No Reliable Test for 'Latex-Free' Claims: FDA

The agency has issued a draft guidance document urging manufacturers that want to indicate natural rubber latex was not used as a material instead use the statement on the product label, "not made with natural rubber latex."

"Latex-free" and "does not contain latex" claims on product labels may give people who are allergic to natural rubber latex a false sense of security, the Food and Drug Administration reported March 8, as it issued a draft guidance document recommending different claims by manufacturers of FDA-regulated medical products.

"The problem with that language is that FDA is aware of no tests that can show a medical product is completely without the natural rubber latex proteins that can cause allergic reactions. Without a way to verify that a product is free of these proteins, claims that a product is 'latex free' may be misleading. FDA wants to promote scientifically accurate labeling," the agency’s news release stated.

The guidance document says manufacturers should instead use "the more scientifically accurate labeling statement 'not made with natural rubber latex.' " Natural rubber latex can be used in medical products such as adhesive bandages, condoms, medical gloves, catheters, sanitary napkins, crutches, and blood-pressure monitoring cuffs, according to the agency. Sensitivity is likely to build up over time, and people who frequently wear latex gloves are generally at highest risk. According to OSHA, 8-12 percent of health care workers are latex-sensitive.

"It is not possible to predict in advance just how much exposure to natural rubber latex might be needed to sensitize any specific person," said Dr. Sheila A. Murphey, a medical officer in FDA's Center for Devices and Radiologic Health.M

OSHA and CDC recommend these steps to prevent allergic reactions:

  • Avoid using gloves with natural rubber latex for activities that are unlikely to involve contact with infectious materials.
  • If you need such gloves, use powder-free gloves labeled with reduced protein content. When wearing them, do not use oil-based lotions. Natural rubber latex proteins can become attached to powder used to lubricate gloves, and when the gloves are removed, the particles become airborne and can be inhaled, which is another form of exposure. Oil-based lotions can cause deterioration of the gloves.
  • After use, wash your hands with a mild soap and dry thoroughly.
  • Learn to recognize the symptoms of a natural rubber latex allergy and take training offered by your employer.

Download Center

HTML - No Current Item Deck
  • Safety Management Software - Free Demo

    IndustrySafe Safety Software’s comprehensive suite of modules help organizations to record and manage incidents, inspections, hazards, behavior based safety observations, and much more. Improve safety with an easy to use tool for tracking, notifying and reporting on key safety data.

  • Create Flexible Safety Dashboards

    IndustrySafe’s Dashboard Module allows organizations allows you to easily create and view safety KPIs to help you make informed business decisions. Our best of breed default indicators can also save you valuable time and effort in monitoring safety metrics.

  • Schedule and Record Observations

    IndustrySafe's Observations module allows managers, supervisors, and employees to conduct observations on employees involved in safety critical behavior. IndustrySafe’s pre-built BBS checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Why Is Near Miss Reporting Important?

    A near miss is an accident that's waiting to happen. Learn how to investigate these close calls and prevent more serious incidents from occurring in the future.

  • Get the Ultimate Guide to Safety Training

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common FAQs.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - June 2019

    June 2019

    Featuring:

    • ASSP SAFETY 2019 PREVIEW
      New Orleans Networking
    • NATION SAFETY MONTH
      Heed These Summer Safety Tips
    • TRAINING
      Education, Skill Development, and Behavior Change
    • SAFETY MANAGEMENT
      What Good Looks Like
    View This Issue

Bulwark Quiz