FDA should end `reckless disregard,’ ban latex gloves

January 12th, 2015

A consumer advocacy group is targeting one of the longstanding tools of infection prevention, saying latex gloves should be banned due to the risk of life-threatening allergic reactions in health care workers and patients.

In an April 25^th petition to the Food and Drug Administration, Washington, DC-based Public Citizen argues that there are now safer alternatives to surgical and patient examination gloves that have cornstarch powder on them or are made of natural rubber latex. Alternative, such as powder-free, non-latex gloves, are readily available, the petition notes.

Allergic reactions can occur when health care workers wear latex gloves or when they inhale cornstarch powder bound to latex proteins that has been released from latex gloves worn by others. Breathing in cornstarch powder bound to latex proteins can cause acute asthma attacks and anaphylactic shock in health care workers sensitized to latex. Patients can experience the same types of allergic reactions that occur in health care workers. Also, when cornstarch is deposited in tissues during surgery, it can promote infections, delay healing and cause inflammation, among other injuries, Public Citizen stressed.

This is the second time the group -- famously founded by consumer advocate Ralph Nader in 1971 -- has petitioned the FDA agency to ban the use of cornstarch powder in latex gloves. A previous attempt in 1998 was not successful, thought the FDA did agree to reclassify surgical and patient examination gloves as class II devices requiring special controls, such as warning labels. Not mollified, the group now not only seeks much bolder action, but has thrown all latex gloves into the mix.

“The FDA’s prolonged failure to take action eliminating the dangers posed by powdered surgical and patient examination gloves demonstrates a reckless and inexcusable disregard for the health and safety of patients and health care workers,” said Michael Carome, MD, deputy director of Public Citizen’s Health Research Group. “The dangers posed by powdered surgical and patient examination gloves and all latex gloves have been widely recognized throughout the medical profession and the world for many years and are indisputable. Safer, equally effective substitutes are available.”