandages.
Author: Jodi Hutchins, RAC (US-RAPS)
Jodi is an Independent Regulatory and Quality Consultant with expansive regulatory and quality experience with medical devices, OTC drugs, supplements, food, cosmetic products and surface cleaners. Over the last 20 years, she has held various senior and executive level management positions within FDA and EPA governed companies. She is currently the owner of Regulatory Matters Consulting.
None of the products manufactured inside of our Caresfield facility contain natural rubber latex so the risk of cross-contamination and transfer of latex between products is negligible.
Please contact us if you have any comments, questions or suggestions.
