The FDA has notified members of the medical
device industry of its intention to change labeling on latex containing products. An
announcement will soon be in the Federal Register stating the requirement that all medical
devices which contain natural rubber latex which comes in contact with the body either
directly or indirectly must state on the principal display panel: "This product contains natural rubber latex."
The announcement will further state "FDA
believes that latex in devices poses a significant health risk to some users, and their health
care providers should be informed of its presence. The new labeling will assist physicians
when there is a need to create a latex-free environment." To most, this appears to be a
positive step. While this regulation surprised
few, what startled many was a second requirement that the term "hypoallergenic" be
removed from products, principally latex surgical and exam gloves. While the term
hypoallergenic is inconsistent and misleading,
it generally refers to a process of post manufacturing glove washing to remove residual
chemicals which may cause contact dermatitis
(Type IV allergy) in some users. "Hypoallergenic" gloves still contain residual water
soluble proteins and may produce an IgE mediated reaction (e.g., contact urticaria) in some
latex-sensitized individuals. While it is appropriate to remove the term "hypoallergenic,"
failure to replace it with a suitable term
denoting the device as safe and effective for
individuals with either irritative or contact
dermatitis due to natural rubber latex will
create confusion.
The situation is further compounded by the fact
that OSHA Universal Precautions final rule
specifications addresses the subject (iii), "Hypo-allergenic gloves, glove liners, powderless
gloves or other similar alternatives shall be
readily accessible to those employees who are
allergic to the gloves normally provided."
Compliance cannot be achieved when the
products cannot be identified.
"Hypoallergenic" claims generally are based
on a manufacturer's glove or device passing
the modified Draize test. In the surgical glove
market, these products represent approximately
50% of glove revenues.
FDA also announced the need for biocompatability testing of all latex examination gloves
against the same criterion currently applied to
surgical gloves and other latex containing
products. This may result in manufacturers
increasing prices in order to recover the cost
of compliance with these regulations.
We suggest an alternative label be designated
to replace "hypoallergenic," such as "low
irritant" on gloves that pass the Draize test.
