Attribute: Contains Latex

The Contains Latex attribute in Data Connect is used to identify products that contain latex. This is crucial for patients with latex allergies, as it helps ensure that latex-containing products are not used for these individuals. This attribute is crucial for healthcare providers to ensure safety and compliance, as latex items require specific handling, usage, and regulatory considerations.

Identifying if a product has latex helps healthcare facilities standardize procedures and make informed decisions about the products they use, improving patient safety and care. If marked, it influences EHR behavior in different internal systems that use this for processing work flows.

The FDA regulates products containing latex and provides guidance on labeling to inform consumers of its presence.

Data Sources

Here are the sources of data for Contains Latex:

Primary Source

FDA's AccessGUDIDGUDID.

Alternate Sources

Manufacturer catalog (when not available in GUDID).

Considerations

Latex information should be available for all direct patient care products, such as:

  • Gloves

  • Breathing circuits

  • Dressings

  • Tapes

  • Other direct patient care items

Not all items have latex information included. Latex details are expected to be added for items with certain United Nations Standard Products and Services Code (UNSPSC) codes where this information is important for the product.

Latex information isn't provided for items that fall into the following categories:

  • Latex information isn't relevant for that specific product.

  • GHX was unable to get valid latex information for an item for which latex information is relevant.

Examples of items that won't have latex information: Lab reagents, stainless steel (SS) implants, or items that by their nature wouldn't contain latex.
Examples of items that should have latex information: Gloves, breathing circuits, dressings and tapes, or items used in patient care that may or may not contain latex.

Manufacturers are required to publish this information to the FDA, but this isn't enforced. GHX provides a pass-through from the FDA when available and also sources this information from the manufacturers directly.

The Contains Latex attribute has three values:

  • Yes: The item is made with natural rubber latex.

  • No: The item is not made with natural rubber latex.

  • Null/blank: Unknown. We don't know if the item is made with natural rubber latex.

FDA comments on common terminology mistakes:

  • First, regarding the term “latex” in the labeling statements: “latex-free” and “does not contain latex” could refer to natural rubber latex or synthetic latex (not derived from natural rubber latex). Labeling statements that do not clearly state the material of concern are not sufficiently specific and therefore should not be included in medical product labeling.

  • Second, users may consider the terms “free” and “does not contain” to mean that the medical product is completely devoid of natural rubber latex. However, there are no analytical methods currently available that can identify all proteins and components in natural rubber latex that may lead to allergic reactions in medical product users. In addition, the use of the term “free” or “does not contain” does not address the potential for accidental contamination of a medical product and/or its container with natural rubber latex during or after manufacturing.

It's recommended to always manually review latex information until you're familiar with the GHX latex methodology. Then you can begin to auto approve them. There can be data inconsistencies submitted to GUDID, GTIN, or descriptions.

See Also

Attributes Overview

Survivorship Rules